Clinical trial NCT03333473: Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
Official title: Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-pregnancy Family Planning
Capacity Building of Healthcare Providers
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Merck for Mothers
First posted: 2017-11-07
Enrollment: 9282
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility 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

Primary outcomes:
measure: Quality of PPFP counseling
timeFrame: 3 years
measure: Clinical competency of service providers in providing all modern FP methods
timeFrame: 3 years
Secondary outcomes:
measure: Postpartum uptake of LARCs
timeFrame: 3 years
measure: Health facility-level leadership management and governance skills
timeFrame: 3 years
measure: Assessment of individual intervention quality
timeFrame: 3 years
Other outcomes:
Locations:
city: Batang
country: Indonesia
facility: RSU QOlbu Insan Mulia
state: Central Java
city: Batang
country: Indonesia
facility: Puskesmas Subah
state: Central Java
city: Batang
country: Indonesia
facility: RSUD Batang
state: Jawa Tengah
city: Batang
country: Indonesia
facility: Puskesmas Bawang
state: Jawa Tengah
city: Brebes
country: Indonesia
facility: RSUD Brebes
state: Jawa Tengah
city: Brebes
country: Indonesia
facility: Puskesmas Kecipir
state: Jawa Tengah
city: Brebes
country: Indonesia
facility: Puskesmas Ketanggungan
state: Jawa Tengah
city: Brebes
country: Indonesia
facility: RSU Alam Medika Bumi Ayu
state: Jawa Tengah
Study officials:
affiliation: Jhpiego
name: Elaine Charurat, MBA, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.