HIVNCT07638618
Healthy Choices to Reduce Stigma and Improve Self-Management of Alcohol and HIV Among Young Adults
A study testing Healthy Choices in people with HIV and Alcohol Misuse, run by Florida State University at 1 site in United States.
Trial summary
The Spanish language Healthy Choices intervention pilot study (N=45) holds direct relevance to the United States and federal priorities related to improving HIV outcomes to reduce transmission using implementation science models. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV, Alcohol Misuse, Stigma
- What is being tested?
- Healthy Choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2027to 28 Feb 2029
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-29 years
- Have HIV
- Live in the Dominican Republic
- Speak Spanish
- Are unsuppressed
- Report being stigmatized in the past 6 months
- Report problem alcohol use in the past 6 months
- Can provide informed consent
Who cannot join
- Doe not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Florida State University
Tallahassee, Florida, 32310
Henna Budhwani, PhD, MPH, (850) 296-7509, hbudhwani@fsu.edu
About this study
The Spanish language Healthy Choices intervention pilot study (N=45) holds direct relevance to the United States and federal priorities related to improving HIV outcomes to reduce transmission using implementation science models. If Healthy Choices is found to have a clinical signal of impact, our team is committed to testing the intervention in the United States and training Spanish speaking HIV care navigators on the intervention, specifically in the southern United States where Spanish speaking populations are concentrated, namely in Alabama, Texas, New Mexico, Arizona, Nevada, and Florida.
Read the detailed description
Three specific aims will guide this work. Aim 1: Elucidate barriers and implementation strategies for the Healthy Choices intervention. Aim 2: Adapt and contextually translate the Healthy Choices intervention for Spanish contexts. Aim 3: Pilot test Healthy Choices with implementation strategies for feasibility and acceptability (N=45). By testing Healthy Choices in the Dominican Republic, we can move quickly with recruitment, ultimately maximizing benefit to Americans. If this study is successful and Healthy Choices is feasible and acceptable, we will have the preliminary data necessary for a full-scale hybrid type 1 effectiveness-implementation randomized controlled clinical trial of the Spanish language Healthy Choices intervention that can be tested in Spanish speaking communities in the United States. This record is for the scientific work detailed in Aim 3, specifically the 2:1 allocation pilot randomized controlled trial.
- Conditions
- HIV, Alcohol Misuse, Stigma
- Being tested
- Healthy Choices, Time Attention Control
- Keywords
- Behavioral Intervention, Young Adults with HIV
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy ChoicesBehavioural
Healthy Choices is a 4-session counseling intervention. Each session is ~30 minutes, and all Healthy Choices sessions are completed in 2 months. Sessions occur in a community setting selected by the YPWH and can be facilitated by a trained peer navigator. Sessions include specific strategies to overtly communicate acceptance and support autonomy to reduce stigma and increase motivational statements, known as change talk. Information or advice is given in Motivational Interviewing-consistent and developmentally appropriate ways. The peer navigator is trained to de-emphasize counter change talk in decisional balance and non-selective reflection
Time Attention ControlOther
Counseling on diet and nutrition in the same 4 session format.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Choices | Experimental | Healthy Choices Receives: Behavioral: Healthy Choices |
| Control | Sham comparator | Time Attention Control Receives: Other: Time Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility by the Feasibility of Intervention Measure (9 items)
Measured: Within 6 Month Post-Enrollment
Acceptability of the Intervention
Acceptability derived from the Acceptability of Intervention Measure (12 items)
Measured: Within 6 Month Post-Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Oct 2027 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Complete a 2:1 randomization of 45 young people with HIV (YPWH) with 30 to Healthy Choices and 15 to a non-HIV time attention control.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henna Budhwani, Florida State University
- Investigators
- Henna Budhwani, PhD, MPH, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638618
- Sponsor's protocol ID
- FP00007242
- Other IDs
- R01TW013191
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be deposited in the NICHD Data and Specimen Hub (DASH), a NIH-supported repository for HIV-related behavioral and intervention research or similar public access repository.
Publications
Budhwani H, Waters J, Wang B, Balan I, Naar S. Healthy Choices Intervention to Address Stigma, Alcohol Use, and Self-Management in Spanish-Speaking Young People With HIV: Protocol for a Pilot Randomized Controlled Implementation Study. JMIR Res Protoc. 2026 Jul 29;15:e103611. doi: 10.2196/103611.
