Clinical trial NCT03773913: Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo
Official title: Integrated Community Based Health Systems Strengthening in Northern Togo: A Preliminary Mixed-Methods Study in Kozah District
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: Integrate Health
Sponsor class: OTHER
Collaborators: name: Ministère de la Santé et de l'Hygiène Publique, Togo
name: Université de Lomé, Faculté des Sciences de la Santé, Togo
name: Albert Einstein College of Medicine
name: Montefiore Medical Center
name: City University of New York, School of Public Health
First posted: 2018-12-12
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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:

-

Primary outcomes:
measure: Under-five year old mortality rate, annual
timeFrame: 72 months
Secondary outcomes:
measure: Under-one year old mortality rate, annual
timeFrame: 72 months
measure: Maternal mortality rate, annual
timeFrame: 72 months
measure: 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.
timeFrame: 72 months
measure: 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.
timeFrame: 72 months
measure: 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.
timeFrame: 72 months
measure: Maternal facility based birth delivery incidence rate, annual
timeFrame: 72 months
measure: Protocol Adherence by IH community health workers in iCCM and maternal consultations
timeFrame: 72 months
measure: Protocol adherence by clinical staff at IH intervention facilities in iCCM and maternal consultations
timeFrame: 72 months
Other outcomes:
Locations:
city: Kara
country: Togo
facility: Integrate Health
Study officials:
affiliation: Integrate Health; Albert Einstein School of Medicine
name: Kevin P Fiori Jr., MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Integrate Health
name: Molly E Lauria, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.