PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      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: 
      1. 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).

        2. 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.
    

Intervention name(s): PrEP My Way
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention