[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609989":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":56,"collaborators":58,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":24,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":24,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Georgetown University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care (SoC)","ACTIVE_COMPARATOR","Receive the standard of care (SoC) per Ministry of Health guidelines for PrEP continuation.",[13],"Behavioral: Standard of Care (SoC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Enhanced continuation support package","Enhanced bundle of clinical support and provider focused intervention package to promote sustained PrEP use.",[13,18],"Behavioral: Enhanced continuation support package",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Participants will receive the standard of care per national guidelines of PrEP counseling, national program quality improvement activities, and follow up text messages and phone calls after missed visit.",[15,9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will receive the SoC and bundle of enhanced PrEP continuation support strategies with the following provider, client and structural components:\n\n1. improving provider-client empathy and communication\n2. expert client\u002F peer 'Dolo wa PrEP'\n3. early openings of clinics",[15],[29],{"name":30,"affiliation":5,"role":31},"Charles Holmes, MD, MPH","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+1 (202) 662-9000","charles.holmes@georgetown.edu",{"name":38,"role":34,"phone":35,"phoneExt":24,"email":39},"Deborah Hoege, MPH","dh1107@georgetown.edu",[41],{"facility":42,"status":43,"city":44,"state":24,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Community Health Science Unit","RECRUITING","Lilongwe","Malawi","MW",{"type":48,"coordinates":49},"Point",[50,51],33.78725,-13.96692,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":24,"phoneExt":24,"email":24},"Washington Ozituosauka",{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[59,62,65,67,69,71,73,75,77,79,82,84,86,89,91,93,95,97],{"name":60,"class":61},"Center for the Development of People","UNKNOWN",{"name":63,"class":64},"Centers for Disease Control and Prevention","FED",{"name":66,"class":6},"Elizabeth Glaser Pediatric AIDS Foundation",{"name":68,"class":61},"Healthqual",{"name":70,"class":61},"Johns Hopkins Research Project, Malawi",{"name":72,"class":6},"Johns Hopkins Bloomberg School of Public Health",{"name":74,"class":61},"Blantyre District Health Office, Malawi",{"name":76,"class":61},"Lilongwe District Health Office, Malawi",{"name":78,"class":6},"Lighthouse Trust",{"name":80,"class":81},"Ministry of Health, Malawi","OTHER_GOV",{"name":83,"class":61},"National AIDS Commission, Malawi",{"name":85,"class":61},"Pakachere Institute of Health and Development Communication",{"name":87,"class":88},"Partners in Hope, Inc.","INDUSTRY",{"name":90,"class":6},"University of North Carolina, Chapel Hill",{"name":92,"class":64},"United States President's Emergency Plan for AIDS Relief",{"name":94,"class":6},"Washington University School of Medicine",{"name":96,"class":6},"Clinton Health Access Initiative Inc.",{"name":98,"class":61},"Quantitative Engineering Design","100609989","pathtoscale-the-persist-trial-100609989",false,"NCT07221747","PathToScale: The PERSIST Trial","ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL","Inclusion Criteria:\n\n•Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:\n\nIndividuals who are 15+ years old AND either\n\n1. Female sex workers (FSW) OR\n2. Men who have sex with men (MSM) OR\n3. Transgender individuals (TG) OR\n4. Women and adolescent girls and young women (AGYW) presenting at STI services and\u002For family planning and\u002For HIV testing services OR\n5. Breastfeeding women (BFW) OR\n6. Male partners of female sex workers and\u002For Men at high risk for HIV and\u002For men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.\n\nExclusion Criteria:\n\n* Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:\n\nThose living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.",true,"ALL","15 Years","110 Years",{"count":111,"type":112},9900,"ESTIMATED","INTERVENTIONAL",[115],"NA","The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.",[118,119],"Oral Pre-exposure Prophylaxis (PrEP)","Long-acting Injectable Cabotegravir for PrEP","2026-03-02",{"date":122,"type":123},"2026-03-04","ACTUAL",{"date":125,"type":123},"2026-02-16",{"date":127,"type":112},"2026-11",{"name":5,"class":6},1]