[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659926":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":44,"studyPopulation":33,"armGroups":45,"interventions":58,"overallOfficials":68,"centralContacts":72,"locations":33,"responsibleParty":77,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":33,"enrollmentInfo":96,"targetDuration":33,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":122,"whyStopped":33,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":33},{"fullName":5,"class":6},"George Washington University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Track A - PrEP initiation","Proportion of HIV-negative, PrEP-eligible participants who initiate pre-exposure prophylaxis (first PrEP prescription dispensed) within 90 days of a qualifying negative HIV self-test result. Ascertained from dispensing, pharmacy, and medical records.","Within 90 days of enrollment",{"measure":14,"description":15,"timeFrame":16},"Track B - ART initiation","Proportion of participants with a reactive\u002Fpositive HIV self-test result who initiate antiretroviral therapy (first ART dispensed) within 7 days. Ascertained from dispensing and medical records.","Within 7 days of a reactive result",[18,22,26,30],{"measure":19,"description":20,"timeFrame":21},"PrEP adherence","Detectable tenofovir diphosphate (TFV-DP) in dried blood spot at the 6-month visit.","6 months",{"measure":23,"description":24,"timeFrame":25},"PrEP continuation","Active PrEP prescription documented in the 30 days before the 12-month visit.","12 months",{"measure":27,"description":28,"timeFrame":29},"Retention in HIV care","≥2 completed HIV care visits ≥90 days apart, from medical records.","6 and 12 months",{"measure":31,"description":32,"timeFrame":29},"Viral suppression","HIV RNA \\\u003C200 copies\u002FmL from routine clinical labs.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","SEQUENTIAL","Stepped-wedge cluster-randomized design. Shelter sites (clusters) begin under standard-of-care and transition to the CONNECT intervention in a randomly assigned, staggered sequence; once a site crosses over it remains in the intervention condition.","HEALTH_SERVICES_RESEARCH",{"masking":40,"maskingDescription":41,"whoMasked":42},"SINGLE","Participants, community health workers, and the nurse care navigator cannot be masked, because the intervention is the on-site presence of nurse-delivered services. The co-primary endpoints (PrEP and ART initiation) are ascertained from dispensing, pharmacy, and medical records by staff who did not deliver the intervention and who are masked to study condition. The statistician conducts the primary analysis with condition coded as a neutral indicator.",[43],"OUTCOMES_ASSESSOR","CONNECT is a hybrid type I effectiveness-implementation study evaluating a community health worker (CHW)- and nurse-led, status-neutral model for delivering HIV prevention and treatment services to adults experiencing homelessness in Washington, DC and Prince George's County, Maryland.\n\nThe study is embedded in the existing shelter outreach of a community partner organization. During routine outreach, CHWs offer HIV self-testing on-site. Based on the test result, a nurse care navigator provides services at the same visit: for individuals who test negative and meet risk criteria, same-day initiation of pre-exposure prophylaxis (PrEP); for individuals with a reactive result, confirmatory testing and rapid initiation of antiretroviral therapy (ART) with linkage to ongoing HIV care. Structured CHW navigation supports retention over 12 months of follow-up. All medications are prescribed and dispensed as part of routine clinical care.\n\nThe study is conducted as a cluster-randomized design in which participating shelters transition from the existing referral-based standard-of-care to the CONNECT intervention in a randomly assigned, staggered sequence. The effectiveness aim examines whether the intervention increases timely initiation of PrEP and ART and improves adherence, retention in care, and viral suppression. The implementation aim examines factors that affect adoption, acceptability, feasibility, fidelity, and sustainability of the model, to inform future scale-up.