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.: PACTR201609001398349 Date of Registration: 22/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Living Goods/BRAC entrepreneurial CHW model in Uganda
Official scientific title Evaluation of Living Goods/BRAC entrepreneurial CHW model in Uganda Phase II
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 (CHW) programs. This randomized control trial 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 (CHP) 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 under-5 mortality rate by 27% (adjusted rate ratio 0.73, 95% CI 0.58-0.93) in the intervention compared to the control arm, over a 3-year period. This is the research protocol for the second phase of the evaluation. The study will answer two main questions: 1) Can the reduction in child mortality observed in the first phase of the evaluation be sustained when the program is running at scale? 2) How does the program affect the level of activity of other CHWs operating in the villages?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrhea, ARI, all cause mortality,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2016
Actual trial start date
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 12500
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)
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 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 experimental villages experience the presence of CHPs. The CHPs conduct home visits, educate households on essential health behaviours, provide basic medical advice, referring the more severe cases to the closest health centre, and to sell preventive and curative health products. 6250
Control Group No Community Health Promoter 3 years No CHP operates in Control villages. Households in both experimental and control group can always benefit from primary health care services provided by other actors, including private clinics, public primary health dispensaries, and other community health workers operating in the village. They can also buy medicine and other medical inputs from local drug stores. 6250
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. A Community Health Worker survey will be administered to community health workers operating in the study villages (if any). At endline, the survey will include also all CHPs operating in the treatment villages. A Household survey will be administered to around 25 eligible households within each study cluster. The evaluation will be based on a fixed sample of households that will be tracked and repeatedly surveyed over time. In order to maximize the power of the analysis, the identification of eligible households at baseline will be guided by the attempt to identify households likely to have children born during the evaluation period. The primary respondent to the survey will be a woman living in the household, aged 18 to 30, and we will first select households in which the woman is pregnant. If not enough households fulfilling this criterion can be identified, we will move to consider households where the woman has (at least) a child under 3 years. Finally, if we will still below the threshold of eligible household that have to be identified within the cluster, we will move to consider households in which the woman is married/in an official relationship. Th identification of the eligible households will take place at enumeration stage, just before the administration of the baseline survey. The Community Health Worker survey will be administered to all Community Health Workers operating in each study cluster. The Household survey will be administered to about 25 households in each study cluster, selected following the criteria outlined above. The primary respondent of the survey will always be a woman aged 18 to 30. 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 21/09/2015 Mildmay Uganda Research and Ethics Committee (MUREC)
Ethics Committee Address
Street address City Postal code Country
Plot 27, Lweza Kampala P.O. Box 24985 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 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 Under 5 mortality - Baseline; - Follow-up survey I; - Follow-up survey II; - Endline
Primary Outcome Infant mortality - Baseline; - Follow-up survey I; - Follow-up survey II; - Endline
Primary Outcome Neonatal mortality - Baseline; - Follow-up survey I; - Follow-up survey II; - Endline
Secondary Outcome interactions with Community Health Promoters - Baseline; - Follow-up survey I; - Follow-up survey II; - Endline
Secondary Outcome knowledge about causes of malaria and diarrhea - Baseline; - Endline
Secondary Outcome knowledge and consumption of food with added vitamins and nutrients - Baseline; - Endline
Secondary Outcome usage of bed-nets for children living in the household - Baseline; - Endline
Secondary Outcome household received follow-up visits after child was sick - Baseline; - Endline
Secondary Outcome household received follow-up visit after delivery - Baseline; - Endline
Secondary Outcome level of activity of other Community Health Workers operating in the village - 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) 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,InstituteforInternational 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
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Result URL Hyperlinks
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