Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo (ICBHSS-Kozah)

Integrated Community Based Health Systems Strengthening in Northern Togo: A Preliminary Mixed-Methods Study in Kozah District

This preliminary study aims to inform the design and delivery of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Kozah District health facilities over a period of 48 months. Specific aims include: (1) Assess maternal and child health outcomes and health service utilization rates in the 4 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.

Study Overview

• Status: Unknown
• Conditions: Maternal-Child Health Services; Health Service Utilization
• Intervention / Treatment: Other: ICBHSS model

Detailed Description

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.

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 Kozah district. It will include: (1) a repeated cross-sectional study to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey as well as (2) qualitative key informant interviews and focus group discussions conducted at 12 months for each intervention health facility. 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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• Togo
  • Kara, Togo
    • Recruiting
    • Integrate Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Four facilities in Kozah District; Baseline estimated population of 33,412 served by four public sector facilities in Kozah District.

Other: ICBHSS model; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Under-five year old mortality rate, annual	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.	72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Under-one year old mortality rate, annual	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.	72 months
Maternal mortality rate, annual	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.	72 months
Annual 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.	72 months
Annual 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.	72 months
Annual 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.	72 months
Maternal facility based birth delivery incidence rate, annual	The proportion of women reported to have delivered in a health facility.	72 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 as measured by CHW supervisor check-list.	72 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 as measured by IH clinical mentor supervision check-list.	72 months

Collaborators and Investigators

• Sponsor: Integrate Health
• Collaborators: Albert Einstein College of Medicine; Montefiore Medical Center; City University of New York, School of Public Health; Ministère de la Santé et de l'Hygiène Publique, Togo; Université de Lomé, Faculté des Sciences de la Santé, Togo
• Investigators: Principal Investigator: Kevin P Fiori Jr., MD MPH, Integrate Health; Albert Einstein School of Medicine

Publications and helpful links

General 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.
• Fiori KP, Lauria ME, Singer AW, Jones HE, Belli HM, Aylward PT, Agoro S, Gbeleou S, Sowu E, Grunitzky-Bekele M, Singham Goodwin A, Morrison M, Ekouevi DK, Hirschhorn LR. An Integrated Primary Care Initiative for Child Health in Northern Togo. Pediatrics. 2021 Sep;148(3):e2020035493. doi: 10.1542/peds.2020-035493.
• Kaplowitz ET, Fiori KP, Lauria ME, Gbeleou S, Miziou A, Sowu E, Schechter J, Jones HE. Sexual Relationship Power and Socio-demographic Factors Predicting Contraceptive Use, Antenatal Visits and Sick Child Health Service Use in Northern Togo. Matern Child Health J. 2020 Jul;24(7):845-855. doi: 10.1007/s10995-020-02948-w.

Helpful Links

• Integrate Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Implementation Research; Health Systems Strengthening; Community Health Workers; Child Mortality; Reproductive, Maternal, Newborn, and Child Health; Preliminary Research
• Other Study ID Numbers: ICBHSS Kozah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No