ContraceptionNCT03571932
Assessment of Family Planning and Immunization Service Integration in Liberia
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 in Lofa and Grand Bassa counties in Liberia. 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 immunization service integration
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jul 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: 18 Intervention health facilities and 18 pair matched comparison health facilities in Grand Bassa and Lofa counties.
Who may be able to join
- 18 intervention facilities in Lofa and Grand Bassa counties
- 18 pair matched comparison facilities in Lofa and Grand Bassa counties
Who cannot join
- Facilities not included in the intervention or selected for pair matching
About this study
This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities in Lofa and Grand Bassa counties in Liberia. MCSP used a longitudinal, pair-matched design to monitor the effect of integrating immunization and FP services on utilization of FP and routine immunization services. In Lofa and Grand Bassa counties, 36 facilities were pair-matched to intervention and comparison sites based on predetermined criteria. After approximately 9 months of implementation, MCSP conducted a qualitative study employing key informant interviews (KIIs) and focus group discussions (FGDs) at intervention and comparison sites, and with district-, county-, and national-level MOH supervisors and managers.
- Being tested
- Family planning and immunization service integration
- 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 immunization service integrationBehavioural
The approach involved integration of immunization and family planning services at health facilities. Vaccinators provided brief FP messages one-on-one to mothers and offered a referral for same-day, co-located FP services at the end of each routine immunization visit. For women coming directly for FP, if women had an infant with them, FP providers asked to see the child's health card, checked the return date for the next vaccination and reminded the mother of the date to return. For women without their child or the child health card with them, FP providers reinforced the importance of vaccination, and encouraged the mothers to bring their child for all their vaccines and complete the immunization schedule in a timely manner. A job aid, referral cards, and IEC materials were introduced to support the integration process.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Facilities | Includes 18 health facilities Receives: Behavioral: Family planning and immunization service integration | |
| Comparison facilities | Infludes 18 health facilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of modern family planning users
Measured: November 2016-July 2017
Number of Penta 1 doses administered
Measured: November 2016-July 2017
Number of Penta 3 doses administered
Measured: November 2016-July 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study startNov 2016
- Primary completionJul 2017
- Study completionJul 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), John Snow, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571932
- Sponsor's protocol ID
- IRB00007524
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- 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 28 Jun 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 Liberia
- ClinicalTrials.gov ID
- NCT03571932
- Acronym / sponsor ID
- IRB00007524
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), John Snow, Inc.
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Jun 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 in Lofa and Grand Bassa counties in Liberia. MCSP used a longitudinal, pair-matched design to monitor the effect of integrating immunization and FP services on utilization of FP and routine immunization services. In Lofa and Grand Bassa counties, 36 facilities were pair-matched to intervention and comparison sites based on predetermined criteria. After approximately 9 months of implementation, MCSP conducted a qualitative study employing key informant interviews (KIIs) and focus group discussions (FGDs) at intervention and comparison sites, and with district-, county-, and national-level MOH supervisors and managers.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Facilities | – | Behavioral: Family planning and immunization service integrationIncludes 18 health facilities |
| Comparison facilities | – | –Infludes 18 health facilities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 18 Intervention health facilities and 18 pair matched comparison health facilities in Grand Bassa and Lofa counties.
Key inclusion criteria (2 listed)
- 18 intervention facilities in Lofa and Grand Bassa counties
- 18 pair matched comparison facilities in Lofa and Grand Bassa counties
Key exclusion criteria (1 listed)
- Facilities not included in the intervention or selected for pair matching
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 immunization service integrationThe approach involved integration of immunization and family planning services at health facilities. Vaccinators provided brief FP messages one-on-one to mothers and offered a referral for same-day, co-located FP services at the end of each routine immunization visit. For women coming directly for FP, if women had an infant with them, FP providers asked to see the child's health card, checked the return date for the next vaccination and reminded the mother of the date to return. For women without their child or the child health card with them, FP providers reinforced the importance of vaccination, and encouraged the mothers to bring their child for all their vaccines and complete the immunization schedule in a timely manner. A job aid, referral cards, and IEC materials were introduced to support the integration process. | Behavioural | Intervention Facilities |
Primary outcome
Number of modern family planning users
Time frame: November 2016-July 2017
Number of Penta 1 doses administered
Time frame: November 2016-July 2017
Number of Penta 3 doses administered
Time frame: November 2016-July 2017
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 28 Jun 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 2 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 28 Jun 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: November 2016-July 2017). 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 28 Jun 2018.