DiarrheaCBEHPPNCT01836731
Impact Evaluation of Community-Based Health Programs in Rwanda
A study testing Classic Intervention and Minimum Intervention in people with Diarrhea and Malaria, run by Georgetown University at 2 sites in Rwanda.
Trial summary
Community Health Clubs to improve local sanitation, hygiene and health conditions have been implemented in several countries in Africa and Asia with some success. The Ministry of Health in Rwanda has committed to rolling out a program designed along similar lines, the Community Based Environmental Health Promotion… Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- What is being tested?
- Classic Intervention and Minimum Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,718 participants
- Where
- 2 sitesRwanda
- Study dates
- Apr 2013to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -All households with children under 5 years in the study communities are eligible for socio-economic and health outcome evaluation.
Who cannot join
- -All households are eligible to participate in the intervention. However, for the purposes of the study, households with no children under the age of 5 will not be selected for data collection purposes.
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
IPA Rwanda District Office
Kamembe, Rusizi District
Innovations for Poverty Action
Kigali
About this study
Official title: Health Impact Evaluation of the "Community-Based Environmental Health Promotion Programme" in Rwanda
Community Health Clubs to improve local sanitation, hygiene and health conditions have been implemented in several countries in Africa and Asia with some success. The Ministry of Health in Rwanda has committed to rolling out a program designed along similar lines, the Community Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages across Rwanda. The main objective of the program is to achieve 'zero open defecation' in all villages of Rwanda, at least 80% hygienic latrine coverage and improvements in a range of health behaviors such as the use of mosquito nets, hand-washing with soap and the use of household water treatment.
To evaluate the impact of the program on health, other socio-economic outcomes and community functioning, a single district has been chosen where 150 communities will be randomized to receive the intervention immediately or 18 months later. The evaluation is led by US based Innovation for Poverty Action (IPA) through researchers based at the National University of Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York University. The research team will work in close collaboration with the implementing team, which consists of the Ministry of Health, Rwanda and Africa AHEAD.
The study will span three years, beginning in May 2013, and ending in late 2015.
Read the detailed description
Preventable diseases such as respiratory infections, diarrheal diseases and malaria account for a large share of mortality in low income economies. For example, diarrheal diseases kill nearly 2.5 million people worldwide and account for a considerable share of under five mortality in low income countries. Broad-based economic development that includes improvements in infrastructure and service delivery can address the challenges associated with the infectious disease burden. But for many countries, these improvements are far in the future and/or very costly. Behavior change of individuals can also address these challenges and more importantly can be done now and relatively cheaply. Understanding how to produce this behavior change in needy contexts is crucial to the short and medium term response to the high costs imposed by these diseases. This protocol outlines an evaluation of an intervention aimed at producing sustainable behavior change around health, hygiene and sanitation. The evaluation consists of two parts: firstly to evaluate the health and socio-economic effects of a well-designed and supported community health club intervention. Secondly to examine whether the intervention can deliver health and other benefits utilizing the resource base available in this context. The answer to this latter question informs the scalability of the intervention. The overall objective of the study is to evaluate whether and how community hygiene/health clubs are an effective and sustainable response to addressing broad health, sanitation and hygiene needs in low-income countries.
A particular challenge associated with health interventions, is the extent to which free-rider problems mediate the adoption of improved behaviors. The community health club approach with regular meetings, is well placed to address these collective action challenges. Community health clubs provide a vehicle to inform and incentivize households to change their behavior in relation to a range of health outcomes. The information component arises from the six month long weekly courses covering a wide range of health, hygiene and sanitary subjects and facilitated by a community health worker. The incentives for sustainable behavior change follow from the social sanctions and rewards that club members can impose/bestow on members accordingly. As with other behavior change programs that have incorporated information components that emphasize the benefits of better health behavior, the evidence base for what works in this domain remains thin. The community health club approach is appealing largely because it mobilizes local resources and is plausibly cheaper and more sustainable than other top-down interventions.
To evaluate the impact of the program on health, other socio-economic conditions and community functioning, a single district has been chosen where communities will be randomly assigned to receive the intervention immediately or 18 months later. The evaluation is led by US-based Innovation for Poverty Action (IPA) through researchers based at the National University of Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York University. The research team will work in close collaboration with the implementing team, which consists of the Ministry of Health, Rwanda and Africa AHEAD.
