[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07112001":3,"trial-entities:NCT07112001":79,"trial-summary:NCT07112001":83},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":63,"locations":66,"central_contacts":75,"overall_officials":76,"references":77,"see_also_links":78},"NCT07112001","202003223","A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression","Adaptation and Implementation of a Behavioral mHealth Intervention to Reduce Anxiety and Depression and End the HIV Epidemic in the Rural South","ACTIVE_NOT_RECRUITING","2026-11-30","2026-09","2026-09-10","2025-07-31","University of Florida","OTHER",false,"This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.","The investigators will conduct a pilot randomized controlled trial to evaluate the preliminary effectiveness of an adapted community health worker (CWH)-delivered positive affect counselling intervention delivered remotely via mHealth. The adapted intervention will include CHW-delivered positive affect skill-based counseling accessible through video call that will be accessible through the mHealth app. The CHW will conduct approximately 5 weekly individual 60-minute counseling sessions via a secure video call feature. If the participant does not have symptomatic improvement, the CHW will refer the participant to a licensed mental health professional. Participants will be randomized to receive access to the counselling intervention that also includes modified features of the mHealth app with increased mental health resources (intervention arm) or to current standard of mental health care that includes the unmodified version of the app (control arm). Participants allocated to the intervention arm will receive the counseling intervention approximately weekly for 5 weeks. The study will continue to abstract data from participants' EMR and mHealth app for approximately 6 months after enrollment. To assess preliminary effectiveness, the investigators will analyze differences by condition in anxiety and depression (primary outcome). Informed consent will be obtained prior to study participation.",[19,20,21],"HIV","Depression","Anxiety",[19,20,21],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","PositiveLinks with Counseling","A community health worker delivered, specialized counseling intervention through video call on the PositiveLinks app",[36],"Modified PositiveLinks app with CHW-delivered counseling",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Standard of Care (SOC)","This intervention includes the use of the unmodified PositiveLinks app and the standard of care for addressing anxiety and depression in the HIV clinic",[41],"Unmodified PositiveLinks with no counseling",[43,47],{"measure":44,"description":45,"timeFrame":46},"Reduction in Depression","The intervention aims to reduce depression. This will be assessed using the Patient Health Questionnaire-8 (PHQ-8). The minimum score is 0. The maximum score is 24. A higher score indicates a worse outcome.","3 months",{"measure":48,"description":49,"timeFrame":46},"Reduction in Anxiety","The intervention aims to reduce anxiety. This will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). The minimum score is 0. The maximum score is 21. A higher score indicates a worse outcome.",[],"ALL","18 Years","90 Years",{"inclusion":55,"exclusion":59,"raw_text":62},[56,57,58],"HIV diagnosis","GAD-7 score of 5 or greater","PHQ-8 score of 5 or greater",[60,61],"Active psychosis","Suicidal ideation","Inclusion Criteria:\n\n* HIV diagnosis\n* GAD-7 score of 5 or greater\n* PHQ-8 score of 5 or greater\n\nExclusion Criteria:\n\n* Active psychosis\n* Suicidal ideation",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":13,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"Gainesville","Florida","32607","United States",{"lat":73,"lon":74},29.65163,-82.32483,[],[],[],[],{"nct_id":4,"conditions":80,"biomarkers":82},[21,20,81],"HIV Infection",[],{"nct_id":4,"found":84,"summary":85,"prompt_version":95},true,{"design":86,"status":87,"heading":88,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of two groups. Approximately 60 people will participate.","completed","Behavioral mHealth Intervention for HIV with Anxiety and Depression","This study is testing a specialized counseling program called PositiveLinks with Counseling for people with HIV who also experience anxiety and depression. This program uses video calls with a community health worker through the PositiveLinks app. The study will compare this new approach to the standard care, which uses the unmodified PositiveLinks app and usual clinic care for anxiety and depression. To join, you must be 18 to 90 years old, have an HIV diagnosis, and have certain scores on anxiety (GAD-7) and depression (PHQ-8) questionnaires. The main goal is to see if PositiveLinks with Counseling can reduce anxiety and depression after 3 months. The study is currently recruiting about 60 participants.","Data will be collected from participants' electronic medical records and mHealth app for approximately 6 months after enrollment.",112,"If you are in the intervention group, you will have about five weekly 60-minute counseling sessions via video call. Data will be collected from your electronic medical records and the mHealth app.","Not stated in the trial record.",[33],"v2"]