- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03555669
Project SOAR-Mental Health Malawi: Depression and HIV Integration
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lilongwe, Malawi
- Area 18 Clinic
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Lilongwe, Malawi
- Area 25 Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (≥18 years)
- HIV-infected
- Newly initiating antiretroviral treatment at one of the program sites
- Screened for depression
Exclusion Criteria:
• None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who are retained in care
Time Frame: 6 months after ART initiation
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Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.
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6 months after ART initiation
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Proportion of participants who are virally suppressed
Time Frame: 6 months after ART initiation
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Viral suppression is defined as HIV RNA viral load of <1,000 copies/mL.
Viral loads are measured approximately 6 months after ART initiation.
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6 months after ART initiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who achieve depression remission (PHQ-9 score less than 5)
Time Frame: 6 months after ART initiation
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Depression remission is defined as scoring less than 5 on the PHQ-9 approximately 6 months after ART initiation.
The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression.
The 9 items describe problems associated with depression, and participants must rate how often the patient has been bothered by the problems in the last 2 weeks on a 0-3 scale.
The scores are summed for a total depression score, ranging from 0-27, with 0-4 being minimum and indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Depressive symptoms will be measured with the PHQ-9 at baseline through approximately 6 months after ART initiation.
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6 months after ART initiation
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Proportion of scheduled ART visits attended
Time Frame: 6 months after ART initiation
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ART visit attendance is defined as attending scheduled ART appointments over the first 6 months on ART.
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6 months after ART initiation
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Collaborators and Investigators
Investigators
- Principal Investigator: Brian Pence, PhD, MPH, UNC Gillings School of Global Public Health
- Principal Investigator: Michael Udedi, MBA MPhil, Malawi Ministry of Health
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2834
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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