Clinical trial Recruiting at 1 site Interventional Ages 16 to 24 Women only

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 typeInterventional
Ages16 Years to 24 Years
SexWomen only
Enrollment500 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Kisumu)
StatusRecruiting
StartedMarch 3, 2025
Main results expectedMay 1, 2028
Study endsDecember 1, 2028
Registry record updatedApril 22, 2026
Trial IDNCT06566430 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.