Implementation of Collaborative Care for Depression in VA HIV Clinics — HITIDES-H3  

Depression Clinical Trial

Official title: Implementation of Collaborative Care for Depression in VA HIV Clinics: Translating Initiatives for Depression Into Effective Solutions (HITIDES)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Background: HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) is a collaborative care intervention that adapts the primary care collaborative care model for depression treatment to HIV clinics. In a randomized controlled trial, HITIDES significantly improved depression symptoms for Veterans Living with HIV (VLWH) and delivered cost savings. However, no VHA HIV clinics have implemented HITIDES. The goal of this study is to support broad implementation of the HITIDES intervention by testing two appropriate implementation strategies: a clinical champion from each site who, with the help of a learning collaborative of peers, will work with local clinicians and leadership to implement the HITIDES intervention at their site with and without the assistance of external facilitation from an implementation expert.

Significance/Impact: Preliminary work has been completed to identify implementation strategies acceptable to VLWH and HIV care providers; however, the relative effectiveness and cost of these implementation strategies is unknown. While the HITIDES depression care team (DCT) is housed off-site and can deliver services consistently with high quality and fidelity, the ability of the DCT to interface and engage with HIV care providers at sites is unknown. Additionally, the mediating effect of site-level implementation outcomes such as reach and adoption on effectiveness of the intervention is unknown. Because the DCT can provide services to multiple HIV clinics, a small-scale rollout of the intervention is needed before considering a national roll out.

Innovation: This study employs an innovative hybrid study design to concurrently examine implementation and effectiveness outcomes. The use of implementation success as a mediating factor for intervention effectiveness is also novel. The relative ability of implementation activities to impact care for vulnerable populations is an area of research where little is known. VHA HIV clinics are an ideal test case for examining these questions because VLWH are a group where racial minority, low income, sexual minority Veterans are disproportionately represented.

Specific Aims: 1) Determine, through a cluster-randomized controlled trial among VHA HIV clinics, the effect of adding external facilitation to an implementation strategy consisting of a site-level clinical champion and learning collaborative. 2) Determine the impact of HITIDES on changes in depression and suicidal ideation among HIV-positive Veterans receiving the intervention. 3) Estimate the budget impact of HITIDES implementation strategies by calculating the costs of each strategy.

Methodology: The use of a hybrid type-3 effectiveness-implementation trial to examine the interaction of implementation and intervention effectiveness is an innovative methodology ideal for situations where the lack of robust evidence of effectiveness is coupled with a cost-saving intervention. This hybrid trial will use a cluster randomization of 8 VHA HIV clinics. These clinics will be chosen for balance and diversity of clinic characteristics and randomly assigned to one of the two implementation arms. Evaluation of each aim will use a mix of primary (e.g., QUERI-developed time-tracking tool) and secondary (e.g., clinical data warehouse) data. The investigators expect the clinical champion, learning collaborative, and external facilitation arm to be associated with greater reach and adoption; however, the clinical champion and learning collaborative alone arm is expected to be less costly.

Next steps: The findings from implementation of the HITIDES intervention to 8 VHA HIV clinics will be used to inform selection of implementation strategies for a broad roll out in the future. Findings will be presented in cooperation with the investigators operational partner, VA HIV, Hepatitis C, and Related Condition Program to VACO and VISN leadership. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV

• NCT number: NCT05901272
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Jacob T Painter, PhD PharmD
• Phone: (501) 257-1740
• Email: Jacob.Painter@va.gov
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Completion date: July 31, 2027