The evaluation will measure impact heterogeneity with respect to key inputs that predict success of CHCs, including training and competence of CHWs, the quality of training materials, and community functioning. The evaluation will also document in detail the cost structure of the low- and high-resource versions of CHCs in order to inform the MOH about the most effective strategies for successful scale up of CHCs nationwide. More broadly, other governments, donor organizations and foundations will benefit from rigorous evidence on the effectiveness and cost-effectiveness of using health clubs to address health and sanitation challenges.
- Being tested
- Classic Intervention, Minimum Intervention
- Keywords
- weight-for age, height-for-age, water sanitation facilities, hygiene behavior
- Medical subject headings
- Diarrhea, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic InterventionBehavioural
The standard "classic" approach will implement a total of 20 community health club sessions delivered through weekly education programs in the target communities as per the training manual. Community health workers (CHW) will receive careful training in the delivery of the CBEHPP instruction. High quality instructional materials (in color) will be used. Club members will each receive a membership card to be used to track attendance and compliance. Finally model home competitions and a graduation ceremony will be held. Monitoring of the clubs will be conducted by community health workers using mobile phones.
Minimum InterventionBehavioural
The "lite" trial arm will only implement 8 sessions covering all the WASH topics. It will be facilitated by CHWs receiving minimal training and using black/white photocopies of instructional materials. Members will not be issued with membership cards and will not have a graduation ceremony or home garden competitions. Minimal monitoring of this arm will be carried out by environmental health officers.
| Study group | Role | What they receive |
|---|---|---|
| Classic Intervention | Experimental | The standard "classic" approach will implement a total of 20 community health club sessions delivered through weekly education programs in the target communities as per the training manual. Community health workers (CHW) will receive careful training in the delivery of the CBEHPP instruction. High quality instructional materials (in color) will be used. Club members will each receive a membership card to be used to track attendance and compliance. Finally model home competitions and a graduation ceremony will be held. Monitoring of the clubs will be conducted by community health workers using mobile phones. Receives: Behavioral: Classic Intervention |
| Minimum Intervention | Experimental | The "lite" trial arm will only implement 8 sessions covering all the WASH topics. It will be facilitated by CHWs receiving minimal training and using black/white photocopies of instructional materials. Members will not be issued with membership cards and will not have a graduation ceremony or home garden competitions. Minimal monitoring of this arm will be carried out by environmental health officers. Receives: Behavioral: Minimum Intervention |
| Control | No intervention | The control group is not enrolled in the CBEHPP. Because of the government's commitment for the national roll out to the CBEHPP, the control population will receive the intervention as soon as possible following the conclusion of the trial phase. Nevertheless, we will continue to evaluate the sustained impact of the intervention for two additional years by monitoring various behavioural outcomes and indicators and their impact on exposure outcomes (drinking water, hand hygiene, consumption, schooling and labour market participation etc.). We will use data from the RCT phase and clinical records to estimate the effect of any sustained impact on health. Long term impacts can be inferred by using data from the trial as well as data on long term behavioural outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diarrhea
The main outcome of the health impact evaluation trial will be 14 day recall self-reported diarrhoea in children under 5 years.
Measured: 2 weeks
Secondary outcomes (7)
Impact of CBEHPP on height-for-age in children under-5 years
Height-for-age data will be collected from all children under 5 years old. Changes in Z-scores for each of these measures between baseline and endline will be compared across the two study arms and the control group.
Measured: 2.5 years
Impact of CBEHPP on weight-for-age in children under-5 years
weight-for-age data will be collected from all children under 5 years old. Changes in Z-scores for each of these measures between baseline and endline will be compared across the two study arms and the control group.
Measured: 2.5 years
Impact of CBEHPP on drinking water quality
Water quality data will be collected at baseline and endline, and at an intermediate visit following implementation of the program. Water quality will be determined testing of drinking water; study households will provide a sample of drinking water for contamination tests.
Measured: 2.5 years
Impact of CBEHPP on incidence of malaria
Self-reported incidence of malaria, will be collected from households.
Measured: 2.5 years
Impact of CBEHPP on individual contribution to public goods game
A public goods game is played with a subset of community members. The researchers examine the impact of the treatment on the level of contributions.
