Trial of Proactive Community Case Management to Reduce Child Mortality

NCT02694055 | Completed DMC

• 1 other identifier: Pro-CCM-028
• Study Type: interventional
• Target: 135,149
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in the under-five child mortality rate between the two study arms

  To assess the effectiveness of ProCCM compared to a passive iCCM intervention, we will compare the three-year under-five mortality rate in treatment versus control clusters collected prospectively in the 12-, 24- and 36-month follow-up surveys. We will calculate under-five mortality rate as the number of deaths among children under five years of age per 1,000 person-years of exposure to the risk of mortality for each cluster over the 36-month trial period.

  36 months

Secondary Outcomes (15)

• Difference in the infant mortality rate between the two study arms

  36 months

• Difference in the newborn mortality rate between the two study arms

  36 months

• Difference in the maternal mortality rate between the two study arms

  36 months

• Difference in the percentage of women receiving 3 or more doses of SP during their last pregnancy between the two study arms

  36 months

• Difference in the percentage of under-five children with fever in the prior two weeks who receive testing and/or effective treatment for malaria within 24 hours of symptom onset between the two study arms

  36 months

Other Outcomes (3)

• Cost-effectiveness ratios of i-CCM and Pro-CCM

  36 months

• Equity implications of i-CCM and Pro-CCM

  36 months

• Affordability of Pro-CCM at scale

  36 months

Study Arms (2)

Proactive Community Case Management (ProCCM)

EXPERIMENTAL

Villages assigned to the experimental arm will receive the following health system strengthening interventions: training of primary health centre staff, infrastructure improvements at primary health centre, removal of point-of-care user fees, and the presence of Community Health Workers providing proactive case detection in addition to integrated Community Case Management (ProCCM).

Other: Proactive Community Case Management; Other: Removal of point-of-care user fees; Other: Infrastructure improvements at primary health centre; Other: Training of primary health centre staff

integrated Community Case Management (iCCM)

ACTIVE COMPARATOR

Villages assigned to the active comparator arm will receive the following health system strengthening interventions: training of primary health centre staff, infrastructure improvements at primary health centre, removal of point-of-care user fees, and the presence of Community Health Workers providing passive integrated Community Case Management (iCCM) exclusively at a fixed health post to patients who initiate their own care-seeking.

Other: Integrated Community Case Management; Other: Removal of point-of-care user fees; Other: Infrastructure improvements at primary health centre; Other: Training of primary health centre staff

Interventions

Proactive Community Case Management OTHER

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.

Also known as: ProCCM

Proactive Community Case Management (ProCCM)

Integrated Community Case Management OTHER

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.

Also known as: iCCM

integrated Community Case Management (iCCM)

Removal of point-of-care user fees OTHER

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.

Also known as: Removal of user fees

Proactive Community Case Management (ProCCM); integrated Community Case Management (iCCM)

Infrastructure improvements at primary health centre OTHER

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.

Also known as: Improvements to health centre infrastructure

Proactive Community Case Management (ProCCM); integrated Community Case Management (iCCM)

Training of primary health centre staff OTHER

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

Also known as: Clinical staff training at primary health centres

Proactive Community Case Management (ProCCM); integrated Community Case Management (iCCM)

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Muso, Inc.: collaborator
• Malaria Research and Training Center, Bamako, Mali: collaborator
• University of California, Berkeley: collaborator
• University of Michigan: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Ministère de la Santé et l'Hygiène Publique, Mali: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Related Publications (7)

• Johnson AD, Thomson DR, Atwood S, Alley I, Beckerman JL, Kone I, Diakite D, Diallo H, Traore B, Traore K, Farmer PE, Murray M, Mukherjee J. Assessing early access to care and child survival during a health system strengthening intervention in Mali: a repeated cross sectional survey. PLoS One. 2013 Dec 11;8(12):e81304. doi: 10.1371/journal.pone.0081304. eCollection 2013.

  PMID: 24349053 BACKGROUND

• Ogbuoji O, Shahid M, Zimmerman A, Liu JX, Kayentao K, Whidden C, Treleaven E, Traore C, Sogoba M, Doumbia S, Boettiger DC, Cisse AB, Keita Y, Berthe M, Johnson A. Cost-effectiveness analysis of proactive home visits compared with site-based community health worker care on antenatal care outcomes in Mali: a cluster-randomised trial. BMJ Glob Health. 2024 Dec 27;9(12):e014940. doi: 10.1136/bmjgh-2023-014940.

  PMID: 39732474 DERIVED

• Ghosh R, Konipo AN, Treleaven E, Rozenshteyn S, Beckerman J, Whidden C, Johnson A, Kayentao K, Liu J. Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial. BMJ Open. 2024 Apr 9;14(4):e084315. doi: 10.1136/bmjopen-2024-084315.

  PMID: 38594181 DERIVED

• Whidden C, Kayentao K, Kone N, Liu J, Traore MB, Diakite D, Coumare M, Berthe M, Guindo M, Greenwood B, Chandramohan D, Leyrat C, Treleaven E, Johnson A. Effects of proactive vs fixed community health care delivery on child health and access to care: a cluster randomised trial secondary endpoint analysis. J Glob Health. 2023 Apr 21;13:04047. doi: 10.7189/jogh.13.04047.

  PMID: 37083317 DERIVED

• Kayentao K, Ghosh R, Guindo L, Whidden C, Treleaven E, Chiu C, Lassala D, Traore MB, Beckerman J, Diakite D, Tembely A, Idriss BM, Berthe M, Liu JX, Johnson A. Effect of community health worker home visits on antenatal care and institutional delivery: an analysis of secondary outcomes from a cluster randomised trial in Mali. BMJ Glob Health. 2023 Mar;8(3):e011071. doi: 10.1136/bmjgh-2022-011071.

  PMID: 36948531 DERIVED

• Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.

  PMID: 33565123 DERIVED

• Whidden C, Treleaven E, Liu J, Padian N, Poudiougou B, Bautista-Arredondo S, Fay MP, Samake S, Cisse AB, Diakite D, Keita Y, Johnson AD, Kayentao K. Proactive community case management and child survival: protocol for a cluster randomised controlled trial. BMJ Open. 2019 Aug 26;9(8):e027487. doi: 10.1136/bmjopen-2018-027487.

  PMID: 31455700 DERIVED

Related Links

• Muso is an international non-governmental organization working to strengthen the health care system in Mali

Study Officials

• Ari D Johnson, MD

  University California San Francisco

  STUDY CHAIR

• Kassoum Kayantao, PhD

  Malaria Research & Training Centre, University of Bamako

  PRINCIPAL INVESTIGATOR

• Nancy S Padian, PhD

  School of Public Health University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: February 29, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share