- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404284
Assessment of Family Planning and Immunization Service Integration in Malawi
January 11, 2018 updated by: Jhpiego
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
43
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
43 health facilities and associated outreach sites in Ntchisi and Dowa districts of Malawi
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intervention facilities
Includes 43 health facilities and their associated outreach sites
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of modern family planning users
Time Frame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
Number of Penta 1 doses administered
Time Frame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
Number of Penta 3 doses administered
Time Frame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (Actual)
January 19, 2018
Study Record Updates
Last Update Posted (Actual)
January 19, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00007595
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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