NCT03404284

Brief Summary

This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities and through outreach services in Dowa and Ntchisi districts of Malawi. The study involved qualitative methods (in depth interviews and focus group discussions with service providers, mothers and fathers of infants \<1 year, and supervisors and program managers) as well as secondary analysis of service statistics for family planning and immunization services and of supervision reports.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

January 11, 2018

Last Update Submit

January 11, 2018

Conditions

Keywords

Immunization

Outcome Measures

Primary Outcomes (3)

  • Number of modern family planning users

    June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)

  • Number of Penta 1 doses administered

    June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)

  • Number of Penta 3 doses administered

    June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)

Study Arms (1)

Intervention facilities

Includes 43 health facilities and their associated outreach sites

Behavioral: Family planning and infant immunization service integration

Interventions

The approach involved integration of services through health surveillance assistant (HSA) outreach as well as through the health facility platform. The HSAs provided door to door FP services in their designated communities as well as provided integrated FP and Immunisation services at village clinics and outreach sessions. At outreach sessions, mothers were offered both routine infant immunization and family planning services (pills, condoms, injectables plus referrals for other methods). At health facilities, mothers who sought routine infant immunization services were offered same-day family planning services and those who seek family planning services are also screened for infant immunization schedule completion / need for infant immunization services. HSAs and health facility providers were trained on FP-immunization service integration and were monitored through regular supportive supervision visits.

Intervention facilities

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

43 health facilities and associated outreach sites in Ntchisi and Dowa districts of Malawi

You may qualify if:

  • All health facilities and associated outreach sites in Ntchisi and Dowa districts implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

You may not qualify if:

  • All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Contraception BehaviorInfant, Newborn, Diseases

Interventions

Family Planning Services

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health Services

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share