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

HIV Prevention Clinical Trial

— PeerPrEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982250
• Other study ID #: RG1121770
• Secondary ID: K99MH121166
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Katrina F Ortblad, ScD, MPH
• Phone: 2066677267
• Email: kortblad[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: January 31, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 24 Years

Eligibility

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
• 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
• 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
• 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
• 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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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.

Locations

Country	Name	City	State
Kenya	Partners in Health and Research Development	Thika

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cRCT: PrEP referral	Number of peer clients referred to PrEP	3 months
Other	cRCT: Client linkage to care	Proportion of referred peer clients that went to a clinic to access HIV prevention or treatment services.	3 months
Other	cRCT: PrEP start	Proportion of referred peer clients that swallowed any PrEP pills.	3 months
Other	cRCT: Materials received	Proportion of referred peer clients that received the intervention or standard-of-care materials.	3 months
Other	cRCT: PrEP/HIVST knowledge	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.	3 months
Other	cRCT: Social support	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).	3 months
Other	cRCT: Sexual behaviors	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.	3 months
Other	cRCT: Acceptability of intervention model	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.	3 months
Other	cRCT: Appropriateness of intervention model	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).	3 months
Other	cRCT: Feasibility of intervention model	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).	3 months
Primary	PILOT: PrEP initiation [Proportion of peer clients]	Proportion of referred peer clients that initiated PrEP	1 month
Primary	cRCT: PrEP initiation	Proportion of referred peer clients that initiated PrEP	3 months
Secondary	PILOT: PrEP referral [Number of peer clients]	Number of peer clients referred to PrEP	1 month
Secondary	PILOT: HIVST use [Proportion of peer clients]	Proportion of referred peer clients that used HIVST	1 month
Secondary	PILOT: HIV risk [Proportion of peer clients]	Proportion of peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST])	1 month
Secondary	cRCT: recent HIV testing	Proportion of referred peer clients who tested for HIV (any form, including HIVST)	3 months
Secondary	cRCT: PrEP continuation	Proportion of peer clients that returned to a clinic to refill PrEP, among those who initiated PrEP	3 months
Secondary	cRCT: PrEP adherence	Proportion of referred peer clients that returned for follow up and self-reported PrEP adherence (blood-level PrEP adherence measurements on random sample)	3 months
Secondary	cRCT: HIV risk	Proportion of referred peers at HIV risk (scores >1/6 on the PrEP Rapid Assessment Screening Tool [RAST])	3 months