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: www.pactr.org
Trial no.: PACTR202102616421588 Date of Approval: 17/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of a Community-Driven Water, Sanitation, and Hygiene Program on Covid-19 knowledge, behavior, and health: A Randomized Control Trial in the Democratic Republic of Congo
Official scientific title Effect of a Community-Driven Water, Sanitation, and Hygiene Program on Covid-19 knowledge, behavior, and health: A Randomized Control Trial in the Democratic Republic of Congo
Brief summary describing the background and objectives of the trial In 2008, the Government of the DRC launched a national program known as National Healthy Villages and Schools (in French Villages et Ecoles Assainis, VEA), a water and sanitation program financed by DFID and implemented by UNICEF and the Government of DRC’s Ministry of Public Health and Ministry of Primary, Secondary, and Professional Education. The VEA’s main objectives are to support communities’ improved access to water, hygiene, and sanitation services and practices through the construction of water and sanitation infrastructure in villages and schools, local community involvement, and a village certification mechanism. This study uses a cluster-level randomized controlled trial to evaluate the causal impact of the VEA program across 332 rural villages. Although VEA has been operational since 2008, the study focused on more recent activities; as the program was implemented in these villages in the later phase of the program (throughout 2019). It involves experimentally varying the provision of the VEA program to a set of villages to examine the causal impacts on water access, infrastructure development, availability of sanitation services, knowledge of hygiene practices, and child health. An earlier paper assesses the short run effects of the program at approximately 5 months post-intervention (https://www.socialscienceregistry.org/trials/4648/history/64498). This pre-analysis plan pertains to a 12, 18, and 24 month follow-up surveys, implemented through mobile phone surveying modalities, to measure program effects on mental and physical health, Covid-19 knowledge and prevention, and governance. This pre-analysis plan was revised after the authors had analyzed data from the first and second round of the phone survey, before they had seen any data from the third round of the phone survey. Data from the third round was collected in June – July 2021, during a period when reported COVID cases were rising to their highest levels to date in DRC.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Covid-19, diarrheal disease
Purpose of the trial Prevention
Anticipated trial start date 01/11/2020
Actual trial start date
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1312
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization 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 The Health Villages and Healthy Schools Program Each village received the program once. Villages were grouped into clusters for randomization, to minimize spillovers. The group size below refers to the number of intervention clusters. The intervention ranged from 1 to 30 months. The median duration was 9 months. The intervention finances the construction of water and sanitation infrastructure in villages and schools and facilitates local community involvement in management of this infrastructure, with the view to fostering an environment in which household health and hygiene is managed by the communities themselves. It is based on the key concept of not just building infrastructure but also encouraging and mobilizing communities to become a “Healthy Village,” which they do by meeting or exceeding minimum standards for water, sanitation and hygiene. The VEA program is implemented in nine steps. 0. The community learns about the program and collectively decides to adopt it before submitting a formal request to the relevant Health Zone. 1. A statement of agreement between the community and the Health Zone is signed. 2. Health Zone officials investigate the behaviors, attitudes and practices of village households. 3. The community analyses its hygiene and sanitation using community mapping, undertakes observation walks, and analyses the three categories of classification for hygiene conditions as well as fecal-oral transmission routes. 4. he Health Zone provides training for 20 volunteers, then the community elects a village committee. 5.The community develops a Community Action Plan and prioritizes interventions. 6. NGOs contracted by UNICEF finance the construction of WASH infrastructure (water points, latrines) as identified by the community, and train the communities on infrastructure maintenance. In addition, the community takes additional actions to improve access to water and sanitation. Volunteers promote good hygiene practices. 7. The final investigation: the office of the Health Zone conducts a study of the community. 8. The chief medical officer of the Health Zone checks whether the village meets the standards required to be designated as a Healthy Village. 50
