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.: PACTR201708002502117 Date of Approval: 05/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Role of Fees and Information in Healthcare Decisions in Mali
Official scientific title The Role of Fees and Information in Healthcare Decisions in Mali
Brief summary describing the background and objectives of the trial The goal of this trial is to determine the impact of providing free healthcare and free health worker visits on the decisions of parents in Mali about when they choose to utilize healthcare resources, which resources they choose to utilize. We study the interaction of these policies with key characteristics of households, allowing us to identify the channels by which they affect outcomes. The results of the study will be important for understanding the effects of abolishing user fees on the efficient delivery of healthcare. We will use them to develop and estimate a structural model of healthcare timing that allows the counterfactual analysis of alternative funding policies. This project is part of our long-term research goal to develop a strong theoretical and empirical base that can be used to design effective and efficient funding policies for healthcare in developing countries. Health outcome and behavior data is also collected from parents and children as part of the trial's secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Child weight, child MUAC, Diarrhea, blood in stool,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied infectious diarrhea
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2013
Actual trial start date 01/01/2013
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/10/2014
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants) 1733
Recruitment status Stopped early/ terminated
Publication URL https://poseidon01.ssrn.com/delivery.php?ID=85909511706606411510312311711910511202306902508409002202908012212307507407302506408504504300701702504302607010512406506701801504600202703500010100712400309412110706308004809407311000300108200309700412209808
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (please state block size and whether or not the block size was variable) Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (please state block size and whether or not the block size was variable) Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health worker visits biweekly duration of trial Health worker visits incl. health promotion messages 422
Experimental Group Subsidized care Continuous duration of trial Abolition of user fees at clinic 434
Experimental Group Health worker visits and subsidized care HW (biweekly); subsidize care (continuous) duration of trial Health worker visits incl. health promotion messages and abolition of user fees at clinic 433
Control Group Control 0 duration of trial no health worker visits or subsidized care 444 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Level of daily average household expenses of CFA475 (approximately $0.90) per person-equivalent. Decided in cooperation with staff members, local members of the community, and the locally recruited health workers. Level of HH expenditure determined through census conducted in target area. 2) Households that contain children aged 3.5 years or younger 1) Level of daily average household expenses higher than CFA475 (approximately $0.90) per person-equivalent 2) Households of which all household members are older than 3.5 years 0 Year(s) 4 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 01/08/2012 Duke University IRB Office
Ethics Committee Address
Street address City Postal code Country
Hock Plaza, Suite 405, 2424 Erwin Road Durham, NC 27705 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 03/09/2012 Institut National de Statistiques (INSTAT) du Mali
Ethics Committee Address
Street address City Postal code Country
BP 12, AVENUE DU MALI, HAMDALLAYE Bamako Mali
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 01/08/2012 Office of Research Integrity (IRB, IACUC, COI, Export Control)
Ethics Committee Address
Street address City Postal code Country
2 Stimson Avenue Providence, RI 02912 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time when participants choose to utilize healthcare resources October 2012 October 2013 October 2014
Primary Outcome Healthcare resources utilization by participants October 2012 October 2013 October 2014
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mali Health, Association Sigida Keneyali Hamdallaye ACI 2000, Rue 407, Porte 267 Bamako Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan Foundation 1825 K St NW #901 Washington, DC 20006 United States of America
ESRC/DFID Development Frontiers Award Number ES/K01207X/1 22 Whitehall, Westminster London SW1A 2EG United Kingdom
Brown University Population Studies and Training Center 68 Waterman St Providence, RI 02912 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mali Health PO Box 426081 Cambridge, Mass 02142 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Pierre Pratley 422 Oakdale Pl NW Washington 20001 United States of America
Mark Dean 420 W 118th New York 10027 United States of America
Anja Sautmann 68 Waterman St Providence, RI 02912 United States of America
Xinyi Zhang 68 Waterman St Providence, RI 02912 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Dean mark@yorkshire-exile.co.uk +1 212 854 3669 420 W. 118th Street, MC 3308
City Postal code Country Position/Affiliation
New York 10027 United States of America Assistant Professor
Role Name Email Phone Street address
Public Enquiries Mark Dean mark@yorkshire-exile.co.uk +1 212 854 3669 420 W. 118th Street, MC 3308
City Postal code Country Position/Affiliation
New York 10027 United States of America Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Mark Dean mark@yorkshire-exile.co.uk +1 212 854 3669 420 W. 118th Street, MC 3308
City Postal code Country Position/Affiliation
New York 10027 United States of America Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information