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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07638618
Enrollment
45
Registered
2026-06-10
Start date
2027-10-01
Completion date
2029-02-28
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Misuse, HIV, Stigma

Keywords

Behavioral Intervention, Young Adults with HIV

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.

Interventions

BEHAVIORALHealthy 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

OTHERTime Attention Control

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

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the InterventionWithin 6 Month Post-EnrollmentFeasibility by the Feasibility of Intervention Measure (9 items)
Acceptability of the InterventionWithin 6 Month Post-EnrollmentAcceptability derived from the Acceptability of Intervention Measure (12 items)

Countries

United States

Contacts

CONTACTHenna Budhwani, PhD, MPH
hbudhwani@fsu.edu(850) 296-7509
PRINCIPAL_INVESTIGATORHenna Budhwani, PhD, MPH

Florida State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026