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.: PACTR201308000601715 Date of Approval: 25/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Community Health Promoters: A Randomized Control Trial
Official scientific title Impact of Community Health Promoters: A Randomized Control Trial
Brief summary describing the background and objectives of the trial By establishing an efficient and secure supply chain for subsidized preventative and curative products, like bed nets, cold medicines, and water-treatment tools, the Living Goods/BRAC model is hypothesized to improve health outcomes through an efficient, sustainable, and scalable health delivery system. The specific objective of this model is to reduce mortality and morbidity rates by at least 25% for children under-five, by improving access to and adoption of affordable health products.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied malaria, diarrhoea, respiratory infections, birth complications,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/07/2009
Actual trial start date 01/07/2009
Anticipated date of last follow up 21/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 8000
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
SS 3195 Uganda National Council for Science and Technology (UNCST)
¿ P20141-101 Harvard School of Public 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community Health Promoter (CHP) Constant presence in the village 3 years People living in treatment villages experienced the presence of a CHP, who provided basic health education and sold a diverse basket of basic health goods anchored by essential items emphasizing prevention, like bed nets and water treatment. 4000
Control Group No Community Health Promoter 3 years People living in control villages did not experience the presence of any CHP 4000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All subjects living in a treatment villages can benefit from the presence of the CHP. However, for inclusion in the survey, a household must have at least one child under 5 years of age. The exclusion criteria regarding the household surverys is the following: no children under 5 years of age. 18 Year(s) 99 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 24/11/2010 Fondazione Istituto Nazionale Tumori
Ethics Committee Address
Street address City Postal code Country
Via Giacomo Venezian, 1 Milan 20100 Italy
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality for children under five After 3 years from the beginning of the intervention (i.e. after that CHPs have been working for 3 years in treatment villages)
Secondary Outcome Malaria morbidity in under 5 children After 3 years from the beginning of the intervention
Secondary Outcome Diarrhoea morbidity in under 5 children After 3 years from the beginning of the intervention
Secondary Outcome Acute Respiratory Infection morbidity in under 5 children After 3 years from the beginning of the intervention
Secondary Outcome Percentage of malaria cases promptly treated with ACTs After 3 years from the beginning of the intervention
Secondary Outcome Percentage of child diarrhoea cases promptly treated After 3 years from the beginning of the intervention
Secondary Outcome Percentage of Acute Respiratory Infections (ARI) promptly treated After 3 years from the beginning of the intervention
Secondary Outcome Percentage of children receiving Vitamin A supplementation (either through vitamin supplements or through fortified foods) After 3 years from the beginning of the intervention
Secondary Outcome Percentage of deliveries in a facility with trained medical help After 3 years from the beginning of the intervention
Secondary Outcome Percentage of first of antenatal care (ANC) visits within first four months of pregnancy After 3 years from the beginning of the intervention
Secondary Outcome Percentage of under-5 children sleeping under bed nets After 3 years from the beginning of the intervention
Secondary Outcome Percentage of households using treated or filtered water After 3 years from the beginning of the intervention
Secondary Outcome Anthropometric indicators (height, weight, mid-upper arm circumference) for under 5 children After 3 years from the beginning of the intervention
Secondary Outcome Haemoglobin level in under 5 children After 3 years from the beginning of the intervention
Secondary Outcome Health knowledge After 3 years from the beginning of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Living Goods Plot 434 Balintuma Road, Namirembe Kampala P.O. Box 4816 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Children's Investment Fund Foundation (CIFF) Clifford Street, 7 London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Children's Investment Fund Foundation (CIFF) Clifford Street, 7 London United Kingdom Funding Agency
Primary Sponsor Jakob Svensson (IIES, Stockholm University) IIES-Institute for International Economic Studies SE-106 91 Stockholm Sweden University
Primary Sponsor Martina Björkman Nyqvist (Stockholm School of Economics) Sveavägen 65 Stockholm Sweden University
Primary Sponsor David Yanagizawa-Drott (Harvard University) 79 JFK Street Cambridge, MA 02138 United States of America University
Primary Sponsor Andrea Guariso (K.U. Leuven) Waaistraat 6 Leuven 3000 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Innovations for Poverty Action (IPA) Plot Katego 5 Road, Kamwokya Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jakob Svensson jakob.svensson@iies.su.se (+46) 8 16 30 60 IIES-Institute for International Economic Studies SE-106 91
City Postal code Country Position/Affiliation
Stockholm Sweden Professor, Institute for International Economic Studies, SU
Role Name Email Phone Street address
Public Enquiries Andrea Guariso andrea.guariso@fastwebnet.it +32 16 324551 waaistraat 6 - bus 3511
City Postal code Country Position/Affiliation
Leuven 3 Belgium PhD student, LICOS Centre for Institutions and Economic Performance, K.U. Leuven
Role Name Email Phone Street address
Scientific Enquiries Andrea Guariso andrea.guariso@fastwebnet.it +32 16 324551 waaistraat 6 - bus 3511
City Postal code Country Position/Affiliation
Leuven Belgium Phd student, LICOS Centre for Institutions and Economic Performance, K.U. Leuven
REPORTING
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