PubMed 42525441
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Choices to Reduce Stigma and Improve Self-Management of Alcohol and HIV Among Young Adults
- ClinicalTrials.gov ID
- NCT07638618
- Acronym / sponsor ID
- FP00007242
- Conditions
- HIV, Alcohol Misuse, Stigma
- Keywords
- Behavioral Intervention, Young Adults with HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 10 Jun 2026 (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 Spanish language Healthy Choices intervention pilot study (N=45) holds direct relevance to the United States and federal priorities related to improving HIV outcomes to reduce transmission using implementation science models. If Healthy Choices is found to have a clinical signal of impact, our team is committed to testing the intervention in the United States and training Spanish speaking HIV care navigators on the intervention, specifically in the southern United States where Spanish speaking populations are concentrated, namely in Alabama, Texas, New Mexico, Arizona, Nevada, and Florida.
Detailed description
Three specific aims will guide this work. Aim 1: Elucidate barriers and implementation strategies for the Healthy Choices intervention. Aim 2: Adapt and contextually translate the Healthy Choices intervention for Spanish contexts. Aim 3: Pilot test Healthy Choices with implementation strategies for feasibility and acceptability (N=45). By testing Healthy Choices in the Dominican Republic, we can move quickly with recruitment, ultimately maximizing benefit to Americans. If this study is successful and Healthy Choices is feasible and acceptable, we will have the preliminary data necessary for a full-scale hybrid type 1 effectiveness-implementation randomized controlled clinical trial of the Spanish language Healthy Choices intervention that can be tested in Spanish speaking communities in the United States. This record is for the scientific work detailed in Aim 3, specifically the 2:1 allocation pilot randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Complete a 2:1 randomization of 45 young people with HIV (YPWH) with 30 to Healthy Choices and 15 to a non-HIV time attention control.
| Arm | Type | Receives |
|---|---|---|
| Healthy Choices | Experimental | Behavioral: Healthy ChoicesHealthy Choices |
| Control | Sham comparator | Other: Time Attention ControlTime Attention Control |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18-29 years
- Have HIV
- Live in the Dominican Republic
- Speak Spanish
- Are unsuppressed
Key exclusion criteria (1 listed)
- Doe not meet the inclusion criteria.
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 a 4-session counseling intervention. Each session is ~30 minutes, and all Healthy Choices sessions are completed in 2 months. Sessions occur in a community setting selected by the YPWH and can be facilitated by a trained peer navigator. Sessions include specific strategies to overtly communicate acceptance and support autonomy to reduce stigma and increase motivational statements, known as change talk. Information or advice is given in Motivational Interviewing-consistent and developmentally appropriate ways. The peer navigator is trained to de-emphasize counter change talk in decisional balance and non-selective reflection | Behavioural | Healthy Choices |
| Time Attention ControlCounseling on diet and nutrition in the same 4 session format. | Other | Control |
Primary outcome
Feasibility of the Intervention
Time frame: Within 6 Month Post-Enrollment
Feasibility by the Feasibility of Intervention Measure (9 items)
Acceptability of the Intervention
Time frame: Within 6 Month Post-Enrollment
Acceptability derived from the Acceptability of Intervention Measure (12 items)
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 10 Jun 2026.
- Derived from this study: PubMed 42525441Budhwani H, Waters J, Wang B, Balan I, Naar S. Healthy Choices Intervention to Address Stigma, Alcohol Use, and Self-Management in Spanish-Speaking Young People With HIV: Protocol for a Pilot Randomized Controlled Implementation Study. JMIR Res Protoc. 2026 Jul 29;15:e103611. doi: 10.2196/103611.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited in the NICHD Data and Specimen Hub (DASH), a NIH-supported repository for HIV-related behavioral and intervention research or similar public access repository.
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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.
Henna Budhwani, PhD, MPH principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Choices in people with HIV and Alcohol Misuse, run by Florida State University at 1 site 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 8 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 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 1 site 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. Some participants in this study may receive a placebo. 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?
Contact Henna Budhwani, PhD, MPH ((850) 296-7509, hbudhwani@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Within 6 Month Post-Enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07638618, which also lists 1 linked publication.
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 10 Jun 2026.