NCT02407691

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,002

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

March 19, 2015

Last Update Submit

November 28, 2023

Conditions

HIV/AIDSDepressionChronic Diseases of Lifestyle

Outcome Measures

Primary Outcomes (2)

  • Viral load suppression

    viral load value of \<1000 RNA copies/ml

    12 months

  • Patient Health Questionnaire 9 (PHQ-9) response

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

    6 months

Secondary Outcomes (20)

  • PHQ-9 Response at 12 months

    12 months

  • Depression Remission at 12 months

    12 months

  • Mean PHQ-9 score at 6 and 12 months

    6 and 12 months

  • Antiretroviral therapy programme retention

    12 months

  • Viral load suppression at 12 months

    12 months

  • +15 more secondary outcomes

Other Outcomes (3)

  • Disability

    12 months

  • Care utilization and resource use

    12 months

  • Productivity and economic measures

    12 months

Study Arms (2)

Primary Care 101 Enhanced guideline

EXPERIMENTAL

Primary Care 101 guideline with enhanced mental health

Other: Primary care 101 plus mental health

Standard of care

ACTIVE COMPARATOR

Primary Care 101 standard version guideline

Other: Standard Primary Care 101

Interventions

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.

Primary Care 101 Enhanced guideline
Standard Primary Care 101OTHER

Standard Primary Care 101 guideline with standard training

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinics:
  • \) Clinics which participate in the formative research and piloting of the intervention
  • Patients:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Kenneth Kaunda District

Klerksdorp, North West, South Africa

Location

Bojanala District

Rustenburg, North West, 0299, South Africa

Location

Related Publications (3)

  • 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.

    PMID: 40799963DERIVED

  • 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.

    PMID: 39442695DERIVED

  • 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.

    PMID: 29566739DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepression

Interventions

Mental Health

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Lara Fairall, PhD

    University of Cape Town, Cape Town, South Africa

    PRINCIPAL INVESTIGATOR

  • Inge Pitersen, PhD

    University of KwaZulu-Natal, Durban, South Africa

    PRINCIPAL INVESTIGATOR

  • Graham Thornicroft, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
www.knowledgetranslation.co.za

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 3, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

ZA(2)