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Trial of Proactive Community Case Management to Reduce Child Mortality (Pro-CCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02694055
Recruitment Status : Active, not recruiting
First Posted : February 29, 2016
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
Muso, Inc.
Malaria Research and Training Center, Bamako, Mali
University of California, Berkeley
University of Michigan
Instituto Nacional de Salud Publica, Mexico
National Institute of Allergy and Infectious Diseases (NIAID)
Ministère de la Santé et l'Hygiène Publique, Mali
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Under-five Child Mortality Access to Health Care Other: Proactive Community Case Management 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Proactive Community Case Management (ProCCM)
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
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 Name: ProCCM

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 Name: Removal of user fees

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 Name: Improvements to health centre infrastructure

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
Other Name: Clinical staff training at primary health centres

Active Comparator: integrated Community Case Management (iCCM)
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
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 Name: iCCM

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 Name: Removal of user fees

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 Name: Improvements to health centre infrastructure

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
Other Name: Clinical staff training at primary health centres




Primary Outcome Measures :
  1. Difference in the under-five child mortality rate between the two study arms [ Time Frame: 36 months ]

    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.



Secondary Outcome Measures :
  1. Difference in the infant mortality rate between the two study arms [ Time Frame: 36 months ]
    Infant mortality rate (IMR) is the number of deaths per 1,000 live births among infants aged 0-11 months. We will calculate the IMR over the 36-month trial period.

  2. Difference in the newborn mortality rate between the two study arms [ Time Frame: 36 months ]
    Newborn mortality rate (NMR) is the number of deaths per 1,000 live births among newborns aged 0-28 days. We will calculate the NMR over the 36-month trial period.

  3. Difference in the maternal mortality rate between the two study arms [ Time Frame: 36 months ]
    Maternal mortality ratio (MMR) is the number of deaths among women while pregnant or within 42 days of delivery or termination per 100,000 live births. We calculate the MMR over the 36-month trial period.

  4. Difference in the percentage of women receiving 3 or more doses of SP during their last pregnancy between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of women receiving 3 or more doses of Sulfadoxine-Pyrimethamine (SP) during their last pregnancy in the context of Intermittent Preventive Treatment (IPTp) over the 36-month trial period.

  5. 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 [ Time Frame: 36 months ]
    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: Among all children who report fever within the two weeks prior to the endline survey (36 months), proportion who report receipt of a malaria rapid diagnostic test (mRDT) and, if the mRDT positive, artemisinin-based combination therapy (arthemeter-lumefantrine) over the 36-month trial period.

  6. Difference in the percentage of children under five with diarrhea in the past two weeks who received zinc and oral rehydration therapy within 24 hours of symptom onset between the two study arms [ Time Frame: 36 months ]
    We will calculate percentage of children under five with diarrhoea in the past two weeks who received zinc and oral rehydration therapy within 24 hours of symptom onset over the 36-month trial period.

  7. Difference in the percentage of children with acute respiratory illness evaluated by a qualified provider within 24 hours of symptom onset between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of children with acute respiratory illness (ARI) evaluated by a qualified provider within 24 hours of symptom onset. Among all children who report ARI within the two weeks prior to the endline survey (36 months), proportion who attended a skilled provider within 24 hours of onset of ARI. Skilled providers include CHWs, doctors, nurses, or other providers based at the health center care.

  8. Difference in the percentage of the population accessing CHW or health centre care per month between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of the population accessing CHW or health centre care per month over the 36-month trial period.

  9. Difference in the percentage of the population visiting the health centre per month between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of the population visiting the health centre per month over the 36-month trial period.

  10. Difference in the percentage of population receiving CHW health care per month between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of population receiving CHW health care per month over the 36-month trial period.

  11. Difference in the percentage of the health care seeking population who receive CHW care per month between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of the health care seeking population who receive CHW care per month over the 36-month trial period.

  12. Difference in the number of curative consultations per year at the community and health centre level between the two study arms [ Time Frame: 36 months ]
    We will calculate the number of curative consultations per year at the community and health centre level over the 36-month trial period.

  13. Difference in the percentage pregnant women completing four or more prenatal consultations between the two study arms [ Time Frame: 36 months ]
    We will calculate the pregnant women completing four or more prenatal consultations over the 36-month trial period.

  14. Difference in the average gestational age at first prenatal consultation between the two study arms [ Time Frame: 36 months ]
    We will calculate the average gestational age at first prenatal consultation over the 36-month trial period. Alternatively, we will consider percentage of pregnant women with first prenatal consultation in the first trimester over the 36-month trial period.

  15. Difference in the percentage of participants using modern method of a family planning between the two study arms [ Time Frame: 36 months ]
    We will calculate the percentage of participants using a modern method of family planning over the 36-month trial period.


Other Outcome Measures:
  1. Cost-effectiveness ratios of i-CCM and Pro-CCM [ Time Frame: 36 months ]
    Cost effectiveness ratios will be presented from three perspectives (i) intervention costs alone, (ii) potential costs/savings to health providers (MoH), (iii) potential societal costs/savings, which includes both health providers and households. Costs to the health care providers and households associated with Pro-CCM and i-CCM will be collected as part of routine trial data collection where possible, with supplementary cost and resource use data collected when necessary. In addition, the economic costs to the health system will be based on detailed cost data from Community Health Workers and health facilities. A standardised costing template will be used in all the sites to record resource use associated with personnel, materials and supplies, equipment, transport, utilities and buildings. Effects will be based on trial outcomes. Specifically, economic evaluation will explore cost of Pro-CCM per disability-adjusted life year saved among children aged 0-59 months.

  2. Equity implications of i-CCM and Pro-CCM [ Time Frame: 36 months ]
    Data on the socio-economic characteristics of study participants will be collected as part of the survey tool, and will include questions that make up the DHS Wealth Index for Mali in order to measure household poverty/wealth. The percentage of children receiving treatment within 24 hours of symptom onset and the survival rate of children 0-59 months will be analysed stratified across wealth quintiles in each trial arm.

  3. Affordability of Pro-CCM at scale [ Time Frame: 36 months ]
    Whether a Pro-CCM program would be affordable to the Ministry of Health will be explored. A simple model forecasting the costs of introducing and sustaining Pro-CCM will be developed and this will run using various 'delivery' (supply) and 'uptake' (demand) scenarios. This model will help to inform decision makers about the affordability of implementing Pro-CCM in their setting.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694055


Sponsors and Collaborators
University of California, San Francisco
Muso, Inc.
Malaria Research and Training Center, Bamako, Mali
University of California, Berkeley
University of Michigan
Instituto Nacional de Salud Publica, Mexico
National Institute of Allergy and Infectious Diseases (NIAID)
Ministère de la Santé et l'Hygiène Publique, Mali
London School of Hygiene and Tropical Medicine
Investigators
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Study Chair: Ari D Johnson, MD University California San Francisco
Principal Investigator: 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
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02694055    
Other Study ID Numbers: Pro-CCM-028
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be made available with publication and dissemination of final results after termination of the study in September 2018. However, all IPD made available will be anonymous. IPD includes anonymous quantitative and qualitative data on health seeking behaviour and health outcomes of the study participants.
Keywords provided by University of California, San Francisco:
Community Health Workers
Community Case Management
Proactive Case Detection
Under-five Child Mortality
Access to Health Care