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Not yet recruitingNCT07911644HC-HMPUpdated Nov 3, 2026

HC-HMP: Healthy Choices Implementation Trial

An interventional study of Healthy Choices (HC) and HealthMpowerment (HMP) in Alcohol Drinking and HIV Infections, sponsored by Florida State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Primary conditionHIV InfectionsRegistry: Alcohol DrinkingReclassifiedWhy we changed it
Registry
Alcohol Drinking — the first condition term the registry derived for this study.
ClinicalTrials.gg
HIV Infections
Why
  1. Alcohol Drinking is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name HIV Infections.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Florida State University · Not applicable, Interventional, and Health services research

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alcohol Drinking
  • HIV Infections

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03

In context

HIV Infections Reclassified

4,344 studies on the registry are indexed under HIV Infections; 243 are open to participants now.

This study's planned enrollment of 360 is above the median of 83 across 3,315 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Florida State University is the lead sponsor of 247 studies on the registry; 47 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Browse Florida State University studies →

Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • Active heavy illegal drug use that is unmanaged/not currently in treatment, as defined by the study eligibility screener
  • Moderate-to-severe suicide risk, including suicidal ideation with plan, as defined by study eligibility and safety procedures
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Factorial Condition 1

    Participants receive HC-HMP without any of the three implementation strategies (Video Introduction, Tailored Digital Messaging, or Asynchronous Support).

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP)

  • Experimental
    Factorial Condition 2

    Participants receive HC-HMP with the Low-Touch implementation strategy (Video Introduction) and without the Medium-Touch or High-Touch implementation strategies.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: Low-Touch: Video Introduction

  • Experimental
    Factorial Condition 3

    Participants receive HC-HMP with the Medium-Touch implementation strategy (Tailored Digital Messaging) and without the Low-Touch or High-Touch implementation strategies.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: Medium-Touch: Tailored Text Messaging

  • Experimental
    Factorial Condition 4

    Participants receive HC-HMP with the High-Touch implementation strategy (Asynchronous Support) and without the Low-Touch or Medium-Touch implementation strategies.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: High-Touch: Asynchronous Support

  • Experimental
    Factorial Condition 5

    Participants receive HC-HMP with the Low-Touch (Video Introduction) and Medium-Touch (Tailored Digital Messaging) implementation strategies and without the High-Touch implementation strategy.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: Low-Touch: Video Introduction · Behavioral: Medium-Touch: Tailored Text Messaging

  • Experimental
    Factorial Condition 6

    Participants receive HC-HMP with the Low-Touch (Video Introduction) and High-Touch (Asynchronous Support) implementation strategies and without the Medium-Touch implementation strategy.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: Low-Touch: Video Introduction · Behavioral: High-Touch: Asynchronous Support

  • Experimental
    Factorial Condition 7

    Participants receive HC-HMP with the Medium-Touch (Tailored Digital Messaging) and High-Touch (Asynchronous Support) implementation strategies and without the Low-Touch implementation strategy.

    Behavioral: Healthy Choices (HC) · Behavioral: HealthMpowerment (HMP) · Behavioral: Medium-Touch: Tailored Text Messaging · Behavioral: High-Touch: Asynchronous Support

  • Experimental
    Factorial Condition 8

    Participants receive HC-HMP with all three implementation strategies: Low-Touch (Video Introduction), Medium-Touch (Tailored Digital Messaging), and High-Touch (Asynchronous Support).

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

Interventions

  • BehavioralHealthy Choices (HC)

    Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

  • BehavioralHealthMpowerment (HMP)

    HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

  • BehavioralLow-Touch: Video Introduction

    Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

  • BehavioralMedium-Touch: Tailored Text Messaging

    Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

  • BehavioralHigh-Touch: Asynchronous Support

    Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

06

What researchers measure

Primary outcomes

  1. Healthy Choices Direct-to-Consumer Fidelity

    Number of Healthy Choices counseling sessions completed by each participant during the 3-month intervention period. Participants may complete 0 to 4 sessions. A session is considered completed when the participant attends at least 15 minutes of the 30-minute virtual session.

    Time frame: Baseline through 3 months

Secondary outcomes

  1. HealthMpowerment Fidelity

    Engagement with the HealthMpowerment platform assessed using platform-generated usage paradata, including frequency of logins, time spent on the platform, and use of individual HMP features.

    Time frame: Baseline through 6 months

  2. Maximum Alcohol Consumption Over a 3-Day Period

    Alcohol use assessed using the Timeline Followback (TLFB), which assesses daily alcohol consumption during the prior 14 days. The outcome is the maximum number of drinks consumed during a 3-day period.

    Time frame: Baseline, 3 months, and 6 months

  3. HIV Transmission Risk

    Dichotomous status-neutral HIV transmission risk measure based on participant self-report. Participants reporting no condomless anal or vaginal intercourse, PrEP adherence of more than four doses per week, or self-reported viral suppression are classified as low risk (0); participants not meeting any of these criteria are classified as higher risk (1).

    Time frame: Baseline, 3 months, and 6 months

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for Aug 2030, 38 months later.

Of 550 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 38 months is above that.

Counting every sponsor, half of 560 studies reached it within 28 months; a quarter within 16 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartEst.
Jun 1, 2027
Primary completionEst.
Aug 31, 2030
CompletionEst.
Nov 30, 2030
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07911644
Lead sponsor
Florida State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Jun 1, 2027 (estimated)
Primary completion
Aug 31, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Sylvie Naar, PhD
Contact
sylvie.naar@med.fsu.edu
850-644-2334
Sara Green, MSW
Contact
sara.green@med.fsu.edu
850-644-2334
Sylvie Naar, PhD
principal investigator · Florida State University
Lisa Hightow-Weidman, MD, MPH
principal investigator · Florida State University College of Nursing
Sara Green, MSW
study director · Florida State University College of Medicine, Center for Translational Behavioral Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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