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"CONNECT Intervention","EXPERIMENTAL","Community health worker- and nurse-led, status-neutral HIV services delivered on-site at the shelter. HIV self-testing followed by same-visit nurse assessment and same-day PrEP initiation (for HIV-negative, at-risk participants) or confirmatory testing and rapid ART initiation (for reactive results), with structured CHW navigation over 12 months.",[51],"Behavioral: CONNECT (status-neutral, nurse-led on-site HIV service delivery)",{"label":53,"type":54,"description":55,"interventionNames":56},"Standard of Care (Control)","ACTIVE_COMPARATOR","Existing referral-based outreach: HIV education, self-test kit distribution and support, prevention counseling, and referral to external providers for PrEP or HIV care.",[57],"Behavioral: Standard of Care (referral-based outreach)",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"BEHAVIORAL","CONNECT (status-neutral, nurse-led on-site HIV service delivery)","The CONNECT intervention delivers status-neutral HIV services on-site at homeless shelters through a combined community health worker (CHW) and nurse team. During routine outreach, a CHW offers HIV self-testing with support. Based on the result, a nurse care navigator provides services at the same visit: for HIV-negative, risk-eligible participants, same-day initiation of PrEP with a starter pack; for reactive results, confirmatory testing and rapid initiation of antiretroviral therapy (ART), targeting within 7 days, with linkage to ongoing HIV care. A single shared CHW-nurse team handles both prevention and treatment pathways, and structured CHW navigation supports adherence and retention through 12 months. Unlike referral-based standard of care, the clinical service is delivered at the point and moment of testing rather than by referral to an external clinic. All medications are prescribed under routine clinical care.",[47],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":33},"Standard of Care (referral-based outreach)","The standard-of-care condition is the existing referral-based shelter outreach: CHW-led HIV education, HIV self-test kit distribution and support, and prevention counseling, with referral to external providers for PrEP or HIV care. Clinical services such as PrEP or ART initiation are not delivered on-site; participants are referred off-site to obtain them. This reflects the usual services available at participating shelters prior to the CONNECT intervention.",[53],[69],{"name":70,"affiliation":5,"role":71},"Donaldson F Conserve, PhD, MS","PRINCIPAL_INVESTIGATOR",[73],{"name":70,"role":74,"phone":75,"phoneExt":33,"email":76},"CONTACT","917-443-6124","dconservejr@gwu.edu",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Donaldson Conserve","Professor",[82],{"name":83,"class":84},"National Institute of Nursing Research (NINR)","NIH","100659926","community-based-outreach-and-navigation-for-nurse-led-engagement-in-hiv-care-and-treatment-100659926",false,"NCT07870603","Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment","The CONNECT Study: Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment","CONNECT","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Currently experiencing homelessness or housing instability, and residing at or regularly accessing services from a participating shelter or temporary housing program in Washington, DC or Prince George's County, Maryland\n3. Willing to undergo HIV self-testing\n4. Willing to provide contact information for follow-up\n5. Able to provide informed consent in English or Spanish\n6. Track A (PrEP) participants must additionally have a negative HIV test result and meet CDC PrEP risk criteria. Track B (ART) participants must have a reactive\u002Fpositive HIV test result.\n\nExclusion Criteria:\n\n1. Currently enrolled in another HIV prevention or treatment clinical trial\n2. Unable to provide informed consent (e.g., due to acute intoxication or acute distress at the time of approach)\n3. Any condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study",true,"ALL","18 Years",{"count":97,"type":98},360,"ESTIMATED","INTERVENTIONAL",[101],"NA","Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment. Testing may be offered where they are, but starting medication usually requires going to a clinic somewhere else, and many people are not able to make that second trip.\n\nThis study tests a program called CONNECT. In CONNECT, a community health worker and a nurse offer HIV services directly at homeless shelters. People can take an HIV self-test on-site. If the test is negative and the person is at risk for HIV, the nurse can start them the same day on a prevention medicine called PrEP. If the test is positive, the nurse can help them start HIV treatment quickly and connect to ongoing care.\n\nThe study will compare this on-site program to the usual approach of referring people elsewhere, to see whether it helps more people start HIV prevention or treatment on time.",[104,105,106,107,108],"HIV Infections","HIV Prevention","Homeless Persons","Homelessness","Pre-Exposure Prophylaxis (PrEP)",[110,111,112,113,114,115,116,117,118,119,120,121],"PrEP (pre-exposure prophylaxis)","Antiretroviral therapy (ART)","Rapid ART initiation","Status-neutral","HIV self-testing","Community health worker","Nurse-led intervention","People experiencing homelessness","Shelter-based","Linkage to care","Implementation science","Stepped-wedge cluster randomized trial","NOT_YET_RECRUITING","2026-10-06",{"date":125,"type":126},"2026-10-13","ACTUAL",{"date":128,"type":98},"2026-11",{"date":130,"type":98},"2029-02",{"name":79,"class":6}]