10 Participants NeededMy employer runs this trial

Implementation Strategies for Depression in HIV

Recruiting at 2 trial locations
SA
Overseen BySteven A Safren, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how to better deliver treatments for depression in people living with HIV. It compares two approaches: one using basic strategies (Core Implementation Strategies) and another adding more intensive training for clinic staff (Enhanced Implementation Strategies). The goal is to determine which method helps more patients start treatment, feel better, and achieve undetectable HIV levels within a year. Suitable participants have HIV with detectable viral loads and have been identified with depression at participating clinics. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance mental health care for people with HIV.

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 patients with HIV and depression?

Research has shown that strategies to integrate depression care into HIV treatment are generally well-received. Studies have found that clinics consistently and effectively follow these basic strategies, indicating they are user-friendly and do not cause major issues for participants.

Enhanced strategies involve more detailed training on treating depression. Research indicates that similar methods, such as group therapy and telehealth, have been safely incorporated into HIV care. These methods have been tested in various locations and used without significant problems.

Overall, evidence suggests that both basic and enhanced strategies are safe for use in clinical settings. Although specific data on side effects is limited, the consistent and positive results from past studies provide reassurance.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to improve depression care for people living with HIV. Unlike standard treatments that primarily focus on medication or therapy, this trial investigates two unique strategies that focus on empowering healthcare providers. The Core Implementation Strategies involve capacity building for nurses and education on mental health, which could enhance the overall treatment environment. Meanwhile, the Enhanced Implementation Strategies add intensive training on depression treatment, potentially leading to more effective care. These approaches could significantly improve how depression is managed in clinics, offering a fresh perspective on integrating mental health care into HIV treatment.

What evidence suggests that this trial's implementation strategies could be effective for depression in HIV?

This trial will compare Core Implementation Strategies with Enhanced Implementation Strategies for treating depression in people with HIV. Research has shown that treating depression in people with HIV can lead to better health outcomes. For instance, when depression is addressed, individuals are more likely to adhere to their HIV medications, enhancing their health. One study found that a team-based approach to treating depression significantly improved the well-being of veterans with HIV. Another review found that treating depression improved both mental health and immune function in people with HIV. This suggests that addressing depression can significantly aid in managing HIV effectively.26789

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) receiving HIV care at one of 10 clinics in Cape Town who have a detectable HIV viral load and/or screen positive for depression. Children under 18 are not eligible.

Inclusion Criteria

Clinics are eligible if they provide HIV primary care via the City of Cape Town (CoCT) Department of Health
Clinics will be assigned to the study upon notice of funding and before start up
Adult patients engaged in care at one of the 10 primary care/HIV treatment clinics in the study will be included if they have a detectable HIV viral load (operationalized as the lower limit of detection on the standard test is used at the local clinic), or presumed detectable viral load per clinic standards
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Exclusion Criteria

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Clinics are randomized into core and enhanced strategy arms, with training and capacity building for depression treatment

1 year
Regular intervals for data abstraction

Follow-up

Participants are monitored for reach and effectiveness of depression treatment and viral load outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Core Implementation Strategies
  • Enhanced Implementation Strategies

Trial Overview

The study compares two ways to help clinics deliver proven treatments for depression among people with HIV: all clinics use basic support strategies, but some get extra training and resources. Clinics are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: EnhancedExperimental Treatment2 Interventions
Group II: CoreExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

University of Cape Town

Collaborator

Trials
257
Recruited
458,000+

Citations

Two implementation strategies to support the integration of ...

We aimed to compare two implementation strategies in achieving high-quality integration of depression care into chronic medical care and improving mental ...

Implementation outcomes and strategies for depression ...

The majority of studies (n = 59; 74.7%) reported outcomes for a depression intervention implemented in pilot researcher-controlled settings.

Assessing the effectiveness of a depression-integrated ...

Primary outcome data were available for 1097 (98%) participants. We observed high levels of fidelity, with 290 (92%) of 316 participants in the ...

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.

NIH Public Access

In this paper we present the rationale and design of the Strategies to Link. Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC).

Stakeholder engagement to co-design implementation ... - PMC

Stakeholder engagement to co-design implementation strategies for integrating depression management into HIV care services in Senegal.

Two implementation strategies to support the integration of ...

We aimed to compare two implementation strategies in achieving high-quality integration of depression care into chronic medical care and improving mental ...

Integration of mental health and HIV interventions

Treatment for depression can improve HIV prevention, treatment adherence and outcomes, especially when combined with adherence skills training (38).

Implementation Science to Optimize HIV Prevention and ...

This topic encourages implementation research to advance innovative strategies to deliver biomedical prevention and treatment options toward ...