NCT05887557Recruiting
Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation
Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the implementation and effectiveness of a flexible, multidisciplinary, integrated drop-in/mobile HIV care approach for people living with HIV (PLH) who are not well engaged in current care systems (i.e. scheduled HIV primary care visits). The hybrid type 2 implementation-effectiveness study involves a set of implementation strategies to support implementation of the integrated drop-in/mobile HIV care approach (i.e. the evidence-informed clinical intervention) at four diverse sites in San Francisco and Alameda counties in California. Sites include an academic clinic located at a public hospital (Ward 86) and a needle exchange site (San Francisco AIDS Foundation Syringe Access Site) in San Francisco and two Federally Qualified Health Centers serving diverse patient populations in Alameda County (Trust and La Clínica). The evidence-informed clinical intervention consists of four key components: 1) active referral to care sites; 2) drop-in, multidisciplinary HIV primary care; 3) mobile HIV care; and 4) staged escalation/de-escalation of care level as needed. The study will use RE-AIM to guide evaluation, with coprimary outcomes of Reach and HIV viral suppression, and mixed methods to assess intervention Adoption, Implementation, and Maintenance. The study draws on the CFIR framework to assess site-specific implementation determinants before and after the study period. The study will undertake micro-costing using a uniform cost data collection protocol to quantify the resources needed to carry out intervention activities.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 May 2023
- Start date
- 16 May 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05887557
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 16 May 2024 to the primary completion date, 31 Mar 2027
- 5 sites in 1 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
- Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.
Who the study is looking for
- Adults or adolescents (≥15 years) living with HIV
- Most recent HIV viral load \>200 copies/mL or off ART by ≥1 month by self-report
- Sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥1 missed HIV primary care visit in the past 6 months)
- ≥1 major barrier to care engagement by self report or chart history (homelessness/ unstable housing, any mental health diagnosis, any illicit substance use).
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| La Clinica de la Raza, Inc Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Lifelong Medical Care Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| San Francisco Department of Public Health Maria X Martinez Clinic Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| San Francisco AIDS Foundation Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Zuckerberg San Francisco General Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.