Control Group Control group The control group does not receive any intervention. The control group does not receive any intervention. The control group does not receive any intervention. 71 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All 1,312 households that were randomly selected for our earlier survey were included in the target list for follow-up interviews. If the household from the earlier survey round could not be reached by phone, then it could be replaced by a nearby household in the same or a neighboring village. These households were located in 332 villages; the village leader and water committee leader (if a water committee existed) were also interviewed in the first survey round. These individuals were eligible for interviews in the phone survey rounds. In the event that they could not be reached, replacements were handled on a case by case basis. See details on the first survey here: https://www.socialscienceregistry.org/trials/4648 Households that did not participate in the early survey, or did not meet the criteria for replacement, were not eligible. 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) 110 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 02/06/2020 Solutions IRB
Ethics Committee Address
Street address City Postal code Country
PO Box 1041 Yarnell 85362 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Covid-like illness. Number of household members in past week with fever, dry cough, difficulty breathing/shortness of breath, or fatigue Nov 2020-Jan 2021 and June-Jul 2021
Primary Outcome Non-Covid illness. Number of sick household members in last seven days [exclude those with Covid symptoms] Nov 2020-Jan 2021 and June-Jul 2021
Primary Outcome Child health index. Summary index of proportion of children under five with fever/cough/diarrhea in last two weeks [this will be three separate numbers for each HH with children under 5] Nov 2020-Jan 2021 and June-Jul 2021
Primary Outcome Mental health. Summary index of scores to following questions (1=All of the time...6=None of the time): Have you been a very nervous person over the past four weeks ? Have you felt so down in the dumps that nothing could cheer you up over the past four weeks ? Have you felt calm and peaceful over the past four weeks ? (negatively coded) Have you felt downhearted and blue over the past four weeks ? Have you been a happy person over the past four weeks ? (negatively coded) Nov 2020-Jan 2021
Secondary Outcome Village Covid prevention. Summary index of the following binary variables as reported by households: banned gatherings; community meetings; HH visits; curfew; closed shops; handwashing materials/water; isolation of sick; medical care; wear mask; social distancing May-July 2020 and Nov 2020-Jan 2021
Secondary Outcome Household Covid prevention. Summary index of the following binary variables from household survey [Have you practiced X in the last two weeks?]: wash hands frequently; avoid physical contact; avoid social gatherings; stay at home; wear mask; keep 1+ meter distance May-July 2020 and Nov 2020-Jan 2021
Secondary Outcome Respondent Covid Knowledge. Summary index of the following binary variables from household survey [Is X effective to prevent Covid?]: wash hands frequently; avoid physical contact; avoid social gatherings; stay at home; wear mask; keep 1+ meter distance; inject/inhale disinfectant (negative) May-July 2020
Secondary Outcome Governance. Summary index of Likert variables: A23. Overall, how well do you think the government is doing in its response to the COVID epidemic? [1=very badly...5=very good] A24. How much do you trust the government to respond well to the COVID epidemic? [1=strongly distrust...5=strongly trust] May-July 2020
Secondary Outcome Livelihoods. Summary index of responses to: A27.a In the past week, how many hours have you spent working on an income generating activity? A27.c In the past week, how many hours has your spouse/partner spent working on an income generating activity for your household? [if applicable] A27.d Has anyone in your household (including you) lost their job (or main source of income) since the coronavirus pandemic began? [negatively coded] A27.e Have you or anyone in your household gained a new job (or main source of income) since the coronavirus pandemic began? A27.f Think of the income you earned each month before the coronavirus pandemic began. How does that compare to the income you are earning now? Nov 2020-Jan 2021 and June-Jul 2021
Secondary Outcome Food security. In the last seven days, how many days (out of 7) did you lack enough food to eat? May-July 2020, Nov 2020-Jan 2021, June-July 2021
Secondary Outcome Access to health care. Have you or any other person your household delayed, skipped or been unable to complete health care visits since the Coronavirus pandemic began? Nov 2020-Jan 2021
Secondary Outcome Hospital visits. Number of household members who visited hospital in last seven days May-July 2020, Nov 2020-Jan 2021, and June-July 2021
Secondary Outcome Household illnesses. Number of sick household members in last seven days [includes those with Covid symptoms, because no data on symptoms was collected] May-July 2020
