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HIV/AIDSCOBALTNCT02407691

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

A study testing Primary care 101 plus mental health and Standard Primary Care 101 in people with HIV/AIDS and Depression, run by University of Cape Town at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Primary care 101 plus mental health and Standard Primary Care 101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,002 participants
Where
2 sitesSouth Africa
Study dates
Apr 2015to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinics:
  • 1) 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
Show all 9Show fewer
  • 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

Who cannot join

  • Clinics:
  • 1) Clinics which participate in the formative research and piloting of the intervention
  • Patients:
  • 1) Inability to meet the above inclusion criteria

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Dr Kenneth Kaunda District

    Klerksdorp, North West

  • Bojanala District

    Rustenburg, North West, 0299

Other trials in South Africa

About this study

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

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.

Being tested
Primary care 101 plus mental health, Standard Primary Care 101
Medical subject headings
Acquired Immunodeficiency Syndrome, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary care 101 plus mental healthOther

    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 101Other

    Standard Primary Care 101 guideline with standard training

Study groups in NCT02407691
Study groupRoleWhat they receive
Primary Care 101 Enhanced guidelineExperimentalPrimary Care 101 guideline with enhanced mental health
Receives: Other: Primary care 101 plus mental health
Standard of careActive comparatorPrimary Care 101 standard version guideline
Receives: Other: Standard Primary Care 101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral load suppression

    viral load value of <1000 RNA copies/ml

    Measured: 12 months

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

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

    Measured: 6 months

Secondary outcomes (20)

  1. PHQ-9 Response at 12 months

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

    Measured: 12 months

  2. Depression Remission at 12 months

    Score of less than 5 in PHQ-9

    Measured: 12 months

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

    Average score in the PHQ-9

    Measured: 6 and 12 months

  4. Antiretroviral therapy programme retention

    continuation in the ART programme

    Measured: 12 months

  5. Viral load suppression at 12 months

    Defined as a viral load of <400 copies/ml

    Measured: 12 months

  6. Virological failure

    Defined as two viral load values >1000 copies/ml

    Measured: 12 months

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

    continuation with the ART regimen OR change

    Measured: 12 months

  8. ART adherence

    30 day VAS self reported measure

    Measured: 12 months

  9. Change in viral load values over time

    change in HIV RNA copies measured by PCR

    Measured: 12 months

  10. Depression severity (categorised as mild, moderate, moderately severe or severe depression at 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.

    Measured: 6 and 12 months

  11. Antidepressant treatment initiated or intensified

    start or intensification of anti-depressants after baseline

    Measured: 12 months

  12. Counselling for depression by a clinic-based counsellor

    Having counselling sessions with the clinic counsellor

    Measured: 12 months

  13. Referral to specialist mental health worker/service

    Referral by a nurse to mental health worker/service

    Measured: 12 months

  14. Hospital admissions

    number and duration of overnight hospital stays

    Measured: 12 months

  15. Mortality

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

    Measured: 12 months

  16. Stress

    Measured through the Percieved Stress Scale

    Measured: 12 months

  17. Stigma

    Measured through the 6-item AIDS related stigma scale

    Measured: 12 months

  18. Risk factors for cardiovascular diseases

    Measured by blood pressure, weight, smoking status

    Measured: 12 months

  19. Detection and treatment of other chronic diseases

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

    Measured: 12 months

  20. Provision of integrated care from patient perspective

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407691
Sponsor's protocol ID
1R01MH100470-01
Acronym
COBALT
Status last verified
Nov 2023
First submitted
19 Mar 2015
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Zani B, Fairall L, Petersen I, Folb N, Bhana A, Thornicroft G, Hanass-Hancock J, Selohilwe O, Petrus R, Carmona S, Lombard C, Lund C, Levitt N, Bachmann M. Sociodemographic and health-related factors associated with viral load non-suppression and body mass index in adults with depression symptoms receiving antiretroviral therapy in South Africa. PLoS One. 2026 Feb 23;21(2):e0329990. doi: 10.1371/journal.pone.0329990. eCollection 2026.

    PubMed 41729879

  • Zani B, Fairall L, Petersen I, Folb N, Bhana A, Thornicroft G, Hanass-Hancock J, Selohilwe O, Petrus R, Carmona S, Lombard C, Lund C, Levitt N, Bachmann M. Sociodemographic and health-related factors associated with viral load non-suppression and body mass index in adults with depression symptoms receiving antiretroviral therapy in South African primary care: secondary analysis of randomised trial data. medRxiv [Preprint]. 2025 Aug 5:2025.08.01.25332690. doi: 10.1101/2025.08.01.25332690.

    PubMed 40799963

  • Zani B, Fairall L, Petersen I, Folb N, Bhana A, Hanass-Hancock J, Selohilwe O, Petrus R, Georgeu-Pepper D, Mntambo N, Kathree T, Carmona S, Lombard C, Lund C, Levitt N, Bachmann M, Thornicroft G. Effectiveness of a task-sharing collaborative care model for the detection and management of depression among adults receiving antiretroviral therapy in primary care facilities in South Africa: A pragmatic cluster randomised controlled trial. J Affect Disord. 2025 Feb 1;370:499-510. doi: 10.1016/j.jad.2024.10.061. Epub 2024 Oct 21.

    PubMed 39442695

  • Fairall L, Petersen I, Zani B, Folb N, Georgeu-Pepper D, Selohilwe O, Petrus R, Mntambo N, Bhana A, Lombard C, Bachmann M, Lund C, Hanass-Hancock J, Chisholm D, McCrone P, Carmona S, Gaziano T, Levitt N, Kathree T, Thornicroft G; CobALT research team. Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial. Trials. 2018 Mar 22;19(1):193. doi: 10.1186/s13063-018-2517-7.

    PubMed 29566739

Questions about this trial

What is this clinical trial studying?

A study testing Primary care 101 plus mental health and Standard Primary Care 101 in people with HIV/AIDS and Depression, run by University of Cape Town at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral load suppression (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407691, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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