[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395527":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":51,"centralContacts":58,"locations":66,"responsibleParty":105,"collaborators":107,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":29,"enrollmentInfo":130,"targetDuration":29,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":69,"whyStopped":29,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Brown University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"PrEP for health","EXPERIMENTAL","Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.",[13,14,15,16,17],"Other: HIV and PrEP education","Behavioral: Motivational interviewing","Behavioral: Problem-solving and planning","Behavioral: Patient navigation","Other: PrEP information",{"label":19,"type":20,"description":21,"interventionNames":22},"Standard of care","ACTIVE_COMPARATOR","Participants in the standard of care arm will receive PrEP information and referrals.",[17,23],"Other: Referrals",[25,30,35,39,43,47],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"HIV and PrEP education","Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"BEHAVIORAL","Motivational interviewing","Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Problem-solving and planning","Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.",[9],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Patient navigation","Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"PrEP information","A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.",[9,19],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"Referrals","Study staff will provide basic information about PrEP and referrals to PrEP clinicians.",[19],[52,55],{"name":53,"affiliation":5,"role":54},"Katie Biello, PhD, MPH","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":57,"role":54},"Angela Bazzi, PhD, MPH","University of California, San Diego",[59,63],{"name":53,"role":60,"phone":61,"phoneExt":29,"email":62},"CONTACT","401-863-6551","katie_biello@brown.edu",{"name":64,"role":60,"phone":29,"phoneExt":29,"email":65},"Angela Bazzi, PhD","abazzi@health.ucsd.edu",[67,88],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"AIDS Action","RECRUITING","Cambridge","Massachusetts","02139","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-71.10561,42.3751,{"lat":79,"lon":78},[82,86],{"name":83,"role":60,"phone":84,"phoneExt":29,"email":85},"Cassidy Ockene","6179276286","cockene@fenwayhealth.org",{"name":87,"role":54,"phone":29,"phoneExt":29,"email":29},"Michelle Bordeu, MPH",{"facility":89,"status":69,"city":90,"state":71,"zip":91,"country":73,"countryCode":74,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Greater Lawrence Family Health Center","Lawrence","01841",{"type":76,"coordinates":93},[94,95],-71.16311,42.70704,{"lat":95,"lon":94},[98,102,103],{"name":99,"role":60,"phone":100,"phoneExt":29,"email":101},"Christopher Bositis, MD","978-689-6444","cbositis@glfhc.org",{"name":99,"role":54,"phone":29,"phoneExt":29,"email":29},{"name":104,"role":54,"phone":29,"phoneExt":29,"email":29},"Katrina Baumgartner, MD",{"type":106,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[108,111,113,115,117,118],{"name":109,"class":110},"National Institute on Drug Abuse (NIDA)","NIH",{"name":112,"class":6},"The Fenway Institute",{"name":114,"class":6},"AIDS Action Committee of Massachusetts",{"name":89,"class":116},"UNKNOWN",{"name":57,"class":6},{"name":119,"class":6},"Beth Israel Deaconess Medical Center","100395527","pre-exposure-prophylaxis-prep-for-health-100395527",false,"NCT04430257","Pre-exposure Prophylaxis (PrEP) for Health","Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast","PrEP","Inclusion Criteria:\n\n* HIV-uninfected (verified by rapid\u002F4th generation test)\n* Reporting past-month injection of any drugs\n* One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)\n* Not currently on and never taken PrEP\n* Able to understand and speak English or Spanish\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment\n* Living in Massachusetts (MA) for \\\u003C3 months\n* Planning to move out of MA within a year","ALL","18 Years",{"count":131,"type":132},200,"ESTIMATED","INTERVENTIONAL",[135],"NA","This randomized controlled trial will test the efficacy of \"PrEP for Health,\" a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston\u002FCambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the \"PrEP for Health\" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical\u002Fpharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.",[138,139],"Substance Dependence","HIV (Human Immunodeficiency Virus)",[141,142,143,144,32,145,146],"PrEP (pre-exposure prophylaxis )","PWID (people who inject drugs)","SSP (syringe service program)","HIV education","Self efficacy","Social cognitive theory","2025-04-30",{"date":149,"type":150},"2025-05-04","ACTUAL",{"date":152,"type":150},"2021-09-02",{"date":154,"type":132},"2026-05-15",{"name":5,"class":6},2]