An interventional study of Depression Treatment in Depression and HIV/AIDS, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in Malawi. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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.
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.
8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 2,082 is above the median of 84 across 6,722 interventional studies indexed under Depression.
Browse Depression studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
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.
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
Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.
Time frame: 6 months after ART initiation
Proportion of participants who are virally suppressed
Viral suppression is defined as HIV RNA viral load of \<1,000 copies/mL. Viral loads are measured approximately 6 months after ART initiation.
Time frame: 6 months after ART initiation
Proportion of participants who achieve depression remission (PHQ-9 score less than 5)
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.
Time frame: 6 months after ART initiation
Proportion of scheduled ART visits attended
ART visit attendance is defined as attending scheduled ART appointments over the first 6 months on ART.
Time frame: 6 months after ART initiation
Plan to share: No
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University of North Carolina, Chapel Hill