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Active, Not Recruiting

NCT Number: NCT06934395

SHARE Program: SUSTAIN

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Center for Translational Behavioral Science, Tallahassee, Florida, United States

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About this study

Primary aim: To 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Adults unable to consent
  • Prisoners
  • Those using long-acting injectables as HIV medication regimen

Treatment and study plan

Healthy Choices

Behavioral

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

Behavioral

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 .

Primary outcomes

  1. ART Adherence

    Time frame: Daily for 56 Days

    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.

Secondary outcomes

  1. Alcohol Use

    Time frame: Baseline, 3 month, and 6 month

    Alcohol will be assessed using the Timeline Followback (TLFB) measure to capture amount of drinking over a 30 day period, assessed at baseline, and at the 3 and 6 month follow-ups. Participants complete a 30 day calendar that assesses number of drinks per day and number of hours spent drinking per drinking day.

  2. HIV Viral Load

    Time frame: Baseline, 3 month, and 6 month

    HIV Viral Load collected via Dried Blood Spot (DBS) kits. The limit of detection (LOD) of the m2000 test is 832 copies/mL or Log 2.92 copies/mL. For samples with VL above the LOD (>Log 2.92) can be quantified so a VL is provided. In case of samples with less than LOD is given as <2.92 but it's reported as detected as the presence of HIV virus is detected but cannot be quantified as it's below the LOD so cannot be measured. And samples that are not detected are reported as 'not detected.'

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • CAN Community Health
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Northeastern University
  • University of Florida
  • University of Michigan
  • University of South Florida

Registry information

Official study title

Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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