Integrated Community Based Health Systems Strengthening in Northern Togo

NCT ID: NCT03694366

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

7600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Maternal and Child Health Health Service Utilization

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Five facilities in Bassar District

Estimated population of 34,676 served by five public sector facilities in Bassar District.

ICBHSS model

Intervention Type OTHER

Bundle 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

Seven facilities in Binah District

Estimated population of 31,027 served by seven public sector facilities in Binah District.

ICBHSS model

Intervention Type OTHER

Bundle 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

Four facilities in Dankpen District

Estimated total population of 40,165 served by four public sector facilities in Dankpen District.

ICBHSS model

Intervention Type OTHER

Bundle 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

Five facilities in Kéran District

Estimated total population of 31,866 served by five public sector facilities in Kéran District.

ICBHSS model

Intervention Type OTHER

Bundle 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

Interventions

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ICBHSS model

Bundle 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* None
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministère de la Santé et de l'Hygiène Publique, Togo

UNKNOWN

Sponsor Role collaborator

Université de Lomé, Faculté des Sciences de la Santé, Togo

UNKNOWN

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role collaborator

City University of New York, School of Public Health

OTHER

Sponsor Role collaborator

Integrate Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin P Fiori, Jr., MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Integrate Health; Albert Einstein School of Medicine

Molly E Lauria, MPH

Role: STUDY_DIRECTOR

Integrate Health

Locations

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Integrate Health

Kara, , Togo

Site Status RECRUITING

Countries

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Togo

Central Contacts

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Molly E Lauria, MPH

Role: CONTACT

646-397-0217

Kevin P Fiori, MD, MPH, MSc

Role: CONTACT

Facility Contacts

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Molly E Lauria, MPH

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27391996 (View on PubMed)

McCarthy 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.

Reference Type BACKGROUND
PMID: 28301539 (View on PubMed)

Lauria 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.

Reference Type DERIVED
PMID: 31619250 (View on PubMed)

Related Links

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Other Identifiers

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ICBHSS

Identifier Type: -

Identifier Source: org_study_id

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