HivNCT06934395
SHARE Program: SUSTAIN
A study testing Healthy Choices and Text Message Prompts in people with Hiv, run by Florida State University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Healthy Choices and Text Message Prompts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Mar 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Adults unable to consent
- Prisoners
- Those using long-acting injectables as HIV medication regimen
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48106
Northeastern University
Boston, Massachusetts, 02115
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310
University of South Florida
Tampa, Florida, 33620
About this study
Official title: Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
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).
Read the 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.
- Conditions
- Hiv
- Being tested
- Healthy Choices, Text Message Prompts
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy ChoicesBehavioural
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 PromptsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Within-participant micro-randomization - Prompt | Experimental | Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress. Receives: Behavioral: Text Message Prompts |
| Within-participant micro-randomization - No Prompt | No intervention | Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress. |
| Between-participant randomization - CIAS + Week 2 Coaching Session | Experimental | 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). Receives: Behavioral: Healthy Choices |
| Between-participant randomization - CIAS + No Week 2 Coaching Session | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
ART Adherence
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.
Measured: Daily for 56 Days
Secondary outcomes (2)
Alcohol Use
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.
Measured: Baseline, 3 month, and 6 month
HIV Viral Load
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.'
Measured: Baseline, 3 month, and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start22 Mar 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Northeastern University, University of Michigan, University of South Florida, CAN Community Health, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sylvie Naar, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934395
- Sponsor's protocol ID
- STUDY00002536
- Other IDs
- 5P01AA029547
- Status last verified
- Jun 2026
- First submitted
- 11 Apr 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
- ClinicalTrials.gov ID
- NCT06934395
- Acronym / sponsor ID
- STUDY00002536
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of Florida, Northeastern University, University of Michigan, University of South Florida, CAN Community Health, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Within-participant micro-randomization - Prompt | Experimental | Behavioral: Text Message PromptsParticipants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress. |
| Within-participant micro-randomization - No Prompt | No intervention | –Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress. |
| Between-participant randomization - CIAS + Week 2 Coaching Session | Experimental | Behavioral: Healthy ChoicesParticipants 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). |
| Between-participant randomization - CIAS + No Week 2 Coaching Session | No intervention | –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). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Adults unable to consent
- Prisoners
- Those using long-acting injectables as HIV medication regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy ChoicesHealthy 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 | Behavioural | Between-participant randomization - CIAS + Week 2 Coaching Session |
| Text Message PromptsThis 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 . | Behavioural | Within-participant micro-randomization - Prompt |
Primary outcome
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.
2 secondary outcomes
Alcohol Use
Time frame: Baseline, 3 month, and 6 month
HIV Viral Load
Time frame: Baseline, 3 month, and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Choices and Text Message Prompts in people with Hiv, run by Florida State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART Adherence (time frame: Daily for 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.