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

NCT04408729 | Completed Results

• 1 other identifier: R34MH122362
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

prevention

Outcome Measures

Primary Outcomes (1)

• PrEP Adherence

  PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots

  Six months

Secondary Outcomes (5)

• Self-reported PrEP Adherence in the Past 30 Days

  Months 1, 3, 6 (intervention arm)

• Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)

  At 6 months

• Rates of STI Testing

  Months 1, 3, and 6

• Rates of Hormonal Contraception

  Months 1, 3, and 6

• Prevention-effective Adherence at 6 Months

  Measured at 6 months

Other Outcomes (2)

• Feasibility of Intervention Use

  Six months

• Acceptability of Intervention

  Six months

Study Arms (2)

PrEP My Way intervention

EXPERIMENTAL

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.

Other: PrEP My Way

Control

NO INTERVENTION

These participants will continue to receive PrEP at the clinic.

Interventions

PrEP My Way 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.

PrEP My Way intervention

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent (e.g., intoxication, mental disability)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Kenya Medical Research Institute: collaborator
• Emory University: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Jessica Haberer, MD, MS
• Organization: Massachusetts General Hospital

jhaberer@mgb.org

617-724-0351

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Center for Global Health

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 29, 2020
• Study Start: August 10, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Locations

KE (1)