NCT03773913

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

6.7 years

First QC Date

November 30, 2018

Last Update Submit

October 11, 2019

Conditions

Maternal-Child Health ServicesHealth Service Utilization

Keywords

Child MortalityReproductive, Maternal, Newborn, and Child HealthCommunity Health WorkersImplementation ResearchPreliminary ResearchHealth Systems Strengthening

Outcome Measures

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.

    72 months

Secondary Outcomes (8)

  • Under-one year old mortality rate, annual

    72 months

  • Maternal mortality rate, annual

    72 months

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Four facilities in Kozah District

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

Other: ICBHSS model

Interventions

ICBHSS modelOTHER

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

Four facilities in Kozah District

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Females of reproductive age (aged 15-49 years) who reside in a selected household within the study catchment area.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrate Health

Kara, Togo

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27391996BACKGROUND

  • 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.

    PMID: 34452981DERIVED

  • 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.

    PMID: 32347439DERIVED

Related Links

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kevin P Fiori Jr., MD MPH

    Integrate Health; Albert Einstein School of Medicine

    PRINCIPAL INVESTIGATOR

  • Molly E Lauria, MPH

    Integrate Health

    STUDY DIRECTOR

Central Study Contacts

Molly E Lauria, MPH

CONTACT

mlauria@integratehealth.org

Kevin P Fiori Jr., MD MPH

CONTACT

kfiori@integratehealth.org

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 12, 2018

Study Start

January 1, 2015

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TO(1)