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NCT Number: NCT03555669

Project SOAR-Mental Health Malawi: Depression and HIV Integration

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.

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Key information

Conditions

Depression Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Area 18 Clinic, Lilongwe, Malawi

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Depression Treatment

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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