Project SOAR-Mental Health Malawi: Depression and HIV Integration

University of North Carolina (UNC)

Status: Completed

Conditions: Depression; HIV/AIDS

Treatments: Other: Depression Treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03555669

16-2834

Details and patient eligibility

About

Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.

Full description

Study population:

The evaluation will abstract screening data for adult (≥18 years old) patients newly initiating antiretroviral therapy (ART) who are screened for depression at the two clinics before and after the integration of the depression treatment program, and additional treatment and outcome data for those patients who screen positive for depression.

Study Size:

Across the two clinics, the investigators expect to abstract depression screening data for approximately 2,300 patients. The investigators expect to abstract further treatment and outcome data for approximately 640 patients who screen positive for mild, moderate, or severe depression.

Study Duration:

Evaluation and dissemination activities will last two years.

Study Evaluation:

To evaluate the impact of the mental health treatment program on HIV care outcomes, the investigators will collect data on HIV appointment adherence and viral load at 6 months following ART initiation.

To evaluate the impact of the mental health treatment program on mental health outcomes the investigators will collect data on depression symptoms at baseline through 6 months following ART initiation.

Study Design Overview:

The study will employ a pre-post design in two HIV clinics in Lilongwe to evaluate the impact of integrating the depression treatment program within existing clinic operations on HIV and mental health outcomes. The investigators will use existing medical records and the depression patient registry maintained by the Ministry of Health-run clinics to abstract routinely collected clinical data. Using these data, the investigators will compare mental health and HIV outcomes before and after the integration of the depression treatment program. Depressive symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) signs and symptoms of major depression. Additionally, the investigators will conduct short qualitative interviews with clinic and Ministry of Health staff about the integration of the depression screening and treatment program and with patients on their understanding of depression and satisfaction with depression screening and treatment.

Enrollment: 2,082 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥18 years)
• HIV-infected
• Newly initiating antiretroviral treatment at one of the program sites
• Screened for depression

Exclusion criteria

• None

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,082 participants in 2 patient groups

Screening Phase (Pre) Group

No Intervention group

Description:

Patients who screen positive on the PHQ-9 for depression during the "pre" period will comprise the comparison group. Participants will receive "standard of care" depression treatment at the providers discretion.

Treatment Phase (Post) Group

Experimental group

Description:

Patients who screen positive during on the PHQ-9 for depression during the "post" period will comprise the active group. Participants will receive the depression treatment intervention in the form of anti-depressants and/or problem solving therapy (PST) based on their PHQ-9 score.

Treatment:

Other: Depression Treatment