CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 211 enrolled
Drug / intervention
Enhanced peer PrEP referral + HIVST deliverybehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04982250
NCT04982250N/ACompleted

Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial

Fred Hutchinson Cancer Center·interventional·Posted Jul 29, 2021·Updated Nov 3, 2025

In Brief

A clinical study evaluating Enhanced peer PrEP referral + HIVST delivery for HIV Prevention. Completed, enrolled 211 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesKenya

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 29, 2021
Enrollment StartFeb 24, 2022
Primary CompletionJun 5, 2024
Study CompletionAug 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.9 years ago

Interventions

Enhanced peer PrEP referral + HIVST deliverybehavioral

After a brief training, young female PrEP users will be encouraged to refer up to 4 peers to PrEP using strategies gained from the training, PrEP educational materials (i.e., brochures), HIVST kits (2 kits/peer = 8 kits total), and Kenya MOH-style referral cards.