N/A
N=150
PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04408729 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: PrEP Adherence — 12; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PrEP My Way (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Adherence |
12; 4 | — |
| SECONDARY Self-reported PrEP Adherence in the Past 30 Days |
92; 79; 68 | — |
| SECONDARY Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill) |
50; 11 | — |
| SECONDARY Rates of STI Testing |
67; 0; 64; 0; 62; 0 | — |
| SECONDARY Rates of Hormonal Contraception |
50; 6 | — |
| SECONDARY Prevention-effective Adherence at 6 Months |
12; 4 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04408729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.