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Completed

NCT Number: NCT03333473

Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia

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

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Bawang, Batang, Central Java, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

PPFP Clinical and Counseling Skills

Behavioral

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 Training

Behavioral

The intervention will strengthen leadership management and governance practices required to help managers establish PPFP services at the facility level.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Merck for Mothers

Registry information

Acronym: PPFP Choices

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2017
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.