Trial Outcomes & Findings for Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa (NCT NCT06274060)
NCT ID: NCT06274060
Last Updated: 2026-06-18
Results Overview
Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
Month 7
Results posted on
2026-06-18
Participant Flow
Recruitment took place at the TB HIV Care drop-in center in uMgungundlovu, KwaZulu-Natal from April to September 2024. The first participant was enrolled on April 16, 2024 and the last participant was enrolled September 6th, 2024.
Participant milestones
| Measure |
Standard of Care
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
19
|
19
|
19
|
19
|
19
|
19
|
19
|
20
|
19
|
19
|
19
|
19
|
19
|
19
|
|
Overall Study
COMPLETED
|
12
|
16
|
16
|
17
|
15
|
19
|
16
|
17
|
17
|
17
|
17
|
18
|
18
|
18
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
3
|
2
|
4
|
0
|
3
|
2
|
2
|
3
|
2
|
1
|
1
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
3
|
2
|
4
|
0
|
3
|
2
|
1
|
2
|
2
|
1
|
1
|
1
|
0
|
3
|
Baseline Characteristics
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
Baseline characteristics by cohort
| Measure |
Standard of Care
n=19 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=18 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=19 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=19 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=19 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=20 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.4 years
STANDARD_DEVIATION 6.1 • n=20 Participants
|
22.3 years
STANDARD_DEVIATION 4.0 • n=20 Participants
|
21.5 years
STANDARD_DEVIATION 2.4 • n=40 Participants
|
22.3 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 4.7 • n=9 Participants
|
22.8 years
STANDARD_DEVIATION 4.9 • n=6 Participants
|
23.5 years
STANDARD_DEVIATION 5.7 • n=6 Participants
|
23.4 years
STANDARD_DEVIATION 5.3 • n=6 Participants
|
24.4 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
22.9 years
STANDARD_DEVIATION 5.6 • n=6 Participants
|
22.5 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
23.5 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
23.5 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
23.5 years
STANDARD_DEVIATION 6.1 • n=73 Participants
|
21.3 years
STANDARD_DEVIATION 3.9 • n=18 Participants
|
22.7 years
STANDARD_DEVIATION 3.3 • n=18 Participants
|
22.8 years
STANDARD_DEVIATION 4.9 • n=14 Participants
|
|
Age, Customized
Age cateogry · 16-17
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=73 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
16 Participants
n=14 Participants
|
|
Age, Customized
Age cateogry · 18-24
|
13 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=6 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=73 Participants
|
14 Participants
n=18 Participants
|
14 Participants
n=18 Participants
|
218 Participants
n=14 Participants
|
|
Age, Customized
Age cateogry · 25-29
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
39 Participants
n=14 Participants
|
|
Age, Customized
Age cateogry · 30-34
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
19 Participants
n=14 Participants
|
|
Age, Customized
Age cateogry · 35-39
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
7 Participants
n=14 Participants
|
|
Age, Customized
Age cateogry · 40+
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=6 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=73 Participants
|
19 Participants
n=18 Participants
|
19 Participants
n=18 Participants
|
304 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=6 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=73 Participants
|
19 Participants
n=18 Participants
|
19 Participants
n=18 Participants
|
304 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
South Africa
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=6 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=73 Participants
|
19 Participants
n=18 Participants
|
19 Participants
n=18 Participants
|
304 Participants
n=14 Participants
|
|
Population
Female sex worker
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=6 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
112 Participants
n=14 Participants
|
|
Population
Adolescent girls and young women
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=6 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=73 Participants
|
12 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
192 Participants
n=14 Participants
|
|
Education
Up to Grade 9
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
10 Participants
n=14 Participants
|
|
Education
Grade 10-11
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=73 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
35 Participants
n=14 Participants
|
|
Education
Grade 12 (Matric)
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=6 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
117 Participants
n=14 Participants
|
|
Education
Post-secondary
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
24 Participants
n=14 Participants
|
|
Education
Currently studying
|
9 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=73 Participants
|
9 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
118 Participants
n=14 Participants
|
|
Living situation
Renting own place
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
78 Participants
n=14 Participants
|
|
Living situation
Family Home
|
14 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=6 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=73 Participants
|
10 Participants
n=18 Participants
|
14 Participants
n=18 Participants
|
201 Participants
n=14 Participants
|
|
Living situation
Partner's place
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
7 Participants
n=14 Participants
|
|
Living situation
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
18 Participants
n=14 Participants
|
|
Ever pregnant
|
9 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=6 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=73 Participants
|
9 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
160 Participants
n=14 Participants
|
|
Homeless in the past 6 months
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=14 Participants
|
|
Prior PrEP use
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=73 Participants
|
8 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
85 Participants
n=14 Participants
|
|
Perceived HIV risk
Not at all
|
2 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
90 Participants
n=14 Participants
|
|
Perceived HIV risk
A little
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=73 Participants
|
5 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
95 Participants
n=14 Participants
|
|
Perceived HIV risk
Somewhat
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=6 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=73 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
92 Participants
n=14 Participants
|
|
Perceived HIV risk
A lot
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
22 Participants
n=14 Participants
|
|
Perceived HIV risk
Prefer not to answer
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=14 Participants
|
|
History of forced sex
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=73 Participants
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
36 Participants
n=14 Participants
|
|
History of physical violence
|
7 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
75 Participants
n=14 Participants
|
|
Alcohol use in the past year
Never
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=6 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=73 Participants
|
9 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
137 Participants
n=14 Participants
|
|
Alcohol use in the past year
Monthly or less
|
9 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=6 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=73 Participants
|
7 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
127 Participants
n=14 Participants
|
|
Alcohol use in the past year
Two or more times per month
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=73 Participants
|
3 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
40 Participants
n=14 Participants
|
|
Depression
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=6 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=73 Participants
|
8 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
105 Participants
n=14 Participants
|
|
Anxiety
|
8 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=73 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
86 Participants
n=14 Participants
|
|
Food insecurity
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=73 Participants
|
4 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
57 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Participants with data collected
Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.
