An interventional study of Healthy Choices and Time Attention Control in HIV, Alcohol Misuse and Stigma, sponsored by Florida State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Florida State University · Not applicable, Interventional, and Supportive care
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.
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.
105 studies on the registry are indexed under Social Stigma; 48 are open to participants now.
This study's planned enrollment of 45 is below the median of 120 across 87 interventional studies indexed under Social Stigma.
Browse Social Stigma studies →Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy Choices
Behavioral: Healthy Choices
Time Attention Control
Other: Time Attention Control
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
Counseling on diet and nutrition in the same 4 session format.
Feasibility of the Intervention
Feasibility by the Feasibility of Intervention Measure (9 items)
Time frame: Within 6 Month Post-Enrollment
Acceptability of the Intervention
Acceptability derived from the Acceptability of Intervention Measure (12 items)
Time frame: Within 6 Month Post-Enrollment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data will be deposited in the NICHD Data and Specimen Hub (DASH), a NIH-supported repository for HIV-related behavioral and intervention research or similar public access repository.
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Florida State University