Measured: 2.5 years
Impact of CBEHPP on administratively verified cases of diarrhea
Total counts of child diarrhea cases recorded in catchment area clinics and community health worker records
Measured: 2.5 years
Impact of CBEHPP on administratively verified cases of pneumonia and severe pneunomia
Total counts of child pneumonia cases recorded in catchment area clinics and community health worker records
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National University, Rwanda, New York University, London School of Hygiene and Tropical Medicine, Innovations for Poverty Action, Bill and Melinda Gates Foundation, Emory University
- Responsible party
- Principal investigator, James Habyarimana, Georgetown University
- Investigators
- James P Habyarimana, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836731
- Sponsor's protocol ID
- CBEHPP
- Acronym
- CBEHPP
- Status last verified
- Jul 2017
- First submitted
- 16 Apr 2013
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sinharoy SS, Schmidt WP, Wendt R, Mfura L, Crossett E, Grepin KA, Jack W, Rwabufigiri BN, Habyarimana J, Clasen T. Effect of community health clubs on child diarrhoea in western Rwanda: cluster-randomised controlled trial. Lancet Glob Health. 2017 Jul;5(7):e699-e709. doi: 10.1016/S2214-109X(17)30217-6.
PubMed 28619228
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impact Evaluation of the "Community-Based Environmental Health Promotion Programme" in Rwanda
- ClinicalTrials.gov ID
- NCT01836731
- Acronym / sponsor ID
- CBEHPP / CBEHPP
- Keywords
- weight-for age, height-for-age, water sanitation facilities, hygiene behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,718 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National University, Rwanda, New York University, London School of Hygiene and Tropical Medicine, Innovations for Poverty Action, Bill and Melinda Gates Foundation, Emory University
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Community Health Clubs to improve local sanitation, hygiene and health conditions have been implemented in several countries in Africa and Asia with some success. The Ministry of Health in Rwanda has committed to rolling out a program designed along similar lines, the Community Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages across Rwanda. The main objective of the program is to achieve 'zero open defecation' in all villages of Rwanda, at least 80% hygienic latrine coverage and improvements in a range of health behaviors such as the use of mosquito nets, hand-washing with soap and the use of household water treatment.
To evaluate the impact of the program on health, other socio-economic outcomes and community functioning, a single district has been chosen where 150 communities will be randomized to receive the intervention immediately or 18 months later. The evaluation is led by US based Innovation for Poverty Action (IPA) through researchers based at the National University of Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York University. The research team will work in close collaboration with the implementing team, which consists of the Ministry of Health, Rwanda and Africa AHEAD.
The study will span three years, beginning in May 2013, and ending in late 2015.
Detailed description
Preventable diseases such as respiratory infections, diarrheal diseases and malaria account for a large share of mortality in low income economies. For example, diarrheal diseases kill nearly 2.5 million people worldwide and account for a considerable share of under five mortality in low income countries. Broad-based economic development that includes improvements in infrastructure and service delivery can address the challenges associated with the infectious disease burden. But for many countries, these improvements are far in the future and/or very costly. Behavior change of individuals can also address these challenges and more importantly can be done now and relatively cheaply. Understanding how to produce this behavior change in needy contexts is crucial to the short and medium term response to the high costs imposed by these diseases. This protocol outlines an evaluation of an intervention aimed at producing sustainable behavior change around health, hygiene and sanitation. The evaluation consists of two parts: firstly to evaluate the health and socio-economic effects of a well-designed and supported community health club intervention. Secondly to examine whether the intervention can deliver health and other benefits utilizing the resource base available in this context. The answer to this latter question informs the scalability of the intervention. The overall objective of the study is to evaluate whether and how community hygiene/health clubs are an effective and sustainable response to addressing broad health, sanitation and hygiene needs in low-income countries.
A particular challenge associated with health interventions, is the extent to which free-rider problems mediate the adoption of improved behaviors. The community health club approach with regular meetings, is well placed to address these collective action challenges. Community health clubs provide a vehicle to inform and incentivize households to change their behavior in relation to a range of health outcomes. The information component arises from the six month long weekly courses covering a wide range of health, hygiene and sanitary subjects and facilitated by a community health worker. The incentives for sustainable behavior change follow from the social sanctions and rewards that club members can impose/bestow on members accordingly. As with other behavior change programs that have incorporated information components that emphasize the benefits of better health behavior, the evidence base for what works in this domain remains thin. The community health club approach is appealing largely because it mobilizes local resources and is plausibly cheaper and more sustainable than other top-down interventions.
To evaluate the impact of the program on health, other socio-economic conditions and community functioning, a single district has been chosen where communities will be randomly assigned to receive the intervention immediately or 18 months later. The evaluation is led by US-based Innovation for Poverty Action (IPA) through researchers based at the National University of Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York University. The research team will work in close collaboration with the implementing team, which consists of the Ministry of Health, Rwanda and Africa AHEAD.
