Clinical trial NCT03694366: Integrated Community Based Health Systems Strengthening in Northern Togo
Official title: Integrated Community Based Health Systems Strengthening in Northern Togo: A Stepped-Wedge Randomized Cluster Pragmatic Control Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal and Child Health
Health Service Utilization
Keywords: Child Mortality
Reproductive, Maternal, Newborn, and Child Health
Community Health Workers
Implementation Research
Health Systems Strengthening
Lead sponsor: Integrate Health
Sponsor class: OTHER
Collaborators: name: Ministère de la Santé et de l'Hygiène Publique, Togo
name: Université de Lomé, Faculté des Sciences de la Santé, Togo
name: Albert Einstein College of Medicine
name: Montefiore Medical Center
name: City University of New York, School of Public Health
First posted: 2018-10-03
Enrollment: 7600
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Under-five year old mortality rate
timeFrame: 48 months
Secondary outcomes:
measure: Under-one year old mortality rate
timeFrame: 48 months
measure: Maternal mortality rate
timeFrame: 48 months
measure: 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.
timeFrame: 48 months
measure: 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.
timeFrame: 48 months
measure: 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.
timeFrame: 48 months
measure: Maternal facility based birth delivery incidence rate
timeFrame: 48 months
measure: Protocol Adherence by IH community health workers in iCCM and maternal consultations
timeFrame: 48 months
measure: Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
timeFrame: 48 months
Other outcomes:
Locations:
city: Kara
country: Togo
facility: Integrate Health
Study officials:
affiliation: Integrate Health; Albert Einstein School of Medicine
name: Kevin P Fiori, Jr., MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Integrate Health
name: Molly E Lauria, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.