ContraceptionNCT03404284
Assessment of Family Planning and Immunization Service Integration in Malawi
An observational study of Contraception and Contraceptive Usage, run by Jhpiego.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Contraception, Contraceptive Usage, Contraception Behavior
- What is being tested?
- Family planning and infant immunization service integration
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 43 health facilities and associated outreach sites in Ntchisi and Dowa districts of Malawi
Who may be able to join
- 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
Who cannot join
- All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program
About this study
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.
- Being tested
- Family planning and infant immunization service integration
- Keywords
- Immunization
- Medical subject headings
- Contraception Behavior, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family planning and infant immunization service integrationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention facilities | Includes 43 health facilities and their associated outreach sites Receives: Behavioral: Family planning and infant immunization service integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of modern family planning users
Measured: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Number of Penta 1 doses administered
Measured: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Number of Penta 3 doses administered
Measured: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study startJun 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404284
- Sponsor's protocol ID
- IRB00007595
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Family Planning and Immunization Service Integration in Malawi
- ClinicalTrials.gov ID
- NCT03404284
- Acronym / sponsor ID
- IRB00007595
- Keywords
- Immunization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- John Snow, Inc.
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention facilities | – | Behavioral: Family planning and infant immunization service integrationIncludes 43 health facilities and their associated outreach sites |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 43 health facilities and associated outreach sites in Ntchisi and Dowa districts of Malawi
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- All health facilities and associated outreach sites not implementing the integrated approach with support from the USAID-funded Maternal and Child Survival Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family planning and infant immunization service integrationThe 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. | Behavioural | Intervention facilities |
Primary outcome
Number of modern family planning users
Time frame: 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)
Number of Penta 3 doses administered
Time frame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Contraceptive Usage, run by Jhpiego.
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 1 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: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of modern family planning users (time frame: June 2016 through September 2017 (we also collected pre-intervention data from January to May 2016)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2018.