Secondary Outcome Perceptions of Covid prevention. Summary index of the following binary variables from household survey [Have most people in your village/community practiced X in the last two weeks?]: wash hands frequently; avoid physical contact; avoid social gatherings; stay at home; wear mask; keep 1+ meter distance. Nov 2020-Jan 2021
Primary Outcome Vaccine acceptance. If a vaccine for COVID-19 becomes available to you, would you take it? June-July 2021
Secondary Outcome Approval of authorities. 10 outcomes. Do you approve or disapprove of the way that the following people have performed their jobs over the past twelve months, or haven’t you heard enough about them to say? 1. President 2. National Assembly 3. Ministry of Health 4. Provincial Government 5. International NGOs 6. Local NGOs 7. Traditional leaders 8. Health zone officials 9. Health area officials 10. Village chief June-July 2021
Secondary Outcome Leader vaccine acceptance. In village leader survey: If a vaccine for COVID-19 becomes available to you, would you take it? June-July 2021
Secondary Outcome Leader vaccine advice. In village leader survey: Will you advise the people in your village to take the Covid vaccine? June-July 2021
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Innovative Hub for Research in Africa 65, Avenue du Livre, Commune de la Gombe Kinshasa 0000 Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Foreign Commonwealth and Development Office King Charles St, Whitehall, Westminster London SW1A 2AH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Development Impact Evaluation Unit World Bank 1225 Connecticut Ave NW Washington DC 20036 United States of America International intergovernmental organization
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kevin Croke kcroke@hsph.harvard.edu 2022858159 677 Huntington Ave
City Postal code Country Position/Affiliation
Boston 02115 United States of America Assistant Professor of Global Health Harvard School of Public Health
Role Name Email Phone Street address
Public Enquiries John Quattrochi john.quattrochi@simmons.edu 8579997192 300 The Fenway
City Postal code Country Position/Affiliation
Boston 02115 United States of America Assistant Professor of Public Health Simmons University
Role Name Email Phone Street address
Principal Investigator John Quattrochi john.quattrochi@simmons.edu 8579997192 300 The Fenway
City Postal code Country Position/Affiliation
Boston 02115 United States of America Assistant Professor of Public Health Simmons University
Role Name Email Phone Street address
Principal Investigator Aidan Coville acoville@worldbank.org 12024582578 1225 Connecticut Ave NW
City Postal code Country Position/Affiliation
Washington DC 20036 United States of America Senior Economist Development Impact Evaluation World Bank
Role Name Email Phone Street address
Principal Investigator Eric Mvukiyehe emvukiyehe@worldbank.org 12024582672 1225 Connecticut Ave NW
City Postal code Country Position/Affiliation
Washington DC 20036 United States of America Economist in Development Impact Evaluation Department at World Bank
Role Name Email Phone Street address
Scientific Enquiries John Quattrochi john.quattrochi@simmons.edu 8579997192 300 The Fenway
City Postal code Country Position/Affiliation
Boston 02115 United States of America Assistant Professor of Public Health Simmons University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification, will be posted publicly once the main manuscript using the endline data has been published. The study protocol, statistical analysis plan, informed consent form, and analytic code will also be available. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol We anticipate that the main manuscript based on the endline data will be published in early 2022. Data will be posted in a public repository that is open to anyone.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.socialscienceregistry.org/trials/4648 No
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 10/07/2021 We added a round of data collection in June-July 2021 In 2008, the Government of the DRC launched a national program known as National Healthy Villages and Schools (in French Villages et Ecoles Assainis, VEA), a water and sanitation program financed by DFID and implemented by UNICEF and the Government of DRC’s Ministry of Public Health and Ministry of Primary, Secondary, and Professional Education. The VEA’s main objectives are to support communities’ improved access to water, hygiene, and sanitation services and practices through the construction of water and sanitation infrastructure in villages and schools, local community involvement, and a village certification mechanism. This study uses a cluster-level randomized controlled trial to evaluate the causal impact of the VEA program across 332 rural villages. Although VEA has been operational since 2008, the study focused on more recent activities; as the program was implemented in these villages in the later phase of the program (throughout 2019). It involves experimentally varying the provision of the VEA program to a set of villages to examine the causal impacts on water access, infrastructure