Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation
Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
1 other identifier
interventional
400
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started May 2024
Typical duration for not_applicable hiv
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
May 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 24, 2026
February 1, 2026
2.9 years
May 15, 2023
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Reach
Proportion of participants who access primary HIV care over the 12 months post-referral/ propensity matching.
12 months
Number of participants with HIV viral suppression
Number of participants with any HIV viral load \<200 copies/mL during the 12 months following referral/propensity matching.
12 months
Secondary Outcomes (2)
Evaluate sustained engagement in HIV care
12 months
Participants with durable viral suppression
12 months
Study Arms (1)
Low-barrier drop-in and mobile care
OTHERThis 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.
Interventions
As an implementation science study, all clinical intervention components will be delivered as part of routine clinical care at participating clinical sites. Clinicians and staff at referral sites throughout San Francisco and Alameda counties (emergency departments, psychiatric emergency services, community clinics, care navigation and case management programs, and community-based services) will refer eligible patients who are out of care and are interested in linking to drop-in and/or mobile care services at one of the study sites. Clinical referrals will include basic patient information and contact/locator information to facilitate linkage to care. Referrals will be site-specific based on the site where the patient is interested in accessing care.
Each site will independently implement a drop-in multidisciplinary site-based HIV care model. Core intervention features include drop-in care (no appointments), panel management to review clinical progress for all referred patients, and case management. Each site may include adaptations to the care model determined during Aim 1 formative work.
Each site will independently implement a mobile care model using site-specific resources. At a minimum, the mobile care team will include a clinical nurse with telemedicine (video visit) consultation with a clinician (MD/NP/PA). Mobile teams will also administer medications (including long-acting ART when available) and collect laboratory specimens (e.g. HIV viral loads)
Clinical decision rules to escalate/de-escalate care intensity will be finalized developed during Aim 1 formative work, though will be based on a combination of clinical assessment and patient preference.
Identify implementation champions at each referral site. Champions will receive marketing materials to promote uptake of clinical referrals to a drop-in/mobile care site by referral site providers/staff. This strategy is aimed at improving referring provider confidence in the value of referral to the care model, reduce perceived referral complexity/improve provider capability to refer, and provide positive peer pressure to promote referrals.
Investigators will provide monthly reports to implementation champions at each referral site on aggregate number of referrals and the success of referrals (proportion linking to care). This strategy is aimed at improving perceived value of the intervention and increasing provider motivation to refer.
Investigators will facilitate formation of a coalition of referral and clinic sites to improve cross-site collaboration and promote positive peer pressure to improve intra-site communication and increase referrals.
Investigators will conduct patient in-depth interviews and clinical team focus group discussions to assess barriers to implementation of the clinical intervention. Findings from interviews and focus group discussions will inform site-specific implementation plans and adaptation of the intervention.
During a co-design workshop among drop-in/mobile care site teams and site-specific meetings, the study team will collectively finalize core clinical intervention components and outline site-specific adaptations (i.e. adaptable periphery of clinical intervention).
With each drop-in/mobile care team, develop site-specific implementation plan that includes defining care team and leadership structure, clinic workflow, implementation timeline, and progress measures. This process, and the resulting blueprint, will incorporate site-specific barriers and facilitators to implementation.
Compile a manual that includes detailed description of core intervention features, planned local adaptations, and implementation guidance. We will conduct site-specific meetings to provide training on this manual. We will also conduct regular (at least monthly) meetings between the study team and the clinic site to provide technical assistance and coaching.
Create a cross-site learning collaborative with periodic meetings and workshops throughout the study period to facilitate cross-site communication, sharing of best practices and encourage positive peer pressure to support implementation.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- La Clínica de La Raza Inc.collaborator
- Lifelong Medical Carecollaborator
- San Francisco AIDS Foundationcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- San Francisco Department of Public Healthcollaborator
- Alameda County Public Health Departmentcollaborator
Study Sites (5)
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
San Francisco Department of Public Health Maria X Martinez Clinic
San Francisco, California, 94105, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (1)
Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.
PMID: 40163072DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Katerina Christopoulos, MD, MPH
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Matthew Hickey, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
June 2, 2023
Study Start
May 16, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- One year after study completion.
- Access Criteria
- Data will be deposited and made available through the Dryad website and these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary data analysis study purposes.
Investigators will share de-identified study data which includes subject demographics and study outcome measures consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards and include a descriptive data dictionary of the available dataset. The primary information sharing channel for the community will be community forums, and community advisory board meetings. Prior to dissemination, all data will be fully de-identified according to standard Safe Harbor guidelines. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.