CClinicalTrials.gg
Status unknownNCT03773913ICBHSS-KozahUpdated Oct 15, 2019

Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo

An observational study in Maternal-Child Health Services and Health Service Utilization, sponsored by Integrate Health. Status unknown at 1 site in Togo. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Integrate Health · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,500
Ages
15 Years to 49 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Maternal-Child Health Services
  • Health Service Utilization

Keywords

  • Child Mortality
  • Reproductive, Maternal, Newborn, and Child Health
  • Community Health Workers
  • Implementation Research
  • Preliminary Research
  • Health Systems Strengthening
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In context

Lead sponsor

Integrate Health is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
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.

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

Exclusion Criteria:

-

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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Four facilities in Kozah District

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

    Other: ICBHSS model

Interventions

  • OtherICBHSS 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 72 months

Secondary outcomes

  1. 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.

    Time frame: 72 months

  2. 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.

    Time frame: 72 months

  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.

    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.

    Time frame: 72 months

  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.

    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.

    Time frame: 72 months

  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.

    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.

    Time frame: 72 months

  6. Maternal facility based birth delivery incidence rate, annual

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

    Time frame: 72 months

  7. 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.

    Time frame: 72 months

  8. 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.

    Time frame: 72 months

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Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 27391996 ↗
  • 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. PubMed 34452981 ↗
  • 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. PubMed 32347439 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03773913
Lead sponsor
Integrate Health
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
Responsible party
Sponsor
First posted
Dec 12, 2018
Start date
Jan 1, 2015
Primary completion
Aug 31, 2021 (estimated)
Completion
Aug 31, 2021 (estimated)
Last update
Oct 15, 2019

Study contacts

Molly E Lauria, MPH
Contact
mlauria@integratehealth.org
Kevin P Fiori Jr., MD MPH
Contact
kfiori@integratehealth.org
Kevin P Fiori Jr., MD MPH
principal investigator · Integrate Health; Albert Einstein School of Medicine
Molly E Lauria, MPH
study director · Integrate Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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