Project SOAR-Mental Health Malawi: Depression and HIV Integration
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|ClinicalTrials.gov Identifier: NCT03555669|
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression HIV/AIDS||Other: Depression Treatment||Not Applicable|
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.
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.
Evaluation and dissemination activities will last two years.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||2082 participants|
|Intervention Model:||Sequential Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||April 24, 2017|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||May 31, 2019|
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.
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.
Other: 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.
- Proportion of participants who are retained in care [ Time Frame: 6 months after ART initiation ]Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.
- Proportion of participants who are virally suppressed [ Time Frame: 6 months after ART initiation ]Viral suppression is defined as HIV RNA viral load of <1,000 copies/mL. Viral loads are measured approximately 6 months after ART initiation.
- Proportion of participants who achieve depression remission (PHQ-9 score less than 5) [ Time Frame: 6 months after ART initiation ]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.
- Proportion of scheduled ART visits attended [ Time Frame: 6 months after ART initiation ]ART visit attendance is defined as attending scheduled ART appointments over the first 6 months on ART.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555669
|Area 18 Clinic|
|Area 25 Clinic|
|Principal Investigator:||Brian Pence, PhD, MPH||UNC Gillings School of Global Public Health|
|Principal Investigator:||Michael Udedi, MBA MPhil||Malawi Ministry of Health|