Clinical trial NCT01836731: Impact Evaluation of Community-Based Health Programs in Rwanda
Official title: Health Impact Evaluation of the "Community-Based Environmental Health Promotion Programme" in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Malaria
Keywords: weight-for age
height-for-age
water sanitation facilities
hygiene behavior
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National University, Rwanda
name: New York University
name: London School of Hygiene and Tropical Medicine
name: Innovations for Poverty Action
name: Bill and Melinda Gates Foundation
name: Emory University
First posted: 2013-04-22
Enrollment: 8718
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

-All households with children under 5 years in the study communities are eligible for socio-economic and health outcome evaluation.

Exclusion Criteria:

-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.

Primary outcomes:
measure: Incidence of Diarrhea
timeFrame: 2 weeks
Secondary outcomes:
measure: Impact of CBEHPP on height-for-age in children under-5 years
timeFrame: 2.5 years
measure: Impact of CBEHPP on weight-for-age in children under-5 years
timeFrame: 2.5 years
measure: Impact of CBEHPP on drinking water quality
timeFrame: 2.5 years
measure: Impact of CBEHPP on incidence of malaria
timeFrame: 2.5 years
measure: Impact of CBEHPP on individual contribution to public goods game
timeFrame: 2.5 years
measure: Impact of CBEHPP on administratively verified cases of diarrhea
timeFrame: 2.5 years
measure: Impact of CBEHPP on administratively verified cases of pneumonia and severe pneunomia
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Kamembe
country: Rwanda
facility: IPA Rwanda District Office
state: Rusizi District
city: Kigali
country: Rwanda
facility: Innovations for Poverty Action
Study officials:
affiliation: Georgetown University
name: James P Habyarimana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.