HIV InfectionsCONNECTNCT07870603
Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
A study testing CONNECT (status-neutral, nurse-led on-site HIV service delivery) in people with HIV Infections and HIV Prevention, run by Donaldson Conserve.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Prevention, Homeless Persons
- What is being tested?
- CONNECT (status-neutral, nurse-led on-site HIV service delivery)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The CONNECT Study: Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
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.
Read the detailed description
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.
- Conditions
- HIV Infections, HIV Prevention, Homeless Persons, Homelessness, Pre-Exposure Prophylaxis (PrEP)
- Being tested
- CONNECT (status-neutral, nurse-led on-site HIV service delivery), Standard of Care (referral-based outreach)
- Keywords
- 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
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECT (status-neutral, nurse-led on-site HIV service delivery)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CONNECT (status-neutral, nurse-led on-site HIV service delivery) |
| 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. Receives: Behavioral: Standard of Care (referral-based outreach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 7 days of a reactive result
Secondary outcomes (4)
PrEP adherence
Detectable tenofovir diphosphate (TFV-DP) in dried blood spot at the 6-month visit.
Measured: 6 months
PrEP continuation
Active PrEP prescription documented in the 30 days before the 12-month visit.
Measured: 12 months
Retention in HIV care
≥2 completed HIV care visits ≥90 days apart, from medical records.
Measured: 6 and 12 months
Viral suppression
HIV RNA <200 copies/mL from routine clinical labs.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donaldson Conserve
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Donaldson Conserve, George Washington University
- Investigators
- Donaldson F Conserve, PhD, MS, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870603
- Sponsor's protocol ID
- 5R01NR021169-03
- Other IDs
- 5R01NR021169-03
- Acronym
- CONNECT
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CONNECT Study: Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
- ClinicalTrials.gov ID
- NCT07870603
- Acronym / sponsor ID
- CONNECT / 5R01NR021169-03
- Conditions
- HIV Infections, HIV Prevention, Homeless Persons, Homelessness, Pre-Exposure Prophylaxis (PrEP)
- Keywords
- PrEP (pre-exposure prophylaxis), Antiretroviral therapy (ART), Rapid ART initiation, Status-neutral, HIV self-testing, Community health worker, Nurse-led intervention, People experiencing homelessness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Donaldson ConserveUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONNECT Intervention | Experimental | Behavioral: CONNECT (status-neutral, nurse-led on-site HIV service delivery)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. |
| Standard of Care (Control) | Active comparator | Behavioral: Standard of Care (referral-based outreach)Existing referral-based outreach: HIV education, self-test kit distribution and support, prevention counseling, and referral to external providers for PrEP or HIV care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CONNECT Intervention |
| 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. | Behavioural | Standard of Care (Control) |
Primary outcome
Track A - PrEP initiation
Time frame: Within 90 days of enrollment
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.
Track B - ART initiation
Time frame: Within 7 days of a reactive result
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.
4 secondary outcomes
PrEP adherence
Time frame: 6 months
PrEP continuation
Time frame: 12 months
Retention in HIV care
Time frame: 6 and 12 months
Viral suppression
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donaldson F Conserve, PhD, MS principal investigator
George Washington University
Questions about this trial
What is this clinical trial studying?
A study testing CONNECT (status-neutral, nurse-led on-site HIV service delivery) in people with HIV Infections and HIV Prevention, run by Donaldson Conserve.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donaldson F Conserve, PhD, MS (917-443-6124, dconservejr@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Track A - PrEP initiation (time frame: Within 90 days of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.