Alcohol DrinkingHC-HMPNCT07911644
HC-HMP: Healthy Choices Implementation Trial
A study testing Healthy Choices (HC), HealthMpowerment (HMP) and Low-Touch: Video Introduction in people with Alcohol Drinking and HIV Infections, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Alcohol Drinking, HIV Infections
- What is being tested?
- Healthy Choices (HC), HealthMpowerment (HMP) and Low-Touch: Video Introduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310
Sara Green, MSW, 8506442334, sara.green@med.fsu.edu
About this study
Official title: Scaling Up Integrated Youth Alcohol and HIV Prevention Interventions: The Healthy Choices Implementation 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.
- Conditions
- Alcohol Drinking, HIV Infections
- Being tested
- Healthy Choices (HC), HealthMpowerment (HMP), Low-Touch: Video Introduction, Medium-Touch: Tailored Text Messaging, High-Touch: Asynchronous Support
- Medical subject headings
- Alcohol Drinking, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Choices (HC)Behavioural
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.
HealthMpowerment (HMP)Behavioural
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.
Low-Touch: Video IntroductionBehavioural
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.
Medium-Touch: Tailored Text MessagingBehavioural
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.
High-Touch: Asynchronous SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Factorial Condition 1 | Experimental | Participants receive HC-HMP without any of the three implementation strategies (Video Introduction, Tailored Digital Messaging, or Asynchronous Support). Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP) |
| Factorial Condition 2 | Experimental | Participants receive HC-HMP with the Low-Touch implementation strategy (Video Introduction) and without the Medium-Touch or High-Touch implementation strategies. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Low-Touch: Video Introduction |
| Factorial Condition 3 | Experimental | Participants receive HC-HMP with the Medium-Touch implementation strategy (Tailored Digital Messaging) and without the Low-Touch or High-Touch implementation strategies. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Medium-Touch: Tailored Text Messaging |
| Factorial Condition 4 | Experimental | Participants receive HC-HMP with the High-Touch implementation strategy (Asynchronous Support) and without the Low-Touch or Medium-Touch implementation strategies. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: High-Touch: Asynchronous Support |
| Factorial Condition 5 | Experimental | 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. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Low-Touch: Video Introduction; Behavioral: Medium-Touch: Tailored Text Messaging |
| Factorial Condition 6 | Experimental | Participants receive HC-HMP with the Low-Touch (Video Introduction) and High-Touch (Asynchronous Support) implementation strategies and without the Medium-Touch implementation strategy. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Low-Touch: Video Introduction; Behavioral: High-Touch: Asynchronous Support |
| Factorial Condition 7 | Experimental | 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. Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Medium-Touch: Tailored Text Messaging; Behavioral: High-Touch: Asynchronous Support |
| Factorial Condition 8 | Experimental | Participants receive HC-HMP with all three implementation strategies: Low-Touch (Video Introduction), Medium-Touch (Tailored Digital Messaging), and High-Touch (Asynchronous Support). Receives: Behavioral: Healthy Choices (HC); Behavioral: HealthMpowerment (HMP); Behavioral: Low-Touch: Video Introduction; Behavioral: Medium-Touch: Tailored Text Messaging; Behavioral: High-Touch: Asynchronous Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 3 months
Secondary outcomes (3)
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.
Measured: Baseline through 6 months
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.
Measured: Baseline, 3 months, and 6 months
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).
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jun 2027 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sylvie Naar, PhD, Principal investigator, Florida State UniversityLisa Hightow-Weidman, MD, MPH, Principal investigator, Florida State University College of NursingSara Green, MSW, Study director, Florida State University College of Medicine, Center for Translational Behavioral Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911644
- Sponsor's protocol ID
- STUDY00007968
- Other IDs
- 1R01AA033555-01
- Acronym
- HC-HMP
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Integrated Youth Alcohol and HIV Prevention Interventions: The Healthy Choices Implementation Trial
- ClinicalTrials.gov ID
- NCT07911644
- Acronym / sponsor ID
- HC-HMP / STUDY00007968
- Conditions
- Alcohol Drinking, HIV Infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Factorial Condition 1 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP)Participants receive HC-HMP without any of the three implementation strategies (Video Introduction, Tailored Digital Messaging, or Asynchronous Support). |
| Factorial Condition 2 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Low-Touch: Video IntroductionParticipants receive HC-HMP with the Low-Touch implementation strategy (Video Introduction) and without the Medium-Touch or High-Touch implementation strategies. |
| Factorial Condition 3 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Medium-Touch: Tailored Text MessagingParticipants receive HC-HMP with the Medium-Touch implementation strategy (Tailored Digital Messaging) and without the Low-Touch or High-Touch implementation strategies. |
| Factorial Condition 4 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: High-Touch: Asynchronous SupportParticipants receive HC-HMP with the High-Touch implementation strategy (Asynchronous Support) and without the Low-Touch or Medium-Touch implementation strategies. |
| Factorial Condition 5 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Low-Touch: Video Introduction, Behavioral: Medium-Touch: Tailored Text MessagingParticipants receive HC-HMP with the Low-Touch (Video Introduction) and Medium-Touch (Tailored Digital Messaging) implementation strategies and without the High-Touch implementation strategy. |
| Factorial Condition 6 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Low-Touch: Video Introduction, Behavioral: High-Touch: Asynchronous SupportParticipants receive HC-HMP with the Low-Touch (Video Introduction) and High-Touch (Asynchronous Support) implementation strategies and without the Medium-Touch implementation strategy. |
| Factorial Condition 7 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Medium-Touch: Tailored Text Messaging, Behavioral: High-Touch: Asynchronous SupportParticipants receive HC-HMP with the Medium-Touch (Tailored Digital Messaging) and High-Touch (Asynchronous Support) implementation strategies and without the Low-Touch implementation strategy. |
| Factorial Condition 8 | Experimental | Behavioral: Healthy Choices (HC), Behavioral: HealthMpowerment (HMP), Behavioral: Low-Touch: Video Introduction, Behavioral: Medium-Touch: Tailored Text Messaging, Behavioral: High-Touch: Asynchronous SupportParticipants receive HC-HMP with all three implementation strategies: Low-Touch (Video Introduction), Medium-Touch (Tailored Digital Messaging), and High-Touch (Asynchronous Support). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy 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. | Behavioural | Factorial Condition 1, Factorial Condition 2, Factorial Condition 3, Factorial Condition 4, Factorial Condition 5, Factorial Condition 6, Factorial Condition 7, Factorial Condition 8 |
| HealthMpowerment (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. | Behavioural | Factorial Condition 1, Factorial Condition 2, Factorial Condition 3, Factorial Condition 4, Factorial Condition 5, Factorial Condition 6, Factorial Condition 7, Factorial Condition 8 |
| Low-Touch: Video IntroductionParticipants 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. | Behavioural | Factorial Condition 2, Factorial Condition 5, Factorial Condition 6, Factorial Condition 8 |
| Medium-Touch: Tailored Text MessagingParticipants 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. | Behavioural | Factorial Condition 3, Factorial Condition 5, Factorial Condition 7, Factorial Condition 8 |
| High-Touch: Asynchronous SupportParticipants 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. | Behavioural | Factorial Condition 4, Factorial Condition 6, Factorial Condition 7, Factorial Condition 8 |
Primary outcome
Healthy Choices Direct-to-Consumer Fidelity
Time frame: Baseline through 3 months
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.
3 secondary outcomes
HealthMpowerment Fidelity
Time frame: Baseline through 6 months
Maximum Alcohol Consumption Over a 3-Day Period
Time frame: Baseline, 3 months, and 6 months
HIV Transmission Risk
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Choices (HC), HealthMpowerment (HMP) and Low-Touch: Video Introduction in people with Alcohol Drinking and HIV Infections, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Naar, PhD (850-644-2334, sylvie.naar@med.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Choices Direct-to-Consumer Fidelity (time frame: Baseline through 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.