Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-03-22
2026-07-31
Brief Summary
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Detailed Description
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Secondary aim: To test whether offering (vs. not offering) a Healthy Choices telehealth coaching session at the end of week 2 (day 14) increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3.
Implementation Aim: Assess barriers and facilitators to the implementation and sustainment of intervention sequences for state-wide scale up using mixed methods (EPIS qualitative interviews, youth satisfaction and dose received, fidelity for telehealth, paradata for mHealth, and cost-effectiveness analysis).
Cross-project Moderator Aim: Explore age, biological sex and gender, ethnicity, other substance use, and mental health as moderators of intervention effects.
Primary hypothesis to be tested: Delivering (vs. not delivering) a text messaged prompt will lead to greater likelihood of medication adherence by the end of the current day.
Secondary hypothesis to be tested: Offering a Healthy Choices telehealth coaching at the end of week 2 will lead to greater likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (post-intervention) compared to not offering a Healthy Choices telehealth coaching session at the end of week 2.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Within-participant micro-randomization - Prompt
Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.
Text Message Prompts
This within-participant micro-randomization will test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day .
Within-participant micro-randomization - No Prompt
Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.
No interventions assigned to this group
Between-participant randomization - CIAS + Week 2 Coaching Session
Participants will be randomized at the end of week 2 (day 14) to receive the Healthy Choices telehealth intervention with trained interventionist at week 2.
All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).
Healthy Choices
Healthy Choices is an adapted and developmentally tailored intervention designed to address self-management of risk behaviors and HIV from Motivational Enhancement Therapy, a brief alcohol intervention in SAMHSA's registry of evidenced-based programs. For the purposes of this project, this intervention will be delivered as a combination approach, with all participants receiving an initial session via CIAS, and randomized to either receiving a telehealth session with a trained interventionist at week 2, with additional randomizations for telehealth sessions at weeks 4 and 6. The goal is to test if delivering (vs. not delivering) a coaching session increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3
Between-participant randomization - CIAS + No Week 2 Coaching Session
Participants will be randomized at the end of week 2 (day 14) to NOT receive the Healthy Choices telehealth intervention with trained interventionist at week 2.
All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).
No interventions assigned to this group
Interventions
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Healthy Choices
Healthy Choices is an adapted and developmentally tailored intervention designed to address self-management of risk behaviors and HIV from Motivational Enhancement Therapy, a brief alcohol intervention in SAMHSA's registry of evidenced-based programs. For the purposes of this project, this intervention will be delivered as a combination approach, with all participants receiving an initial session via CIAS, and randomized to either receiving a telehealth session with a trained interventionist at week 2, with additional randomizations for telehealth sessions at weeks 4 and 6. The goal is to test if delivering (vs. not delivering) a coaching session increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3
Text Message Prompts
This within-participant micro-randomization will test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day .
Eligibility Criteria
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Inclusion Criteria
* Currently reside in Florida
* History of alcohol use
* Are not pregnant nor trying to conceive within the study's timeline
* Are able to read and understand English
* Have internet access via smartphone, tablet or computer
* Are willing to provide informed consent.
Exclusion Criteria
* Prisoners
* Those using long-acting injectables as HIV medication regimen
18 Years
29 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Northeastern University
OTHER
University of Michigan
OTHER
University of South Florida
OTHER
CAN Community Health
OTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Florida State University
OTHER
Responsible Party
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Sylvie Naar
Principal Investigator
Locations
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Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Northeastern University
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00002536
Identifier Type: -
Identifier Source: org_study_id
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