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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

211 participants

Primary outcome timeframe

3 months

Results posted on

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

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

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

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 months

Population: 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

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 month

Population: 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

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 month

Population: 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

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 month

Population: 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

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 month

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: Outcome only applies to cRCT index peers.

Median number of referred peers referred to PrEP services by each index peer.

Outcome measures

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Number 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 months

Number 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 months

Normal 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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pilot: Referred Peers (n)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

cRCT: Enhanced Group; Index Peers (k)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

cRCT: Standard Group; Index Peers (k)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

cRCT: Enhanced Group; Referred Peers (n)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

cRCT: Standard Group; Referred Peers (n)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 2066677267

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place