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Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
Sponsor: Donaldson Conserve
Summary
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.
Official title: The CONNECT Study: Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-11
Completion Date
2029-02
Last Updated
2026-10-13
Healthy Volunteers
Yes
Interventions
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.
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.