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

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

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 Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Enhanced peer PrEP referral + HIVST delivery

Detailed Description

HIV PrEP is highly effective, but uptake remains low among young women in Africa, one of the populations at greatest HIV risk. In Kenya, one of the target groups for HIV incidence reduction is young women (16-24 years), who account for 33% of the total of new HIV infections yet comprise only 10% of the population. Barriers to PrEP initiation for this population are multi-faceted and include institutional (e.g., stigma associated with use) and intra-personal (e.g., lack of PrEP knowledge or self-efficacy) barriers. Thus, innovative PrEP delivery models that can overcome these barriers are needed. The opinion of peers often influences the behaviors and preferences of young women, including those related to health and health care. Most young women who have initiated PrEP in Kenya to date have done so because of informal peer referral, thus peer referral enhanced with training and HIVST delivery has the potential to increase PrEP initiation among members of this population. HIVST is a new technology that has the potential to enhance peer PrEP referral. Much of the emphasis on HIVST to date has been on identifying new individuals living with HIV and facilitating linkage to treatment, but most individuals who self-test will test negative and may be interested in starting prevention services, like PrEP.

We hypothesize that an enhanced peer PrEP referral model with HIVST delivery can increase PrEP initiation among young Kenyan women at HIV risk compared to standard informal peer PrEP referral. We conducted formative qualitative research to inform the design of such a model and propose refining this model in a pilot study with 16 young female PrEP users (i.e., "peer providers" or "index peers") who will be encouraged to referred up to four peer (i.e., "peer clients" or "referred peers"; =64 in total) using the defined implementation strategies (i.e., formalized training on PrEP and HIVST, and HIVST delivery). At one month, we will measure model adoption (e.g., peer referral, PrEP initiation) and feasibility (e.g., peer follow up) using survey data and qualitatively measure model acceptability using focus group discussions (FDGs) with index and referred peers (4-5 FDGs, 3-6 women/FDG).

We will incorporate findings from the pilot into a refined version of the enhanced peer PrEP referral with HIVST delivery model and test this compared to standard peer PrEP referral in hybrid effectiveness-implementation cluster-randomized controlled trial (cRCT). In our cRCT, we will randomize 80 index peers to either: 1) enhanced peer PrEP referral, where they are encouraged to refer 4 peer (i.e., "referred peers") to PrEP using an educational brochure, HIVSTs (2/peer), and a MOH-style referral slip, or 2) standard peer PrEP referral, where they are encouraged to refer 4 peer clients to PrEP using word-of-mouth, as is ongoing in Kenya, and a MOH-style referral slip. All trial outcomes will be measured among referred peers, as reported by index peers, three months later. Effectiveness outcomes will include PrEP initiation [primary], PrEP continuation (any refilling), and recent HIV testing (past 3 months); self-reported PrEP adherence will be assessed among referred peers reached for follow-up. Implementation outcomes will include model acceptability, fidelity, and costs. The results from this cRCT will address one of the greatest challenges to PrEP scale-up today and inform an R01 proposal for a community-randomized trial and budget impact analysis.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Thika, Kenya
    • Partners in Health and Research Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "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.	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.
No Intervention: "Standard peer PrEP referral"; Young female PrEP users will be encouraged to refer 4 peers to PrEP using informal word-of-mouth recruitment strategies and Kenya MOH-style referral cards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cRCT: PrEP Initiation	Number of referred peers that initiated PrEP, among all referred peers, as reported by index peers.	3 months
Pilot: PrEP Initiation, as Reported by Index Peers	Number of referred peers that initiated PrEP, among all eligible referred peers, as reported by index peers.	1 month
Pilot: PrEP Initiation, as Reported by Referred Peers	Number of referred peers that initiated PrEP, among eligible referred peers who enrolled and completed follow-up, as reported by referred peers.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot: PrEP Referral	Number of referred peers referred to PrEP, among all referred peers, as reported by index peers.	1 month
Pilot: HIVST Use	Number of referred peers that used HIVST, among referred peers who enrolled and completed follow-up, as reported by referred peers.	1 month
cRCT: Recent HIV Testing	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.	3 months
cRCT: PrEP Continuation (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.	3 months
cRCT: PrEP Continuation (Index Peers)	Number of index peers that returned to a clinic to refill PrEP in the past 3 months.	3 months
cRCT: PrEP Adherence	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cRCT: PrEP Referral	Median number of referred peers referred to PrEP services by each index peer.	3 months
cRCT: HIVST Use	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.	3 months
cRCT: Linkage to Care	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.	3 months
cRCT: Materials Received	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.	3 months
cRCT: Acceptability of Intervention Model	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.	3 months
cRCT: Appropriateness of Intervention Model	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.	3 months
cRCT: Feasibility of Intervention Model	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.	3 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Katrina F Ortblad, ScD, MPH, Fred Hutchinson Cancer Center

Publications and helpful links

General Publications

• Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
• Wairimu N, Malen RC, Reedy AM, Mogere P, Njeru I, Culquichicon C, McGowan M, Gao F, Baeten JM, Ngure K, Ortblad KF. Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial. Trials. 2023 Nov 4;24(1):705. doi: 10.1186/s13063-023-07734-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Kenya; adolescent girls and young women (AGYW); HIV pre-exposure prophylaxis (PrEP) delivery; HIV self-testing delivery
• Other Study ID Numbers: RG1121770; K99MH121166 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data (deidentified) used for primary, secondary, and other outcomes reported in the main manuscript along with a data dictionary.
• IPD Sharing Time Frame: September 2025 (around the time of publication). No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No