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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: PrEP My Way

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control; These participants will continue to receive PrEP at the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Adherence	PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported PrEP Adherence in the Past 30 Days	PrEP adherence as measured by questionnaires at kit delivery.	Months 1, 3, 6 (intervention arm)
Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)	PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months	At 6 months
Rates of STI Testing	Testing for gonorrhea and chlamydia	Months 1, 3, and 6
Rates of Hormonal Contraception	Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)	Months 1, 3, and 6
Prevention-effective Adherence at 6 Months	Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) >1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV)	Measured at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Use	The PrEP My Way intervention will be considered feasible if >70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) have a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at >66% (2/3) of visits. The outcome indicates the number of participants at each time point who received a kit and were able to 1) read their HIV test (if testing was desired), 2) provide a vaginal swab that could be assessed for gonorrhea/chlamydia (if testing was desired), and 3) inject medroxyprogesterone (if the product was desired).	Six months
Acceptability of Intervention	The PrEP My Way intervention will be considered acceptable if >70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale (SUS) as "very good" or higher. The scores on the SUS are normalized on a scale 0-100 (higher scores indicate higher usability).	Six months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Emory University; Kenya Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R34MH122362 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No