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NCT Number: NCT07638618

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

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.

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Key information

Conditions

HIV Alcohol Misuse Behavior Social Behavior Social Stigma Stigma

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Choices

Behavioral

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 Control

Other

Counseling on diet and nutrition in the same 4 session format.

Primary outcomes

  1. Feasibility of the Intervention

    Time frame: Within 6 Month Post-Enrollment

    Feasibility by the Feasibility of Intervention Measure (9 items)

  2. Acceptability of the Intervention

    Time frame: Within 6 Month Post-Enrollment

    Acceptability derived from the Acceptability of Intervention Measure (12 items)

Study contacts

Contact information is provided by the study sponsor or research team.

Henna Budhwani, PhD, MPH

CONTACT

[email protected]

(850) 296-7509

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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