Clinical trial NCT05887557: Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation
Official title: Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: La Clínica de La Raza Inc.
name: Lifelong Medical Care
name: San Francisco AIDS Foundation
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid type 2 implementation-effectiveness Trial
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reach
timeFrame: 12 months
measure: Number of participants with HIV viral suppression
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate sustained engagement in HIV care
timeFrame: 12 months
measure: Participants with durable viral suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: La Clinica de la Raza, Inc
state: California
city: Oakland
country: United States
facility: Lifelong Medical Care
state: California
city: San Francisco
country: United States
facility: San Francisco AIDS Foundation
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katerina Christopoulos, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Matthew Hickey, MD
role: PRINCIPAL_INVESTIGATOR
References: