[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552370":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":112,"collaborators":115,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":12,"enrollmentInfo":136,"targetDuration":12,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":12,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Columbia University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","The control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug\u002Falcohol treatment, and\u002For other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention CHAMPS+","EXPERIMENTAL","Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.",[18,19],"Behavioral: CHW Sessions","Device: CleverCap",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"BEHAVIORAL","CHW Sessions","Sessions with a Community Health Worker (CHW).",[14],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"DEVICE","CleverCap","The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.",[14],[32,35],{"name":33,"affiliation":5,"role":34},"Rebecca Schnall, PhD, MPH","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Scott Batey, PhD, MSW","Tulane University",[39,43],{"name":33,"role":40,"phone":41,"phoneExt":12,"email":42},"CONTACT","212-342-6886","rb897@columbia.edu",{"name":44,"role":40,"phone":45,"phoneExt":12,"email":46},"Maeve Brin","212-305-8198","mb4953@cumc.columbia.edu",[48,65,77,90,99],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Health Services Center, Inc.","RECRUITING","Hobson City","Alabama","36202","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-85.84413,33.62149,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":12,"phoneExt":12,"email":12},"Kelly Turner, MS, ADC",{"facility":66,"status":50,"city":67,"state":52,"zip":68,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Unity Wellness Center","Opelika","36801",{"type":57,"coordinates":70},[71,72],-85.37828,32.64541,{"lat":72,"lon":71},[75],{"name":76,"role":40,"phone":12,"phoneExt":12,"email":12},"Tracy Wynne, MBA",{"facility":78,"status":50,"city":79,"state":80,"zip":81,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Louisiana State University Health Sciences Center in New Orleans","New Orleans","Louisiana","70112",{"type":57,"coordinates":83},[84,85],-90.07507,29.95465,{"lat":85,"lon":84},[88],{"name":89,"role":40,"phone":12,"phoneExt":12,"email":12},"Meredith Clement, MD",{"facility":37,"status":50,"city":79,"state":80,"zip":81,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},{"type":57,"coordinates":92},[84,85],{"lat":85,"lon":84},[95],{"name":96,"role":40,"phone":97,"phoneExt":12,"email":98},"D. Scott Batey, PhD, MSW","(504) 862-3485","dsbatey@tulane.edu",{"facility":100,"status":50,"city":101,"state":102,"zip":103,"country":54,"countryCode":55,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":57,"coordinates":105},[106,107],-90.18481,32.29876,{"lat":107,"lon":106},[110],{"name":111,"role":40,"phone":12,"phoneExt":12,"email":12},"Mauda Monger, PhD, MPH",{"type":34,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Rebecca Schnall, RN, MPH, PhD","Professor of Disease Prevention and Health Promotion and Professor of Population and Family Health; Associate Dean of Faculty Development",[116,118,120,121,122,123,126],{"name":117,"class":6},"University of Alabama at Birmingham",{"name":49,"class":119},"UNKNOWN",{"name":66,"class":119},{"name":78,"class":6},{"name":100,"class":6},{"name":124,"class":125},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH",{"name":37,"class":6},"100552370","community-health-workers-and-mhealth-to-improve-viral-suppression-plus-champs-100552370",false,"NCT06472206","Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)","CHAMPS+","Inclusion Criteria:\n\n* Be able to speak, read, and write in English;\n* Be above 18 years of age;\n* Be willing to participate in any assigned arm of the intervention;\n* Have an HIV-1 RNA level \\>200 copies\u002FmL;\n* Own a smartphone;\n* Be able and willing to provide informed consent for study participation and consent for access to medical records.\n* Live, work and or receive care in AL, LA, or MS\n\nExclusion Criteria:\n\n* Reside in a nursing home, prison, and\u002For receiving in-patient psychiatric care at time of enrollment;\n* Terminal illness with life expectancy \\\u003C6 months; and\n* Planning to move out of the area in the next 12 months.","ALL","18 Years",{"count":137,"type":138},420,"ESTIMATED","INTERVENTIONAL",[141],"NA","Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.",[144],"HIV\u002FAIDS","2025-07-02",{"date":147,"type":148},"2025-07-04","ACTUAL",{"date":150,"type":148},"2024-09-23",{"date":152,"type":138},"2027-12-22",{"name":5,"class":6},5]