Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201504001078347 Date of Approval: 19/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa
Official scientific title Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa
Brief summary describing the background and objectives of the 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 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 adults with depression receiving ART by measuring the 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. The objectives are: 1. To improve HIV outcomes and ART adherence through improved identification and management of depression and chronic diseases of lifestyle 2. To improve comorbid depression outcomes in patients receiving ART through improved detection and management using a stepped care model. 3. To reduce the risk profile among ART patients for cardiovascular disease and its risk factors through improved detection and management of these conditions. 4. To improve integrated treatment/care of long-term conditions at the primary health care level among patients receiving ART and to evaluate the health synergies and health systems implications, including cost-effectiveness of better integrated care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression, Chronic Diseases of Lifestyle,Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 16/04/2015
Actual trial start date 16/04/2015
Anticipated date of last follow up 30/11/2017
Actual Last follow-up date 30/11/2017
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants) 2000
Recruitment status Recruiting
Publication URL www.knowledgetranslation.co.za
Secondary Ids Issuing authority/Trial register
NCT02407691 ClicicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated randomisation by statistician, stratified by district Randomization and enrolment will be carried out independently to ensure concealment Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Primary Care 101 plus (1) Supplementary training in PC101+ focusing on increasing nurse capacity to detect and manage non-communicable diseases, specifically depression, cardiovascular disease, diabetes and alcohol misuse in patients receiving lifelong ART; and (2) the provision of a group counselling intervention for depression for these participants. 1000
Control Group Standard Primary Care 101 guideline and standard training Standard of care: provision of the standard version of the PC 101 guideline excluding mental health and standard training 1000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 2) Receiving ART at the time of enrollment 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 5) Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, three six and twelve months later and 6) Written consent to participate in the study Clinics: 1) Clinics which participate in the formative research and piloting of the intervention Patients: 1) Inability to meet the above inclusion criteria 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/08/2015 UCT Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2013 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Westville Campus Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/08/2013 Psychiatry, Nursing and Midwifery Research Ethics Subcommittee
Ethics Committee Address
Street address City Postal code Country
King's College London SE5 8AF United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PHQ-9 response defined as at least 50% improvement in the baseline score 6 months
Secondary Outcome Adherence to ART medication (30 day VAS self reported measure) 12 months
Secondary Outcome Risk factors for cardiovascular diseases (blood pressure, weight, smoking status) 12 months
Secondary Outcome Detection and treatment of other chronic diseases 12 months
Secondary Outcome Antiretroviral therapy programme retention (continuation in the ART programme) 12 months
Secondary Outcome Appropriate maintenance on enrollment ART 12 months
Secondary Outcome Mortality (Mortality reported at loss to follow-up or through the South African Population register) 12 months
Secondary Outcome Hospital admissions (number and duration of overnight hospital stays) 12 months
Secondary Outcome Stigma (Measured through the 6-item AIDS related stigma scale) 12 months
Secondary Outcome Stress (Measured through the Percieved Stress Scale) 12 months
Secondary Outcome PHQ-9 response at 12 months (50% reduction in the PHQ-9 score) 12 months
Secondary Outcome Depression remission at 12 months (Score of less than 5 in PHQ-9) 12 months
Secondary Outcome Mean PHQ-9 score at 6 and 12 months 6 months 12 months
Secondary Outcome Depression severity categorised as mild, moderate, moderately severe or severe depression 6 month 12 months
Secondary Outcome Virological failure defined as two viral load values >1000 copies/ml 12 months
Secondary Outcome Treatment for depression (initiation or intensification of antidepressant medication, referral to a counsellor for depression counselling; number of contacts with a counsellor; and referral to a mental health specialist). 6 months 12 months
Secondary Outcome Viral suppression at 12 months, defined as a viral load of <400 copies/ml 12 months
Secondary Outcome Virological failure defined as two viral load values >1000 copies/ml 12 months
Secondary Outcome Change in viral load values over time. 12 months
Secondary Outcome Disability measured by WHO Disability Assessment Schedule 12 months
Secondary Outcome Care utilisation and resource use 12 months
Secondary Outcome Provision of integrated care from patient perspective will be assessed using the Patient Assessment of Care for Chronic Conditions (PACIC) 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr Kenneth Kaunda District OR Tambo Street Klerksdorp 2571 South Africa
Bojanala District Rustenburg Rustenburg 0299 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institue of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda MD 20892-9663 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Lung Institute George Street, Mowbray Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
University of KwaZulu-Natal Westville Durban 4000 South Africa
King's College Institute of Psychiatry London SE5 8AF United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lara Fairall lara.fairall@uct.ac.za +27214066979 George Street, Mowbray
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa University of Cape Town Lung Institute
Role Name Email Phone Street address
Public Enquiries Babalwa Zani babalwa.zani@uct.ac.za +27797875390 George Street, Mowbray
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Trial Site Coordinator, University of Cape Town Lung Institute
Role Name Email Phone Street address
Scientific Enquiries Lara Fairall lara.fairall@uct.ac.za +27214066979 George Street, Mowbray
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa University of Cape Town Lung Institute
REPORTING
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