NCT07870603Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Donaldson Conserve
- Diseases
- HIV
- NCT number
- NCT07870603
What you commit to
- Study type: Interventional
- Planned participants: 360
- From Nov 2026 to the primary completion date, Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Currently enrolled in another HIV prevention or treatment clinical trial
- Any condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study
Other
- Unable to provide informed consent (e.g., due to acute intoxication or acute distress at the time of approach)
Who the study is looking for
- Age 18 years or older
- 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
- Willing to undergo HIV self-testing
- Willing to provide contact information for follow-up
- Able to provide informed consent in English or Spanish
- 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/positive HIV test result.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.