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Search / Trial NCT06566430

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Aug 19, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Prevention

ClinConnect Summary

The "PrEP My Way" trial is studying a new approach to help young women in Kenya stay on PrEP, a medication that prevents HIV. This trial highlights a delivery system that starts with women receiving PrEP at a clinic and then providing them with peer support. Participants will receive kits for self-testing for HIV, refills for their PrEP, and tests for sexually transmitted infections like gonorrhea and chlamydia, along with pregnancy tests and contraception if they choose. The goal is to make using PrEP easier and more comfortable for young women, addressing common challenges like stigma and access.

To join the study, you need to be a young woman aged 16 to 24 who lives in Kisumu County and is starting PrEP. It's important that you own a phone and can understand either KiSwahili, DhoLuo, or English. If you participate, you’ll have the chance to choose from different types of PrEP and receive support from peers through text messages or group chats. The study will also look at how well this new approach helps women continue using PrEP and whether it is cost-effective. Your experience and feedback will be valuable in shaping future health services for young women.

Gender

FEMALE

Eligibility 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)

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Kisumu, , Kenya

Patients applied

0 patients applied

Trial Officials

Jessica Haberer, MD, MS

Principal Investigator

Director of Research, Center for Global Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported