[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07292792":3,"trial-entities:NCT07292792":83,"trial-summary:NCT07292792":87},{"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":21,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":56,"locations":59,"central_contacts":73,"overall_officials":78,"references":81,"see_also_links":82},"NCT07292792","STU-2024-0736","The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services","Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals","RECRUITING","2026-11-21","2026-01","2026-01-15","2025-05-21","University of Texas Southwestern Medical Center","OTHER",null,"This 18-month study, \"Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals,\" aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.","This 18-month study, \"Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals,\" aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will:\n\nConduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP.\n\nUse rapid qualitative analysis to adapt the health coach intervention and workflows.\n\nImplement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV\u002Fsyphilis testing, and linkage to PrEP care and other services.\n\nEnroll up to 600 consented\u002Fscreened individuals to achieve a target of 100 participants in the intervention.\n\nAssess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time.\n\nThe study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.",[19,20],"HIV Disease","HIV Prevention",[22],"PrEP","OBSERVATIONAL",[],{"count":26,"type":27},100,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Health Coach Intervention","The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.",[34],"Health Coach Intervention Group",[36,40,43],{"measure":37,"description":38,"timeFrame":39},"Feasibility of Integrating a PrEP-Focused Health Coach","Feasibility will be assessed by the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.","18 Months",{"measure":41,"description":42,"timeFrame":39},"Acceptability of the Health Coach Model","Acceptability will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale, and which will be asked of clients and staff. These questions will assess satisfaction, comfort, and perceived usefulness of health coach interactions. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of acceptability. Qualitative feedback will supplement these ratings to capture overall acceptability.",{"measure":44,"description":45,"timeFrame":39},"Appropriateness of the Health Coach Model","Appropriateness will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale. These questions assess perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of appropriateness. Qualitative feedback will supplement these ratings to capture overall appropriateness.",[],"ALL","18 Years","99 Years",true,{"inclusion":52,"exclusion":54,"raw_text":55},[53],"Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.",[],"Inclusion Criteria:\n\n1. Age 18 years or older\n2. Client of Unlocking Doors\n3. Able to provide informed consent\n4. Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP\n5. Willing to complete health screening and eligibility assessment\n6. For qualitative interview participants:\n\n   * Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Unable to provide informed consent\n3. Not receiving services at Unlocking Doors\n4. Non-English speakers\n5. Diagnosed with HIV\n6. Incarcerated individuals at the time of recruitment",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":70},"UT Southwestern Medical Center","Dallas","Texas","75390","United States",[67],{"name":68,"role":69},"Ank E Nijhawan, MD","CONTACT",{"lat":71,"lon":72},32.78306,-96.80667,[74],{"name":75,"role":69,"phone":76,"email":77},"Laura A Hansen, MA","7133057882","Laura.Hansen@UTSouthwestern.edu",[79],{"name":68,"affiliation":13,"role":80},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Stroke prevention",[],{"nct_id":4,"found":50,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an observational study with a planned enrollment of 100 participants. It is not a randomized or blinded study.","completed","The Unlocking PrEP Study: Integrating Health Coaching for HIV Prevention","This 18-month observational study, called \"The Unlocking PrEP Study,\" is looking at how well a PrEP-focused health coach can be integrated into services for people who have been involved with the justice system in Dallas. PrEP (Pre-Exposure Prophylaxis) is a medication that can prevent HIV. The study aims to increase awareness and use of PrEP among clients of Unlocking Doors. The health coach will provide general health guidance, sexual health education, HIV and syphilis testing, PrEP education, and help people get linked to PrEP care. The study will assess if this health coach model is practical, acceptable, and appropriate. You may be able to join if you are 18 or older, a client of Unlocking Doors, and willing to discuss health topics and complete screenings. The study is currently unclear on its recruitment status.","The primary endpoints are measured at 18 months, indicating follow-up for that duration.",134,"You would participate in discussions about general health, sexual health, HIV prevention, and PrEP, and complete health screenings and eligibility assessments. The study duration is 18 months.","Not stated in the trial record.",[],"v2"]