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

• ClinicalTrials.gov Identifier: NCT04982250
• Recruitment Status: Recruiting
• First Posted: July 29, 2021
• Last Update Posted: March 9, 2023
• Sponsor: Fred Hutchinson Cancer Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Katrina Ortblad, Fred Hutchinson Cancer Center

Study Description

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: peer PrEP referral + 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 informal word-of-month peer PrEP referral (currently ongoing in Kenya), formalized peer PrEP referral + HIVST delivery will increase PrEP adoption (i.e., initiation, retention, and adherence) among peers, and be low cost and have high fidelity in Kenya.

Condition or disease	Intervention/treatment	Phase
HIV Prevention	Behavioral: Formal peer PrEP referral + HIVST delivery	Not Applicable

Detailed Description:

Pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low among young women in sub-Saharan 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 help 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 peer referral, thus formalized and enhanced peer referral has the potential to increase PrEP initiation among members of this population. HIV self-testing (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 the majority of individuals who self-test will test negative and may be interested in facilitated linkage to prevention services, like PrEP.

We hypothesize that a formalized peer PrEP referral + HIVST delivery model can amplify PrEP initiation among young Kenyan women at HIV risk. We conducted formative qualitative research and stakeholder engagement to develop a model of formalized peer PrEP referral + HIVST delivery to increase PrEP initiation among young Kenyan women. We propose refining this model in a pilot study. In our pilot, we will recruit 16 young female PrEP users (i.e. peer providers) in Thika, Kenya to deliver the formalized peer PrEP referral + HIVST model to ~4 peers (i.e., peer clients, =64 peer clients in total). At one month, we will quantitatively measure model adoption (e.g., peer referral, PrEP initiation) and feasibility (e.g., peer follow up) using surveys, and qualitatively measure acceptability using focus group discussions (FDGs) with those delivering and receiving the model (4-5 FDGs, 3-6 women/FDG).

We then propose testing the refined model in hybrid effectiveness-implementation trial. In our trial, we will randomize 80 peer providers to: 1) "formal peer PrEP referral + HIVST delivery", where they are encouraged to refer 4 peer clients to PrEP using an educational brochure, HIVSTs (2/peer, =8 total), and a MOH-style referral slip, vs. 2) "informal 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 peer clients, as reported by peer providers, three months later. Implementation outcomes will include acceptability, fidelity, and costs. The effectiveness outcomes will be PrEP initiation [primary], PrEP continuation (i.e., refilling), recent HIV testing use (past 3 months), and PrEP adherence, confirmed using dried blood spots. The results from this trial 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 504 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The pilot study will be a single group model (N=104), and the RCT will be a parallel model (N=400).
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial
• Actual Study Start Date: February 24, 2022
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: January 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: "Formal 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: Formal 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: "Informal 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.

Outcome Measures

Primary Outcome Measures :

1. PILOT: PrEP initiation [Number of peer clients] [ Time Frame: 1 month ]
   Number of referred peer clients that initiated PrEP
2. PILOT: PrEP initiation [Proportion of peer clients] [ Time Frame: 1 month ]
   Proportion of referred peer clients that initiated PrEP
3. cRCT: PrEP initiation [ Time Frame: 3 months ]
   Proportion of referred peer clients that initiated PrEP

Secondary Outcome Measures :

1. PILOT: PrEP referral [Number of peer clients] [ Time Frame: 1 month ]
   Number of peer clients referred to PrEP
2. PILOT: PrEP referral [Proportion of peer clients] [ Time Frame: 1 month ]
   Proportion of peer clients referred to PrEP
3. PILOT: HIVST use [Number of peer clients] [ Time Frame: 1 month ]
   Number of referred peer clients that used HIVST
4. PILOT: HIVST use [Proportion of peer clients] [ Time Frame: 1 month ]
   Proportion of referred peer clients that used HIVST
5. PILOT: HIV risk [Number of peer clients] [ Time Frame: 1 month ]
   Number of peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST])
6. PILOT: HIV risk [Proportion of peer clients] [ Time Frame: 1 month ]
   Proportion of peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST])
7. cRCT: recent HIV testing [ Time Frame: 3 months ]
   Proportion of referred peer clients who tested for HIV (any form, including HIVST)
8. cRCT: PrEP continuation [ Time Frame: 3 months ]
   Proportion of peer clients that returned to a clinic to refill PrEP, among those who initiated PrEP
9. cRCT: PrEP adherence [ Time Frame: 3 months ]
   Proportion of referred peer clients that returned for follow up and self-reported PrEP adherence (blood-level PrEP adherence measurements on random sample)
10. cRCT: HIV risk [ Time Frame: 3 months ]
    Proportion of referred peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST])

