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.: 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 Health and governance effects of a Randomized Control Trial of a Community-Driven Water, Sanitation, and Hygiene Program in the Democratic Republic of Congo
Official scientific title Health and governance effects of a Randomized Control Trial of a Community-Driven Water, Sanitation, and Hygiene Program 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. Two earlier papers assesses the short run effects of the program at approximately 5 months post-intervention and 12-24 months post-intervention (see pre-analysi plans at https://www.socialscienceregistry.org/trials/4648). We are now registering analysis plans for the 36-month follow-up.
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 24/11/2022
Actual trial start date
Anticipated date of last follow up 13/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 3390
Actual target sample size (number of participants)
Recruitment status Completed
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
We aimed to interview all households that were targeted at 5-month follow up (four households per village), and an additional six, new, randomly-selected households in each village (n=332). That yields 1,328 households from 5-month follow-up and 1,992 new households, for a total of 3,320 households. We also aim to interview the village leader and water committee leader (if a water committee existed) in each village. In the event that they cannot be reached, replacements will be sought on a case by case basis. More details here: https://www.socialscienceregistry.org/trials/4648 Households that have lived in the village for less than four years will be excluded. 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(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),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 Diarrhea. The household survey will include a detailed battery of questions for the child’s caretaker which will ask about number of symptoms/illness episodes across symptoms related to diarrhea over the past 7 days (question include whether or not the child has experienced diarrhea, or has had 3 or more bowel movements within 24 hours, soft stools, or blood in stool at any point in the last 7 days) Dec 2022-Feb 2023
Primary Outcome Length-for-age. We will collect anthropometric data, notably height and weight, for all children under 5 years old in study households. We will use WHO Child Growth Standards to calculate z-scores for each child’s length for age (HAZ). Dec 2022-Feb 2023
Primary Outcome Water institutions. This is an index comprised of: 1. Presence of water committee 2. Frequency of meeting 3. Time spent on non-maintenance activities 4. Has a maintenance plan 5. Tracks health conditions 6. Tracks hygiene and sanitation Dec 2022-Feb 2023
Secondary Outcome Psychological well-being Summary index of 9 questions on well-being and stress in last 2-4 weeks Dec 2022-Feb 2023
Secondary Outcome Water committee performance (length of water point breakdowns) Dec 2022-Feb 2023
Secondary Outcome Water governance perception index (fairness of selection of water governance entity, perception of fair treatment, confidence in managing money, confidence in response to breakdowns, confidence in management, overall satisfaction) Dec 2022-Feb 2023
Secondary Outcome Thermotolerant coliforms per 100 mL water. Households and water points will be separate outcomes. Dec 2022-Feb 2023
Secondary Outcome Primary source of drinking water is improved source (JMP definition) Dec 2022-Feb 2023
Secondary Outcome Household water use expenses in last week Dec 2022-Feb 2023
Secondary Outcome Time spent collecting water Dec 2022-Feb 2023
Secondary Outcome Household uses an improved latrine (JMP definition) Dec 2022-Feb 2023
Secondary Outcome Handwashing practices of caregiver based on handwashing with soap and water or ash at critical junctures, measured via structured observations Dec 2022-Feb 2023
Secondary Outcome Health knowledge and behavior. Self-reports of: Knowledge: Caregiver knows how and when to wash hands; what causes diarrhea Sanitation practices: Cleanliness of household area and latrine (presence of flies and fecal matter); open defecation; observed indicators of toilet use –worn pathway, presence of water; improvements to latrine; disposes of child feces safely (JMP definition) Water storage practices: has a clean pot for water that is covered Dec 2022-Feb 2023
Secondary Outcome School attendence. Number of days present per child in past week, conditional on child being enrolled in school Dec 2022-Feb 2023
Secondary Outcome Life satisfaction and self-esteem Summary index of 11 questions Dec 2022-Feb 2023
Secondary Outcome Wasting Prevalence of wasting, children under 5 (weight for height z score) Dec 2022-Feb 2023
Secondary Outcome Underweight Prevalence of underweight, children under 5 (weight for age z score) Dec 2022-Feb 2023
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@georgetown.edu 8579997192 3600 M Street, N.W.
City Postal code Country Position/Affiliation
Washington 20007 United States of America Associate Teaching Professor Georgetown University
Role Name Email Phone Street address
Principal Investigator John Quattrochi john.quattrochi@georgetown.edu 8579997192 3600 M Street, N.W.
City Postal code Country Position/Affiliation
Washington DC 20007 United States of America Associate Teaching Professor Georgetown 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@georgetown.edu 8579997192 3000 M St NW
City Postal code Country Position/Affiliation
Washington 20007 United States of America Associate Teaching Professor Georgetown 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