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

NCT04982250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2025-11-03

Study results available
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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.

Conditions

  • HIV Prevention

Interventions

BEHAVIORAL

Enhanced peer PrEP referral + HIVST delivery

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Katrina F Ortblad, ScD, MPH · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2024-06-05
Completion
2024-08-27

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982250 on ClinicalTrials.gov