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

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.

Conditions

• HIV

Interventions

OTHER

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.

OTHER

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.

OTHER

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)

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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).

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• La Clínica de La Raza Inc.

  collaborator OTHER

• Lifelong Medical Care

  collaborator UNKNOWN

• San Francisco AIDS Foundation

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• San Francisco Department of Public Health

  collaborator OTHER_GOV

• Alameda County Public Health Department

  collaborator UNKNOWN

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Katerina Christopoulos, MD, MPH · University of California, San Francisco

• Matthew Hickey, MD · University of California, San Francisco

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-16

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United States

Study Locations