Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: t
View:

• 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).

Locations
United States
California
La Clinica de la Raza, Inc
RECRUITING
Oakland
Lifelong Medical Care
RECRUITING
Oakland
San Francisco AIDS Foundation
RECRUITING
San Francisco
Zuckerberg San Francisco General Hospital
RECRUITING
San Francisco
Contact Information
Primary
Katerina Christopoulos, MD, MPH
Katerina.Christopoulos@ucsf.edu
415-476-4082
Backup
Jennifer Cohen, MPA
Jennifer.Cohen@ucsf.edu
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 400
Treatments
Other: Low-barrier drop-in and mobile care
This is a single-arm trial of a set of implementation strategies to encourage uptake of drop-in and mobile HIV care for people living with HIV who experience barriers to engage in usual scheduled appointments.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), San Francisco AIDS Foundation, La Clínica de La Raza Inc., Lifelong Medical Care
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov