NCT07911644Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Scaling Up Integrated Youth Alcohol and HIV Prevention Interventions: The Healthy Choices Implementation Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This study is a national, fully virtual Type 3 hybrid implementation-effectiveness clinical trial using the Multiphase Optimization Strategy (MOST) to evaluate implementation strategies designed to optimize delivery of the Healthy Choices (HC) behavioral intervention through the HealthMpowerment (HMP) digital health platform. A total of 360 emerging adults ages 18-29 who are eligible for antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) and report recent alcohol use will be randomized using a factorial design to combinations of three implementation strategies: a personalized video introduction to an HC peer counselor, tailored digital messaging, and asynchronous support from an HC counselor. All participants receive HC-HMP. The primary implementation outcome is HC direct-to-consumer fidelity, measured by the number of HC counseling sessions completed. Secondary outcomes include HMP fidelity assessed using platform-generated paradata, alcohol use, and HIV transmission risk. Participants complete assessments at baseline, 3 months, and 6 months.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- 1 Jun 2027
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Florida State University
- Diseases
- HIV
- NCT number
- NCT07911644
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 1 Jun 2027 to the primary completion date, 31 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active heavy illegal drug use that is unmanaged/not currently in treatment, as defined by the study eligibility screener
Other
- Pregnant at the time of screening
- Currently incarcerated
- Unable to provide legally effective informed consent
- Self-reported unmanaged moderate-to-severe mental health symptoms or concerns that would interfere with safe study participation, including active psychosis
- Moderate-to-severe suicide risk, including suicidal ideation with plan, as defined by study eligibility and safety procedures
Who the study is looking for
- Age 18-29 years
- Resident of the United States
- Able to read and understand English
- Self-reported as eligible for HIV pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART)
- Self-reported alcohol use within the past 30 days
- Regular access to an internet-connected smartphone capable of supporting the HMP mobile application (Android version 7.0 or higher or iPhone iOS version 16.4 or higher)
Age in the registry: 18 years to 29 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Florida State University, Center for Translational Behavioral Science Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.