search
Back to results

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

Primary Purpose

HIV/AIDS, Depression, Chronic Diseases of Lifestyle

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Primary care 101 plus mental health
Standard Primary Care 101
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

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

Exclusion Criteria:

Clinics:

1) Clinics which participate in the formative research and piloting of the intervention

Patients:

1) Inability to meet the above inclusion criteria

Sites / Locations

  • Dr Kenneth Kaunda District
  • Bojanala District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary Care 101 Enhanced guideline

Standard of care

Arm Description

Primary Care 101 guideline with enhanced mental health

Primary Care 101 standard version guideline

Outcomes

Primary Outcome Measures

Viral load suppression
viral load value of <1000 RNA copies/ml
Patient Health Questionnaire 9 (PHQ-9) response
At least 50% improvement in PHQ-9 score compared with baseline

Secondary Outcome Measures

PHQ-9 Response at 12 months
At least 50% improvement in PHQ-9 score compared with baseline
Depression Remission at 12 months
Score of less than 5 in PHQ-9
Mean PHQ-9 score at 6 and 12 months
Average score in the PHQ-9
Antiretroviral therapy programme retention
continuation in the ART programme
Viral load suppression at 12 months
Defined as a viral load of <400 copies/ml
Virological failure
Defined as two viral load values >1000 copies/ml
Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line
continuation with the ART regimen OR change
ART adherence
30 day VAS self reported measure
Change in viral load values over time
change in HIV RNA copies measured by PCR
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.
Antidepressant treatment initiated or intensified
start or intensification of anti-depressants after baseline
Counselling for depression by a clinic-based counsellor
Having counselling sessions with the clinic counsellor
Referral to specialist mental health worker/service
Referral by a nurse to mental health worker/service
Hospital admissions
number and duration of overnight hospital stays
Mortality
Mortality reported at loss to follow-up or through the South African Population register
Stress
Measured through the Percieved Stress Scale
Stigma
Measured through the 6-item AIDS related stigma scale
Risk factors for cardiovascular diseases
Measured by blood pressure, weight, smoking status
Detection and treatment of other chronic diseases
Identification of new cases of NCDs or risk factors of Chronic deseases
Provision of integrated care from patient perspective
Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)

Full Information

First Posted
March 19, 2015
Last Updated
October 17, 2018
Sponsor
University of Cape Town
Collaborators
King's College London, University of KwaZulu
search

1. Study Identification

Unique Protocol Identification Number
NCT02407691
Brief Title
Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa
Acronym
COBALT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
King's College London, University of KwaZulu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Depression, Chronic Diseases of Lifestyle

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2002 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care 101 Enhanced guideline
Arm Type
Experimental
Arm Description
Primary Care 101 guideline with enhanced mental health
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Primary Care 101 standard version guideline
Intervention Type
Other
Intervention Name(s)
Primary care 101 plus mental health
Intervention Description
A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.
Intervention Type
Other
Intervention Name(s)
Standard Primary Care 101
Intervention Description
Standard Primary Care 101 guideline with standard training
Primary Outcome Measure Information:
Title
Viral load suppression
Description
viral load value of <1000 RNA copies/ml
Time Frame
12 months
Title
Patient Health Questionnaire 9 (PHQ-9) response
Description
At least 50% improvement in PHQ-9 score compared with baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PHQ-9 Response at 12 months
Description
At least 50% improvement in PHQ-9 score compared with baseline
Time Frame
12 months
Title
Depression Remission at 12 months
Description
Score of less than 5 in PHQ-9
Time Frame
12 months
Title
Mean PHQ-9 score at 6 and 12 months
Description
Average score in the PHQ-9
Time Frame
6 and 12 months
Title
Antiretroviral therapy programme retention
Description
continuation in the ART programme
Time Frame
12 months
Title
Viral load suppression at 12 months
Description
Defined as a viral load of <400 copies/ml
Time Frame
12 months
Title
Virological failure
Description
Defined as two viral load values >1000 copies/ml
Time Frame
12 months
Title
Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line
Description
continuation with the ART regimen OR change
Time Frame
12 months
Title
ART adherence
Description
30 day VAS self reported measure
Time Frame
12 months
Title
Change in viral load values over time
Description
change in HIV RNA copies measured by PCR
Time Frame
12 months
Title
Depression severity (categorised as mild, moderate, moderately severe or severe depression at 6 and 12 months)
Description
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.
Time Frame
6 and 12 months
Title
Antidepressant treatment initiated or intensified
Description
start or intensification of anti-depressants after baseline
Time Frame
12 months
Title
Counselling for depression by a clinic-based counsellor
Description
Having counselling sessions with the clinic counsellor
Time Frame
12 months
Title
Referral to specialist mental health worker/service
Description
Referral by a nurse to mental health worker/service
Time Frame
12 months
Title
Hospital admissions
Description
number and duration of overnight hospital stays
Time Frame
12 months
Title
Mortality
Description
Mortality reported at loss to follow-up or through the South African Population register
Time Frame
12 months
Title
Stress
Description
Measured through the Percieved Stress Scale
Time Frame
12 months
Title
Stigma
Description
Measured through the 6-item AIDS related stigma scale
Time Frame
12 months
Title
Risk factors for cardiovascular diseases
Description
Measured by blood pressure, weight, smoking status
Time Frame
12 months
Title
Detection and treatment of other chronic diseases
Description
Identification of new cases of NCDs or risk factors of Chronic deseases
Time Frame
12 months
Title
Provision of integrated care from patient perspective
Description
Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Disability
Description
Measured by WHODAS 2
Time Frame
12 months
Title
Care utilization and resource use
Description
Measured by service use questionnaire
Time Frame
12 months
Title
Productivity and economic measures
Description
Self reported
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 1) Clinics which participate in the formative research and piloting of the intervention Patients: 1) Inability to meet the above inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Fairall, PhD
Organizational Affiliation
University of Cape Town, Cape Town, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inge Pitersen, PhD
Organizational Affiliation
University of KwaZulu-Natal, Durban, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Thornicroft, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Kenneth Kaunda District
City
Klerksdorp
State/Province
North West
Country
South Africa
Facility Name
Bojanala District
City
Rustenburg
State/Province
North West
ZIP/Postal Code
0299
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
29566739
Citation
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.
Results Reference
derived
Links:
URL
http://www.knowledgetranslation.co.za
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs