NCT03694366

Brief Summary

The general objective of this study is to optimize implementation and assess effectiveness of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Northern Togo districts, using the RE-AIM implementation science framework. Specific study aims include: (1) Analyze longitudinal changes regarding maternal and child health outcomes, health service utilization rates, and public sector facility readiness in the 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. These findings are expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide generalizable knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.

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
7,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

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

May 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

4.3 years

First QC Date

September 27, 2018

Last Update Submit

October 11, 2019

Conditions

Maternal and Child HealthHealth Service Utilization

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Under-five year old mortality rate

    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.

    48 months

Secondary Outcomes (8)

  • Under-one year old mortality rate

    48 months

  • Maternal mortality rate

    48 months

  • 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.

    48 months

  • 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.

    48 months

  • 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.

    48 months

  • +3 more secondary outcomes

Study Arms (4)

Five facilities in Bassar District

Estimated population of 34,676 served by five public sector facilities in Bassar District.

Other: ICBHSS model

Seven facilities in Binah District

Estimated population of 31,027 served by seven public sector facilities in Binah District.

Other: ICBHSS model

Four facilities in Dankpen District

Estimated total population of 40,165 served by four public sector facilities in Dankpen District.

Other: ICBHSS model

Five facilities in Kéran District

Estimated total population of 31,866 served by five public sector facilities in Kéran 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

Five facilities in Bassar DistrictFive facilities in Kéran DistrictFour facilities in Dankpen DistrictSeven facilities in Binah 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

You may not qualify if:

  • None

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

  • McCarthy KJ, Braganza S, Fiori K, Gbeleou C, Kpakpo V, Lopez A, Schechter J, Singham Goodwin A, Jones HE. Identifying inequities in maternal and child health through risk stratification to inform health systems strengthening in Northern Togo. PLoS One. 2017 Mar 16;12(3):e0173445. doi: 10.1371/journal.pone.0173445. eCollection 2017.

    PMID: 28301539BACKGROUND

  • Lauria ME, Fiori KP, Jones HE, Gbeleou S, Kenkou K, Agoro S, Agbere AD, Lue KD, Hirschhorn LR. Assessing the Integrated Community-Based Health Systems Strengthening initiative in northern Togo: a pragmatic effectiveness-implementation study protocol. Implement Sci. 2019 Oct 16;14(1):92. doi: 10.1186/s13012-019-0921-3.

    PMID: 31619250DERIVED

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

646-397-0217mlauria@integratehealth.org

Kevin P Fiori, MD, MPH, MSc

CONTACT

kfiori@integratehealth.org

Study Design

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

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 3, 2018

Study Start

May 1, 2018

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TO(1)