Trial Outcomes & Findings for Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya (NCT NCT04982250)
NCT ID: NCT04982250
Last Updated: 2025-11-03
Results Overview
Number of referred peers that initiated PrEP, among all referred peers, as reported by index peers.
COMPLETED
NA
211 participants
3 months
2025-11-03
Participant Flow
To identify index peers for recruitment, we reviewed the records of public clinics and research programs delivering PrEP in the region and called adolescent girls and young women (AGYW) who met the study eligibility criteria. Referred peers were recruited by index peers, who were given instructions to only recruit peers between 16 to 24 years who they thought might benefit from PrEP.
In both the pilot and the 2-arm cRCT, index peers (k) referred their peers to HIV services (i.e., referred peers, n). At follow-up, index peers reported outcomes for all the referred peers (started). At follow up, some of the referred peers were also enrolled (completed). Thus, some outcomes are measured among index peers, referred peers who started (as reported by index peers), and referred peers who completed (as reported by referred peers). Enrollment totals reflect those who completed.
Participant milestones
| Measure |
Pilot: Index Peers (k)
Index peers who received formalized training on PrEP referral strategies and HIV self-testing.
|
Pilot: Referred Peers (n)
Referred peers who were referred to HIV services by index peers.
|
cRCT: Enhanced Group; Index Peers (k)
Index peers assigned to the enhanced peer referral group.
|
cRCT: Standard Group; Index Peers (k)
Index peers assigned to the standard peer referral group.
|
cRCT: Enhanced Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
56
|
40
|
42
|
137
|
104
|
|
Overall Study
COMPLETED
|
16
|
30
|
40
|
42
|
55
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
26
|
0
|
0
|
82
|
76
|
Reasons for withdrawal
| Measure |
Pilot: Index Peers (k)
Index peers who received formalized training on PrEP referral strategies and HIV self-testing.
|
Pilot: Referred Peers (n)
Referred peers who were referred to HIV services by index peers.
|
cRCT: Enhanced Group; Index Peers (k)
Index peers assigned to the enhanced peer referral group.
|
cRCT: Standard Group; Index Peers (k)
Index peers assigned to the standard peer referral group.
|
cRCT: Enhanced Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
26
|
0
|
0
|
72
|
69
|
|
Overall Study
Not Eligible to Enroll
|
0
|
0
|
0
|
0
|
10
|
7
|
Baseline Characteristics
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Baseline characteristics by cohort
| Measure |
Pilot: Index Peers (k)
n=16 Participants
Index peers who received formalized training on PrEP referral strategies and HIV self-testing.
|
Pilot: Referred Peers (n)
n=30 Participants
Referred peers recruited by index peers whom we were able to reach for follow-up (completed enrollment).
|
cRCT: Enhanced Group; Index Peers (k)
n=40 Participants
Index peers assigned to the enhanced peer referral group.
|
cRCT: Standard Group; Index Peers (k)
n=42 Participants
Index peers assigned to the standard peer referral group.
|
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers recruited by index peers in the enhanced peer referral group whom we were able to reach for follow-up (completed enrollment).
|
cRCT: Standard Group; Referred Peers (n)
n=28 Participants
Referred peers recruited by index peers in the standard peer referral group whom we were able to reach for follow-up (completed enrollment).
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
23 years
n=15 Participants
|
21 years
n=161 Participants
|
22 years
n=100 Participants
|
22 years
n=3 Participants
|
22 years
n=8 Participants
|
22 years
n=7 Participants
|
22 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=15 Participants
|
30 Participants
n=161 Participants
|
40 Participants
n=100 Participants
|
42 Participants
n=3 Participants
|
55 Participants
n=8 Participants
|
28 Participants
n=7 Participants
|
211 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=15 Participants
|
30 Participants
n=161 Participants
|
40 Participants
n=100 Participants
|
42 Participants
n=3 Participants
|
55 Participants
n=8 Participants
|
28 Participants
n=7 Participants
|
211 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers.
Number of referred peers that initiated PrEP, among all referred peers, as reported by index peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=137 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=104 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: PrEP Initiation
|
41 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Outcome only applies to pilot referred peers. The denominator (n=55) excludes one referred peer reported as HIV-positive.
Number of referred peers that initiated PrEP, among all eligible referred peers, as reported by index peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
Pilot: PrEP Initiation, as Reported by Index Peers
|
43 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Outcome only applies to pilot referred peers who enrolled and completed follow-up. The denominator (n=26) excludes four referred peers who were already/currently using PrEP at the time of referral.
Number of referred peers that initiated PrEP, among eligible referred peers who enrolled and completed follow-up, as reported by referred peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=26 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
Pilot: PrEP Initiation, as Reported by Referred Peers
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Outcome only applies to pilot referred peers.
Number of referred peers referred to PrEP, among all referred peers, as reported by index peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=56 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
Pilot: PrEP Referral
|
56 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Outcome only applies to pilot referred peers who enrolled and completed follow-up.
