[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637980":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":38,"responsibleParty":71,"collaborators":22,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":22,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":22,"enrollmentInfo":83,"targetDuration":22,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":22,"overallStatus":41,"whyStopped":22,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Oswaldo Cruz Foundation","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Community-Based PrEP Delivery","EXPERIMENTAL","Participants will receive HIV prevention services through a community-based delivery model, including HIV testing, counseling, and initiation of daily oral pre-exposure prophylaxis (PrEP) according to national guidelines. Services will be provided in non-traditional settings, such as non-governmental organizations and mobile health units, with additional support through telehealth and mobile health (mHealth) strategies to enhance engagement, adherence, and retention in care. Participants diagnosed with HIV during screening or follow-up will be referred for treatment within the public health system.",[13,14,15],"Drug: Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate\u002FEmtricitabine)","Behavioral: Community-Based PrEP Delivery Model","Behavioral: Telehealth and mHealth Support",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Oral Pre-Exposure Prophylaxis (PrEP) (Tenofovir Disoproxil Fumarate\u002FEmtricitabine)","Participants will receive daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate\u002Femtricitabine (TDF\u002FFTC), in accordance with Brazilian national guidelines for HIV prevention. PrEP will be offered to eligible individuals who test HIV-negative at enrollment and during follow-up, with clinical monitoring and counseling provided as part of routine care.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"BEHAVIORAL","Community-Based PrEP Delivery Model","Participants will receive HIV prevention services through community-based delivery strategies designed to reduce barriers to access. These include provision of services in non-traditional settings such as non-governmental organizations and mobile health units, with on-site HIV testing, counseling, and same-day PrEP initiation by trained healthcare staff.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Telehealth and mHealth Support","Participants will have access to telehealth consultations and mobile health (mHealth) interventions to support engagement in care, adherence to PrEP, and retention in follow-up. These strategies may include remote clinical support, digital communication tools, and tailored adherence support interventions.",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Beatriz Grinsztejn","CONTACT","+55 2138659128","beatriz.grinsztejn@gmail.com",[39,58],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Geral de Nova Iguaçu","RECRUITING","Nova Iguaçu","Rio de Janeiro","26030-380","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-43.45111,-22.75917,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":22,"phoneExt":56,"email":57},"José Henrique Pilotto, PhD","+552135132812","pilotto@uninet.com.br",{"facility":59,"status":41,"city":43,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Instituto Nacional de Infectologia Evandro Chagas","21040360",{"type":48,"coordinates":62},[63,64],-43.18223,-22.90642,{"lat":64,"lon":63},[67],{"name":68,"role":35,"phone":69,"phoneExt":22,"email":70},"Emilia Jalil, PhD","55 2138659128","emiliajalil@gmail.com",{"type":72,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100637980","improving-access-to-prep-hiv-prevention-medication-for-people-in-underserved-areas-of-rio-de-janeiro-100637980",false,"NCT07584122","Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro","Bringing PrEP to Underserved Communities in Rio de Janeiro: the PrEPOUT Rio Study","Inclusion Criteria:\n\n* Individuals aged 15 years or older\n* Gay, bisexual, and other men who have sex with men (MSM)\n* Transgender women and travestis\n* Other sexual and gender minorities (SGM)\n* Cisgender women in situations of social or economic vulnerability\n* Sex workers\n* Individuals seeking HIV testing and\u002For pre-exposure prophylaxis (PrEP)\n* HIV-negative at screening\n* Willing and interested in initiating PrEP\n* Eligible for PrEP according to Brazilian national guidelines\n\nExclusion Criteria:\n\n* Positive HIV test result at screening or during study participation\n* Individuals not eligible for PrEP according to Brazilian national guidelines",true,"ALL","15 Years",{"count":84,"type":85},400,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study aims to improve access to HIV prevention using pre-exposure prophylaxis (PrEP) among underserved populations in Rio de Janeiro, including gay and bisexual men, transgender women, and sex workers. Despite the proven effectiveness of PrEP, many people at higher risk of HIV face barriers to accessing and continuing this prevention method, especially those living in socially and economically vulnerable communities.\n\nThe study will evaluate whether offering PrEP directly in community-based settings-such as non-governmental organizations, mobile health units, and through telehealth and digital tools-can increase its uptake and continued use. Participants who test negative for HIV will be offered daily oral PrEP, along with counseling and follow-up support. Those who test positive will be referred for appropriate treatment.\n\nThe main hypothesis is that delivering PrEP in community settings, combined with supportive strategies like mobile health interventions, will be feasible, acceptable, and more effective in reaching and engaging vulnerable populations, ultimately helping to reduce new HIV infections.",[91],"HIV Infections","2026-05-06",{"date":94,"type":95},"2026-05-13","ACTUAL",{"date":97,"type":95},"2025-09-01",{"date":99,"type":85},"2026-12",{"name":5,"class":6},2]