development, availability of sanitation services, knowledge of hygiene practices, and child health. An earlier paper assesses the short run effects of the program at approximately 5 months post-intervention (https://www.socialscienceregistry.org/trials/4648/history/64498). This pre-analysis plan pertains to a 12 month and 18 month follow-up surveys, implemented through mobile phone surveying modalities, to measure program effects on mental and physical health and Covid-19 knowledge and prevention. This pre-analysis plan was written after the authors had analyzed data from the first round of the phone survey, before they had seen any data from the second round of the phone survey. Therefore all pre-specified primary outcomes come from the second round. Data from the second round was collected in November - January 2020-2021, during a period when reported COVID cases were ris In 2008, the Government of the DRC launched a national program known as National Healthy Villages and Schools (in French Villages et Ecoles Assainis, VEA), a water and sanitation program financed by DFID and implemented by UNICEF and the Government of DRC’s Ministry of Public Health and Ministry of Primary, Secondary, and Professional Education. The VEA’s main objectives are to support communities’ improved access to water, hygiene, and sanitation services and practices through the construction of water and sanitation infrastructure in villages and schools, local community involvement, and a village certification mechanism. This study uses a cluster-level randomized controlled trial to evaluate the causal impact of the VEA program across 332 rural villages. Although VEA has been operational since 2008, the study focused on more recent activities; as the program was implemented in these villages in the later phase of the program (throughout 2019). It involves experimentally varying the provision of the VEA program to a set of villages to examine the causal impacts on water access, infrastructure development, availability of sanitation services, knowledge of hygiene practices, and child health. An earlier paper assesses the short run effects of the program at approximately 5 months post-intervention (https://www.socialscienceregistry.org/trials/4648/history/64498). This pre-analysis plan pertains to a 12, 18, and 24 month follow-up surveys, implemented through mobile phone surveying modalities, to measure program effects on mental and physical health, Covid-19 knowledge and prevention, and governance. This pre-analysis plan was revised after the authors had analyzed data from the first and second round of the phone survey, before they had seen any data from the third round of the phone survey. Data from the third round was collected in June – July 2021, during a period when reported COVID cases were rising to their highest levels to date in DRC.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 10/07/2021 We added a round of data collection. 31 Jan 2021 31 Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Vaccine acceptance. If a vaccine for COVID-19 becomes available to you, would you take it?, June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Covid-like illness. Number of household members in past week with fever, dry cough, difficulty breathing/shortness of breath, or fatigue, Nov 2020-Jan 2021 Primary Outcome, Covid-like illness. Number of household members in past week with fever, dry cough, difficulty breathing/shortness of breath, or fatigue, Nov 2020-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Non-Covid illness. Number of sick household members in last seven days [exclude those with Covid symptoms] , Nov 2020-Jan 2021 Primary Outcome, Non-Covid illness. Number of sick household members in last seven days [exclude those with Covid symptoms] , Nov 2020-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Child health index. Summary index of proportion of children under five with fever/cough/diarrhea in last two weeks [this will be three separate numbers for each HH with children under 5], Nov 2020-Jan 2021 Primary Outcome, Child health index. Summary index of proportion of children under five with fever/cough/diarrhea in last two weeks [this will be three separate numbers for each HH with children under 5], Nov 2020-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Livelihoods. Summary index of responses to: A27.a In the past week, how many hours have you spent working on an income generating activity? A27.c In the past week, how many hours has your spouse/partner spent working on an income generating activity for your household? [if applicable] A27.d Has anyone in your household (including you) lost their job (or main source of income) since the coronavirus pandemic began? [negatively coded] A27.e Have you or anyone in your household gained a new job (or main source of income) since the coronavirus pandemic began? A27.f Think of the income you earned each month before the coronavirus pandemic began. How does that compare to the income you are earning now? , Nov 2020-Jan 2021 Secondary Outcome, Livelihoods. Summary index of responses to: A27.a In the past week, how many hours have you