NCT04982250Completed
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 23 Jul 2021
- Start date
- 24 Feb 2022
- Primary completion date
- 5 Jun 2024
- Lead sponsor
- Fred Hutchinson Cancer Center
- Diseases
- HIV
- NCT number
- NCT04982250
What you commit to
- Study type: Interventional
- Participants enrolled: 211
- From 24 Feb 2022 to the primary completion date, 5 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Not able to identify up to 4 peers at risk of HIV infection
- Currently enrolled in an HIV study
- Not able to identify up to 4 peers at risk of HIV infection
Age
- Age ≥16 or \>24 years
- Age ≥16 or \>24 years
- Age ≥16 or \>24 years
Other
- For peer providers (qualitative data, pilot):
- Male
- Have not used PrEP for a minimum of three months
- Not willing to disclose PrEP use to their peers
- 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):
- Male
- Have not used PrEP
- 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):
- Male
- Not referred by peer (i.e., a PrEP users) to initiate PrEP
- Not able and willing to provide written informed consent
Who the study is looking for
- 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.
Age in the registry: 16 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Partners in Health and Research Development Coordinator of this site? Confirm its status | Thika | Kenya | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.