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.: PACTR201311000681314 Date of Approval: 18/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Expanded Quality Management Using Information Power to improve maternal and newborn health in Tanzania and Uganda
Official scientific title Expanded Quality Management Using Information Power to improve maternal and newborn health in Tanzania and Uganda
Brief summary describing the background and objectives of the trial EQUIP implements a quality management (QM) intervention in each one intervention and comparison district in Tanzania and Uganda to improve maternal and newborn health. The QM links communities and facilities and is powered by information made available on report cards from continuous household and health facility surveys. A plausibility design is used to evaluate health and quality outcomes and the impact on mortality will be modelled using the Lives Saved Tool.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EQUIP
Disease(s) or condition(s) being studied Maternal, newborn
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2010
Actual trial start date 01/11/2010
Anticipated date of last follow up 30/04/2014
Actual Last follow-up date 10/05/2014
Anticipated target sample size (number of participants) 1087000
Actual target sample size (number of participants) 1087000
Recruitment status Completed
Publication URL http://www.implementationscience.com/content/9/1/41
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 Non-randomised purposefully selected implementation and comparison district Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Quality management continious 30 months Quality management at district, health facilities and communities 438000
Experimental Group Quality management continious 30 months Quality management at district, health facilities and communities 640000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Population in intervention districts no exclusion 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 100 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 National Institute for Medical Research (NIMR)
Ethics Committee Address
Street address City Postal code Country
Dar-es-Salaam Box 9653 United Republic of Tanzania
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 14/01/2011 School of Public Health, Higher Degrees, Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kampala Box 7072 Uganda
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 03/11/2010 National Institute for Medical Research (NIMR)
Ethics Committee Address
Street address City Postal code Country
Dar-es-Salaam Box 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Uptake and quality of care indicators along the continuum of care between 1st Nov 2011 to 30 April 2014
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mayuge District Health Office Box 1317 Mayuge Uganda
Newala District Box 16 Newala United Republic of Tanzania
Tandahimba District Box 03 Tandahimba United Republic of Tanzania
Namayingo District Health Office Box 54 Bugiru Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
European Commission ¿ Research and Innovation, FP-7 framework Rue du Champs de Mars, 21 (CDMA), Brussels, Belgium Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No Sponsor for study Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Ifakara Health Institute Plot 463, Kiko Ave Dar-es-Salaam Box 78373 United Republic of Tanzania
Makerere University.School of Public Health, Dpt of Health Policy Planning and Mgmt Main Campus Kampala PO Box 7072 Uganda
Evaplan am Universitätsklinikum Ringstrasse 15d Heidelberg 69115 Germany
Dpt Public Health Sciences, Karolinska Institutet Tomtebodavaegen Stockholm 17177 Sweden
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stefan Peterson stefan.peterson@ki.se +46 70 446 0787 Widerstroemska Huset
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden
Role Name Email Phone Street address
Public Enquiries Claudia Hanson Claudia.hanson@ki.se 004673404567 Widerstroemska Huset
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden
Role Name Email Phone Street address
Scientific Enquiries Stefan Hanson stefan.peterson@ki.se +46 70 446 0787 Widerstroemska Huset
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden
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