CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135,149 enrolled
Drug / intervention
Proactive Community Case Management +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02694055
NCT02694055N/ACompleted

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

University of California, San Francisco·interventional·Posted Feb 29, 2016·Updated Jun 12, 2023

In Brief

A clinical study evaluating Proactive Community Case Management, Integrated Community Case Management, and 3 other interventions for Under-five Child Mortality and Access to Health Care. Completed, enrolled 135,149 participants.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 29, 2016
Enrollment StartDec 1, 2016
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.3 years ago

Interventions

Proactive Community Case Managementother

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.

Integrated Community Case Managementother

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.

Removal of point-of-care user feesother

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.

Infrastructure improvements at primary health centreother

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.

Training of primary health centre staffother

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