An interventional study of CONNECT (status-neutral, nurse-led on-site HIV service delivery) and Standard of Care (referral-based outreach) in HIV Infections, HIV Prevention and Homeless Persons, sponsored by Donaldson Conserve. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Donaldson Conserve · Not applicable, Interventional, and Health services research
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.
This 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.
The 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.
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.
The 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.
The 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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 360 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →This is the only study on the registry with Donaldson Conserve as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: CONNECT (status-neutral, nurse-led on-site HIV service delivery)
Existing referral-based outreach: HIV education, self-test kit distribution and support, prevention counseling, and referral to external providers for PrEP or HIV care.
Behavioral: Standard of Care (referral-based outreach)
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.
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.
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.
Time frame: Within 90 days of enrollment
Track B - ART initiation
Proportion of participants with a reactive/positive HIV self-test result who initiate antiretroviral therapy (first ART dispensed) within 7 days. Ascertained from dispensing and medical records.
Time frame: Within 7 days of a reactive result
PrEP adherence
Detectable tenofovir diphosphate (TFV-DP) in dried blood spot at the 6-month visit.
Time frame: 6 months
PrEP continuation
Active PrEP prescription documented in the 30 days before the 12-month visit.
Time frame: 12 months
Retention in HIV care
≥2 completed HIV care visits ≥90 days apart, from medical records.
Time frame: 6 and 12 months
Viral suppression
HIV RNA \<200 copies/mL from routine clinical labs.
Time frame: 6 and 12 months
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying published results will be shared in accordance with the NIH Data Management and Sharing Policy and the terms of the award. Because the study involves a small number of shelter clusters and a highly identifiable population, data will be shared through a controlled-access mechanism under a data use agreement that prohibits re-identification and onward redistribution, with direct identifiers and shelter names removed and small cells suppressed or aggregated to protect confidentiality. Requests are reviewed by the study team in consultation with the community partner. Certificate of Confidentiality protections apply.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data underlying peer-reviewed publications will be shared by the time of publication; other findings by the end of the period of performance (including any no-cost extensions). Data will remain available for at least as long as required by the repository's and applicable journal policies.
Access criteria: Controlled (registered) access rather than open public access, appropriate to a structurally vulnerable population. De-identified data are deposited under a controlled-access model in which approved users must register with the repository, agree to data-use terms that prohibit re-identification and restrict use to scientific research and aggregate reporting, and comply with the participant protections in NIH NOT-OD-22-213. Indirect identifiers and geographic detail that could enable re-identification are removed, coarsened, or restricted. Qualitative interview data are shared only as de-identified excerpts or summaries where full transcripts would risk participant identification. Access is managed through the repository's controlled/restricted-access tier.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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