Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation

Recruiting now · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT05887557

Run by

University of California, San Francisco

People needed

400

Starts

2024-05-16

Expected to finish

2027-03-31

Last updated by the study team

2026-02-24

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.

Where it is running

• La Clinica de la Raza, Inc — Oakland, California, United States (enrolling)
• Lifelong Medical Care — Oakland, California, United States (enrolling)
• San Francisco AIDS Foundation — San Francisco, California, United States (enrolling)
• San Francisco Department of Public Health Maria X Martinez Clinic — San Francisco, California, United States (enrolling)
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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