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Eligibility
for females ages 15 years to 49 years
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion:
Principal Investigator
Nancy S Padian

Description

Summary

The purpose of this study is to evaluate whether the addition of Proactive Case Detection to Community Case Management will provide an increase in early access to health care and a reduction in deaths among children aged 0-59 months. Integrated Community Case Management is the package of community-based services for children delivered by Community Health Workers (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and malnutrition. In many i-CCM interventions, CHWs are stationed in their villages and available in a passive, reactive manner to provide care to patients who seek them out. This study seeks to determine whether the addition of proactive case detection by CHWs, in which the conduct daily door-to-door home visits to find and care for patients, improve early access to care and reduce child mortality. Villages will be randomised to receive Integrated Community Case Management (i-CCM) from a passive CHW or Proactive Community Case Management (Pro-CCM) from a CHW that conducts daily active case finding home visits. All villages in both study arms will receive additional interventions that could significantly reduce under-five mortality, including removal of point-of-care fees, clinical staff training at primary health centres, and improvement in health centre infrastructure. All women of reproductive age eligible for inclusion in the study will be surveyed at baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction in child mortality in both study arms, with a significantly larger reduction where there is proactive case detection, or Pro-CCM, by CHWs. An exhaustive survey of 22 847 women of reproductive age followed for three years will give a study which has 90% power to detect an absolute difference of 0.75% (and a relative difference of 25%) in under-five child mortality reduction between the two study arms.

Official Title

Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial

Details

The study is a cluster-randomised controlled trial to evaluate whether the addition of proactive case detection to Community Case Management will provide an increase in early access to care and a reduction in deaths among children aged 0-59 months. The unit of randomisation is the village, as defined by the Government of Mali's Health Information Systems. Villages will be randomised to receive Integrated Community Case Management (i-CCM) from a passive CHW or Proactive Community Case Management (Pro-CCM) from a CHW that conducts daily active case finding home visits. Randomisation will be stratified by health catchment area, distance from the primary health care clinic, and CHW supervisor. All villages in both study arms will receive the removal of point-of-care fees, clinical staff training at primary health centres, and improvement in health centre infrastructure.

An exhaustive census will be administered to the population of the study area (both arms) at baseline. The census will assign a unique identification number to each person surveyed. At each household, a screening will take place to identify women eligible for inclusion. Eligible women identified in the study area will be asked to give written informed consent for their inclusion in the study (or their legal guardians in the case of unemancipated minors). The baseline survey will be administered after consent is obtained. Using the unique census ID number, the same participants will be identified and surveyed again at 12, 24 and 36 months.

The survey tool is excerpted and adapted from Mali's Demographic and Health Survey. The survey tool will collect qualitative and quantitative data on health seeking behaviour and health outcomes. It will include a life-table tracking all live births occurring in the 59 months prior to enrolment and during the 36 months of study follow up. Surveyors will not be members of the villages they survey, nor will they be members of the intervention health care delivery staff. All surveyors will be female, as the survey tool contains potentially sensitive questions on family planning.

Community Health Workers will collect data on the number of active case finding visits they conduct, the number of patients they treat, the delay from symptom onset to treatment onset for each patient, the gestational age at pregnancy diagnosis and first prenatal consultation, and the care services they provide. This data is collected during patient care by CHWs on smartphones using the Medic Mobile for CHWs platform customized for Pro-CCM. Primary care health centre providers will collect patient care data per village.

An exhaustive survey of 22 847 women of reproductive age followed for three years will give a study which has 90% power to detect an absolute difference of 0.75% (and a relative difference of 25%) in under-five child mortality reduction between the two study arms.

Keywords

Under-five Child Mortality Access to Health Care Community Health Workers Community Case Management Proactive Case Detection

Eligibility

You can join if…

Open to females ages 15 years to 49 years

  • Reproductive age women (aged 15-49 years)
  • Permanently living in the study area
  • No plans to leave the study area in the subsequent three years
  • Written informed consent is obtained

You CAN'T join if...

  • Non-permanent community members (i.e. seasonal migrants)
  • Plans to leave study area in the subsequent three years

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Ari Johnson, MD
Links
Muso is an international non-governmental organization working to strengthen the health care system in Mali
ID
NCT02694055
Lead Scientist
Nancy S Padian
Study Type
Interventional
Last Updated
March 2016