ContraceptionNCT02447913
Integrating Family Planning With Immunization to Improve Maternal and Child Health
A study testing Voucher in people with Contraception, run by Greenstar Social Maketing at 1 site in Pakistan.
Trial summary
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Voucher
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,000 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2011to Jul 2015
- Phase
- Interventional
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women who are married in their reproductive age group i-e 15 to 19 years and who have given birth to a child within past one month
Who cannot join
- Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month
Trial locations and contacts
1 site in 1 country.
Wajiha Javed contact
Pakistan1 site, 1 recruiting
- Recruiting
Study site
Faisalabad, Punjab Province
About this study
Official title: To Observe the Effectiveness of a Demand-Side Financing Project in Increasing Demand and Utilization of Contraceptives for Birth Spacing Among Women From Poorest Two Quintiles in Faisalabad District of Pakistan
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services. This approach will use postnatal and infant health as a gateway to family planning - building confidence among the client and her influencers in the provider and repositioning family planning as part of a continuum of care to ensure the health of the mother and the infant. Vouchers will help in creating demand among poor women for the Family planning and child immunization. Also incentivizing providers against each voucher will help in improving their counselling skills as they will spend more time with voucher clients resulting is a satisfied client and better compliance with Family planning methods.
Read the detailed description
Study hypothesis: Contraceptive Prevalence Rate will increase up to 20% from the baseline to end line survey in the intervention area .Contraceptive Prevalence Rate will increase by 5% between baseline and end line survey in the control area.
Ethics approval: The study has been approved by Population Services International Research Ethics Board.
Study design: This is a quasi experimental design. The study is a single center.
Primary study design: Interventional Trial setting: Community. Interventions: Introduction of vouchers will improve uptake of family method as well as child immunization.
Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method.
Intervention Type: Behavioral Primary outcome measures: Number of women who took up modern, reversible contraceptive methods ,number of women who availed postnatal care and number of women whose infants were immunized among the two poorest quintiles.
Secondary outcome measures: Improve the quality of family planning service provision in private sector health facilities serving low-income women.
Eligibility
Participant inclusion criteria - Participant type: Other. Participant inclusion criteria - Description: Women who are married in their reproductive age group i-e 15 to 49 years and who have given birth to a child within past one month.
Participant inclusion criteria - Target number of participants: 28000. Participant exclusion criteria: Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month.
- Conditions
- Contraception
- Being tested
- Voucher
- Keywords
- Family planning, Voucher, Immunisations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoucherBehavioural
Introduction of vouchers will improve uptake of family method as well as child immunization.
Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method
| Study group | Role | What they receive |
|---|---|---|
| Voucher | Experimental | Not described Receives: Behavioral: Voucher |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women who used modern,reversible contraceptive methods
Measured: 2-3 years
number of women who had postnatal care
Measured: 2-3 years
number of women whose infants had immunizations
Measured: 2-3years
Secondary outcomes (1)
Improve the quality of family planning service provision in private sector health facilities as judged by client satisfaction criteria
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionJul 2015 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greenstar Social Maketing
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- David and Lucile Packard Foundation, Population Services International
- Responsible party
- Sponsor
- Investigators
- Zahid Memon, Principal investigator, Greenstar Social Marketing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447913
- Sponsor's protocol ID
- Grant #2011-37081
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe the Effectiveness of a Demand-Side Financing Project in Increasing Demand and Utilization of Contraceptives for Birth Spacing Among Women From Poorest Two Quintiles in Faisalabad District of Pakistan
- ClinicalTrials.gov ID
- NCT02447913
- Acronym / sponsor ID
- Grant #2011-37081
- Conditions
- Contraception
- Keywords
- Family planning, Voucher, Immunisations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- Greenstar Social MaketingIndustry (pharma, biotech, devices)
- Collaborators
- David and Lucile Packard Foundation, Population Services International
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 May 2015 (estimated)
- 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.
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services. This approach will use postnatal and infant health as a gateway to family planning - building confidence among the client and her influencers in the provider and repositioning family planning as part of a continuum of care to ensure the health of the mother and the infant. Vouchers will help in creating demand among poor women for the Family planning and child immunization. Also incentivizing providers against each voucher will help in improving their counselling skills as they will spend more time with voucher clients resulting is a satisfied client and better compliance with Family planning methods.
Detailed description
Study hypothesis: Contraceptive Prevalence Rate will increase up to 20% from the baseline to end line survey in the intervention area .Contraceptive Prevalence Rate will increase by 5% between baseline and end line survey in the control area.
Ethics approval: The study has been approved by Population Services International Research Ethics Board.
Study design: This is a quasi experimental design. The study is a single center.
Primary study design: Interventional Trial setting: Community. Interventions: Introduction of vouchers will improve uptake of family method as well as child immunization.
Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method.
Intervention Type: Behavioral Primary outcome measures: Number of women who took up modern, reversible contraceptive methods ,number of women who availed postnatal care and number of women whose infants were immunized among the two poorest quintiles.
Secondary outcome measures: Improve the quality of family planning service provision in private sector health facilities serving low-income women.
Eligibility
Participant inclusion criteria - Participant type: Other. Participant inclusion criteria - Description: Women who are married in their reproductive age group i-e 15 to 49 years and who have given birth to a child within past one month.
Participant inclusion criteria - Target number of participants: 28000. Participant exclusion criteria: Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voucher | Experimental | Behavioral: Voucher |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who are married in their reproductive age group i-e 15 to 19 years and who have given birth to a child within past one month
Key exclusion criteria (1 listed)
- Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month
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 |
|---|---|---|
| VoucherIntroduction of vouchers will improve uptake of family method as well as child immunization. Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method | Behavioural | Voucher |
Primary outcome
number of women who used modern,reversible contraceptive methods
Time frame: 2-3 years
number of women who had postnatal care
Time frame: 2-3 years
number of women whose infants had immunizations
Time frame: 2-3years
1 secondary outcome
Improve the quality of family planning service provision in private sector health facilities as judged by client satisfaction criteria
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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.
Wajiha Javed contact
Zahid Memon principal investigator
Greenstar Social Marketing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voucher in people with Contraception, run by Greenstar Social Maketing at 1 site in Pakistan.
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: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahid Memon (+923085550859, zahidmemon@greenstar.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women who used modern,reversible contraceptive methods (time frame: 2-3 years). 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 May 2015.