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

NCT04982250 | Completed Results DMC

• 2 other identifiers: RG1121770K99MH121166
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kenya; adolescent girls and young women (AGYW); HIV pre-exposure prophylaxis (PrEP) delivery; HIV self-testing delivery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Pilot: PrEP Referral

  1 month

• Pilot: HIVST Use

  1 month

• cRCT: Recent HIV Testing

  3 months

• cRCT: PrEP Continuation (Referred Peers)

  3 months

• cRCT: PrEP Continuation (Index Peers)

  3 months

Other Outcomes (7)

• cRCT: PrEP Referral

  3 months

• cRCT: HIVST Use

  3 months

• cRCT: Linkage to Care

  3 months

Study Arms (2)

"Enhanced peer PrEP referral + HIVST delivery"

EXPERIMENTAL

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

"Standard peer PrEP referral"

NO INTERVENTION

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.

Interventions

Enhanced peer PrEP referral + HIVST delivery BEHAVIORAL

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.

"Enhanced peer PrEP referral + HIVST delivery"

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Partners in Health and Research Development

Thika, Kenya

Location

Related Publications (2)

• 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.

  PMID: 27098408 BACKGROUND

• 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.

  PMID: 37925450 DERIVED

Limitations and Caveats

Limitations included relying on index peers to report outcomes for referred peers in our primary analysis; low enrollment and follow-up among referred peers; relying on self-report for HIV testing and PrEP outcomes; and the relatively short follow-up period for all study participants (one month for pilot and three months for cRCT).

Results Point of Contact

• Title: Katrina F Ortblad, ScD, MPH
• Organization: Fred Hutchinson Cancer Center

kortblad@fredhutch.org

2066677267

Study Officials

• Katrina F Ortblad, ScD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The pilot study will be a single group model (anticipated N=104), and the RCT will be a parallel model (anticipated N=400).

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: February 24, 2022
• Primary Completion: June 5, 2024
• Study Completion: August 27, 2024
• Last Updated: November 3, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: September 2025 (around the time of publication). No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

KE (1)