Under-five Child MortalityPro-CCMNCT02694055
Trial of Proactive Community Case Management to Reduce Child Mortality
A study testing Proactive Community Case Management, Integrated Community Case Management and Removal of point-of-care user fees in people with Under-five Child Mortality and Access to Health Care, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Under-five Child Mortality, Access to Health Care
- What is being tested?
- Proactive Community Case Management, Integrated Community Case Management and Removal of point-of-care user fees
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135,149 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Non-permanent community members (i.e. seasonal migrants)
- Plans to leave study area in the subsequent three years
About this study
Official title: Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial
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.
Read the detailed description
The trial is an un-blinded, cluster-randomised controlled trial, with 69 clusters in the intervention arm and 68 clusters in the comparison arm. The cluster is defined as a geographical grouping of homes greater than one kilometre from the next nearest geographical grouping of homes (determined by the cardinal distances between GPS coordinates collected at the public gathering space). In practice, this means a cluster can consist of one village or one hamlet, or a collection of neighbouring villages and/or hamlets.
Clusters were randomised to receive either iCCM from a stationary CHW based at a community health post (control) or ProCCM from a CHW who conducts daily active case-finding home visits for at least two hours a day, six days per week. Randomisation was stratified by distance to PHC (1.0-5.0 km vs. greater than 5.0 km); an additional stratum was defined for all villages where the PHC was located to ensure balanced assignment of PHC villages across arms. Within each strata, villages were randomly assigned to the control or treatment arm using a computer-generated random number, then rank ordered based on this number.
All clusters receive PHC infrastructure improvements and staff training, the removal of user fees at all levels of care, and CHW(s) who provide iCCM of common childhood illnesses in accordance with national and international standards, as well as other community-based services, including a reproductive health package for women of child-bearing age. CHW coverage is based on Mali's national iCCM strategy, which assigns each CHW to an average population of 700 in the southern region. Clusters with less than 200 people and within three kilometres of another cluster assigned to the same study arm share a CHW, provided there is no geographic barrier (i.e. river) between the two clusters and no linguistic barrier for the CHW. CHWs in both arms are required to be on call, available to receive and care for patients who seek them out, 24 hours per day, seven days per week.
The primary outcome is a cluster-level outcome, the under-five mortality rate. It is measured within each cluster as the number of deaths among children under five years of age per 1,000 person-years at risk of mortality. After 36 months, we hypothesize that there will be an absolute difference of 0.75% (or a relative difference of 25%) in under-five child mortality between the two study arms, as measured by the number of deaths per 1,000 person-years among children aged 0 to 59 months. Secondary endpoints include a number of reproductive, maternal, and child health outcomes, as well as access and service delivery outcomes. Secondary objectives also include an economic evaluation of the cost-effectiveness, equity, and affordability at scale of ProCCM compared to iCCM.
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 ProCCM. Primary care health centre providers will collect patient care data per village on an electronic medical records system.
- Conditions
- Under-five Child Mortality, Access to Health Care
- Being tested
- Proactive Community Case Management, Integrated Community Case Management, Removal of point-of-care user fees, Infrastructure improvements at primary health centre, Training of primary health centre staff
- Keywords
- Community Health Workers, Community Case Management, Proactive Case Detection, Under-five Child Mortality, Access to Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Community Case ManagementOther
Also called ProCCM
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
Also called iCCM
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
Also called Removal of 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.
Infrastructure improvements at primary health centreOther
Also called Improvements to health centre infrastructure
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
Also called Clinical staff training at primary health centres
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (15)
Difference in the infant mortality rate between the two study arms
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.
Measured: 36 months
Difference in the newborn mortality rate between the two study arms
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.
Measured: 36 months
Difference in the maternal mortality rate between the two study arms
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.
Measured: 36 months
Difference in the percentage of women receiving 3 or more doses of SP during their last pregnancy between the two study arms
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.
Measured: 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
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.
Measured: 36 months
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
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.
Measured: 36 months
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
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.
Measured: 36 months
Difference in the percentage of the population accessing CHW or health centre care per month between the two study arms
We will calculate the percentage of the population accessing CHW or health centre care per month over the 36-month trial period.
Measured: 36 months
Difference in the percentage of the population visiting the health centre per month between the two study arms
We will calculate the percentage of the population visiting the health centre per month over the 36-month trial period.
Measured: 36 months
Difference in the percentage of population receiving CHW health care per month between the two study arms
We will calculate the percentage of population receiving CHW health care per month over the 36-month trial period.
Measured: 36 months
Difference in the percentage of the health care seeking population who receive CHW care per month between the two study arms
We will calculate the percentage of the health care seeking population who receive CHW care per month over the 36-month trial period.
Measured: 36 months
Difference in the number of curative consultations per year at the community and health centre level between the two study arms
We will calculate the number of curative consultations per year at the community and health centre level over the 36-month trial period.
Measured: 36 months
Difference in the percentage pregnant women completing four or more prenatal consultations between the two study arms
We will calculate the pregnant women completing four or more prenatal consultations over the 36-month trial period.
Measured: 36 months
Difference in the average gestational age at first prenatal consultation between the two study arms
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.
Measured: 36 months
Difference in the percentage of participants using modern method of a family planning between the two study arms
We will calculate the percentage of participants using a modern method of family planning over the 36-month trial period.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Under-five Child MortalityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Ari D Johnson, MD, Study chair, University California San FranciscoKassoum Kayantao, PhD, Principal investigator, Malaria Research & Training Centre, University of BamakoNancy S Padian, PhD, Principal investigator, School of Public Health University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694055
- Sponsor's protocol ID
- Pro-CCM-028
- Acronym
- Pro-CCM
- Status last verified
- Jun 2023
- First submitted
- 13 Jan 2016
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 24349053Thwing J, Doumbia S, Traore A, Sylla M, Sogoba M, Kamara I, Samake Y, Guindo L, Rapp S, Treleaven E, Chiu C, Whidden C, Kone A, Djimde AA, Johnson AD, Kayentao K. Impact of proactive community case management of malaria on malaria prevalence in Bankass, Mali: a cluster-randomised controlled trial. Malar J. 2026 May 20;25(1):261. doi: 10.1186/s12936-026-05849-5.
PubMed 42163249Ogbuoji 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.
PubMed 39732474Ghosh 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.
PubMed 38594181Whidden 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.
PubMed 37083317Kayentao 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.
PubMed 36948531Oliphant 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.
PubMed 33565123Whidden 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.
PubMed 31455700
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02694055
- Acronym / sponsor ID
- Pro-CCM / Pro-CCM-028
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135,149 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial is an un-blinded, cluster-randomised controlled trial, with 69 clusters in the intervention arm and 68 clusters in the comparison arm. The cluster is defined as a geographical grouping of homes greater than one kilometre from the next nearest geographical grouping of homes (determined by the cardinal distances between GPS coordinates collected at the public gathering space). In practice, this means a cluster can consist of one village or one hamlet, or a collection of neighbouring villages and/or hamlets.
Clusters were randomised to receive either iCCM from a stationary CHW based at a community health post (control) or ProCCM from a CHW who conducts daily active case-finding home visits for at least two hours a day, six days per week. Randomisation was stratified by distance to PHC (1.0-5.0 km vs. greater than 5.0 km); an additional stratum was defined for all villages where the PHC was located to ensure balanced assignment of PHC villages across arms. Within each strata, villages were randomly assigned to the control or treatment arm using a computer-generated random number, then rank ordered based on this number.
All clusters receive PHC infrastructure improvements and staff training, the removal of user fees at all levels of care, and CHW(s) who provide iCCM of common childhood illnesses in accordance with national and international standards, as well as other community-based services, including a reproductive health package for women of child-bearing age. CHW coverage is based on Mali's national iCCM strategy, which assigns each CHW to an average population of 700 in the southern region. Clusters with less than 200 people and within three kilometres of another cluster assigned to the same study arm share a CHW, provided there is no geographic barrier (i.e. river) between the two clusters and no linguistic barrier for the CHW. CHWs in both arms are required to be on call, available to receive and care for patients who seek them out, 24 hours per day, seven days per week.
