Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo

Maternal-Child Health Services Clinical Trial

— ICBHSS-Kozah  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773913
• Other study ID #: ICBHSS Kozah
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2019
• Source: Integrate Health
• Contact: Molly E Lauria, MPH
• Email: mlauria[@]integratehealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Health Service Utilization
• Maternal-Child Health Services

Intervention

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

Locations

Country	Name	City	State
Togo	Integrate Health	Kara

Sponsors (6)

Lead Sponsor	Collaborator
Integrate Health	Albert Einstein College of Medicine, City University of New York, School of Public Health, Ministère de la Santé et de l'Hygiène Publique, Togo, Montefiore Medical Center, Université de Lomé, Faculté des Sciences de la Santé, Togo

Country where clinical trial is conducted

Togo, 

References & Publications (1)

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 2:29-33. doi: 10.1080/09540121.2016.1176678. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal facility based birth delivery incidence rate, annual	The proportion of women reported to have delivered in a health facility.	72 months
Secondary	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
Secondary	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

External Links

•   Integrate Health