Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773913
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Integrate Health

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
Maternal-Child Health Services Health Service Utilization 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.


Layout table for study information
Study Type : Observational
Estimated 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 : January 1, 2015
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


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:

  1. Community engagement meetings and feedback;
  2. Elimination of public sector facility user fees for children under five and pregnant women;
  3. 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;
  4. Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;
  5. Basic infrastructure improvements and supply chain management training of pharmacy managers




Primary Outcome Measures :
  1. Under-five year old mortality rate, annual [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773913


Contacts
Layout table for location contacts
Contact: Molly E Lauria, MPH mlauria@integratehealth.org
Contact: Kevin P Fiori Jr., MD MPH kfiori@integratehealth.org

Locations
Layout table for location information
Togo
Integrate Health Recruiting
Kara, Togo
Contact: Molly E Lauria, MPH    646-397-0217    mlauria@integratehealth.org   
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
Layout table for investigator information
Principal Investigator: Kevin P Fiori Jr., MD MPH Integrate Health; Albert Einstein School of Medicine
Study Director: Molly E Lauria, MPH Integrate Health

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Integrate Health
ClinicalTrials.gov Identifier: NCT03773913     History of Changes
Other Study ID Numbers: ICBHSS Kozah
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Integrate Health:
Child Mortality
Reproductive, Maternal, Newborn, and Child Health
Community Health Workers
Implementation Research
Preliminary Research
Health Systems Strengthening