Mobile and flexible HIV care to improve patient engagement and health outcomes
Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
This study is testing a new, flexible way to provide HIV care to see if it helps people who struggle with traditional healthcare stay engaged and manage their health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 5 sites (Oakland, California and 4 other locations) |
| Trial ID | NCT05887557 on ClinicalTrials.gov |
What this trial studies
This study evaluates a flexible, multidisciplinary approach to HIV care aimed at improving retention and viral suppression among individuals who are not well engaged in traditional care systems. It involves implementing a drop-in/mobile care model at four diverse sites in San Francisco and Alameda counties, including an academic clinic and needle exchange site. The study employs a hybrid implementation-effectiveness design, engaging stakeholders to tailor interventions and support their delivery. A cohort of 400 participants will be followed to assess the effectiveness of this innovative care model.
Who should consider this trial
Good fit: Ideal candidates for this study are adults or adolescents living with HIV who have a recent viral load greater than 200 copies/mL and have experienced barriers to care engagement.
Not a fit: Patients who are unable to provide informed consent due to cognitive impairment, psychosis, or intoxication may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the health outcomes of individuals living with HIV by improving their engagement in care and achieving better viral suppression.
How similar studies have performed: Other studies have shown success with similar multidisciplinary and mobile care approaches for HIV, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.
Where this trial is running
Oakland, California and 4 other locations
- La Clinica de la Raza, Inc — Oakland, California, United States (Recruiting)
- Lifelong Medical Care — Oakland, California, United States (Recruiting)
- San Francisco AIDS Foundation — San Francisco, California, United States (Recruiting)
- San Francisco Department of Public Health Maria X Martinez Clinic — San Francisco, California, United States (Recruiting)
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Katerina Christopoulos, MD, MPH — University of California, San Francisco
- Study coordinator: Katerina Christopoulos, MD, MPH
- Email: Katerina.Christopoulos@ucsf.edu
- Phone: 415-476-4082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.