Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    Depression | Malawi
Previous Study | Return to List | Next Study

Project SOAR-Mental Health Malawi: Depression and HIV Integration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03555669
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Depression HIV/AIDS Other: Depression Treatment Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2082 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• None


Information from the National Library of Medicine

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


Locations
Layout table for location information
Malawi
Area 18 Clinic
Lilongwe, Malawi
Area 25 Clinic
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
United States Agency for International Development (USAID)
Investigators
Layout table for investigator information
Principal Investigator: Brian Pence, PhD, MPH UNC Gillings School of Global Public Health
Principal Investigator: Michael Udedi, MBA MPhil Malawi Ministry of Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03555669     History of Changes
Other Study ID Numbers: 16-2834
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Implementation Science
Malawi

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders