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.: PACTR201610001825403 Date of Approval: 17/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Strengthening South Africa's health system through integrating treatment for mental illness into chronic disease care:
Official scientific title Strengthening South Africa's health system through integrating treatment for mental illness into chronic disease care: A cluster randomized controlled trial.
Brief summary describing the background and objectives of the trial Background: Integrating mental health care into primary health services could reduce the impact of chronic communicable and non-communicable diseases (NCDs) in low- and middle-income countries (LMICs). There is limited knowledge of how mental health care can be integrated into chronic disease services in ways that are acceptable, feasible and effective. Design: A three-arm, phase 3 cluster randomized controlled trial that compares the relative effectiveness of two models of service integration relative to treatment as usual on common mental disorder outcomes at 6 and 12 month follow up. Objectives: 1. To compare the effectiveness of two approaches to mental health service integration (dedicated versus designated) relative to treatment as usual (TAU), with depression and risky alcohol use as primary outcomes and HIV1 RNA viral load and HbA1c as secondary outcomes. 2. To determine the cost-effectiveness of a dedicated model of service integration relative to a designated model relative to TAU. Population: Adults (>= 18 years) using antiretroviral therapy for HIV or diabetes medication who are hazardous/harmful drinkers or at moderate to high risk for depression and who are not currently receiving treatment for a common mental disorder. Arms: Models of service integration. (a) Dedicated model: Three session brief blended MI-PST intervention delivered by dedicated community health workers with the sole responsibility of providing mental health counselling. (b) Designated model: Three session brief blended MI-PST intervention delivered by community health workers designated to provide this BI in addition to their usual chronic disease responsibilities. (c) Treatment as usual (TAU). Referral to standard mental health services. Outcomes:Primary outcomes: Change in self-reported hazardous/harmful alcohol use as measured by the AUDIT and risk of depression as measured by the CES-D, measured at 6 and 12 month follow up assessment time points.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) project MIND
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2017
Actual trial start date 19/04/2017
Anticipated date of last follow up 02/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation based on urban-rural status of clinics. Sequence computer generated Allocation determined by the holder of the sequence, an independent statistician Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dedicated arm 3 counselling sessions Up to one hour per session A three-session blended motivational interviewing-problem solving therapy (MI-PST) intervention delivered by community health workers who will work across both the HIV and diabetes clinics. They will be dedicated staff, who will have no other chronic disease duties and who will be responsible only for delivering this mental health intervention package. 8
Experimental Group Designated arm 3 counselling sessions up to one hour per session In clinics allocated to this Arm, participants will receive a blended MI-PST intervention delivered by community health workers who will work across both the HIV and diabetes services. They will be designated to provide this mental health care package and referrals to additional specialized services (if indicated) in addition to their other chronic disease-related duties. 8
Control Group Treatment as usual 1 session of screening and referral up to one hour In CHCs assigned to the TAU arm, participants will receive the standard package of care when a health provider suspects a patient may have a common mental disorder. This includes screening for a common mental disorder and referring patients for further assessment and treatment to onsite or offsite mental health nurses or social workers for further assessment and treatment. 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for inclusion, all participants recruited from the HIV clinics must: ¿ Be at least 18 years old ¿ Be taking ART for their HIV disease ¿ Screen at risk for depression, with a CES-D scores ¿16 and/or screen at risk for hazardous or harmful alcohol use (with AUDIT scores ¿ 8) ¿ Provide written informed consent to participate in the study ¿ Agree to comply with all study requirements. To be eligible for inclusion , all participants recruited from the diabetes clinics must: ¿ Be At least 18 years old ¿ Be taking medication for their diabetes disease (Type 1 or Type 2) ¿ Screen at risk for depression, with a CES-D scores ¿16 and/or screen at risk for hazardous or harmful alcohol use (with AUDIT scores ¿ 8) ¿ Provide written informed consent to participate in the study ¿ Agree to comply with all study requirements. Regardless of whether they are recruited from HIV or diabetes clinics, any individual who meets any of the following criteria on screening will be excluded from participation in this study: ¿ Currently receiving treatment (counselling or medication) for a mental disorder ¿ Participating in another research study. 18 Year(s) 0 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 02/11/2016 South African Medical Research Council Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 19070 Tygerberg 7505 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 27/10/2016 G50 Old Main Building Groote Schuur Hospital
Ethics Committee Address
Street address City Postal code Country
Anzio Road Observatory Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression scores as measured by CES-D baseline 6 months post-enrollment 12 months post-enrollment
Primary Outcome hazardous alcohol use as measured by AUDIT baseline 6 months post-enrollment 12 months post-enrollment
Secondary Outcome hBA1c baseline 6 months post-enrollment 12 months post-enrollment
Secondary Outcome HIV RNA viral load baseline 6 months post-enrollment 12 months post-enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malmesbury clinic Malmesbury South Africa
Lutzville clinic Lutzville South Africa
Vredendal clinic Vredendal South Africa
Grabouw clinic Grabouw South Africa
Hermanus clinic Hermanus South Africa
Railton clinic Swellendam South Africa
Michael Mapongwana clinic Khayelitsha South Africa
Khayelitsha site B clinic Khayelitsha South Africa
Nolungile clinic Khayelitsha South Africa
Mfuleni clinic Mfuleni South Africa
Nyanga clinic Nyanga South Africa
Gugulethu clinic Gugulethu South Africa
Browns Farm clinic Browns Farm South Africa
Heideveld clinic Heideveld South Africa
Crossroads clinic Crossroads South Africa
Kraaifontein clinic Kraaifontein South Africa
Elsiesriver clinic Elsiesriver South Africa
Delft clinic Delft South Africa
Retreat clinic Retreat South Africa
Hanover park clinic Hanover park South Africa
Mitchell's Plain clinic Mitchell's plain South Africa
Worcester clinic Worcester South Africa
TC Newman clinic Paarl South Africa
Ceres clinic Ceres South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
British Medical Research Council United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie Van Zyl Drive Parow 7505 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Katherine Sorsdahl University of Cape Town Cape Town South Africa
Crick Lund University of Cape Town Cape Town South Africa
John Joska University of Cape Town Cape Town South Africa
Dan Stein University of Cape Town Cape Town South Africa
Naomi Levitt University of Cape Town Cape Town South Africa
Tracey Naledi Western Cape Department of Health Cape Town South Africa
Peter Milligan Western Cape Department of Health Cape Town South Africa
Christopher Butler Oxford University Oxford United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bronwyn Myers bmyers@mrc.ac.za +27219380993 PO Box 19070
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa South African Medical Research Council
Role Name Email Phone Street address
Public Enquiries Lesley-Ann Erasmus-Claasen lesley-ann.erasmus@mrc.ac.za +27219380857 PO box 19070
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa South African Medical Research Council
Role Name Email Phone Street address
Scientific Enquiries Petal Petersen Williams petal.petersen@mrc.ac.za +27219380334 PO box 19070
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa South African Medical Research Council
REPORTING
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