NCT03176914

Brief Summary

This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
765

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

May 24, 2017

Last Update Submit

March 29, 2019

Conditions

Keywords

Community mobilisation

Outcome Measures

Primary Outcomes (1)

  • Reduction in child morbidity

    Incidence of childhood illnesses

    9- 12 months

Secondary Outcomes (4)

  • Early ANC uptake

    3 Months

  • Institutional deliveries

    3 months

  • Postnatal care uptake

    3 months

  • Knowledge levels on child care

    3 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Eleven clusters (Villages) will be randomly selected. A cluster will comprises of 10-15 volunteers selected from a cohort 10-15 households. Educative sessions will be held in each cluster once every fortnight using a participatory methods by a trained Village Health Worker (VHW). A session will focus on one thematic area running for 1-2 hours. Trained volunteers will in turn replicate the session(s) in their cohorts and do home visits to monitor care practices and screen children for various ailment. Health information is collated from each cluster and consolidated by the VHW who reports monthly at the clinic.

Behavioral: prevention and management of childhood illnesses at community level

Conventional Intervention arm

ACTIVE COMPARATOR

In the conventional mobilization system, a Village Health Worker facilitates community health programs as the sole source of health education for the entire villages. She does home visits, child growth monitoring and the various components primary health care at village level inclusive of disease surveillance and community case management using the 'supermarket approach' , whereby 3 or more themes are covered in a space of 10- 30 minutes in functions like funerals, village gatherings and other opportune moments. The Village Health worker prepares village monthly reports on all the indicators on community health and submits to the local health centre.

Behavioral: conventional community interventions

Interventions

provision of critical health education and targeted promotion services to the participants in their locality

Intervention arm

community health programs as the sole source of health education

Conventional Intervention arm

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant and lactating women staying in the study area with children below 4 years

You may not qualify if:

  • Women of child bearing age who do not dwell permanently in the study area
  • Women who are very ill and mentally challenged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Health Sciences

Harare, 00263, Zimbabwe

Location

MeSH Terms

Conditions

PneumoniaDiarrheaMalnutritionFever

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesBody Temperature Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data analysts will be provided with coded data that doesn't reflect which arm the data is from.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study will have an intervention arm under which the study intervention will be implemented and this will be compared with the outcomes in the conventional intervention arm. Each arm will have 11 clusters of an average size of 50.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 6, 2017

Study Start

January 19, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Locations