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

NCT03333473 | Completed

• 1 other identifier: IRB00007462
• Study Type: interventional
• Target: 9,282
• Locations: 1 country
• Sites: 8

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

Conditions

Post-pregnancy Family Planning; Capacity Building of Healthcare Providers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 years

Secondary Outcomes (3)

• Postpartum uptake of LARCs

  3 years

• Health facility-level leadership management and governance skills

  3 years

• Assessment of individual intervention quality

  3 years

Study Arms (2)

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).

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.

Interventions

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.

Intervention

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.

Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: 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 \[Indonesia\]).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Post-delivery baby or mother being treated for trauma or in an intensive care unit

Sponsors & Collaborators

• Jhpiego: lead
• Bill and Melinda Gates Foundation: collaborator
• Merck for Mothers: collaborator

Study Sites (8)

RSUD Batang

Batang, Central Java, 51215, Indonesia

Location

RSU QOlbu Insan Mulia

Batang, Central Java, 51216, Indonesia

Location

Puskesmas Subah

Batang, Central Java, 51262, Indonesia

Location

Puskesmas Bawang

Batang, Central Java, 51274, Indonesia

Location

RSUD Brebes

Brebes, Central Java, 52212, Indonesia

Location

Puskesmas Kecipir

Brebes, Central Java, 52255, Indonesia

Location

Puskesmas Ketanggungan

Brebes, Central Java, 52263, Indonesia

Location

RSU Alam Medika Bumi Ayu

Brebes, Central Java, 52273, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 33693315 DERIVED

Study Officials

• Elaine Charurat, MBA, MHS

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 7, 2017
• Study Start: November 9, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

ID (8)