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

RecruitingNAAges 16 Years - 24 YearsFemaleMassachusetts General Hospital
NCT06566430 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fr

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📋 Eligibility rules (as published)
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)
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What it tests

  • PrEP My Way intervention
  • PrEP My Way intervention without STI testing
  • Enhanced standard of care
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Where

1 site
Kenya Medical Research Institute
Kisumu, Kenya
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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