SHARE Program: SUSTAIN
Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tallahassee, Florida, United States, 32310
- Florida State University, Center for Translational Behavioral Science
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Tampa, Florida, United States, 33620
- University of South Florida
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Northeastern University
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Michigan
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Ann Arbor, Michigan, United States, 48106
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Within-participant micro-randomization - Prompt
Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.
|
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 .
|
|
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). |
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
|
|
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.
|
|
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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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Daily for 56 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, 3 month, and 6 month
|
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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.'
|
Baseline, 3 month, and 6 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- STUDY00002536
- 5P01AA029547 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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