SHARE Program: SUSTAIN

NCT06934395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-19

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

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

BEHAVIORAL

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 .

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER
  • Northeastern University

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • University of South Florida

    collaborator OTHER
  • CAN Community Health

    collaborator OTHER
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Florida State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-22
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934395 on ClinicalTrials.gov