Outcome measures
| Measure |
Standard of Care
n=16 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=14 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=18 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=18 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=18 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=14 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=16 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Persistence at 7 Months After PrEP Initiation
|
6 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Participants with data collected
The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will not be included in this outcome.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=18 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=19 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=19 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=19 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Adherence at 7 Months After PrEP Initiation
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 1Population: Participants with data collected
Participants who had PrEP in their possession 1-month after initiation, or returned for their 1-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.
Outcome measures
| Measure |
Standard of Care
n=17 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=15 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=18 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=18 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=18 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=14 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=18 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=17 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Persistence at 1 Month After PrEP Initiation
|
10 Participants
|
11 Participants
|
14 Participants
|
10 Participants
|
15 Participants
|
9 Participants
|
16 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Month 4Population: Participants with data collected
Participants who had PrEP in their possession 4-months after initiation, or returned for their 4-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.
Outcome measures
| Measure |
Standard of Care
n=17 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=15 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=18 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=18 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=18 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=14 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=19 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=16 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Persistence at 4 Months After PrEP Initiation
|
6 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
12 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Month 13Population: Participants with data collected
Participants who had PrEP in their possession 13-months after initiation, or returned for their 13-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.
Outcome measures
| Measure |
Standard of Care
n=10 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=8 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=9 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=11 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=10 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=13 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=13 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=10 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=9 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=10 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=11 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=9 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=13 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=12 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=12 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=12 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Persistence at 13 Months After PrEP Initiation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 7Population: Those who did not return at 7-months or did not provide a DBS sample were excluded from this analysis.
The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Those who do not return at 7-months or do not provide a DBS sample will be excluded from this analysis.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=16 Participants
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=14 Participants
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=16 Participants
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=13 Participants
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=15 Participants
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=13 Participants
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=16 Participants
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=16 Participants
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=14 Participants
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=17 Participants
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=15 Participants
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=18 Participants
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=17 Participants
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=14 Participants
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PrEP Adherence at 7 Months After PrEP Initiation Among Trial Participants Who Provided Dried Blood Spot Samples
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Vouchers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PrEP Support Buddy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PrEP Support Buddy + Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Vouchers + Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Vouchers + PrEP Support Buddy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + Community-based PrEP Pickup Points
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + PrEP Support Buddy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + Food Vouchers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + Food Vouchers + Community-based PrEP Pickup Points
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Management + Food Vouchers + PrEP Support Buddy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=19 participants at risk
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
|
Case Management
n=18 participants at risk
Participants will receive case management layered on existing standard of care.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
|
Food Vouchers
n=19 participants at risk
Participants will receive food vouchers layered on existing standard of care.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
PrEP Support Buddy
n=19 participants at risk
Participants will receive the PrEP support buddies layered on existing standard of care.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Community-based PrEP Pickup Points
n=19 participants at risk
Participants will receive the community-based PrEP pickup points layered on existing standard of care.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Food Vouchers + PrEP Support Buddy
n=19 participants at risk
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy
n=20 participants at risk
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers
n=19 participants at risk
Participants in this arm will receive both the case management and food voucher interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
|
Food Voucher + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
Case Management + Food Vouchers + PrEP Support Buddy
n=19 participants at risk
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
|
Case Management + Food Vouchers + PrEP Support Buddy + Community-based PrEP Pickup Points
n=19 participants at risk
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Case management: Delivered by a peer with PrEP experience with the goal of improving self-efficacy to take PrEP. This includes weekly face-to-face support in the first month, followed by monthly sessions, and on-demand phone consultations. The intention of this intervention is to help participants develop individualized strategies to overcome barriers to adherence and develop disclosure strategies. Participants may also opt into daily SMS pill-taking reminders.
Food vouchers: Participants will be given food vouchers (200 ZAR) at PrEP initiation and at 1-, 4-, and 7-month clinical visits where PrEP refills are provided.
PrEP support buddy: Participants will identify someone their network (e.g., friend, partner, parent) to be their PrEP support buddy. The buddy will receive a one-time training on PrEP, support strategies, and informational materials to provide ongoing support.
Community-based PrEP pickup points: Ten community pickup points established at Hubs of Hope in subdistricts served by TB HIV Care that participants can opt-in to collect their PrEP.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
HIV Seroconversion
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/18 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
5.3%
1/19 • Number of events 1 • During the trial period from April 2024-May 2025, approximately 13 months
|
5.0%
1/20 • Number of events 1 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
0.00%
0/19 • During the trial period from April 2024-May 2025, approximately 13 months
|
5.3%
1/19 • Number of events 1 • During the trial period from April 2024-May 2025, approximately 13 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sheree Schwartz
Johns Hopkins Bloomberg School of Public Health
Phone: 443-983-2564
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place