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NOT YET RECRUITING
NCT07510048
PHASE2

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

Sponsor: Westat

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

MALE

Age Range

13 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-04

Completion Date

2029-09

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

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.

Locations (6)

San Francisco Department of Public Health

San Francisco, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of South Florida

Tampa, Florida, United States

University Illinois Chicago

Chicago, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States