spent working on an income generating activity? A27.c In the past week, how many hours has your spouse/partner spent working on an income generating activity for your household? [if applicable] A27.d Has anyone in your household (including you) lost their job (or main source of income) since the coronavirus pandemic began? [negatively coded] A27.e Have you or anyone in your household gained a new job (or main source of income) since the coronavirus pandemic began? A27.f Think of the income you earned each month before the coronavirus pandemic began. How does that compare to the income you are earning now? , Nov 2020-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Food security. In the last seven days, how many days (out of 7) did you lack enough food to eat? , May-July 2020 and Nov 2020-Jan 2021 Secondary Outcome, Food security. In the last seven days, how many days (out of 7) did you lack enough food to eat? , May-July 2020, Nov 2020-Jan 2021, June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Hospital visits. Number of household members who visited hospital in last seven days, May-July 2020 and Nov 2020-Jan 2021 Secondary Outcome, Hospital visits. Number of household members who visited hospital in last seven days, May-July 2020, Nov 2020-Jan 2021, and June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Approval of authorities. 10 outcomes. Do you approve or disapprove of the way that the following people have performed their jobs over the past twelve months, or haven’t you heard enough about them to say? 1. President 2. National Assembly 3. Ministry of Health 4. Provincial Government 5. International NGOs 6. Local NGOs 7. Traditional leaders 8. Health zone officials 9. Health area officials 10. Village chief, June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Leader vaccine acceptance. In village leader survey: If a vaccine for COVID-19 becomes available to you, would you take it? , June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Leader vaccine advice. In village leader survey: Will you advise the people in your village to take the Covid vaccine? , June-July 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Covid-like illness. Number of household members in past week with fever, dry cough, difficulty breathing/shortness of breath, or fatigue, Nov 2020-Jul 2021 Primary Outcome, Covid-like illness. Number of household members in past week with fever, dry cough, difficulty breathing/shortness of breath, or fatigue, Nov 2020-Jan 2021 and June-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Non-Covid illness. Number of sick household members in last seven days [exclude those with Covid symptoms] , Nov 2020-Jul 2021 Primary Outcome, Non-Covid illness. Number of sick household members in last seven days [exclude those with Covid symptoms] , Nov 2020-Jan 2021 and June-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Primary Outcome, Child health index. Summary index of proportion of children under five with fever/cough/diarrhea in last two weeks [this will be three separate numbers for each HH with children under 5], Nov 2020-Jul 2021 Primary Outcome, Child health index. Summary index of proportion of children under five with fever/cough/diarrhea in last two weeks [this will be three separate numbers for each HH with children under 5], Nov 2020-Jan 2021 and June-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2021 Additional data collection Secondary Outcome, Livelihoods. Summary index of responses to: A27.a In the past week, how many hours have you spent working on an income generating activity? A27.c In the past week, how many hours has your spouse/partner spent working on an income generating activity for your household? [if applicable] A27.d Has anyone in your household (including you) lost their job (or main source of income) since the coronavirus pandemic began? [negatively coded] A27.e Have you or anyone in your household gained a new job (or main source of income) since the coronavirus pandemic began? A27.f Think of the income you earned each month before the coronavirus pandemic began. How does that compare to the income you are earning now? , Nov 2020-Jul 2021 Secondary Outcome, Livelihoods. Summary index of responses to: A27.a In the past week, how many hours have you spent working on an income generating activity? A27.c In the past week, how many hours has your spouse/partner spent working on an income generating activity for your household? [if applicable] A27.d Has anyone in your household (including you) lost their job (or main source of income) since the coronavirus pandemic began? [negatively coded] A27.e Have you or anyone in your household gained a new job (or main source of income) since the coronavirus pandemic began? A27.f Think of the income you earned each month before the coronavirus pandemic began. How does that compare to the income you are earning now? , Nov 2020-Jan 2021 and June-Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 02/08/2021 Uploaded pre-analysis plan for phone surveys to the AEA registry https://www.socialscienceregistry.org/trials/4648/history/64498 https://www.socialscienceregistry.org/trials/4648