Number of referred peers that used HIVST, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=30 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
Pilot: HIVST Use
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers.
Number of referred peers who tested for HIV (any form, including HIVST) since peer PrEP referral, among all referred peers, as reported by index peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=137 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=104 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: Recent HIV Testing
|
125 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers.
Number of referred peers that returned to a clinic to refill PrEP since referral, among all referred peers, as reported by index peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=137 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=104 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: PrEP Continuation (Referred Peers)
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT index peers.
Number of index peers that returned to a clinic to refill PrEP in the past 3 months.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=40 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=42 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: PrEP Continuation (Index Peers)
|
19 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers who enrolled and completed follow-up.
A 0-100 point PrEP adherence score derived from the validated three-item Wilson et al Adherence scale with higher scores indicating higher adherence, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=28 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: PrEP Adherence
|
4.9 Scores on a scale
Interval 0.0 to 100.0
|
58.9 Scores on a scale
Interval 0.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT index peers.
Median number of referred peers referred to PrEP services by each index peer.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=40 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=42 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: PrEP Referral
|
4.0 referred peers
Interval 3.0 to 4.0
|
3.0 referred peers
Interval 3.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: We do not include the arm/group "cRCT: Standard group; referred peers (n)" here because this outcome only applies to referred peers in the enhanced group. Referred peers in the standard group did not receive HIVST as part of the intervention.
Number of referred peers in the enhanced group that used HIVST, among referred peers in the enhanced group who enrolled and completed follow-up, as reported by referred peers in the enhanced group.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: HIVST Use
|
54 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers who enrolled and completed follow-up.
Number of referred peers that went to a clinic to access HIV prevention or treatment services, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=28 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: Linkage to Care
|
17 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Outcome only applies to cRCT referred peers who enrolled and completed follow-up.
Number of referred peers that received the intervention or standard-of-care materials, among referred peers who enrolled and completed follow-up, as reported by referred peers.
Outcome measures
| Measure |
cRCT: Enhanced Group; Referred Peers (n)
n=55 Participants
Referred peers who were referred to HIV services by index peers in the enhanced peer referral group.
|
cRCT: Standard Group; Referred Peers (n)
n=28 Participants
Referred peers who were referred to HIV services by index peers in the standard peer referral group.
|
|---|---|---|
|
cRCT: Materials Received
|
46 Participants
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNumber of referred peers and index peers who agree/strongly agree (on a 5-point Likert scale) to statements adapted from the Theoretical Framework of Acceptability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNumber of referred peers and index peers who agree/strongly agree (on a 5-point Likert scale) to statements adapted from the Appropriateness of Intervention Measure instrument.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNormal of referred peers and index peers who agree/strongly agree (on a 5-point Likert scale) to statements adapted from the Feasibility of Intervention Measure instrument.
Outcome measures
Outcome data not reported
Adverse Events
Pilot: Index Peers (k)
Pilot: Referred Peers (n)
cRCT: Enhanced Group; Index Peers (k)
cRCT: Standard Group; Index Peers (k)
cRCT: Enhanced Group; Referred Peers (n)
cRCT: Standard Group; Referred Peers (n)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pilot: Index Peers (k)
n=16 participants at risk
Index peers who received formalized training on PrEP referral strategies and HIV self-testing.
|
Pilot: Referred Peers (n)
n=30 participants at risk
Referred peers recruited by index peers whom we were able to reach for follow-up (completed enrollment).
|
cRCT: Enhanced Group; Index Peers (k)
n=40 participants at risk
Index peers assigned to the enhanced peer referral group.
|
cRCT: Standard Group; Index Peers (k)
n=42 participants at risk
Index peers assigned to the standard peer referral group.
|
cRCT: Enhanced Group; Referred Peers (n)
n=55 participants at risk
Referred peers recruited by index peers in the enhanced peer referral group whom we were able to reach for follow-up (completed enrollment).
|
cRCT: Standard Group; Referred Peers (n)
n=28 participants at risk
Referred peers recruited by index peers in the standard peer referral group whom we were able to reach for follow-up (completed enrollment).
|
|---|---|---|---|---|---|---|
|
Social circumstances
Social Harms
|
0.00%
0/16 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
0.00%
0/30 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
2.5%
1/40 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
2.4%
1/42 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
0.00%
0/55 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
0.00%
0/28 • Adverse event data was collected for index peers at both baseline and the month 3 follow-up visit, and for referred peers at the month 3 visit (so only collected among referred peers who enrolled and completed follow-up). During data collection and study follow-up, participants were asked to report if they've had any of these events and whether they are or are not study related.
Adverse events (AEs) include any forms of verbal (e.g., yelling, fighting), physical (e.g., hitting), emotional (e.g., depression) or economic (e.g., job loss) abuse attributable to the study. While serious adverse events (SAEs) include hospitalization (for any condition, including those outside the study) or death.
|
Additional Information
Katrina F Ortblad, ScD, MPH
Fred Hutchinson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place