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Lay Fieldworker Led School Health Program for Rural Primary Schools (CHHIP)

Primary Purpose

Health Promotion, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Comprehensive Health & Hygiene Improvement Program (CHHIP)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Health Promotion focused on measuring School Health Services, Health Education, Primary Schools, Republic of India

Eligibility Criteria

3 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers
Three geographic regions representative of rural Darjeeling were identified and all primary schools in these regions were considered eligible for participation in the intervention. A convenience sample of 22 schools were pragmatically selected.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CHHIP Arm

    Comparison Arm

    Arm Description

    All enrolled students in schools in the CHHIP Arm were eligible to receive the CHHIP intervention. The CHHIP intervention was delivered by lay fieldworkers (SHAs). Intervention activities included: Health Education: activity-based curriculum with lessons delivered once per week. Units include hygiene, nutrition, safety, disease prevention& management, and social, emotional, and behavior development. Basic Primary Health Services: school-based treatment including deworming and iron supplementation; screening and referral programs including growth monitoring, well-child exam, vision screening, epilepsy screening, and oral health; psychosocial and counseling support for students with atypical behaviors. Health School Environment: improvements to physical infrastructure including latrines and water systems; modeling of positive behavior reinforcement, inclusive learning environment, and avoidance of corporal punishment.

    All enrolled students in schools in the Comparison Arm received school health activities as were routinely available in their school, through their curriculum, or through special events.

    Outcomes

    Primary Outcome Measures

    Diarrhea incidence
    Diarrheal incidence was assessed by verbal parental recall based on previous 14-days.

    Secondary Outcome Measures

    Health Knowledge
    Health knowledge was assessed by an internally created written health knowledge test

    Full Information

    First Posted
    January 20, 2018
    Last Updated
    January 30, 2018
    Sponsor
    University of Colorado, Denver
    Collaborators
    Broadleaf Health and Education Alliance, Darjeeling Ladenla Road Prerna (DLRP)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03423615
    Brief Title
    Lay Fieldworker Led School Health Program for Rural Primary Schools
    Acronym
    CHHIP
    Official Title
    Lay Fieldworker Led Comprehensive School Health Program for Rural Primary Schools in India
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    November 15, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Broadleaf Health and Education Alliance, Darjeeling Ladenla Road Prerna (DLRP)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    School-aged children in low and middle-income countries (LMIC) face significant challenges to their health and development which contribute to poor academic achievement. Multi-component comprehensive school health programs guided by the World Health Organization's (WHO) Health Promoting Schools (HPS) framework have been shown to positively impact health outcomes. Such programs are implemented widely throughout the world. However, in LMIC the scope and reach of school health programs are limited by human resource constraints. A key challenge to effective implementation has been the identification of effective delivery agents. A potential alternative approach is to leverage existing community members as lay fieldworkers for the delivery of school health promotion. Our hypothesis is that lay-fieldworkers can effectively implement comprehensive school health programs in resource-constrained primary schools. This hypothesis will be tested by retrospectively analyzing data obtained during a 5-year pilot of a school health program (CHHIP) in rural primary schools of the Darjeeling Himalayas of India.
    Detailed Description
    The Comprehensive Health and Hygiene Improvement Program (CHHIP) is an intense multi-component comprehensive school health program. The content of the program is structured around three reinforcing components: 1) health education, 2) basic primary health services, and 3) a healthy school environment. This holistic approach is based on the WHO's Health Promoting Schools framework and designed in accordance with the Indian National Rural Health Mission's operational guidelines for the school health programme. Delivery of the program is led by lay fieldworkers termed School Health Activists (SHAs). SHAs are existing community members without formal background or certification. The SHAs serve as the primary delivery agent for all components of the program. From 2012 to 2016, the CHHIP program was implemented by Darjeeling Prerna, an Indian non-governmental organization, in the rural Darjeeling Himalayas, a region of the state of West Bengal in India. The program was implemented in both low-cost private and government primary schools. A convenience sample of 22 primary schools (13 government and 9 low-cost private) was chosen by the project team. Program implementation occurred in 16 schools and was led by 4 lay fieldworkers. The intervention was implemented as a community development program with a rigorous evaluation component and all data was collected prospectively. This research study was added post-hoc with data transmitted to the research team prior to any analysis. The study is designed as a mixed methods stepped-wedge cluster controlled evaluation. A primary school will be a cluster and each step in the study will be a single academic year. In accordance with guidelines for the design and evaluation of complex evaluations, this study will couple process evaluation with that of definitive impact. The intervention will be evaluated across three domains: outcomes, implementation, and mechanism of impact. The primary impact outcome will be the incidence of diarrheal illness as assessed by 14-day parental recall. A secondary outcome, health knowledge as assessed by pre and post-test, will be utilized as a key mediator to assess for differential impact on mechanisms of impact. Statistical analysis will be carried out as a comparison between the intervention and control arms within the context of the stepped-wedge framework. The analysis will be based on individual student-level data, with the unit of assignment (schools) included as a cluster effect in the regression analysis. Exposures of interest will be explored for association with the outcome in univariate analyses. Diarrheal incidence rate ratios will be calculated via multivariable Poisson regression analysis and mean difference in health knowledge post-test scores will be obtained using a multivariable linear mixed model. All P-values will be 2-tailed and significance will be set at P<0.05. To study implementation, process outcomes will be obtained via a series of descriptive analysis. Coverage rates for individual health interventions and performance evaluations scores expressed as means and standard deviations will be obtained. In consultation with the project team, the research study team will define benchmarks for reach and fidelity, prior to analysis of data. Qualitative data will be integrated with quantitative data via a process of triangulation. This data was obtained from parents and teachers in focus groups and lay fieldworkers in semi-structured interviews. Coding and analysis of the qualitative data will begin with a deductive coding method. Common themes, including important contrary opinions, will be identified and illustrative quotes will be selected. All quantitative analysis will be done in SPSS and qualitative analysis completed in CATMA. The reporting and presentation of this trial will be in accordance with the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) guidelines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Promotion, Diarrhea
    Keywords
    School Health Services, Health Education, Primary Schools, Republic of India

