[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07638618":3,"trial-entities:NCT07638618":95,"trial-summary:NCT07638618":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":67,"locations":69,"central_contacts":84,"overall_officials":86,"references":89,"see_also_links":94},"NCT07638618","FP00007242","Healthy Choices to Reduce Stigma and Improve Self-Management of Alcohol and HIV Among Young Adults","NOT_YET_RECRUITING","2029-02-28","2026-06","2026-06-10","2027-10-01","Florida State University","OTHER",null,"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.",[18,19,20],"HIV","Alcohol Misuse","Stigma",[22,23],"Behavioral Intervention","Young Adults with HIV","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},45,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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 developmentally appropriate ways. The peer navigator is trained to de-emphasize counter change talk in decisional balance and non-selective reflection",[34],{"type":13,"name":38,"description":39,"armGroupLabels":40},"Time Attention Control","Counseling on diet and nutrition in the same 4 session format.",[41],"Control",[43,47],{"measure":44,"description":45,"timeFrame":46},"Feasibility of the Intervention","Feasibility by the Feasibility of Intervention Measure (9 items)","Within 6 Month Post-Enrollment",{"measure":48,"description":49,"timeFrame":46},"Acceptability of the Intervention","Acceptability derived from the Acceptability of Intervention Measure (12 items)",[],"ALL","18 Years","29 Years",false,{"inclusion":56,"exclusion":65,"raw_text":66},[57,58,59,60,61,62,63,64],"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",[],"Inclusion Criteria:\n\n* Aged 18-29 years\n* Have HIV\n* Live in the Dominican Republic\n* Speak Spanish\n* Are unsuppressed\n* Report being stigmatized in the past 6 months\n* Report problem alcohol use in the past 6 months\n* Can provide informed consent\n\nExclusion Criteria:\n\n* Doe not meet the inclusion criteria.",[68],"ADULT",[70],{"facility":12,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Tallahassee","Florida","32310","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Henna Budhwani, PhD, MPH","CONTACT","(850) 296-7509","hbudhwani@fsu.edu",{"lat":82,"lon":83},30.43826,-84.28073,[85],{"name":77,"role":78,"phone":79,"email":80},[87],{"name":77,"affiliation":12,"role":88},"PRINCIPAL_INVESTIGATOR",[90],{"pmid":91,"type":92,"citation":93},"42525441","DERIVED","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\u002F103611.",[],{"nct_id":4,"conditions":96,"biomarkers":99},[97,98,20],"Alcohol use disorder","HIV Infection",[],{"nct_id":4,"found":54,"summary":14,"prompt_version":14}]