PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

Study Overview
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Brief Summary
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The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.

Detailed Description
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Develop PrEP My Way. Using a client-centered approach, the study team will iteratively conduct individual interviews and focus group discussions with up to 25 Kenyan women (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and peer delivery system (including phone communication and kit delivery plans). Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. The investigators will randomize 100 Kenyan women (age 16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 and 6 months.

Official Title
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PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: PrEP My Way


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation) per Kenyan national guidelines [39]) or 16-17 year-olds with parental consent Reported sexual activity within the past 3 months Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1) Residence in the Kisumu region Phone ownership Ability to understand KiSwahili, DhoLuo, and/or English Exclusion Criteria: Inability to provide informed consent (e.g., intoxication, mental disability)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP My Way intervention<br>PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. | Other: PrEP My Way<br>* Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests). This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.<br>|
| No Intervention: Control<br>These participants will continue to receive PrEP at the clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | PrEP adherence as measured by tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) testing | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported PrEP adherence | PrEP adherence as measured by questionnaires | Months 1, 3, 6 (intervention arm), Month 6 (control arm) | 
| PrEP persistence | PrEP adherence as measured by pharmacy pick up over the six months | Over the six month period | 
| Rates of STI testing |  | Months 1, 3, and 6 | 
| Rates of pregnancy test and contraception pick up |  | Months 1, 3, and 6 | 
| Cost estimate | The study team will conduct a micro-costing analysis to assess the cost of the intervention in a standard clinic setting from the payer perspective. Cost will be presented as US dollars per intervention and sub-divided into amounts for capital goods, personnel, supplies, overhead, and training. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention