Clinical trial NCT06934395: SHARE Program: SUSTAIN
Official title: Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: University of Florida
name: Northeastern University
name: University of Michigan
name: University of South Florida
name: CAN Community Health
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ART Adherence
timeFrame: Daily for 56 Days
Secondary outcomes:
measure: Alcohol Use
timeFrame: Baseline, 3 month, and 6 month
measure: HIV Viral Load
timeFrame: Baseline, 3 month, and 6 month
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Center for Translational Behavioral Science
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: