Collaborative Care for Depression in HIV Clinics

(HITIDES-H3 Trial)

Not currently recruiting at 1 trial location

Overseen By Eva N Woodward, PhD MA BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve depression care for Veterans living with HIV by testing two methods of implementing a service called HITIDES in clinics. HITIDES is a team-based approach that manages depression more effectively and efficiently than standard care. The trial compares whether clinics perform better by recruiting a local HIV provider to connect with HITIDES or by also adding an external expert for additional support. Veterans with HIV who experience depression and visit VA clinics may benefit from participating in this trial. As an unphased trial, this study offers Veterans the opportunity to contribute to innovative care strategies that could enhance their treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these implementation strategies are safe for managing depression in Veterans Living with HIV?

Research has shown that the HITIDES service, a team-based care approach for depression in veterans with HIV, is safe and well-liked. Past studies have proven that this method improves depression symptoms without causing harm. Veterans who participated did not report any serious side effects. The model emphasizes regular check-ups and support, making it a safe choice for managing depression alongside HIV care. This study aims to identify the best ways to connect veterans to the HITIDES service, ensuring effective and safe depression care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new approach to managing depression in HIV clinics by implementing collaborative care strategies. Traditional treatments for depression often involve medication and therapy, but this trial focuses on enhancing the healthcare system itself. By using a local clinical champion to lead efforts and fostering a learning collaborative, this approach aims to boost coordination and support within clinics. The inclusion of external facilitation in one of the strategy bundles adds an extra layer of guidance and resources, which could lead to more effective and sustainable integration of mental health care into HIV treatment settings. This could revolutionize how depression is managed in such clinics, potentially leading to better patient outcomes.

What evidence suggests that this trial's treatments could be effective for managing depression in Veterans Living with HIV?

Studies have shown that the HITIDES program greatly improves depression symptoms for Veterans Living with HIV (VLWH). This approach not only alleviates depression but also reduces healthcare costs. In trials, HITIDES proved more effective than the usual care provided to veterans with HIV. Both healthcare providers and veterans value the service. This trial tests two methods of offering HITIDES in clinics: one involves local leaders and group learning (Implementation strategy bundle 1), while the other includes additional outside support (Implementation strategy bundle 2). Both methods aim to ensure veterans receive the best possible care for depression. ^{2 3 6 7 8}

Who Is on the Research Team?

Jacob T Painter, PhD PharmD

Principal Investigator

Central Arkansas Veterans Healthcare System , Little Rock, AR

Eva N Woodward, PhD MA BS

Principal Investigator

Central Arkansas Veterans Healthcare System , Little Rock, AR

Are You a Good Fit for This Trial?

This trial is for Veterans Living with HIV (VLWH) who are experiencing depression. Eligible VA clinics must have more than 20 VLWH, data on depression prevalence, a clinical champion to lead implementation, and willingness to participate. They should also offer diverse clinic characteristics like referral rates to mental health services.

Inclusion Criteria

Sites must have an adequately sized population of Veterans Living with HIV (greater than 20)

Sites must 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)

Sites must be able to identify a clinical champion for implementation activities

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy

Implementation of HITIDES intervention with a local clinical champion and learning collaborative, with or without external facilitation

18 months

Regular site visits and virtual meetings

Follow-up

Participants are monitored for changes in depression and suicidal ideation using PHQ-9 and C-SSRS

18 months

Follow-up calls and assessments

Cost and Adoption Assessment

Assessment of cost impact and adoption of intervention strategies

18 months

What Are the Treatments Tested in This Trial?

Interventions

• External facilitation
• Implementation of Collaborative Care for Depression in VA HIV Clinics
• Learning collaborative
• Local clinical champion

Trial Overview The study tests two methods of integrating HITIDES—a service managing depression in VLWH—into VA clinics. One method involves an internal clinical champion supported by a network; the other adds an external expert facilitator. The impact on patient care and costs will be evaluated.

