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.
Brief Title
Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo
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: 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.
Central Contacts
Central Contact Role
Contact
Central Contact Email
mlauria@integratehealth.org
Central Contact Role
Contact
Central Contact Email
kfiori@integratehealth.org
Completion Date
Completion Date Type
Estimated
Conditions
Maternal-Child Health Services
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:
-
* 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:
-
Inclusion 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
* 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
Gender
Female
Gender Based
false
Keywords
Child Mortality
Reproductive, Maternal, Newborn, and Child Health
Community Health Workers
Implementation Research
Preliminary Research
Health Systems Strengthening
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
49 Years
Minimum Age
15 Years
NCT Id
NCT03773913
Org Class
Other
Org Full Name
Integrate Health
Org Study Id
ICBHSS Kozah
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Integrated Community Based Health Systems Strengthening in Northern Togo: A Preliminary Mixed-Methods Study in Kozah District
Primary Outcomes
Outcome Description
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.
Outcome Measure
Under-five year old mortality rate, annual
Outcome Time Frame
72 months
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
Under-one year old mortality rate, annual
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
Maternal mortality rate, annual
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
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.
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
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.
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
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.
Outcome Description
The proportion of women reported to have delivered in a health facility.
Outcome Time Frame
72 months
Outcome Measure
Maternal facility based birth delivery incidence rate, annual
Outcome Description
The average adherence by IH community health workers to evidence-based protocols for iCCM and maternal consultations as measured by CHW supervisor check-list.
Outcome Time Frame
72 months
Outcome Measure
Protocol Adherence by IH community health workers in iCCM and maternal consultations
Outcome Description
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.
Outcome Time Frame
72 months
Outcome Measure
Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
49
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kevin Fiori
Investigator Email
kfiori@montefiore.org
Investigator Phone
718-920-8133