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Maternal-Child Health ServicesICBHSS-KozahNCT03773913

Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo

An observational study of Maternal-Child Health Services and Health Service Utilization, run by Integrate Health at 1 site in Togo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
ICBHSS model
How many people
1,500 participants
Where
1 siteTogo
Study dates
1 Jan 2015to 31 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Molly E Lauria, MPH contact

mlauria@integratehealth.org

Kevin P Fiori Jr., MD MPH contact

kfiori@integratehealth.org

Togo1 site, 1 recruiting

  • Integrate Health

    Kara

    Molly E Lauria, MPH, 646-397-0217, mlauria@integratehealth.org

    Recruiting

About this study

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

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.

Being tested
ICBHSS model
Keywords
Child Mortality, Reproductive, Maternal, Newborn, and Child Health, Community Health Workers, Implementation Research, Preliminary Research, Health Systems Strengthening
Medical subject headings
Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT03773913
Study groupRoleWhat they receive
Four facilities in Kozah DistrictBaseline estimated population of 33,412 served by four public sector facilities in Kozah District.
Receives: Other: ICBHSS model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 72 months

Secondary outcomes (8)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 72 months

  6. Maternal facility based birth delivery incidence rate, annual

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

    Measured: 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.

    Measured: 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.

    Measured: 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2018
  2. Study start1 Jan 2015
  3. Primary completion31 Aug 2021 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773913
Sponsor's protocol ID
ICBHSS Kozah
Acronym
ICBHSS-Kozah
Status last verified
Oct 2019
First submitted
30 Nov 2018
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Maternal-Child Health Services and Health Service Utilization, run by Integrate Health at 1 site in Togo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Togo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Molly E Lauria, MPH (mlauria@integratehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Under-five year old mortality rate, annual (time frame: 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773913, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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