N/A Completed N=395 Randomized Prevention

Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya

HIV

Source: ClinicalTrials.gov NCT04982250 ↗

Enrolled (actual)

395

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcomePrimary: cRCT: PrEP Initiation — 41; 41 Participants

Summary

Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: enhanced peer PrEP referral with HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to standard informal word-of-month peer PrEP referral (currently ongoing in Kenya), enhanced peer PrEP referral with HIVST delivery will increase PrEP initiation, continuation, and adherence among peers; have high fidelity; and be low cost.

Outcome Measures

Outcome	Result	p-value
PRIMARY cRCT: PrEP Initiation	41; 41	—
PRIMARY Pilot: PrEP Initiation, as Reported by Index Peers	43	—
PRIMARY Pilot: PrEP Initiation, as Reported by Referred Peers	22	—
SECONDARY Pilot: PrEP Referral	56	—
SECONDARY Pilot: HIVST Use	29	—
SECONDARY cRCT: Recent HIV Testing	125; 56	—
SECONDARY cRCT: PrEP Continuation (Referred Peers)	17; 11	—
SECONDARY cRCT: PrEP Continuation (Index Peers)	19; 28	—
SECONDARY cRCT: PrEP Adherence	4.9; 58.9	—

Eligibility Criteria

Inclusion Criteria

For peer providers (qualitative data, pilot):

Age ≥16 to 24 years*
Female
Have been on PrEP for a minimum of three months
Good adherence to PrEP (i.e., self-report take PrEP all the time)
Willing to disclose PrEP use to their peers
Able to identify up to 4 peers at risk of HIV infection
Willing to participate in training with study counselors on PrEP referral and HIVST use
Willing to refer peers to PrEP and deliver HIVSTs
Able and willing to provide written informed consent
Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery

For peer providers (cRCT):

Age ≥16 to 24 years*
Female
Must have refilled or initiated PrEP (i.e., been dispensed PrEP)
Not currently enrolled in an HIV study
Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition
Willing to participate in training with study counselors on PrEP referral and HIVST use
Willing to refer peers to PrEP and deliver HIVSTs
Able and willing to provide written informed consent
Willing to provide contact information for follow-up
Willing to engage in all research activities including completion of questionnaires
Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery

For peer clients (pilot, RCT):

Age ≥16 to 24 years*
Female
Referred by peer (i.e., a PrEP users) to initiate PrEP
Able and willing to provide informed consent
NOTE: We will only enroll young women ≥16 to 17 years into the study if they are emancipated minors and thus able to legally provide consent for participation in research. Kenyan law acknowledges women ages 14 to 17 who have become pregnant as emancipated minors. The PHRD site/UW collaboration has successfully enrolled emancipated minors into a number of prior studies, including PrEP clinical trials. In addition, Kenya's national policy guidelines explicitly permit PrEP use in this age group.

Exclusion Criteria

For peer providers (qualitative data, pilot):

Age ≥16 or >24 years
Male
Have not used PrEP for a minimum of three months
Not willing to disclose PrEP use to their peers
Not able to identify up to 4 peers at risk of HIV infection
Not willing to participate in training with study counselors on PrEP referral and HIVST use
Not willing to refer peers to PrEP and deliver HIVSTs
Not able and willing to provide written informed consent

For peer providers (cRCT):

Age ≥16 or >24 years
Male
Have not used PrEP
Currently enrolled in an HIV study
Not able to identify up to 4 peers at risk of HIV infection
Illiterate
Not willing to participate in training with study counselors on PrEP referral and HIVST use
Not willing to refer peers to PrEP and deliver HIVSTs
Not able and willing to provide written informed consent

For peer clients (pilot, cRCT):

Age ≥16 or >24 years
Male
Not referred by peer (i.e., a PrEP users) to initiate PrEP
Not able and willing to provide written informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04982250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.