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

NCT ID: NCT04408729

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2022-10-26

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PrEP My Way intervention

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.

Group Type: EXPERIMENTAL

PrEP My Way

Intervention Type: OTHER

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.

Control

These participants will continue to receive PrEP at the clinic.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PrEP My Way

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Responsible Party

Jessica Haberer, MD

Director of Research, Center for Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kenya Medical Research Institute

Kisumu, , Kenya

Countries

Kenya

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34MH122362

Identifier Type: NIH

Identifier Source: org_study_id

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