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.: PACTR201403000676264 Date of Approval: 11/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title AFFIRM-SA trial
Official scientific title The effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa
Brief summary describing the background and objectives of the trial The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers) Specific Aims: ¿ To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied perinatal depression,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 07/10/2013
Actual trial start date 07/10/2013
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date 31/05/2016
Anticipated target sample size (number of participants) 420
Actual target sample size (number of participants) 425
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
226/2011 Human Research Ethics Committee, University of Cape Town
1U19MH095699 National Institute of Mental Health
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 simple randomisation using a randomisation table created by a computer software program done directly by the computer without human involvement Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Basic manual based counselling for 6 sessions by trained lay counsellors 6 sessions 3 - 5 months 6 sessions are provided in sequence to pregnant women with depressive symptoms 210
Control Group Enhanced usual care 3 monthly telephone calls 3 - 5 months phone call by CHW not trained in counseling 210 Active-Treatment of Control Group
Experimental Group Basic manual based counselling for 6 sessions by trained community health workers 6 sessions 3-5 months 6 sessions are provided in sequence to pregnant women with depressive symptoms 210
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation ¿ Living in Khayelitsha ¿ 18 years or older ¿ Screen positive for depression with a cut off of 13 or more on the EPDS ¿ Able to give informed consent ¿ Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis. ¿ Individuals assessed as being suicidal and requiring immediate referral to a mental health specialist (as indicated by a score of 17 or higher on the Suicide module of the Mini International Neuropsychiatric Interview 6.0.0 (MINI). ¿ Women who do not speak isiXhosa as a first language 18 Year(s) 45 Year(s) Female
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 12/05/2011 Faculty of Health Sciences Human Research Ethics Committee, UCT
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory, CapeTown 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 15/05/2012 UCT Faculty of Health Sciences Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory 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 15/05/2012 UCT Faculty of Health Sciences Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory 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 17/05/2013 UCT Faculty of Health Sciences Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory, 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 16/05/2014 UCT Faculty of Health Sciences Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory 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 09/09/2013 NIMH Global Mental Health DSMB
Ethics Committee Address
Street address City Postal code Country
National Institutes of Health Washington DC United States of America
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 20/05/2015 Faculty of Health Sciences Human Research Ethics Committee, UCT
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, 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 26/04/2016 Faculty of Health Sciences Human Research Ethics Committee, UCT
Ethics Committee Address
Street address City Postal code Country
E53, room 46, Old Main Building, 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 26/04/2017 Faculty of Health Sciences Human Research Ethics Committee, UCT
Ethics Committee Address
Street address City Postal code Country
E53, room 46, Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome scores on Hamilton depression rating scale baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Edinburgh Postnatal depression scale (EPDS) baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Mini International Psychiatric Interview 2.0.0 (MINI) Major depression baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Mini International Psychiatric Interview 2.0.0 (MINI) Suicidality baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Multidimensional Scale of Perceived Social Support (MSPSS) baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome WHO-DAS 2.0 12 item version baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Health services utilisation questionnaire baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Cape Town Functional Assessment Instrument for Maternal Depression baseline 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Secondary Outcome Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation follow-up 3 months postnatal follow-up 12 months postnatal follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Michael Mapongwana Midwife Obstetric Unit Steve Biko Rd Khayelitsha, Cape Town 7000 South Africa
Site B Midwife Obstetric Unit Lwandle Rd Khayelitsha South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Mental Health Department of Health and Human Services, 6001 Executive Boulevard, Rm. 6219B, MSC 9659 Bethesda, Maryland 20892-9659 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alan J Flisher Centre for Public Mental Health, Psychiatry and Mental Health, University of Cape Town 46 Sawkins Rd, Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Atalay Alem Dept of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa Ethiopia
Prof Ezra Susser Mailman School of Public Health, Columbia University, room 1508, 722 West 168th Str, New York 10032 United States of America
Prof Martin Prince Centre for Global Mental Health, Institute oif Psychiatry, King's College London. London SES 8AF United Kingdom
Prof Graham Thornicroft Centre for Global Mental Health, Institute oif Psychiatry, King's College London. London SES 8AF United Kingdom
Dr Judith Bass Dept of Mental Health, Johns Hopkins School of Public Health, 624 N Broadway Baltimore MD 21205 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Crick Lund crick.lund@uct.ac.za +2721 6850120 46 Sawkins Rd, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Director of Alan J Flisher Centre for Public Mental Health
Role Name Email Phone Street address
Public Enquiries Marguerite Schneider marguerite.schneider@uct.ac.za +27214066308 46 Sawkins Rd, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa AFFIRM Project Manager
Role Name Email Phone Street address
Scientific Enquiries Crick Lund crick.lund@uct.ac.za +27216850120 46 Sawkins Rd, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Director of Alan J Flisher Centre for Public Mental Health
REPORTING
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Result URL Hyperlinks
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