Post-pregnancy Family PlanningPPFP ChoicesNCT03333473
Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
A study testing PPFP Clinical and Counseling Skills and Facility-Level Leadership Management and Governance Training in people with Post-pregnancy Family Planning and Capacity Building of Healthcare Providers, run by Jhpiego at 8 sites in Indonesia.
Trial summary
The primary goal of PPFP Choices is to generate actionable evidence that can be used to increase programmatic activities to address post-pregnancy family planning in the public and private-for-profit sectors. The ultimate intent of this investment is to advance and scale up post-pregnancy FP. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-pregnancy Family Planning, Capacity Building of Healthcare Providers
- What is being tested?
- PPFP Clinical and Counseling Skills and Facility-Level Leadership Management and Governance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,282 participants
- Where
- 8 sitesIndonesia
- Study dates
- 9 Nov 2017to 16 Mar 2020
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Kenyan postpartum participant (Enrollment starts at ANC):
- At least 28 weeks pregnant
- Plans to deliver at the study facility
- Aged 15-49 years at enrollment
- Provides voluntary informed consent
- Not planning to relocate in the next 12 months
Show all 17Show fewer
- Indonesian postpartum participant (Enrollment starts at L\&D):
- In the immediate postpartum period (within 72 hours, prior to leaving the health facility),
- Reported having attended ANC within her 3rd trimester (28-weeks pregnant and later),
- Aged 15-49 years at time of enrollment (Indonesian adolescents aged 15-16 must be married for purposes of the study consent)
- Provides voluntary informed consent
- Not planning to relocate in the next 12 months
- Kenyan and Indonesian postabortion participants:
- A female in the immediate post-pregnancy treatment phase (within 72 hours in Indonesia, within 48 hours in Kenya, prior to leaving the health facility for treatment of incomplete abortion)
- Aged 15-49 years at time of enrollment (Indonesian adolescents aged 15-16 must be married for purposes of the study consent)
- Provides voluntary informed consent
- Not planning to relocate in the next 6 months
Who cannot join
- Refusal to sign consent form for inclusion in the study
- Post-delivery baby or mother being treated for trauma or in an intensive care unit
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Indonesia8 sites
RSUD Batang
Batang, Central Java, 51215
RSU QOlbu Insan Mulia
Batang, Central Java, 51216
Puskesmas Subah
Batang, Central Java, 51262
Puskesmas Bawang
Batang, Central Java, 51274
RSUD Brebes
Brebes, Central Java, 52212
Puskesmas Kecipir
Brebes, Central Java, 52255
Puskesmas Ketanggungan
Brebes, Central Java, 52263
RSU Alam Medika Bumi Ayu
Brebes, Central Java, 52273
About this study
The primary goal of PPFP Choices is to generate actionable evidence that can be used to increase programmatic activities to address post-pregnancy family planning in the public and private-for-profit sectors. The ultimate intent of this investment is to advance and scale up post-pregnancy FP. Programmatic learning will be crucial to understanding what it will take to accelerate post-pregnancy FP in these two countries, and these can later be adapted by other countries with similar settings. Our vision of PPFP Choices can be achieved through the following objectives:
- Objective 1: Establish a comprehensive program implementation framework for the private sector to embrace post-pregnancy FP
- Objective 2: Improve the quality of post-pregnancy FP counseling and service provision in both public and private sectors
- Objective 3: Build evidence and contribute to the literature and programmatic guidance around post-pregnancy FP uptake and continuation in both public and private sectors
- Objective 4: Ensure effective documentation and strategic dissemination which will benefit post-pregnancy FP introduction and scale-up more broadly
Read the detailed description
PPFP Choices is an operations research study seeking to examine the barriers and facilitators in offering a full range of FP methods in the immediate post-pregnancy period in both the public and private sectors.
Jhpiego will implement the study in two counties in Kenya; Meru and Kilifi, and two districts in Indonesia; Brebes and Batang.
This study will employ a quasi-experimental design with an intervention and control group. Prior to study start-up, the the intervention group will receive a Jhpiego-designed package of interventions designed to advance post-pregnancy FP in both the public and private sectors. These interventions draw on WHO's Programming Strategies for Postpartum Family Planning, as well as Jhpiego's experience and assessments. After the study is completed, the control groups will receive the same intervention. For the study, a mixed method approach will be used; both quantitative and qualitative data will be collected through Client Quantitative Interviews, Client In-Depth interviews, Focus Group Discussions, Key Informant Interviews, and Facility Assessments.
- Being tested
- PPFP Clinical and Counseling Skills, Facility-Level Leadership Management and Governance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPFP Clinical and Counseling SkillsBehavioural
Facilities will receive whole-site orientations on PPFP basics and skills Through training of trainers, followed by classroom and model-based and clinical-based practice, providers will receive training in PPDP counseling and service provision.
Facility-Level Leadership Management and Governance TrainingBehavioural
The intervention will strengthen leadership management and governance practices required to help managers establish PPFP services at the facility level.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will be applied to health facilities in one district in Indonesia and one county in Kenya. The intervention package will work within existing public and private health facilities to strengthen and assess the effectiveness of facility and provider level PPFP service provision and counseling, and expand method choice for women during antenatal, early labor, and post-pregnancy pre-discharge periods. Training within the intervention package include provider-lever PPFP counseling and service provision (PPFP Clinical and Counseling Skills), as well as provider and facility-level leadership management and governance training (Facility-Level Leadership Management and Governance Training). Receives: Behavioral: PPFP Clinical and Counseling Skills; Behavioral: Facility-Level Leadership Management and Governance Training |
| Control | No intervention | The health facilities control district in Indonesia and county in Kenya will continue with their standard counseling and service provision throughout the study period. At the conclusion of the study period, the facilities in these areas will receive the same intervention that Intervention facilities received prior to study startup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of PPFP counseling
80% of ANC attendees and women receiving postabortion care receive appropriate PPFP counseling prior to discharge compared to baseline in the comparison group.
Measured: 3 years
Clinical competency of service providers in providing all modern FP methods
100% of service providers in intervention arm of study are deemed competent and retain competencies to provide all modern FP methods to women during postpartum and postabortion periods.
Measured: 3 years
Secondary outcomes (3)
Postpartum uptake of LARCs
50% increase in Long-Acting and Permanent Method use by study participants whose infants are six months old in study intervention sites in Indonesia and 70% increase in LARC use by study participants whose infants are six months old in study intervention sites in Kenya. A change in use of LARCs and other permanent methods of FP by study participants whose infants are six months old, from 10% to 15% in Indonesia and from 6% to 10% in Kenya at intervention facilities over the course of the study
Measured: 3 years
Health facility-level leadership management and governance skills
80% of health facilities in the intervention group show improvement in leadership management and government measured through use of quality improvement approaches
Measured: 3 years
Assessment of individual intervention quality
Using a quality improvement framework, assess individual pieces of the intervention package using multi-level modeling
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start9 Nov 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-pregnancy Family PlanningStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Merck for Mothers
- Responsible party
- Sponsor
- Investigators
- Elaine Charurat, MBA, MHS, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333473
- Sponsor's protocol ID
- IRB00007462
- Acronym
- PPFP Choices
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2017
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the Bill and Melinda Gates Foundation and Merck for Mothers policies.
Publications
Charurat E, Kennedy S, Qomariyah S, Schuster A, Christofield M, Breithaupt L, Kariuki E, Muthamia M, Kabue M, Omanga E, Stekelenburg J. Study protocol for Post Pregnancy Family Planning Choices, an operations research study examining the effectiveness of interventions in the public and private sectors in Indonesia and Kenya. Gates Open Res. 2020 Dec 18;4:89. doi: 10.12688/gatesopenres.13147.2. eCollection 2020.
PubMed 33693315
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
- ClinicalTrials.gov ID
- NCT03333473
- Acronym / sponsor ID
- PPFP Choices / IRB00007462
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,282 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Merck for Mothers
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 7 Nov 2017 (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.
The primary goal of PPFP Choices is to generate actionable evidence that can be used to increase programmatic activities to address post-pregnancy family planning in the public and private-for-profit sectors. The ultimate intent of this investment is to advance and scale up post-pregnancy FP. Programmatic learning will be crucial to understanding what it will take to accelerate post-pregnancy FP in these two countries, and these can later be adapted by other countries with similar settings. Our vision of PPFP Choices can be achieved through the following objectives:
- Objective 1: Establish a comprehensive program implementation framework for the private sector to embrace post-pregnancy FP
- Objective 2: Improve the quality of post-pregnancy FP counseling and service provision in both public and private sectors
- Objective 3: Build evidence and contribute to the literature and programmatic guidance around post-pregnancy FP uptake and continuation in both public and private sectors
- Objective 4: Ensure effective documentation and strategic dissemination which will benefit post-pregnancy FP introduction and scale-up more broadly
Detailed description
PPFP Choices is an operations research study seeking to examine the barriers and facilitators in offering a full range of FP methods in the immediate post-pregnancy period in both the public and private sectors.
