NCT01836731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,718

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

April 16, 2013

Last Update Submit

July 12, 2017

Conditions

Keywords

weight-for ageheight-for-agewater sanitation facilitieshygiene behavior

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (7)

  • Impact of CBEHPP on height-for-age in children under-5 years

    2.5 years

  • Impact of CBEHPP on weight-for-age in children under-5 years

    2.5 years

  • Impact of CBEHPP on drinking water quality

    2.5 years

  • Impact of CBEHPP on incidence of malaria

    2.5 years

  • Impact of CBEHPP on individual contribution to public goods game

    2.5 years

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

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.

Interventions

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.

Classic Intervention

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.

Minimum Intervention

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IPA Rwanda District Office

Kamembe, Rusizi District, Rwanda

Location

Innovations for Poverty Action

Kigali, Rwanda

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DiarrheaMalaria

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • James P Habyarimana, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Public Policy Institute

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 22, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

June 30, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations