RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-16
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05887557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults or adolescents (≥15 years) living with HIV
  2. * Most recent HIV viral load \>200 copies/mL or off ART by ≥1 month by self-report
  3. * 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)
  4. * ≥1 major barrier to care engagement by self report or chart history (homelessness/ unstable housing, any mental health diagnosis, any illicit substance use).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katerina Christopoulos, MD, MPH
CONTACT
415-476-4082
Katerina.Christopoulos@ucsf.edu
Jennifer Cohen, MPA
CONTACT
Jennifer.Cohen@ucsf.edu

Principal Investigator

Katerina Christopoulos, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Matthew Hickey, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

La Clinica de la Raza, Inc
Oakland, California, 94601
United States
Lifelong Medical Care
Oakland, California, 94612
United States
San Francisco AIDS Foundation
San Francisco, California, 94103
United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Katerina Christopoulos, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Matthew Hickey, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-16
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-05-16
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • HIV