The primary outcome is a cluster-level outcome, the under-five mortality rate. It is measured within each cluster as the number of deaths among children under five years of age per 1,000 person-years at risk of mortality. After 36 months, we hypothesize that there will be an absolute difference of 0.75% (or a relative difference of 25%) in under-five child mortality between the two study arms, as measured by the number of deaths per 1,000 person-years among children aged 0 to 59 months. Secondary endpoints include a number of reproductive, maternal, and child health outcomes, as well as access and service delivery outcomes. Secondary objectives also include an economic evaluation of the cost-effectiveness, equity, and affordability at scale of ProCCM compared to iCCM.
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 ProCCM. Primary care health centre providers will collect patient care data per village on an electronic medical records system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive Community Case Management (ProCCM) | Experimental | 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 staffVillages 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). |
| integrated Community Case Management (iCCM) | Active comparator | 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 staffVillages 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Non-permanent community members (i.e. seasonal migrants)
- Plans to leave study area in the subsequent three years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Community Case ManagementAlso: ProCCMCHWs 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 | Proactive Community Case Management (ProCCM) |
| Integrated Community Case ManagementAlso: iCCMCHWs 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 | integrated Community Case Management (iCCM) |
| Removal of point-of-care user feesAlso: Removal of user feesUser 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 | Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM) |
| Infrastructure improvements at primary health centreAlso: Improvements to health centre infrastructureTargeted 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 | Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM) |
| Training of primary health centre staffAlso: Clinical staff training at primary health centresHealth 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 | Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM) |
Primary outcome
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.
15 secondary outcomes
Difference in the infant mortality rate between the two study arms
Time frame: 36 months
Difference in the newborn mortality rate between the two study arms
Time frame: 36 months
Difference in the maternal mortality rate between the two study arms
Time frame: 36 months
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
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
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
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
Difference in the percentage of the population accessing CHW or health centre care per month between the two study arms
Time frame: 36 months
Difference in the percentage of the population visiting the health centre per month between the two study arms
Time frame: 36 months
Difference in the percentage of population receiving CHW health care per month between the two study arms
Time frame: 36 months
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
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
Difference in the percentage pregnant women completing four or more prenatal consultations between the two study arms
Time frame: 36 months
Difference in the average gestational age at first prenatal consultation between the two study arms
Time frame: 36 months
Difference in the percentage of participants using modern method of a family planning between the two study arms
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 24349053Johnson 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.
- Derived from this study: PubMed 42163249Thwing J, Doumbia S, Traore A, Sylla M, Sogoba M, Kamara I, Samake Y, Guindo L, Rapp S, Treleaven E, Chiu C, Whidden C, Kone A, Djimde AA, Johnson AD, Kayentao K. Impact of proactive community case management of malaria on malaria prevalence in Bankass, Mali: a cluster-randomised controlled trial. Malar J. 2026 May 20;25(1):261. doi: 10.1186/s12936-026-05849-5.
- Derived from this study: PubMed 39732474Ogbuoji 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.
- Derived from this study: PubMed 38594181Ghosh 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.
- Derived from this study: PubMed 37083317Whidden 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.
- Derived from this study: PubMed 36948531Kayentao 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.
- Derived from this study: PubMed 33565123Oliphant 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.
- Derived from this study: PubMed 31455700Whidden 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.
- Muso is an international non-governmental organization working to strengthen the health care system in MaliLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari D Johnson, MD study chair
University California San Francisco
Kassoum Kayantao, PhD principal investigator
Malaria Research & Training Centre, University of Bamako
Nancy S Padian, PhD principal investigator
School of Public Health University of California San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Community Case Management, Integrated Community Case Management and Removal of point-of-care user fees in people with Under-five Child Mortality and Access to Health Care, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the under-five child mortality rate between the two study arms (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694055, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.