The evaluation will measure impact heterogeneity with respect to key inputs that predict success of CHCs, including training and competence of CHWs, the quality of training materials, and community functioning. The evaluation will also document in detail the cost structure of the low- and high-resource versions of CHCs in order to inform the MOH about the most effective strategies for successful scale up of CHCs nationwide. More broadly, other governments, donor organizations and foundations will benefit from rigorous evidence on the effectiveness and cost-effectiveness of using health clubs to address health and sanitation challenges.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classic Intervention | Experimental | Behavioral: Classic InterventionThe standard "classic" approach will implement a total of 20 community health club sessions delivered through weekly education programs in the target communities as per the training manual. Community health workers (CHW) will receive careful training in the delivery of the CBEHPP instruction. High quality instructional materials (in color) will be used. Club members will each receive a membership card to be used to track attendance and compliance. Finally model home competitions and a graduation ceremony will be held. Monitoring of the clubs will be conducted by community health workers using mobile phones. |
| Minimum Intervention | Experimental | Behavioral: Minimum InterventionThe "lite" trial arm will only implement 8 sessions covering all the WASH topics. It will be facilitated by CHWs receiving minimal training and using black/white photocopies of instructional materials. Members will not be issued with membership cards and will not have a graduation ceremony or home garden competitions. Minimal monitoring of this arm will be carried out by environmental health officers. |
| Control | No intervention | –The control group is not enrolled in the CBEHPP. Because of the government's commitment for the national roll out to the CBEHPP, the control population will receive the intervention as soon as possible following the conclusion of the trial phase. Nevertheless, we will continue to evaluate the sustained impact of the intervention for two additional years by monitoring various behavioural outcomes and indicators and their impact on exposure outcomes (drinking water, hand hygiene, consumption, schooling and labour market participation etc.). We will use data from the RCT phase and clinical records to estimate the effect of any sustained impact on health. Long term impacts can be inferred by using data from the trial as well as data on long term behavioural outcomes. |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -All households with children under 5 years in the study communities are eligible for socio-economic and health outcome evaluation.
Key exclusion criteria (1 listed)
- -All households are eligible to participate in the intervention. However, for the purposes of the study, households with no children under the age of 5 will not be selected for data collection purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic InterventionThe standard "classic" approach will implement a total of 20 community health club sessions delivered through weekly education programs in the target communities as per the training manual. Community health workers (CHW) will receive careful training in the delivery of the CBEHPP instruction. High quality instructional materials (in color) will be used. Club members will each receive a membership card to be used to track attendance and compliance. Finally model home competitions and a graduation ceremony will be held. Monitoring of the clubs will be conducted by community health workers using mobile phones. | Behavioural | Classic Intervention |
| Minimum InterventionThe "lite" trial arm will only implement 8 sessions covering all the WASH topics. It will be facilitated by CHWs receiving minimal training and using black/white photocopies of instructional materials. Members will not be issued with membership cards and will not have a graduation ceremony or home garden competitions. Minimal monitoring of this arm will be carried out by environmental health officers. | Behavioural | Minimum Intervention |
Primary outcome
Incidence of Diarrhea
Time frame: 2 weeks
The main outcome of the health impact evaluation trial will be 14 day recall self-reported diarrhoea in children under 5 years.
7 secondary outcomes
Impact of CBEHPP on height-for-age in children under-5 years
Time frame: 2.5 years
Impact of CBEHPP on weight-for-age in children under-5 years
Time frame: 2.5 years
Impact of CBEHPP on drinking water quality
Time frame: 2.5 years
Impact of CBEHPP on incidence of malaria
Time frame: 2.5 years
Impact of CBEHPP on individual contribution to public goods game
Time frame: 2.5 years
Impact of CBEHPP on administratively verified cases of diarrhea
Time frame: 2.5 years
Impact of CBEHPP on administratively verified cases of pneumonia and severe pneunomia
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Derived from this study: PubMed 28619228Sinharoy SS, Schmidt WP, Wendt R, Mfura L, Crossett E, Grepin KA, Jack W, Rwabufigiri BN, Habyarimana J, Clasen T. Effect of community health clubs on child diarrhoea in western Rwanda: cluster-randomised controlled trial. Lancet Glob Health. 2017 Jul;5(7):e699-e709. doi: 10.1016/S2214-109X(17)30217-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Habyarimana, PhD principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Intervention and Minimum Intervention in people with Diarrhea and Malaria, run by Georgetown University at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Diarrhea (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.