SHARE Program: SUSTAIN

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06934395
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • 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 .

Study Details

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).

Key Dates

Start date
Mar 22, 2025
Status verified
Jun 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Within-participant micro-randomization - Prompt
    Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.
  • No Intervention: Within-participant micro-randomization - No Prompt
    Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.
  • Experimental: Between-participant randomization - CIAS + Week 2 Coaching Session
    Participants 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).
  • No Intervention: Between-participant randomization - CIAS + No Week 2 Coaching Session
    Participants 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).

Primary Outcome Measure

ART Adherence [ Time Frame: Daily for 56 Days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Florida State University, Center for Translational Behavioral ScienceTallahasseeFlorida32310-
University of South FloridaTampaFlorida33620-
Northeastern UniversityBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48106-

Find similar trials in Tallahassee, FL

By condition
HIV
By specialty
Infectious disease
By research site
Florida State University, Center for Translational Behavioral Science· Tallahassee, FLUniversity of South Florida· Tampa, FLNortheastern University· Boston, MAUniversity of Michigan· Ann Arbor, MI

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