[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566912":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":34,"locations":43,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":33,"enrollmentInfo":89,"targetDuration":33,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":105,"whyStopped":33,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"C4 Intervention","EXPERIMENTAL","Participants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests.",[13],"Behavioral: C4 Program",{"label":15,"type":10,"description":16,"interventionNames":17},"C4 + 3MV Intervention","Participants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence.",[18],"Behavioral: C4 + 3MV Program",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","C4 Program","The C4 intervention is a behavioral program designed to provide care coordination to address structural barriers to PrEP adherence among Black men who have sex with men (MSM). It includes personalized support services, focusing on healthcare access, mental health, and stigma reduction to promote consistent PrEP use. Participants will receive counseling sessions and follow-ups based on their individual needs.",[9],[26],"Client Centered Care Coordination",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"C4 + 3MV Program","This intervention combines the C4 care coordination with the 3MV behavioral program. The 3MV program focuses on behavior change, addressing self-efficacy, stigma, and promoting healthy practices. Through this combination, participants receive both structural and behavioral support to maximize their adherence to PrEP.",[15],[32],"Many Men Many Voices and Client Centered Care Coordination Integrated Intervention",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA","CONTACT","203-737-2339","ysn.c4_3mvstudy@yale.edu",{"name":41,"role":37,"phone":42,"phoneExt":33,"email":39},"LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA","203-785-5797",[44,59],{"facility":45,"status":33,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Bronx Health Center","New York","10035","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":33,"phoneExt":33,"email":39},"3MVCare Team",{"facility":60,"status":33,"city":61,"state":62,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Abounding Prosperity, Inc.","Dallas","Texas","06477",{"type":51,"coordinates":65},[66,67],-96.80667,32.78306,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":33,"phoneExt":33,"email":39},"3MVCare Study Team",{"type":73,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[75],{"name":76,"class":77},"National Institute of Mental Health (NIMH)","NIH","100566912","pre-exposure-prophylaxis-prep-adherence-for-black-msm-100566912",false,"NCT06661343","Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM","A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale","C4+3MV","Inclusion Criteria:\n\n* Self-identify as male.\n* Self-Identify as Black people.\n* Aged 18 or older.\n* Self Report having sex with men in the past 6 months.\n* Eligible for PrEP or currently prescribed PrEP.\n* Willing to participate in behavioral intervention sessions.\n\nExclusion Criteria:\n\n* Currently diagnosed with HIV.\n* Unable to provide informed consent.\n* Unable to fully engage with the intervention due to health issues.\n* Participating in another clinical trial with conflicting outcomes.",true,"MALE","18 Years",{"count":90,"type":91},500,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time.\n\nThe main questions it aims to answer are:\n\n* Does the C4 program help participants take PrEP more regularly?\n* Does adding the 3MV intervention to C4 provide additional support for adherence?\n\nResearchers will compare two intervention strategies to see if they result in better PrEP adherence:\n\n* C4 Intervention: A program focused on individualized care coordination and addressing structural needs.\n* C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions.\n\nParticipants will:\n\n* Participate in PrEP education and counseling sessions.\n* Have their PrEP use monitored through dried blood spot (DBS) tests.\n* Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.",[97],"HIV Prevention",[99,100,101,102,26,103,104],"HIV","PrEP","Black MSM","Stigma Reduction","Many Men Many Voices","Evidence-based Intervention","NOT_YET_RECRUITING","2026-05-13",{"date":108,"type":109},"2026-05-18","ACTUAL",{"date":111,"type":91},"2026-08-01",{"date":113,"type":91},"2029-06-30",{"name":5,"class":6},2]