Other Outcome Measures:

1. cRCT: PrEP referral [ Time Frame: 3 months ]
   Number of peer clients referred to PrEP
2. cRCT: Client linkage to care [ Time Frame: 3 months ]
   Proportion of referred peer clients that went to a clinic to access HIV prevention or treatment services.
3. cRCT: PrEP start [ Time Frame: 3 months ]
   Proportion of referred peer clients that swallowed any PrEP pills.
4. cRCT: Materials received [ Time Frame: 3 months ]
   Proportion of referred peer clients that received the intervention or standard-of-care materials.
5. cRCT: PrEP/HIVST knowledge [ Time Frame: 3 months ]
   Proportion of facts related to PrEP/HIVST correctly reported by peer clients and providers that received or delivered the intervention or standard-of-care referral.
6. cRCT: Social support [ Time Frame: 3 months ]
   Proportion of participants (peer providers and peer clients referred) with high social support, measured using the Multidimensional Scale of Perceived Social Support (MSPSS) scale (scores: 1-7 points, >5 points=high support).
7. cRCT: Sexual behaviors [ Time Frame: 3 months ]
   Proportion of peer clients that reported any sexual behaviors associated with risk of HIV acquisition according to the Kenya Rapid Assessment Screening Tool, which includes self-reported recent condomless sex, sexual partner(s) of unknown HIV status, multiple sexual partners, and engagement in transactional sex.
8. cRCT: Acceptability of intervention model [ Time Frame: 3 months ]
   Proportion of peer clients and providers who report our intervention model is acceptable using questions based on the Theoretical Framework of Acceptability (TFA), which assessed different component constructs of acceptability (no validated score available). If ≥80% of participants agree/strongly agree with a statement assessing a component construct (e.g., affective attitude), that component construct will be considered acceptable.
9. cRCT: Appropriateness of intervention model [ Time Frame: 3 months ]
   Proportion of peer clients and providers who report our intervention model is appropriate using select questions adapted from the Appropriateness of Intervention Measure (adapted scores: 1-10, with higher scores indicating greater appropriateness).
10. cRCT: Feasibility of intervention model [ Time Frame: 3 months ]
    Proportion of peer clients and providers who report our intervention model is feasible using select questions adapted from the Feasibility of Intervention Measure (adapted score: 1-20, with higher scores indicating greater feasibility).

Eligibility Criteria

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

Criteria

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
• Good communication skills, determined by the study counselor
• 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
• Have been on PrEP for a minimum of one month and have returned for one refill
• 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
• Good communication skills, determined by the study counselor
• 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

• Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home

  • 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
• Poor communication skills, determined by the study counselor
• Not able and willing to provide written informed consent

For peer providers (cRCT):

• Age ≥16 or >24 years
• Male
• Have not used PrEP for a minimum of 1 month and returned for one refill
• 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
• Poor communication skills, determined by the study counselor
• 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

Contacts and Locations

Contacts

Contact: Katrina F Ortblad, ScD, MPH; 2066677267; kortblad@fredhutch.org

Contact: Rachel Malen, MPH; 206-667-2695; rmalen@fredhutch.org

Locations

Kenya

Partners in Health and Research Development; Recruiting

Thika, Kenya

Contact: Kenneth Ngure, PhD kngure@pipsthika.org

Sponsors and Collaborators

Fred Hutchinson Cancer Center

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Katrina F Ortblad, ScD, MPH; Fred Hutchinson Cancer Center

More Information

• Responsible Party: Katrina Ortblad, Assistant Professor, Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT04982250
• Other Study ID Numbers: RG1121770; K99MH121166 ( U.S. NIH Grant/Contract )
• First Posted: July 29, 2021
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Deidentified data may be available upon request at the discretion of the study PI (Ortblad).

• 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

Keywords provided by Katrina Ortblad, Fred Hutchinson Cancer Center:

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