[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":80,"collaborators":84,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":12,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":12,"enrollmentInfo":105,"targetDuration":12,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Brown University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care (Control Arm)","NO_INTERVENTION","Standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at study sites and to facilitate initiation of, and obtaining, PrEP medications)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"RAMP-It-Up intervention","EXPERIMENTAL","The RAMP-It-Up intervention focuses on personalized navigation informed by strengths-based case management. RAMP-It-Up consists of a brief in-person patient navigation session, ongoing bidirectional communication as needed, short (10-minute) phone or text message check-ins with the navigator, strengths-based case management strategies to overcome barriers, optional daily medication text reminders, transportation assistance to clinical visits as needed, and monthly calls to patients' pharmacies to assess prescription pick-up, allowing the navigator to provide real-time support in addressing barriers to PrEP initiation, adherence, and retention in care.",[18],"Behavioral: RAMP-It-Up Initiation, Adherence, and Retention Intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","RAMP-It-Up Initiation, Adherence, and Retention Intervention","The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Dr. Amy Nunn, ScD","CONTACT","401-863-6568","amy_nunn@brown.edu",[32,51,66],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Whitman Walker Health","RECRUITING","Washington D.C.","District of Columbia","20005","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-77.03637,38.89511,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":12,"email":50},"Jowanna Malone, PhD, MSc","202-207-2499","jmalone@whitman-walker.org",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":41,"coordinates":57},[58,59],-90.18481,32.29876,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":64,"phoneExt":12,"email":65},"Thomas Dobbs, MD","(601) 984-5560","tdobbs@umc.edu",{"facility":67,"status":34,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The Rhode Island Public Health Institute","Providence","Rhode Island","02907",{"type":41,"coordinates":72},[73,74],-71.41283,41.82399,{"lat":74,"lon":73},[77],{"name":78,"role":28,"phone":29,"phoneExt":12,"email":79},"Amy Nunn, ScD","amy.nunn@riphi.org",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Amy Nunn","Professor of Public Health and Medicine at Brown University; Executive Director of the Rhode Island Public Health Institute",[85,88,91,92],{"name":86,"class":87},"Whitman-Walker Institute","OTHER_GOV",{"name":89,"class":90},"Rhode Island Public Health Institute","UNKNOWN",{"name":52,"class":6},{"name":93,"class":94},"National Institute of Mental Health (NIMH)","NIH","100583129","intervention-to-enhance-prep-persistence-100583129",false,"NCT06872307","Intervention to Enhance PrEP Persistence","Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men","Inclusion Criteria:\n\n* Aged 18 years and older\n* Assigned male sex at birth\n* Identify as Black\u002FAfrican American\n* Report at least one male sex partner in the past 12 months\n* Meet the CDC eligibility criteria for PrEP\n* Have not taken PrEP for at least 30 days\n* Are HIV-negative based on antibody testing at the time of enrollment\n* Understand and speak English\n* Able to provide informed consent\n* Agree to authorize study access to their EHR and pharmacy fill data. Eligible patients who are interested in participating will be consented and enrolled into the study.\n\nExclusion Criteria:\n\n* Under the age of 18\n* Assigned female sex at birth\n* Does not identify as Black\u002FAfrican American\n* Has not had a male sex partner in the past 12 months\n* Does not meet CDC eligibility criteria for PrEP\n* Has taken PrEP within the last 30 days\n* HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment\n* Does not understand or speak English\n* Unable to provide informed consent\n* Does not agree to authorize study access to their EHR and pharmacy fill data.",true,"MALE","18 Years",{"count":106,"type":107},300,"ESTIMATED","INTERVENTIONAL",[110],"NA","The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for Black\u002FAfrican American (B\u002FAA) men who have sex with men (MSM) on PrEP initiation, adherence and retention in care. B\u002FAA men who have sex with men (MSM) are disproportionately impacted by the HIV\u002FAIDS epidemic in the United States. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care among B\u002FAA MSM. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young B\u002FAA MSM. The intervention was found to be highly acceptable among B\u002FAA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits. Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among B\u002FAA MSM in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among B\u002FAA MSM attending CHCs compared to standard of care. The investigators will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1. Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence for B\u002FAA MSM which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence among B\u002FAA MSM, which aligns with federal Ending the HIV Epidemic and National HIV\u002FAIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV, PrEP and disparities research in real-world clinical settings.",[113,114],"HIV Prevention","HIV Infection Primary",[116],"pre-exposure prophylaxis","2025-03-06",{"date":119,"type":120},"2025-03-12","ACTUAL",{"date":122,"type":120},"2024-10-01",{"date":124,"type":107},"2028-07-31",{"name":5,"class":6},3]