Clinical trial NCT04408729: PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
Official title: "PrEP My Way": A Novel PrEP Delivery System to Meet the Needs of Young African Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: prevention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Emory University
First posted: 2020-05-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: PrEP Adherence
timeFrame: Six months
Secondary outcomes:
measure: Self-reported PrEP Adherence in the Past 30 Days
timeFrame: Months 1, 3, 6 (intervention arm)
measure: Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)
timeFrame: At 6 months
measure: Rates of STI Testing
timeFrame: Months 1, 3, and 6
measure: Rates of Hormonal Contraception
timeFrame: Months 1, 3, and 6
measure: Prevention-effective Adherence at 6 Months
timeFrame: Measured at 6 months
Other outcomes:
measure: Feasibility of Intervention Use
timeFrame: Six months
measure: Acceptability of Intervention
timeFrame: Six months
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
References: