Clinical trial NCT03555669: Project SOAR-Mental Health Malawi: Depression and HIV Integration
Official title: UNCPM 21609 Project SOAR Mental Health: Evaluation of the Impact of a Depression Treatment Program on Mental Health and HIV Care Outcomes in Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
HIV/AIDS
Keywords: Implementation Science
Malawi
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2018-06-13
Enrollment: 2082
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will employ a multiple baseline evaluation design in two clinics to evaluate the impact of depression treatment on HIV outcomes. Patients who screen positive for depression using PHQ-9 during the "pre" period will comprise the comparison group, while patients who screen positive during the "post" period will comprise the active group.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Proportion of participants who are retained in care
timeFrame: 6 months after ART initiation
measure: Proportion of participants who are virally suppressed
timeFrame: 6 months after ART initiation
Secondary outcomes:
measure: Proportion of participants who achieve depression remission (PHQ-9 score less than 5)
timeFrame: 6 months after ART initiation
measure: Proportion of scheduled ART visits attended
timeFrame: 6 months after ART initiation
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 18 Clinic
city: Lilongwe
country: Malawi
facility: Area 25 Clinic
Study officials:
affiliation: UNC Gillings School of Global Public Health
name: Brian Pence, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Malawi Ministry of Health
name: Michael Udedi, MBA MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.