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Combatting HIV Or Other STIs Early (CHOOSE)

RecruitingNAAges 13 Years - 24 YearsMaleWestat
NCT07510048 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.

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📋 Eligibility rules (as published)
Inclusion Criteria * Age 13-24 years, inclusive; * Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime; * Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package; * Not currently on PrEP and interested in learning more about PrEP; * Is not living with HIV; * Weighs at least 35 kg; * Willing to receive PrEP care from a provider at a participating ATN SC; * Able to understand, read, and speak English; * Able to participate at the study site; and * Willing and able to provide written informed consent. * If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation. * If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation. Exclusion Criteria: * Female; * In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months; * Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study); * Plan to move within 18 months to an area inaccessible to a participating ATN SC; * An employee of the participating SC; or * Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team. * Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.
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What it tests

  • Standard of care and PrEP Choice at Enrollment
  • Standard of care followed by PrEP Choice at Month 9
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Where

6 sites
San Francisco Department of Public Health
San Francisco, United States
Children's National Medical Center
Washington D.C., United States
University of South Florida
Tampa, United States
University Illinois Chicago
Chicago, United States
Tulane University
New Orleans, United States
St. Jude Children's Research Hospital
Memphis, United States
🤝 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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