Implementation of Collaborative Care for Depression in VA HIV Clinics

NCT05901272 | Active Not Recruiting

• 2 other identifiers: IIR 18-294I01HX002759-01A1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) is a team-based service to manage depression in Veterans Living with HIV (VLWH). This service is more effective for managing depression than the care VLWH usually receive and saves resources. HITIDES is also liked by HIV care providers and VLWH. Despite this, no VA clinics currently offer this service. This study examines two approaches to engage clinics with HITIDES, the resulting effects on VLWH, and the costs of these approaches. The first approach includes recruiting an HIV care provider at the site to help connect with the service and a network of providers to support this person. The second approach uses an additional external expert to facilitate these connections. Understanding how to connect Veterans to the HITIDES service will allow VA to improve depression care for VLWH and save VA resources.

Conditions

Depression; HIV

Keywords

HIV; Depression; Hybrid type 3 effectiveness-implementation trial; Facilitation

Outcome Measures

Primary Outcomes (1)

• Reach

  Reach. Reach will be calculated as a proportion of eligible patients receiving the intervention at 12 months. The primary comparison of interest, and the one on which the study is powered, is the comparison of reach at 12 months in Arm 1 vs. Arm 2.

  12 months

Secondary Outcomes (7)

• Reach

  18 months

• Adoption

  12 months

• Depression - Patient Health Questionnaire-9

  12 months

• Suicidal ideation - Columbia-Suicide Severity Rating Scale

  12 months

• Cost - Budget Impact

  12 months

Study Arms (2)

Implementation strategy bundle 1

OTHER

Local clinical champion and learning collaborative.

Other: Local clinical champion; Other: Learning collaborative

Implementation strategy bundle 2

OTHER

Local clinical champion, learning collaborative, and external facilitation.

Other: Local clinical champion; Other: Learning collaborative; Other: External facilitation

Interventions

Local clinical champion OTHER

A clinical champion is a local provider who serves as a liaison between local clinics and local or regional leadership or national program offices (e.g., HHRC) and advocates for the HITIDES intervention with their local peers. A clinical champion can provide ongoing promotion of and education about HITIDES and remind care providers of its presence and value either formally (e.g., presentations at staff meetings) or informally (e.g., individual conversations about HITIDES benefits). Clinical champions can also engage middle managers or local leadership to buy in to and support intervention uptake. Clinical champions may also work with Veterans in quality improvement efforts to garner their ideas for how to outreach to other Veteran patients, plan quality improvement cycles, or consult in an advisory capacity. Potential champions will be approached about participation after consultation with site HIV care providers and HHRC.

Implementation strategy bundle 1; Implementation strategy bundle 2

Learning collaborative OTHER

Learning Collaboratives are groups of providers or provider organizations and foster a collaborative learning environment to improve implementation of the clinical innovation (HITIDES). There are several approaches to this in the literature including peer consultation networks, online communities of practice, quality circles, and learning collaboratives. Groups will meet virtually using a wide variety of media. Participation will be monitored by research staff and recorded by participants in a time-tracking log but not controlled. The learning collaboratives will be comprised of a group of site clinical champions, HIV care providers, and other VHA HIV care representatives, potentially including Veterans who are engaged in implementation activities, to foster a learning environment to improve the implementation of HITIDES through consultation.

Implementation strategy bundle 1; Implementation strategy bundle 2

External facilitation OTHER

. External facilitation will be provided by a trained external facilitator who is given the HITIDES Operations Guide and Consumer Voice tools for Veteran engagement in quality improvement. Facilitation is a process to enable sites to increase uptake of HITIDES through supportive relationships and strategies to navigate the implementation process. Virtual external facilitation is a recognized modality of facilitation delivery in VHA. The external facilitator will work with the clinical champion, site personnel, and Veterans-not conducting research activities but engaging in quality improvement processes with these individuals. The addition of a facilitator allows problem identification and problem-solving, using processes based on supportive relationships.

Implementation strategy bundle 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The research team will work with VISN 10 to identify sites that
• have an adequately sized (i.e. greater than 20) population of Veterans Living with HIV,
• have adequate PHQ-2 screen data to assess depression prevalence,
• can identify a clinical champion for implementation activities,
• are willing to participate, and
• allow for diversity and balance of clinic characteristics across arms (e.g. rate of referral to specialty mental health for VLWH and presence of HIV-only specialty clinic versus broad infectious disease clinic).
• For criterion 5, these factors that are important will be determined with VISN 10 clinical leadership and the research advisory council. Randomization at the VAMC level has limited ability to completely balance observed and unobserved health-system factors. However, efforts to balance key site characteristics are important; therefore, site-level characteristics thought to impact implementation efforts were identified by building consensus among HIV, Hepatitis, and Related Conditions Program (HHRC) leadership and the HIV care and implementation experts on the research team. Data on the following observable site-level characteristics will be collected from these sites during Year 1 of the study: baseline PHQ-2 screen rate, clinic size (unique patients, provider full-time equivalents \[FTE\], change in enrollment over the past 3 years), and current care manager FTE. Based on the five criteria described above and the power calculation below, eight eligible sites will be selected. Sites will be grouped into four couplets based on balance of the identified site-level characteristics.

You may not qualify if:

• None.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Painter JT, Pyne J, Curran G, Raciborski RA, Russell S, Fortney J, Gifford AL, Ohl M, Woodward EN. Implementation of collaborative care for depression in VA HIV clinics: Translating Initiatives for Depression into Effective Solutions (HITIDES): protocol for a cluster-randomized type 3 hybrid effectiveness-implementation trial. Implement Sci Commun. 2024 Sep 16;5(1):99. doi: 10.1186/s43058-024-00639-z.

  PMID: 39285308 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jacob T Painter, PhD PharmD

  Central Arkansas Veterans Healthcare System , Little Rock, AR

  PRINCIPAL INVESTIGATOR

• Eva N Woodward, PhD MA BS

  Central Arkansas Veterans Healthcare System , Little Rock, AR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a two-arm randomized controlled trial (RCT) with four VA HIV clinics in each arm. Arm 1 receives a learning collaborative and clinical champions at each site Arm 2 receives these plus external facilitation. Learning collaboratives will be hosted separately for sites in Arm 1 and sites in Arm 2 to avoid contamination. Across all aims, there are research activities proposed to evaluate the quality improvement (referred to as "implementation strategy bundles"). All implementation strategy bundles are supported by educational materials about HITIDES and tools to engage Veterans in implementation activities.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 13, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)