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Clinical Trials/NCT07638618
NCT07638618Not yet recruitingNot Applicable

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

Florida State University1 site in 1 country45 target enrollmentStarted: October 1, 2027Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
45
Locations
1

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 29 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 18-29 years
  • 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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henna Budhwani

Endowed Professor

Florida State University

Study Sites (1)

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