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Combatting HIV Or Other STIs Early (CHOOSE)

Not Yet RecruitingPhase 2

Sponsor: Westat

Conditions: HIV, STIs, STIs Prevention, HIV Prevention

Interventions: Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 13 Years to 24 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (6)

San Francisco, California, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Memphis, Tennessee, United States