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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201609001400175 Date of Registration: 25/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Living Goods/BRAC entrepreneurial CHW model in Uganda (drugs quality)
Official scientific title Evaluation of Living Goods/BRAC entrepreneurial CHW model in Uganda (drugs quality)
Brief summary describing the background and objectives of the trial Despite improvements in under-five child mortality in recent decades, an estimated 6.9 million children die from preventable diseases worldwide every year. A majority of these deaths occur in the poorest countries in the world, in areas within countries of underserved populations with inadequate access to preventative and curative services. An increasingly common approach to reach these populations has been through Community Health Worker programs. This RCT serves to evaluate the efficacy of a CHW model with a business incentive tied to the CHW. The program is implemented by Living Goods, a US based NGO active in Uganda, in collaboration with BRAC Uganda and the Uganda Ministry of Health. Unlike volunteer-based community health worker programs, the Community Health Promoters model enables health workers to earn a living selling basic government approved health products. A first evaluation of the impact of the CHP program began in 2010 and was completed in 2014. The evaluation found that the CHP program reduced under5 mortality rate by 27% in the intervention compared to the control arm, over a 3-year period. This is the research protocol for a research project embedded in the second phase of the evaluation. Its focus is on drug quality. The persistence of counterfeit and substandard drugs in the developing world represents indeed a major market failure and a severe public health problem. The WHO has estimated that more than 25% of the drug supply is counterfeit. This evaluation will will allow quantifying the extent and evolution of substandard and counterfeit products in a set of local markets across Uganda. The research will then enable an assessment of how existing market actors in the new study villages will be affected by the entry of a new actor ¿ the BRAC/Living Goods CHP ¿ that will sell high quality drugs at subsidized prices. The randomized control design will allow us to determine the impact of the CHP program on the quality of drugs sold in local markets
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Drugs quality,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2016
Actual trial start date
Anticipated date of last follow up 01/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
13774 Innovations for Poverty Action IRB
SS3938 Uganda National Council for Science and Technology (UNCST)
13774 Innovations for Poverty Action IRB
SS3938 Uganda National Council for Science and Technology (UNCST)
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 Stratified allocation, based on geographical location of the clusters (there are 14 geographical areas in the sample). The randomization is performed using a random number generator on a computer ¿Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation, based on geographical location of the clusters (there are 14 geographical areas in the sample). The randomization is performed using a random number generator on a computer ¿Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,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 Outlets and drug shops in Treatment village experience the presence in the village of Community Health Promoters, who - among other things - sell high quality drugs at subsidized prices. 250
Control Group No Community Health Promoter 3 years No CHP operates in Control villages 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sample drugs agains malaria and pneumonia (children dosage) will be bought from any drug store, outlet, or pharmacy operating in the village. In cases in which no outlet is present within the village borders, the closest outlet outside the village (i.e. the one where locals typically go to buy drugs) will be selected. Outlets located outside and/or far away from the village will not be included in the study. 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 15/10/2015 ¿INNOVATIONS FOR POVERTY ACTION IRB
Ethics Committee Address
Street address City Postal code Country
101 Whitney Avenue New Haven, CT 06510 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Antimalarial drug quality - Baseline; - Endline
Secondary Outcome Anti-pneumonia drug quality - Baseline; - Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Living Goods Plot 8, Spring Road, Bugolobi Kampala P.O. Box 4816 Uganda
BRAC Plot 90, Busingiri Zone, Nyanam Kampala 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 Andrea Guariso (K.U. Leuven) Waaistraat 6 Leuven 3000 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Innovations for Poverty Action (IPA), Uganda office Plot 21 Kanjokya street Kampala PO Box 40260 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 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
Scientific Enquiries 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
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