Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation (NCT05887557)
Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: La Clinica de la Raza, Inc — Oakland, California
Age range: 15 Years
🧪 Interventions in This Study
- Active Referral (OTHER)
- Drop-In Multidisciplinary HIV Care (OTHER)
- Mobile HIV Care (OTHER)
- Staged Care (OTHER)
- Identify and prepare champions at referral sites (OTHER)
- Audit and feedback at referral sites (OTHER)
- Build a coalition among referral and clinical sites (OTHER)
- Assess for readiness and identify barriers (OTHER)
- Promote adaptability (OTHER)
- Develop a formal implementation blueprint (OTHER)
- Develop educational materials; conduct ongoing training (OTHER)
- Create a learning collaborative (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- La Clinica de la Raza, Inc — Oakland, California
- Lifelong Medical Care — Oakland, California
- San Francisco AIDS Foundation — San Francisco, California
- San Francisco Department of Public Health Maria X Martinez Clinic — San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California
📞 Contact the Study Coordinator
Phone: (415) 476-4082
Email: Katerina.Christopoulos@ucsf.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.