Healthy Choices to Reduce Stigma and Improve Self-Management of Alcohol and HIV Among Young Adults

June 4, 2026 updated by: Henna Budhwani, Florida State University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Henna Budhwani, PhD, MPH
  • Phone Number: (850) 296-7509
  • Email: hbudhwani@fsu.edu

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32310
        • Florida State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Doe not meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Choices
Behavioral: Healthy Choices
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
Sham Comparator: Control
Time Attention Control
Other: Time Attention Control
Counseling on diet and nutrition in the same 4 session format.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Intervention
Time Frame: Within 6 Month Post-Enrollment
Feasibility by the Feasibility of Intervention Measure (9 items)
Within 6 Month Post-Enrollment
Acceptability of the Intervention
Time Frame: Within 6 Month Post-Enrollment
Acceptability derived from the Acceptability of Intervention Measure (12 items)
Within 6 Month Post-Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Investigators

  • Principal Investigator: Henna Budhwani, PhD, MPH, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00007242
  • R01TW013191 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Files will be attached to this record and will be made available for as long as this record Is publicly available.

IPD Sharing Access Criteria

Upon upload, data will be publicly available upon request via controlled-access mechanism to ensure protection of sensitive information, given the stigmatized nature of HIV and potential re-identification risks in small populations. Access will be granted to qualified researchers under a data use agreement prohibiting attempts at re-identification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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