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Not yet recruiting NCT07638618

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

No phase Interventional HIV Alcohol Misuse Stigma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Choices, Time Attention Control.
Who it may be relevant to
Registry conditions: HIV, Alcohol Misuse, Stigma. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • Other Time Attention Control
    Counseling on diet and nutrition in the same 4 session format.

Primary outcome measures

  • Feasibility of the Intervention [Time frame: Within 6 Month Post-Enrollment]
  • Acceptability of the Intervention [Time frame: Within 6 Month Post-Enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Florida State University — Tallahassee

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. PMID 42525441

Identifiers

NCT: NCT07638618 · FP00007242 · R01TW013191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