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

NCT07638618 | Not Yet Recruiting

• 2 other identifiers: FP00007242R01TW013191
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Alcohol Misuse; Stigma

Keywords

Behavioral Intervention; Young Adults with HIV

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Intervention

  Feasibility by the Feasibility of Intervention Measure (9 items)

  Within 6 Month Post-Enrollment

• Acceptability of the Intervention

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

  Within 6 Month Post-Enrollment

Study Arms (2)

Healthy Choices

EXPERIMENTAL

Healthy Choices

Behavioral: Healthy Choices

Control

SHAM COMPARATOR

Time Attention Control

Other: Time Attention Control

Interventions

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

Healthy Choices

Time Attention Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Henna Budhwani, PhD, MPH

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henna Budhwani, PhD, MPH

CONTACT

(850) 296-7509; hbudhwani@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Files will be attached to this record and will be made available for as long as this record Is publicly available.
• 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.

Locations

US (1)