Project SOAR-Mental Health Malawi: Depression and HIV Integration

NCT ID: NCT03555669

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2082 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2019-05-31

Brief Summary

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.

Detailed 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.

Conditions

Depression; HIV/AIDS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Screening Phase (Pre) Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment Phase (Post) Group

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.

Group Type: EXPERIMENTAL

Depression Treatment

Intervention Type: OTHER

The depression treatment program combines measurement-based antidepressant treatment with PST with clinical response appropriate to the level of depressive severity. Patients scoring 0-4 on the PHQ-9, indicating no depression, receive no treatment. Patients scoring 5-9 on the PHQ-9, indicating mild depressive symptoms that likely are not a full major depressive episode, are offered PST. Patients scoring 10 or above on the PHQ-9, indicating moderate-to-severe depressive symptoms, are first offered anti-depressants. For this group, PST will be an alternative or augmentation option for those who do not tolerate or respond to antidepressant treatment. All patients' depressive severity is monitored with the option of modifying their treatment plan if their symptoms worsen or do not improve.

Interventions

Depression Treatment

The depression treatment program combines measurement-based antidepressant treatment with PST with clinical response appropriate to the level of depressive severity. Patients scoring 0-4 on the PHQ-9, indicating no depression, receive no treatment. Patients scoring 5-9 on the PHQ-9, indicating mild depressive symptoms that likely are not a full major depressive episode, are offered PST. Patients scoring 10 or above on the PHQ-9, indicating moderate-to-severe depressive symptoms, are first offered anti-depressants. For this group, PST will be an alternative or augmentation option for those who do not tolerate or respond to antidepressant treatment. All patients' depressive severity is monitored with the option of modifying their treatment plan if their symptoms worsen or do not improve.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Pence, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Gillings School of Global Public Health

Michael Udedi, MBA MPhil

Role: PRINCIPAL_INVESTIGATOR

Malawi Ministry of Health

Locations

Area 18 Clinic

Lilongwe, , Malawi

Area 25 Clinic

Lilongwe, , Malawi

Countries

Malawi

References

Kulisewa K, Minnick CE, Stockton MA, Gaynes BN, Hosseinipour MC, Mphonda S, Sansbury G, Udedi MM, Pence BW. The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective. Glob Public Health. 2023 Jan;18(1):2201327. doi: 10.1080/17441692.2023.2201327.

Reference Type: DERIVED

PMID: 37088107 (View on PubMed)

Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Pence BW. The effectiveness of depression management for improving HIV care outcomes in Malawi: protocol for a quasi-experimental study. BMC Public Health. 2019 Jun 26;19(1):827. doi: 10.1186/s12889-019-7132-3.

Reference Type: DERIVED

PMID: 31242877 (View on PubMed)

Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Mwagomba BM, Mazenga AC, Pence BW. Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program. BMC Health Serv Res. 2018 Jul 31;18(1):593. doi: 10.1186/s12913-018-3388-z.

Reference Type: DERIVED

PMID: 30064418 (View on PubMed)

Other Identifiers

16-2834

Identifier Type: -

Identifier Source: org_study_id