NCT07510048

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

Combatting HIV Or Other STIs Early (CHOOSE): An Integrated Strategy of Pre-Exposure Prophylaxis (PrEP) Mobile Health (mHealth) Support and Doxycycline Post-Exposure Prophylaxis (DoxyPEP)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Westat · Academic / Other
• Sex: Male
• Age: 13 Years – 24 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• HIV
• STIs
• STIs Prevention
• HIV Prevention

Interventions

Type	Name	Description
OTHER	Standard of care and PrEP Choice at Enrollment	Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.
OTHER	Standard of care followed by PrEP Choice at Month 9	Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

6 sites across 1 country: United States