SHARE Program: SUSTAIN

Not Applicable

Recruiting

• Conditions: Hiv

• Registration Number: NCT06934395
• Lead Sponsor: Florida State University

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).

Detailed Description

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.

Study Timeline

• Study Start: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
ART Adherence	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 Outcome Measures

Name	Time	Method
Alcohol Use	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.
HIV Viral Load	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.'

Trial Locations

Locations (4)

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