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Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment

ConditionsHIV InfectionsHIV PreventionHomeless PersonsHomelessnessPre-Exposure Prophylaxis (PrEP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDonaldson Conserve

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Currently enrolled in another HIV prevention or treatment clinical trial

Unable to provide informed consent (e.g., due to acute intoxication or acute distress at the time of approach)

Any condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study

Trial design

Design model

Sequential

Treatments tested in this trial

  • CONNECT (status-neutral, nurse-led on-site HIV service delivery)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: CONNECT InterventionExperimental treatment 1 intervention
Group B: Standard of Care (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

PrEP adherence

Detectable tenofovir diphosphate (TFV-DP) in dried blood spot at the 6-month visit.

Time frame
6 months
2

PrEP continuation

Active PrEP prescription documented in the 30 days before the 12-month visit.

Time frame
12 months
3

Retention in HIV care

≥2 completed HIV care visits ≥90 days apart, from medical records.

Time frame
6 and 12 months
4

Viral suppression

HIV RNA \<200 copies/mL from routine clinical labs.

Time frame
6 and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Donaldson Conserve

Lead sponsor

George Washington University

Sponsor institution

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: