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

Mass General Brigham

Status: Completed

Conditions: HIV/AIDS

Treatments: Other: PrEP My Way

Study type: Interventional

Funder types: Other

Identifiers

NCT04408729

R34MH122362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PrEP My Way intervention

Experimental group

Description:

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.

Treatment:

Other: PrEP My Way

Control

No Intervention group

Description:

These participants will continue to receive PrEP at the clinic.