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    We will use a stepped-wedge cluster controlled model to reflect the pragmatic enrollment and crossover of schools between intervention arms.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2909 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHHIP Arm
    Arm Type
    Experimental
    Arm Description
    All enrolled students in schools in the CHHIP Arm were eligible to receive the CHHIP intervention. The CHHIP intervention was delivered by lay fieldworkers (SHAs). Intervention activities included: Health Education: activity-based curriculum with lessons delivered once per week. Units include hygiene, nutrition, safety, disease prevention& management, and social, emotional, and behavior development. Basic Primary Health Services: school-based treatment including deworming and iron supplementation; screening and referral programs including growth monitoring, well-child exam, vision screening, epilepsy screening, and oral health; psychosocial and counseling support for students with atypical behaviors. Health School Environment: improvements to physical infrastructure including latrines and water systems; modeling of positive behavior reinforcement, inclusive learning environment, and avoidance of corporal punishment.
    Arm Title
    Comparison Arm
    Arm Type
    No Intervention
    Arm Description
    All enrolled students in schools in the Comparison Arm received school health activities as were routinely available in their school, through their curriculum, or through special events.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Comprehensive Health & Hygiene Improvement Program (CHHIP)
    Intervention Description
    CHHIP is an intense, multi-component holistic school health program based on the WHO Health Promoting School framework and designed for implementation by lay fieldworkers.
    Primary Outcome Measure Information:
    Title
    Diarrhea incidence
    Description
    Diarrheal incidence was assessed by verbal parental recall based on previous 14-days.
    Time Frame
    March, July, and November of each academic school year through the duration of the study (up to 5-years)
    Secondary Outcome Measure Information:
    Title
    Health Knowledge
    Description
    Health knowledge was assessed by an internally created written health knowledge test
    Time Frame
    Baseline and week 32 of each academic year through the duration of the study (up to 5-years)
    Other Pre-specified Outcome Measures:
    Title
    Coverage rates
    Description
    Coverage rates for selected health interventions will be assessed as the proportion of eligible students receiving the intervention.
    Time Frame
    At the time of intervention delivery
    Title
    Fidelity
    Description
    Fidelity was assessed by performance assessment scores of SHA service delivery based on standardized rubrics.
    Time Frame
    At the time of intervention delivery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Three geographic regions representative of rural Darjeeling were identified and all primary schools in these regions were considered eligible for participation in the intervention. A convenience sample of 22 schools were pragmatically selected.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Matergia, MD
    Organizational Affiliation
    Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30872330
    Citation
    Matergia M, Ferrarone P, Khan Y, Matergia DW, Giri P, Thapa S, Simoes EAF. Lay Field-worker-Led School Health Program for Primary Schools in Low- and Middle-Income Countries. Pediatrics. 2019 Apr;143(4):e20180975. doi: 10.1542/peds.2018-0975. Epub 2019 Mar 14.
    Results Reference
    derived

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