A program to improve PrEP use among young women in Kenya
PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
NA · Massachusetts General Hospital · NCT06566430
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 16 Years to 24 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT06566430 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are young women aged 16-24 who are initiating PrEP and reside in Kisumu County.
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.
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 performed: Preliminary testing of similar approaches in Kisumu has shown feasibility and acceptability, suggesting potential for success.
Eligibility criteria
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 this trial is running
Kisumu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV/AIDS, prevention