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

Sponsor
Integrate Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT03773913
Collaborator
Ministère de la Santé et de l'Hygiène Publique, Togo (Other), Université de Lomé, Faculté des Sciences de la Santé, Togo (Other), Albert Einstein College of Medicine (Other), Montefiore Medical Center (Other), City University of New York, School of Public Health (Other)
1,500
1
80
18.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Integrated Community Based Health Systems Strengthening in Northern Togo: A Preliminary Mixed-Methods Study in Kozah District
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Under-five year old mortality rate, annual [72 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.

Secondary Outcome Measures

  1. Under-one year old mortality rate, annual [72 months]

    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.

  2. Maternal mortality rate, annual [72 months]

    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.

  3. 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. [72 months]

    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.

  4. 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. [72 months]

    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.

  5. 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. [72 months]

    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.

  6. Maternal facility based birth delivery incidence rate, annual [72 months]

    The proportion of women reported to have delivered in a health facility.

  7. Protocol Adherence by IH community health workers in iCCM and maternal consultations [72 months]

    The average adherence by IH community health workers to evidence-based protocols for iCCM and maternal consultations as measured by CHW supervisor check-list.

  8. Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations [72 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrate Health Kara Togo

Sponsors and Collaborators

  • Integrate Health
  • 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

Investigators

  • Principal Investigator: Kevin P Fiori Jr., MD MPH, Integrate Health; Albert Einstein School of Medicine
  • Study Director: Molly E Lauria, MPH, Integrate Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Integrate Health
ClinicalTrials.gov Identifier:
NCT03773913
Other Study ID Numbers:
  • ICBHSS Kozah
First Posted:
Dec 12, 2018
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Integrate Health

Study Results

No Results Posted as of Oct 15, 2019