Combatting HIV Or Other STIs Early (CHOOSE) in an RCT of mHealth Tool Support

Westat

Status and phase: Not yet enrolling; Phase 2

Conditions: HIV Prevention; HIV; STIs Prevention; STIs

Treatments: Other: Standard of care followed by PrEP Choice at Month 9; Other: Standard of care and PrEP Choice at Enrollment

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07510048

ATN166 Phase 2

Details and patient eligibility

About

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.

Full description

This is an individual-level randomized trial with a wait-list control and provides PrEP and DoxyPEP for study participants at the Adolescent Medicine Trials Network for HIV Interventions (ATN) Site Consortiums (SCs). This study will be conducted to determine the efficacy and cost of the PrEP Choice package on initiation and long-term adherence (persistence) of PrEP use over 18 months among young people (n=200). All participants will receive brief, basic counseling about the different PrEP methods and a PrEP handout from the participating SC. They will also receive counseling and a handout about DoxyPEP. Participants in the intervention arm will receive the PrEP Choice package starting at enrollment. Participants in the control arm will receive the PrEP Choice package starting at 9 months after enrollment. Both intervention and control groups will be followed for a total of 18 months.

All PrEP drugs will be dispensed by the participating SCs. Participants can select from the following PrEP agents and regimens:

(1) daily oral tenofovir/emtricitabine (tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]; (2) daily oral tenofovir alafenamide (TAF)/FTC; (3) 2-1-1 event-driven oral TDF/FTC; (4) bimonthly long-acting injectable cabotegravir (CAB-LA); or (5) twice yearly long-acting injectable lenacapavir (LEN). Participants can opt to start PrEP or change regimens at any time in the 18 months of follow-up. At 9 months, participants originally randomized to the control condition will begin to receive the PrEP Choice package in a wait-list control design. This addresses ethical concerns about withholding a potentially effective intervention from the control arm for an extended period. This design also allows for comparison both between arms (intervention versus control), as well as within arms (before versus after the PrEP Choice package in control arm) and allows measurement of extended outcomes and switching patterns for those initially randomized to the PrEP Choice package over 18 months. In addition, DoxyPEP will be offered to both study arms throughout the study.

Enrollment: 200 estimated patients

Sex: Male

Ages: 13 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Standard of Care and PrEP Choice at Enrollment

Experimental group

Description:

Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.

Treatment:

Other: Standard of care and PrEP Choice at Enrollment

Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9

Active Comparator group

Description:

Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.

Treatment:

Other: Standard of care followed by PrEP Choice at Month 9