Recruiting

Integrated HIV Care

Sponsor:

UCLA

Code:

NCT05887557

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

Active Referral

Drop-In Multidisciplinary HIV Care

Mobile HIV Care

Staged Care

Identify and prepare champions at referral sites

Study Details

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.

Conditions

HIV

Study ID

NCT05887557

Start date

May 16, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

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

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

  • Reach [ Time Frame: 12 months ]
  • Number of participants with HIV viral suppression [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Katerina Christopoulos, MD, MPH

415-476-4082Katerina.Christopoulos@ucsf.edu

Jennifer Cohen, MPA

Jennifer.Cohen@ucsf.edu

Locations

La Clinica de la Raza, Inc

Recruiting

Oakland, California, United States, 94601

Contacts

Jennifer Huggans-Zapeta, NP

jhzapeta@laclinica.org

Principal Investigator:

Jennifer Huggans-Zapeta, NP

Lifelong Medical Care

Recruiting

Oakland, California, United States, 94612

Contacts

Kevin Critchlow, MD

kcritchlow@lifelongmedical.org

Principal Investigator:

Kevin Critchlow, MD

San Francisco AIDS Foundation

Recruiting

San Francisco, California, United States, 94103

Contacts

Jorge Roman, NP

jroman@sfaf.org

Principal Investigator:

Jorge Roman, NP

San Francisco Department of Public Health Maria X Martinez Clinic

Recruiting

San Francisco, California, United States, 94105

Contacts

Stephen Matzat, MD

stephen.matzat@sfdph.org

Principal Investigator:

Stephen Matzat, MD

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Katerina Christopoulos, MD, MPH

415-476-4082Katerina.Christopoulos@ucsf.edu

Matt Hickey, MD

Matt.Hickey@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-02-24.