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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PrEP My Way intervention	PrEP My Way	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.

Primary Outcome Measures

Name	Time	Method
PrEP Adherence	Six months	PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots

Secondary Outcome Measures

Name	Time	Method
Self-reported PrEP Adherence in the Past 30 Days	Months 1, 3, 6 (intervention arm)	PrEP adherence as measured by questionnaires at kit delivery.
Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)	At 6 months	PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months
Rates of STI Testing	Months 1, 3, and 6	Testing for gonorrhea and chlamydia
Rates of Hormonal Contraception	Months 1, 3, and 6	Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)
Prevention-effective Adherence at 6 Months	Measured at 6 months	Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) \>1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV)