Maternal and Child HealthICBHSS-TogoNCT03694366
Integrated Community Based Health Systems Strengthening in Northern Togo
An observational study of Maternal and Child Health and Health Service Utilization, run by Integrate Health at 1 site in Togo.
Trial summary
The general objective of this study is to optimize implementation and assess effectiveness of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Northern Togo districts, using the RE-AIM implementation science framework. 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
- Maternal and Child Health, Health Service Utilization
- What is being tested?
- ICBHSS model
- How many people
- 7,600 participants
- Where
- 1 siteTogo
- Study dates
- 1 May 2018to 31 Jul 2022
- Phase
- Observational
- 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
Study population: Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.
Who may be able to join
- Female of reproductive age (aged 15-49 years)
- Individuals aged 15-17 years will only be included if they have children and/or are pregnant
- Lives in selected household within study catchment area
- Informed consent is obtained for participants 18-49
- Waiver of parental permission is obtained for 15-17 year-old participants
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Kevin P Fiori, MD, MPH, MSc contact
Togo1 site, 1 recruiting
- Recruiting
Integrate Health
Kara
Molly E Lauria, MPH, mlauria@integratehealth.org
About this study
Official title: Integrated Community Based Health Systems Strengthening in Northern Togo: A Stepped-Wedge Randomized Cluster Pragmatic Control Trial
The general objective of this study is to optimize implementation and assess effectiveness of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Northern Togo districts, using the RE-AIM implementation science framework. Specific study aims include: (1) Analyze longitudinal changes regarding maternal and child health outcomes, health service utilization rates, and public sector facility readiness in the ICBHSS model intervention sites catchment areas; (2) Identify barriers to and facilitators of access and quality services related to ICBHSS model; and (3) Assess changes in health care services coverage, effectiveness, and adoption of ICBHSS model. These findings are expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide generalizable knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.
Read the detailed description
Background: Over the past decade the burden of poor maternal and child health outcomes in Togo, particularly in the Northern regions, have remained high despite global progress. The principal causes of under-5 deaths in Togo are diseases with effective and low-cost prevention and or treatment strategies, including malaria (18%), acute lower respiratory infections (15%), and diarrheal diseases (8%).While Togo has an official plan for the integrated management of childhood illness (IMCI), including a permissive policy on integrated community case management (iCCM), challenges in implementation persist with low public sector health service utilization.There are critical gaps in access and quality of community health systems throughout the country and an urgent need to improve health outcomes through expanding access and quality of services.
Intervention: The investigators have adapted an integrated facility and community-based health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo. The ICBHSS model includes a bundle of evidence based interventions including (1) community engagement meetings and feedback; (2) the elimination of facility user fees for children under five and pregnant women; (3) pro-active community based IMCI using Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; (4) clinical mentoring and enhanced supervision at public sector facilities; and (5) improved supply chain management and facility structures. In 2015, a pilot ICBHSS initiative was launched in partnership with the Ministry of Health (MOH) at four public sector clinics in Northern Togo. Preliminary results from this pilot intervention suggested a meaningful reduction in children under-5 deaths, with a trend in reduction for under-one deaths as well as increased health service utilization at all 4 sites. In collaboration with MOH and technical partners, IH developed a plan to expand the ICBHSS model to 21 distinct health facilities over a four-year period in four additional districts: Bassar, Binah, Dankpen, and Kéran. The planned roll out includes expanding into a new district every 12 months based on budgetary and feasibility considerations. As part of this expansion planned for 2018, Integrate Health (IH) and MOH partners are planning an implementation study to both improve service delivery at expansion sites and inform national scale strategies.
Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework to evaluate the impact and implementation of the ICBHSS initiative in 4 districts. Consists of three key components: (1) a stepped-wedge randomized cluster pragmatic control trial to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey, (2) health facility assessments to be completed at the cluster (district) level for each health facility prior to intervention launch and post-intervention, and (3) key informant interviews conducted at 12, 24, 48 months for each cluster. The primary outcome will be under 5 year old mortality rate, with secondary outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and child health service utilization.
- Being tested
- ICBHSS model
- Keywords
- Child Mortality, Reproductive, Maternal, Newborn, and Child Health, Community Health Workers, Implementation Research, Health Systems Strengthening
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBHSS modelOther
Bundle of evidence-based interventions that include the following 5 components:
- Community engagement meetings and feedback;
- Elimination of public sector facility user fees for children under five and pregnant women;
- Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals;
- Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;
- Basic infrastructure improvements and supply chain management training of pharmacy managers
| Study group | Role | What they receive |
|---|---|---|
| Five facilities in Bassar District | Estimated population of 34,676 served by five public sector facilities in Bassar District. Receives: Other: ICBHSS model | |
| Seven facilities in Binah District | Estimated population of 31,027 served by seven public sector facilities in Binah District. Receives: Other: ICBHSS model | |
| Four facilities in Dankpen District | Estimated total population of 40,165 served by four public sector facilities in Dankpen District. Receives: Other: ICBHSS model | |
| Five facilities in Kéran District | Estimated total population of 31,866 served by five public sector facilities in Kéran District. Receives: Other: ICBHSS model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Under-five year old mortality rate
The under-five mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 5 years of age.
Measured: 48 months
Secondary outcomes (8)
Under-one year old mortality rate
The under-one mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 1 year of age.
Measured: 48 months
Maternal mortality rate
The maternal mortality rate (expressed as a rate per 100,000 live births) is the probability of a mother dying in a specified year within 42 days of pregnancy termination .
Measured: 48 months
Proportion of children under age five reported to be febrile in the prior two weeks who received an effective antimalarial treatment within 24 hours of symptom onset.
The number of febrile children under-five who received an effective antimalarial treatment within 24 hours of symptom onset out of the total number of children under age five reported to be febrile in the prior two weeks.
Measured: 48 months
Proportion of children under age five reported to have a cough in the prior two weeks who received an effective pneumonia treatment within 24 hours of symptom onset.
The number of children under-five who received an effective pneumonia treatment within 24 hours of symptom onset out of the total number of children under age five reported to have a cough in the prior two weeks.
Measured: 48 months
Proportion of children under age five reported to have diarrhea in the prior two weeks who received an effective treatment for diarrheal disease within 24 hours of symptom onset.
The number of children under-five who received an effective treatment for diarrheal disease within 24 hours of symptom onset out of the total number of children under age five reported to have diarrhea in the prior two weeks.
Measured: 48 months
Maternal facility based birth delivery incidence rate
The proportion of women reported to have delivered in a health facility.
Measured: 48 months
Protocol Adherence by IH community health workers in iCCM and maternal consultations
The average adherence by IH community health workers to evidence based protocols for iCCM and maternal consultations.
Measured: 48 months
Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
The average adherence by public sector clinical staff at IH intervention sites to evidence based protocols for iCCM and maternal consultations.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 May 2018
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 7,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrate Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de la Santé et de l'Hygiène Publique, Togo, Université de Lomé, Faculté des Sciences de la Santé, Togo, Albert Einstein College of Medicine, Montefiore Medical Center, City University of New York, School of Public Health
- Responsible party
- Sponsor
- Investigators
- Kevin P Fiori, Jr., MD, MPH, Principal investigator, Integrate Health; Albert Einstein School of MedicineMolly E Lauria, MPH, Study director, Integrate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694366
- Sponsor's protocol ID
- ICBHSS
- Acronym
- ICBHSS-Togo
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiori K, Schechter J, Dey M, Braganza S, Rhatigan J, Houndenou S, Gbeleou C, Palerbo E, Tchangani E, Lopez A, Bensen E, Hirschhorn LR. Closing the delivery gaps in pediatric HIV care in Togo, West Africa: using the care delivery value chain framework to direct quality improvement. AIDS Care. 2016 Mar;28 Suppl 2(sup2):29-33. doi: 10.1080/09540121.2016.1176678.
PubMed 27391996McCarthy KJ, Braganza S, Fiori K, Gbeleou C, Kpakpo V, Lopez A, Schechter J, Singham Goodwin A, Jones HE. Identifying inequities in maternal and child health through risk stratification to inform health systems strengthening in Northern Togo. PLoS One. 2017 Mar 16;12(3):e0173445. doi: 10.1371/journal.pone.0173445. eCollection 2017.
