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

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Other: 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

• Registration Number: NCT05887557
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Aim 1: Formative work guided by an implementation mapping process to engage key stakeholders, finalize implementation strategies to maximize successful implementation of the evidence-informed clinical intervention, and develop site specific adaptations of the interventions along with an implementation blueprint to guide intervention delivery. Proposed implementation strategies include 1) identify and prepare referral site champions, 2) audit and feedback for referral sites, 3) build a coalition between referral and study care sites, 4) assess for readiness and identify of implementation barriers at care sites, 5) adaptation of intervention components to site-specific context, 6) develop a formal implementation blueprint to guide site-specific intervention delivery, 7) develop educational materials and conduct ongoing training at each site to support implementation fidelity, and 8) create a learning collaborative to facilitate cross-site sharing of best practices and positive peer pressure.

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.

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-02
• Study Start: 2024-05-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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).

Exclusion Criteria

Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-barrier drop-in and mobile care	Drop-In Multidisciplinary HIV 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.
Low-barrier drop-in and mobile care	Active Referral	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.
Low-barrier drop-in and mobile care	Identify and prepare champions at referral sites	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.
Low-barrier drop-in and mobile care	Develop educational materials; conduct ongoing training	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.
Low-barrier drop-in and mobile care	Create a learning collaborative	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.
Low-barrier drop-in and mobile care	Mobile HIV 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.
Low-barrier drop-in and mobile care	Build a coalition among referral and clinical sites	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.
Low-barrier drop-in and mobile care	Promote adaptability	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.
Low-barrier drop-in and mobile care	Develop a formal implementation blueprint	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.
Low-barrier drop-in and mobile care	Staged 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.
Low-barrier drop-in and mobile care	Audit and feedback at referral sites	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.
Low-barrier drop-in and mobile care	Assess for readiness and identify barriers	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.

Primary Outcome Measures

Name	Time	Method
Reach	12 months	Proportion of participants who access primary HIV care over the 12 months post-referral/ propensity matching.
Number of participants with HIV viral suppression	12 months	Number of participants with any HIV viral load \<200 copies/mL during the 12 months following referral/propensity matching.

Secondary Outcome Measures

Name	Time	Method
Evaluate sustained engagement in HIV care	12 months	Participants with ≥2 HIV primary care visits separated by ≥ 60 days with the most recent visit occurring between months 8-12.
Participants with durable viral suppression	12 months	Participants with ≥2 consecutive viral load measures \<200 copies/mL separated by ≥60 days with most recent viral load measured during months 8-12.

Trial Locations

Locations (4)

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