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Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia (PPFP Choices)

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ClinicalTrials.gov Identifier: NCT03333473
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Merck for Mothers
Information provided by (Responsible Party):
Jhpiego

Brief 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. 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

Condition or disease Intervention/treatment Phase
Post-pregnancy Family Planning Capacity Building of Healthcare Providers Behavioral: PPFP Clinical and Counseling Skills Behavioral: Facility-Level Leadership Management and Governance Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9282 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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).
Behavioral: PPFP Clinical and Counseling Skills
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.

Behavioral: Facility-Level Leadership Management and Governance Training
The intervention will strengthen leadership management and governance practices required to help managers establish PPFP services at the facility level.

No Intervention: Control
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Postpartum uptake of LARCs [ Time Frame: 3 years ]
    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

  2. Health facility-level leadership management and governance skills [ Time Frame: 3 years ]
    80% of health facilities in the intervention group show improvement in leadership management and government measured through use of quality improvement approaches

  3. Assessment of individual intervention quality [ Time Frame: 3 years ]
    Using a quality improvement framework, assess individual pieces of the intervention package using multi-level modeling



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be women in the ANC period with a gestational age of 28 weeks or greater [Kenya], in the immediate postpartum period (within 72 hours after childbirth)[Indonesia], or immediately following receipt of postabortion care (within 48 hours [Kenya] or 72 hours [Indonesia]).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Kenyan postpartum participant (Enrollment starts at ANC):

    1. At least 28 weeks pregnant
    2. Plans to deliver at the study facility
    3. Aged 15-49 years at enrollment
    4. Provides voluntary informed consent
    5. Not planning to relocate in the next 12 months
  2. Indonesian postpartum participant (Enrollment starts at L&D):

    1. In the immediate postpartum period (within 72 hours, prior to leaving the health facility),
    2. Reported having attended ANC within her 3rd trimester (28-weeks pregnant and later),
    3. Aged 15-49 years at time of enrollment (Indonesian adolescents aged 15-16 must be married for purposes of the study consent)
    4. Provides voluntary informed consent
    5. Not planning to relocate in the next 12 months
  3. Kenyan and Indonesian postabortion participants:

    1. 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)
    2. Aged 15-49 years at time of enrollment (Indonesian adolescents aged 15-16 must be married for purposes of the study consent)
    3. Provides voluntary informed consent
    4. Not planning to relocate in the next 6 months

Exclusion Criteria:

  1. Refusal to sign consent form for inclusion in the study
  2. Post-delivery baby or mother being treated for trauma or in an intensive care unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333473


Contacts
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Contact: Sara A Kennedy, MPH 410 537-1803 sara.kennedy@jhpiego.org
Contact: Elaine Charurat, MBA, MHS 410 537-945 elaine.charurat@jhpiego.org

Locations
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Indonesia
RSU QOlbu Insan Mulia Recruiting
Batang, Central Java, Indonesia, 51216
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
Puskesmas Subah Recruiting
Batang, Central Java, Indonesia, 51262
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
RSUD Batang Recruiting
Batang, Jawa Tengah, Indonesia, 51215
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
Puskesmas Bawang Recruiting
Batang, Jawa Tengah, Indonesia, 51274
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
RSUD Brebes Recruiting
Brebes, Jawa Tengah, Indonesia, 52212
Contact: Siti Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
Puskesmas Kecipir Recruiting
Brebes, Jawa Tengah, Indonesia, 52255
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
Puskesmas Ketanggungan Recruiting
Brebes, Jawa Tengah, Indonesia, 52263
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
RSU Alam Medika Bumi Ayu Recruiting
Brebes, Jawa Tengah, Indonesia, 52273
Contact: Siti N Qomariyah, PhD    021-2920-1497 ext 176    SitiNurul.Qomariyah@jhpiego.org   
Sponsors and Collaborators
Jhpiego
Bill and Melinda Gates Foundation
Merck for Mothers
Investigators
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Principal Investigator: Elaine Charurat, MBA, MHS Jhpiego
  Study Documents (Full-Text)

Documents provided by Jhpiego:
Study Protocol  [PDF] October 5, 2017
Statistical Analysis Plan  [PDF] October 31, 2017
Informed Consent Form  [PDF] September 14, 2017


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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03333473     History of Changes
Other Study ID Numbers: IRB00007462
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No