Trial of Proactive Community Case Management to Reduce Child Mortality

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 iCCM 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 to a standard iCCM intervention (ProCCM), in which they conduct daily door-to-door home visits to find and care for patients, will improve early access to care and reduce child mortality.

Village-clusters will be randomised to receive Integrated Community Case Management (iCCM) from a passive CHW or Proactive Community Case Management (ProCCM) 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 primary 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 ProCCM, by CHWs. A survey of all women enrolled in the three-year study (eligible and consenting) has 82% power to detect an absolute difference in under-five mortality of 0.75% (a relative difference of 25%) between the two study arms.

Conditions

• Under-five Child Mortality
• Access to Health Care

Interventions

OTHER

Proactive Community Case Management

CHWs will be trained and deployed to conduct daily active case finding home visits door-to-door for at least two hours each day, with the goal of visiting each household at least two times each month. At these active case finding home visits, CHWs will screen each household of sick children and will offer home pregnancy testing and family planning services to reproductive aged women. For patients they identify, they will offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package.

OTHER

Integrated Community Case Management

CHWs will be trained offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package to patients that visit them at their work post.

OTHER

Removal of point-of-care user fees

User fees will be removed across the catchment areas for both study and control villages. No fees will be charged for care by CHWs or at all primary care centres.

OTHER

Infrastructure improvements at primary health centre

Targeted infrastructure improvements to rehabilitate, expand and equip the capacity of the seven government primary care centres in the study area. Each health center will be equipped with solar power.

OTHER

Training of primary health centre staff

Health center staff will receive targeted training in * Integrated management of childhood illness * Diagnosis and treatment of simple and severe cases of malaria * Helping babies breathe * Managing post-partum haemorrhage * Gestational dating using frontal height, last menstrual period and ultrasound * Family planning counselling and administration of long-acting contraceptives * Pharmacy stock management * Health center management

Sponsors & Collaborators

• Muso, Inc.

  collaborator UNKNOWN

• Malaria Research and Training Center, Bamako, Mali

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Instituto Nacional de Salud Publica, Mexico

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Ministère de la Santé et l'Hygiène Publique, Mali

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Ari D Johnson, MD · University California San Francisco

• Kassoum Kayantao, PhD · Malaria Research & Training Centre, University of Bamako

• Nancy S Padian, PhD · School of Public Health University of California San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2020-07-31

Completion

2020-07-31