Clinical trial NCT04982250: Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Official title: Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: Kenya
adolescent girls and young women (AGYW)
HIV pre-exposure prophylaxis (PrEP) delivery
HIV self-testing delivery
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-07-29
Enrollment: 211
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pilot study will be a single group model (anticipated N=104), and the RCT will be a parallel model (anticipated N=400).
Primary purpose: PREVENTION

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.

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" or "index peers") in Thika, Kenya to deliver the formalized peer PrEP referral + HIVST model to \~4 peers (i.e., "peer clients" or "referred peers", =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 ("index peers") to: 1) "formal (or "enhanced") peer PrEP referral + HIVST delivery", where they are encouraged to refer 4 peer clients ("referred peers") to PrEP using an educational brochure, HIVSTs (2/peer, =8 total), and a MOH-style referral slip, vs. 2) "informal (or "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 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.

Eligibility 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
* 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

Primary outcomes:
measure: PILOT: PrEP initiation [Proportion of peer clients]
timeFrame: 1 month
measure: cRCT: PrEP initiation
timeFrame: 3 months
Secondary outcomes:
measure: PILOT: PrEP referral [Number of peer clients]
timeFrame: 1 month
measure: PILOT: HIVST use [Proportion of peer clients]
timeFrame: 1 month
measure: PILOT: HIV risk [Proportion of peer clients]
timeFrame: 1 month
measure: cRCT: recent HIV testing
timeFrame: 3 months
measure: cRCT: PrEP continuation
timeFrame: 3 months
measure: cRCT: PrEP adherence
timeFrame: 3 months
measure: cRCT: HIV risk
timeFrame: 3 months
Other outcomes:
measure: cRCT: PrEP referral
timeFrame: 3 months
measure: cRCT: Client linkage to care
timeFrame: 3 months
measure: cRCT: Materials received
timeFrame: 3 months
measure: cRCT: PrEP/HIVST knowledge
timeFrame: 3 months
measure: cRCT: Social support
timeFrame: 3 months
measure: cRCT: Sexual behaviors
timeFrame: 3 months
measure: cRCT: Acceptability of intervention model
timeFrame: 3 months
measure: cRCT: Appropriateness of intervention model
timeFrame: 3 months
measure: cRCT: Feasibility of intervention model
timeFrame: 3 months
Locations:
city: Thika
country: Kenya
facility: Partners in Health and Research Development
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Katrina F Ortblad, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: