SHARE Program: SUSTAIN
Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
2 other identifiers
interventional
150
1 country
4
Brief Summary
The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and scalable intervention designed to improve self-management of alcohol and HIV in Young People with HIV (YPWH) while understanding the context for state-wide implementation and sustainment in a Hybrid Experimental Design (HED). SUSTAIN utilizes mHealth and telehealth intervention delivery of Healthy Choices (HC), combined with text messaging between sessions, to increase the likelihood of daily medication adherence (primary outcome), and increase the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (secondary outcome).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Mar 2025
Shorter than P25 for not_applicable hiv
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2025
CompletedFirst Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 19, 2025
June 1, 2025
1.4 years
April 11, 2025
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ART Adherence
Antiretroviral (ART) adherence will be assessed daily using an Ecological Momentary Assessment (EMA) survey delivered via SMS. Individuals will be asked whether they took some or all of their medication.
Daily for 56 Days
Secondary Outcomes (2)
Alcohol Use
Baseline, 3 month, and 6 month
HIV Viral Load
Baseline, 3 month, and 6 month
Study Arms (4)
Within-participant micro-randomization - Prompt
EXPERIMENTALParticipants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.
Within-participant micro-randomization - No Prompt
NO INTERVENTIONParticipants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.
Between-participant randomization - CIAS + Week 2 Coaching Session
EXPERIMENTALParticipants 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).
Between-participant randomization - CIAS + No Week 2 Coaching Session
NO INTERVENTIONParticipants 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).
Interventions
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
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
You may qualify if:
- Be 18 years and 0 months to 29 years and 11 months.
- 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.
You may not qualify if:
- Adults unable to consent
- Prisoners
- Those using long-acting injectables as HIV medication regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida State Universitylead
- University of Floridacollaborator
- Northeastern Universitycollaborator
- University of Michigancollaborator
- University of South Floridacollaborator
- CAN Community Healthcollaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (4)
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310, United States
University of South Florida
Tampa, Florida, 33620, United States
Northeastern University
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 18, 2025
Study Start
March 22, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 19, 2025
Record last verified: 2025-06