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Healthy Choices Intervention for Alcohol Use and HIV Risk

(HC-HMP Trial)

SN
SG
Overseen BySara Green, MSW
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Florida State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SN

Sylvie Naar, PhD

Principal Investigator

Florida State University

LH

Lisa Hightow-Weidman, MD, MPH

Principal Investigator

Florida State University College of Nursing

SG

Sara Green, MSW

Principal Investigator

Florida State University College of Medicine, Center for Translational Behavioral Science

Are You a Good Fit for This Trial?

This trial is for adults aged 18-29 who are living with or at risk for HIV, eligible for HIV treatment or prevention medication, and have recently used alcohol.

Inclusion Criteria

I am between 18 and 29 years old.
Resident of the United States
Able to read and understand English
See 3 more

Exclusion Criteria

Pregnant at the time of screening
Currently incarcerated
I am not able to give legal consent for my medical treatment.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • HealthMpowerment (HMP)
  • Healthy Choices (HC)
  • High-Touch: Asynchronous Support
  • Low-Touch: Video Introduction
  • Medium-Touch: Tailored Text Messaging

Trial Overview

The study tests different ways to deliver a digital health program called Healthy Choices (HC) through the HealthMpowerment (HMP) platform. Participants get HC-HMP plus combinations of video introductions, tailored text messages, and online counselor support.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: Factorial Condition 8Experimental Treatment5 Interventions
Group II: Factorial Condition 7Experimental Treatment4 Interventions
Group III: Factorial Condition 6Experimental Treatment4 Interventions
Group IV: Factorial Condition 5Experimental Treatment4 Interventions
Group V: Factorial Condition 4Experimental Treatment3 Interventions
Group VI: Factorial Condition 3Experimental Treatment3 Interventions
Group VII: Factorial Condition 2Experimental Treatment3 Interventions
Group VIII: Factorial Condition 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

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