Jhpiego will implement the study in two counties in Kenya; Meru and Kilifi, and two districts in Indonesia; Brebes and Batang.
This study will employ a quasi-experimental design with an intervention and control group. Prior to study start-up, the the intervention group will receive a Jhpiego-designed package of interventions designed to advance post-pregnancy FP in both the public and private sectors. These interventions draw on WHO's Programming Strategies for Postpartum Family Planning, as well as Jhpiego's experience and assessments. After the study is completed, the control groups will receive the same intervention. For the study, a mixed method approach will be used; both quantitative and qualitative data will be collected through Client Quantitative Interviews, Client In-Depth interviews, Focus Group Discussions, Key Informant Interviews, and Facility Assessments.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PPFP Clinical and Counseling Skills, Behavioral: Facility-Level Leadership Management and Governance TrainingThe intervention will be applied to health facilities in one district in Indonesia and one county in Kenya. The intervention package will work within existing public and private health facilities to strengthen and assess the effectiveness of facility and provider level PPFP service provision and counseling, and expand method choice for women during antenatal, early labor, and post-pregnancy pre-discharge periods. Training within the intervention package include provider-lever PPFP counseling and service provision (PPFP Clinical and Counseling Skills), as well as provider and facility-level leadership management and governance training (Facility-Level Leadership Management and Governance Training). |
| Control | No intervention | –The health facilities control district in Indonesia and county in Kenya will continue with their standard counseling and service provision throughout the study period. At the conclusion of the study period, the facilities in these areas will receive the same intervention that Intervention facilities received prior to study startup. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Kenyan postpartum participant (Enrollment starts at ANC):
- Indonesian postpartum participant (Enrollment starts at L\&D):
- Kenyan and Indonesian postabortion participants:
Key exclusion criteria (2 listed)
- Refusal to sign consent form for inclusion in the study
- Post-delivery baby or mother being treated for trauma or in an intensive care unit
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 |
|---|---|---|
| PPFP Clinical and Counseling SkillsFacilities will receive whole-site orientations on PPFP basics and skills Through training of trainers, followed by classroom and model-based and clinical-based practice, providers will receive training in PPDP counseling and service provision. | Behavioural | Intervention |
| Facility-Level Leadership Management and Governance TrainingThe intervention will strengthen leadership management and governance practices required to help managers establish PPFP services at the facility level. | Behavioural | Intervention |
Primary outcome
Quality of PPFP counseling
Time frame: 3 years
80% of ANC attendees and women receiving postabortion care receive appropriate PPFP counseling prior to discharge compared to baseline in the comparison group.
Clinical competency of service providers in providing all modern FP methods
Time frame: 3 years
100% of service providers in intervention arm of study are deemed competent and retain competencies to provide all modern FP methods to women during postpartum and postabortion periods.
3 secondary outcomes
Postpartum uptake of LARCs
Time frame: 3 years
Health facility-level leadership management and governance skills
Time frame: 3 years
Assessment of individual intervention quality
Time frame: 3 years
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 17 Aug 2021.
- Derived from this study: PubMed 33693315Charurat E, Kennedy S, Qomariyah S, Schuster A, Christofield M, Breithaupt L, Kariuki E, Muthamia M, Kabue M, Omanga E, Stekelenburg J. Study protocol for Post Pregnancy Family Planning Choices, an operations research study examining the effectiveness of interventions in the public and private sectors in Indonesia and Kenya. Gates Open Res. 2020 Dec 18;4:89. doi: 10.12688/gatesopenres.13147.2. eCollection 2020.
- Individual participant dataSharing planned: Undecided. The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the Bill and Melinda Gates Foundation and Merck for Mothers policies.
Related trials for Post-pregnancy Family Planning
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Maternal Health Assessment in Pediatric Care
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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.
Elaine Charurat, MBA, MHS principal investigator
Jhpiego
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPFP Clinical and Counseling Skills and Facility-Level Leadership Management and Governance Training in people with Post-pregnancy Family Planning and Capacity Building of Healthcare Providers, run by Jhpiego at 8 sites in Indonesia.
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 17 inclusion and 2 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Indonesia. 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?
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?
Quality of PPFP counseling (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333473, which also lists 1 linked publication.
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 17 Aug 2021.