PubMed 28301539Lauria ME, Fiori KP, Jones HE, Gbeleou S, Kenkou K, Agoro S, Agbere AD, Lue KD, Hirschhorn LR. Assessing the Integrated Community-Based Health Systems Strengthening initiative in northern Togo: a pragmatic effectiveness-implementation study protocol. Implement Sci. 2019 Oct 16;14(1):92. doi: 10.1186/s13012-019-0921-3.
PubMed 31619250
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Community Based Health Systems Strengthening in Northern Togo: A Stepped-Wedge Randomized Cluster Pragmatic Control Trial
- ClinicalTrials.gov ID
- NCT03694366
- Acronym / sponsor ID
- ICBHSS-Togo / ICBHSS
- Keywords
- Child Mortality, Reproductive, Maternal, Newborn, and Child Health, Community Health Workers, Implementation Research, Health Systems Strengthening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,600 participants (estimated)
- Lead sponsor
- Integrate HealthUniversity, hospital or other
- Collaborators
- Ministère de la Santé et de l'Hygiène Publique, Togo, Université de Lomé, Faculté des Sciences de la Santé, Togo, Albert Einstein College of Medicine, Montefiore Medical Center, City University of New York, School of Public Health
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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 general objective of this study is to optimize implementation and assess effectiveness of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Northern Togo districts, using the RE-AIM implementation science framework. Specific study aims include: (1) Analyze longitudinal changes regarding maternal and child health outcomes, health service utilization rates, and public sector facility readiness in the ICBHSS model intervention sites catchment areas; (2) Identify barriers to and facilitators of access and quality services related to ICBHSS model; and (3) Assess changes in health care services coverage, effectiveness, and adoption of ICBHSS model. These findings are expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide generalizable knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.
Detailed description
Background: Over the past decade the burden of poor maternal and child health outcomes in Togo, particularly in the Northern regions, have remained high despite global progress. The principal causes of under-5 deaths in Togo are diseases with effective and low-cost prevention and or treatment strategies, including malaria (18%), acute lower respiratory infections (15%), and diarrheal diseases (8%).While Togo has an official plan for the integrated management of childhood illness (IMCI), including a permissive policy on integrated community case management (iCCM), challenges in implementation persist with low public sector health service utilization.There are critical gaps in access and quality of community health systems throughout the country and an urgent need to improve health outcomes through expanding access and quality of services.
Intervention: The investigators have adapted an integrated facility and community-based health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo. The ICBHSS model includes a bundle of evidence based interventions including (1) community engagement meetings and feedback; (2) the elimination of facility user fees for children under five and pregnant women; (3) pro-active community based IMCI using Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; (4) clinical mentoring and enhanced supervision at public sector facilities; and (5) improved supply chain management and facility structures. In 2015, a pilot ICBHSS initiative was launched in partnership with the Ministry of Health (MOH) at four public sector clinics in Northern Togo. Preliminary results from this pilot intervention suggested a meaningful reduction in children under-5 deaths, with a trend in reduction for under-one deaths as well as increased health service utilization at all 4 sites. In collaboration with MOH and technical partners, IH developed a plan to expand the ICBHSS model to 21 distinct health facilities over a four-year period in four additional districts: Bassar, Binah, Dankpen, and Kéran. The planned roll out includes expanding into a new district every 12 months based on budgetary and feasibility considerations. As part of this expansion planned for 2018, Integrate Health (IH) and MOH partners are planning an implementation study to both improve service delivery at expansion sites and inform national scale strategies.
Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework to evaluate the impact and implementation of the ICBHSS initiative in 4 districts. Consists of three key components: (1) a stepped-wedge randomized cluster pragmatic control trial to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey, (2) health facility assessments to be completed at the cluster (district) level for each health facility prior to intervention launch and post-intervention, and (3) key informant interviews conducted at 12, 24, 48 months for each cluster. The primary outcome will be under 5 year old mortality rate, with secondary outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and child health service utilization.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Five facilities in Bassar District | – | Other: ICBHSS modelEstimated population of 34,676 served by five public sector facilities in Bassar District. |
| Seven facilities in Binah District | – | Other: ICBHSS modelEstimated population of 31,027 served by seven public sector facilities in Binah District. |
| Four facilities in Dankpen District | – | Other: ICBHSS modelEstimated total population of 40,165 served by four public sector facilities in Dankpen District. |
| Five facilities in Kéran District | – | Other: ICBHSS modelEstimated total population of 31,866 served by five public sector facilities in Kéran District. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.
Key inclusion criteria (5 listed)
- Female of reproductive age (aged 15-49 years)
- Individuals aged 15-17 years will only be included if they have children and/or are pregnant
- Lives in selected household within study catchment area
- Informed consent is obtained for participants 18-49
- Waiver of parental permission is obtained for 15-17 year-old participants
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ICBHSS modelBundle of evidence-based interventions that include the following 5 components: 1. Community engagement meetings and feedback; 2. Elimination of public sector facility user fees for children under five and pregnant women; 3. Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; 4. Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities; 5. Basic infrastructure improvements and supply chain management training of pharmacy managers | Other | Five facilities in Bassar District, Five facilities in Kéran District, Four facilities in Dankpen District, Seven facilities in Binah District |
Primary outcome
Under-five year old mortality rate
Time frame: 48 months
The under-five mortality rate (expressed as a rate per 1,000 live births) is the probability of a child dying in a specified year between birth and 5 years of age.
8 secondary outcomes
Under-one year old mortality rate
Time frame: 48 months
Maternal mortality rate
Time frame: 48 months
Proportion of children under age five reported to be febrile in the prior two weeks who received an effective antimalarial treatment within 24 hours of symptom onset.
Time frame: 48 months
Proportion of children under age five reported to have a cough in the prior two weeks who received an effective pneumonia treatment within 24 hours of symptom onset.
Time frame: 48 months
Proportion of children under age five reported to have diarrhea in the prior two weeks who received an effective treatment for diarrheal disease within 24 hours of symptom onset.
Time frame: 48 months
Maternal facility based birth delivery incidence rate
Time frame: 48 months
Protocol Adherence by IH community health workers in iCCM and maternal consultations
Time frame: 48 months
Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 27391996Fiori K, Schechter J, Dey M, Braganza S, Rhatigan J, Houndenou S, Gbeleou C, Palerbo E, Tchangani E, Lopez A, Bensen E, Hirschhorn LR. Closing the delivery gaps in pediatric HIV care in Togo, West Africa: using the care delivery value chain framework to direct quality improvement. AIDS Care. 2016 Mar;28 Suppl 2(sup2):29-33. doi: 10.1080/09540121.2016.1176678.
- Background: PubMed 28301539McCarthy KJ, Braganza S, Fiori K, Gbeleou C, Kpakpo V, Lopez A, Schechter J, Singham Goodwin A, Jones HE. Identifying inequities in maternal and child health through risk stratification to inform health systems strengthening in Northern Togo. PLoS One. 2017 Mar 16;12(3):e0173445. doi: 10.1371/journal.pone.0173445. eCollection 2017.
- Derived from this study: PubMed 31619250Lauria ME, Fiori KP, Jones HE, Gbeleou S, Kenkou K, Agoro S, Agbere AD, Lue KD, Hirschhorn LR. Assessing the Integrated Community-Based Health Systems Strengthening initiative in northern Togo: a pragmatic effectiveness-implementation study protocol. Implement Sci. 2019 Oct 16;14(1):92. doi: 10.1186/s13012-019-0921-3.
- Integrate HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kevin P Fiori, MD, MPH, MSc contact
Kevin P Fiori, Jr., MD, MPH principal investigator
Integrate Health; Albert Einstein School of Medicine
Molly E Lauria, MPH study director
Integrate Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal and Child Health and Health Service Utilization, run by Integrate Health at 1 site in Togo.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Togo. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Molly E Lauria, MPH (646-397-0217, mlauria@integratehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Under-five year old mortality rate (time frame: 48 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 NCT03694366, which also lists 3 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 15 Oct 2019.