How Is the Trial Designed?

Group I: Implementation strategy bundle 2 Experimental Treatment 3 Interventions

Local clinical champion, learning collaborative, and external facilitation.

Group II: Implementation strategy bundle 1 Experimental Treatment 2 Interventions

Local clinical champion and learning collaborative.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 416 HIV patients receiving collaborative care, 23.79% achieved remission from depression and 21.39% showed a response without remission after 12 months, indicating that this approach can effectively improve depression outcomes in real-world settings.

Factors such as older age were linked to higher remission rates, while psychiatric comorbidities, substance use disorders, and social isolation were associated with poorer outcomes, highlighting areas for targeted intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of depression outcomes in collaborative care for HIV. Lavakumar, M., Lewis, S., Webel, A., et al.[2021]

The collaborative care model for depression in HIV care settings was well-received by patients, who found the support and routine screening beneficial for managing their depressive symptoms.

Using the Patient Health Questionnaire-9 not only helped providers assess patients' depression but also empowered patients to self-manage their symptoms, indicating its potential as a valuable self-management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The collaborative care model for HIV and depression: Patient perspectives and experiences from a safety-net clinic in the United States. Fuller, SM., Koester, KA., Erguera, XA., et al.[2022]

Collaborative care for depression has proven to improve patient outcomes, but its implementation in clinics remains low; this study outlines specific steps to adapt these models to local needs while ensuring adherence to evidence-based practices.

The authors provide a detailed checklist and additional resources, such as training materials and decision support systems, to assist clinicians and administrators in effectively implementing collaborative care models for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steps for implementing collaborative care programs for depression. Fortney, JC., Pyne, JM., Smith, JL., et al.[2019]

The study found that a centralized offsite depression care team, including a psychiatrist and a depression care manager, effectively provided care to HIV patients, leading to high satisfaction among both patients and providers.

Implementing routine depression screening during patient intake processes improved screening rates, highlighting the importance of integrating mental health care into standard HIV treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV patient and provider feedback on a telehealth collaborative care for depression intervention. Drummond, KL., Painter, JT., Curran, GM., et al.[2019]

The HITIDES project aimed to implement a collaborative care model for depression specifically in HIV clinics, involving a multi-site randomized trial with 249 depressed HIV patients to compare this new approach against usual care.

Qualitative evaluations and evidence-based quality improvement methods were used to adapt the intervention to the unique needs of each clinic, highlighting the importance of tailoring mental health interventions in specialty settings with high rates of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of collaborative care for depression in HIV clinics. Curran, GM., Pyne, J., Fortney, JC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11404036/

Implementation of collaborative care for depression in VA HIV ... In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39285308/

Implementation of collaborative care for depression in VA ... This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05901272

Implementation of Collaborative Care for Depression in VA ... The goal of this study is to support broad implementation of the HITIDES intervention by testing two appropriate implementation strategies: a clinical champion ...

4. withpower.com withpower.com/trial/phase-depression-3-2024-ac185

Collaborative Care for Depression in HIV Clinics (HITIDES ... 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 ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05901272/implementation-of-collaborative-care-for-depression-in-va-hiv-clinics

Implementation of Collaborative Care for Depression in VA HIV ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6446432/

The collaborative care model for HIV and depression Collaborative care models may improve outcomes for both HIV and depression. The model includes routine screening and re-assessment of depressive symptoms as ...

7. hsrd.research.va.gov hsrd.research.va.gov/research/citations/PubBriefs/articles.cfm?RecordID=316

Collaborative Care Intervention Improves Depression in ... Findings show that the HITIDES intervention was successfully implemented in HIV settings and improved both depression and HIV symptom outcomes. Veterans who ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724017567

Effectiveness of a task-sharing collaborative care model for ... A task-sharing collaborative care model for depression among people living with HIV had no effect on depression symptoms and viral load suppression.