A program to improve PrEP use among young women in Kenya
Official title: PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Run by Massachusetts General Hospital · NCT06566430 · Data updated 2026-11-12
This study is testing a new program to help young women in Kenya use HIV prevention medication more effectively by providing support and resources tailored to their needs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 24 Years |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Kisumu) |
| Status | Recruiting |
| Started | March 3, 2025 |
| Main results expected | May 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06566430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are young women aged 16-24 who are initiating PrEP and reside in Kisumu County.
✕Probably not a fit
Patients who are not eligible include those unable to provide informed consent or those who do not meet the age and residency criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PrEP My Way is an innovative program designed to enhance the delivery of pre-exposure prophylaxis (PrEP) for HIV prevention among young women in Kisumu, Kenya. The program includes clinic-based initiation of PrEP, followed by peer-delivered kits that provide HIV self-testing, PrEP refills, and other health services. The study aims to empower participants by offering choices in PrEP formulations and adherence support, while addressing stigma and barriers to PrEP use. A total of 432 women aged 16-24 will be enrolled and randomized to assess the effectiveness of the intervention compared to standard care.
Why it matters
Potential benefit: If successful, this program could significantly increase PrEP persistence and reduce HIV transmission among young women in Kenya.
How similar studies have gone: Preliminary testing of similar approaches in Kisumu has shown feasibility and acceptability, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * inability to provide informed consent (e.g., intoxication)
Where it's running
-
Kenya Medical Research Institute
Kisumu, Kenya Recruiting
Study contacts
- Principal investigator: Jessica Haberer, MD, MS — Director of Research, Center for Global Health
- Study coordinator: Lindsey Garrison, MPH
- Email: legarrison@mgh.harvard.edu
- Phone: 617-643-9195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.