Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation
NCT ID: NCT05887557
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
400 participants
INTERVENTIONAL
2024-05-16
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
NCT05110963
Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM
NCT01457066
Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
NCT04549259
Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa
NCT01188941
Optimizing Care for Challenging People Living With HIV
NCT06183723
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim 2: Following initial formative work, a type 2 hybrid implementation-effectiveness study will be conducted using a prospective cohort of persons referred to drop-in/mobile HIV care at one of the four participating care sites (n=400). Patients are eligible for referral to the drop-in/mobile care model if they meet the following three criteria: 1) most recent HIV viral load \>200 copies/mL or off ART by ≥1 month by self-report; 2) 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); and 3) ≥1 major barrier to care engagement by self report, chart history, or clinical assessment (homelessness/unstable housing, any mental health diagnosis, any illicit substance use). The study will compare outcomes over 12 months to two propensity score-matched control groups: 1) contemporaneous patients identified using Alameda and San Francisco Departments of Public Health (DPH) HIV surveillance data (n=400) and 2) historical patients at participating clinic sites (n=400). The evaluation will be guided by the RE-AIM implementation framework, with co-primary outcomes of Reach (≥ 1 HIV primary care visit over 12 months following referral) and Effectiveness (≥1 HIV viral load \<200 copies/mL over 12 months following referral).
In Aim 3: Impact Analysis to understand and model the individual, clinic, and population-level impacts of the staged care approach, the study will use several approaches: 1) Heterogeneity and Health Equity Analysis, 2) Pathway \& Scenario Analysis, 3) Cost and Cost-effectiveness Analysis, and 4) Population-level Health Impact Modeling. Analyses will use mixed-methods to assess for whom the staged care approach worked and did not work and why. The Cost and Cost-effectiveness Analysis will estimate total program costs, costs associated with each intervention strategy, cost per person referred, cost per person engaged in each intervention strategy and cost per person engaged in optimized pathways. Observed study outcomes and scenario analysis results will be used to estimate the additional number of patients with suppressed viral load within the entire program, for each intervention strategy and for the identified optimized pathways.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Active Referral
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.
Drop-In Multidisciplinary HIV 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.
Mobile HIV Care
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)
Staged Care
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 and prepare champions at referral sites
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.
Audit and feedback at referral sites
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.
Build a coalition among referral and clinical sites
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.
Assess for readiness and identify barriers
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.
Promote adaptability
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).
Develop a formal implementation blueprint
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.
Develop educational materials; conduct ongoing training
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 learning collaborative
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active Referral
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.
Drop-In Multidisciplinary HIV 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.
Mobile HIV Care
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)
Staged Care
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 and prepare champions at referral sites
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.
Audit and feedback at referral sites
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.
Build a coalition among referral and clinical sites
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.
Assess for readiness and identify barriers
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.
Promote adaptability
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).
Develop a formal implementation blueprint
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.
Develop educational materials; conduct ongoing training
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 learning collaborative
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
15 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
La Clínica de La Raza Inc.
OTHER
Lifelong Medical Care
UNKNOWN
San Francisco AIDS Foundation
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katerina Christopoulos, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Matthew Hickey, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
La Clinica de la Raza, Inc
Oakland, California, United States
Lifelong Medical Care
Oakland, California, United States
San Francisco AIDS Foundation
San Francisco, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.