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Completed

NCT Number: NCT02407691

Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa

With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Chronic Diseases of Lifestyle Communicable Diseases Depression Genital Diseases HIV Infections 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

Dr Kenneth Kaunda District, Klerksdorp, North West, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinics:

  • 40 nurse-led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa

Patients:

  • Age ≥ 18 years and
  • Receiving ART at the time of enrollment and
  • Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and
  • Planning to reside in the area for the next year and
  • Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and
  • Written consent to participate in the study

Exclusion criteria

Clinics:

  • Clinics which participate in the formative research and piloting of the intervention

Patients:

  • Inability to meet the above inclusion criteria

Treatment and study plan

Primary care 101 plus mental health

Other

A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.

Standard Primary Care 101

Other

Standard Primary Care 101 guideline with standard training

Primary outcomes

  1. Viral load suppression

    Time frame: 12 months

    viral load value of <1000 RNA copies/ml

  2. Patient Health Questionnaire 9 (PHQ-9) response

    Time frame: 6 months

    At least 50% improvement in PHQ-9 score compared with baseline

Secondary outcomes

  1. PHQ-9 Response at 12 months

    Time frame: 12 months

    At least 50% improvement in PHQ-9 score compared with baseline

  2. Depression Remission at 12 months

    Time frame: 12 months

    Score of less than 5 in PHQ-9

  3. Mean PHQ-9 score at 6 and 12 months

    Time frame: 6 and 12 months

    Average score in the PHQ-9

  4. Antiretroviral therapy programme retention

    Time frame: 12 months

    continuation in the ART programme

  5. Viral load suppression at 12 months

    Time frame: 12 months

    Defined as a viral load of <400 copies/ml

  6. Virological failure

    Time frame: 12 months

    Defined as two viral load values >1000 copies/ml

  7. Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line

    Time frame: 12 months

    continuation with the ART regimen OR change

  8. ART adherence

    Time frame: 12 months

    30 day VAS self reported measure

  9. Change in viral load values over time

    Time frame: 12 months

    change in HIV RNA copies measured by PCR

  10. Depression severity (categorised as mild, moderate, moderately severe or severe depression at 6 and 12 months)

    Time frame: 6 and 12 months

    Mild depression defined as a score of 5 to 9; moderate depression defined as a score of 10-14 Moderately severe depression defines as a core of 15-19, and Severe depression defined as a score of 20-27.

  11. Antidepressant treatment initiated or intensified

    Time frame: 12 months

    start or intensification of anti-depressants after baseline

  12. Counselling for depression by a clinic-based counsellor

    Time frame: 12 months

    Having counselling sessions with the clinic counsellor

  13. Referral to specialist mental health worker/service

    Time frame: 12 months

    Referral by a nurse to mental health worker/service

  14. Hospital admissions

    Time frame: 12 months

    number and duration of overnight hospital stays

  15. Mortality

    Time frame: 12 months

    Mortality reported at loss to follow-up or through the South African Population register

  16. Stress

    Time frame: 12 months

    Measured through the Percieved Stress Scale

  17. Stigma

    Time frame: 12 months

    Measured through the 6-item AIDS related stigma scale

  18. Risk factors for cardiovascular diseases

    Time frame: 12 months

    Measured by blood pressure, weight, smoking status

  19. Detection and treatment of other chronic diseases

    Time frame: 12 months

    Identification of new cases of NCDs or risk factors of Chronic deseases

  20. Provision of integrated care from patient perspective

    Time frame: 12 months

    Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)

Other outcomes

  1. Disability

    Time frame: 12 months

    Measured by WHODAS 2

  2. Care utilization and resource use

    Time frame: 12 months

    Measured by service use questionnaire

  3. Productivity and economic measures

    Time frame: 12 months

    Self reported

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • King's College London
  • University of KwaZulu

Registry information

Official study title

Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial

Acronym: COBALT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Nov 29, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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