PrEP My Way: a Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. Preliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir/emtricitabine, injectable cabotegravir-long acting \[CAB-LA\], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS \[short message service\], routine check-ins and/or WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 24
Healthy Volunteers: t
View:

• young women (age 16-24 years)

• initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection)

• resident in Kisumu County

• phone ownership

• ability to understand KiSwahili, DhoLuo, and/or English

Locations
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Kisumu
Contact Information
Primary
Lindsey Garrison, MPH
legarrison@mgh.harvard.edu
617-643-9195
Backup
Jessica Haberer, MD, MS
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 500
Treatments
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.~Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support.
Experimental: PrEP My Way intervention without STI testing
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, condoms, and/or self-injection medroxyprogesterone, as desired.~Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support.
Experimental: Enhanced standard of care
Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir).
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Jomo Kenyatta University of Agriculture and Technology, Kenya Medical Research Institute, Kenya National AIDS & STI Control Programme
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov