Implementation Strategies for Depression in HIV

Recruiting at 2 trial locations

Overseen By Steven A Safren, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Children below age 18

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression. The main questions it aims to answer are:

What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)?

Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance.

Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.

Are You a Good Fit for This Trial?

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

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

How Is the Trial Designed?

Group I: Enhanced Experimental Treatment 2 Interventions

Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.

Group II: Core Experimental Treatment 1 Intervention

Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.

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+