Capacity Building of Healthcare Providers Clinical Trial
— PPFP ChoicesOfficial title:
Postpregnancy Family Planning Choices in Public and Private Sectors in Kenya and Indonesia
| Verified date | August 2021 |
| Source | Jhpiego |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 9282 |
| Est. completion date | March 16, 2020 |
| Est. primary completion date | March 16, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Puskesmas Bawang | Batang | Jawa Tengah |
| Indonesia | Puskesmas Subah | Batang | Central Java |
| Indonesia | RSU QOlbu Insan Mulia | Batang | Central Java |
| Indonesia | RSUD Batang | Batang | Jawa Tengah |
| Indonesia | Puskesmas Kecipir | Brebes | Jawa Tengah |
| Indonesia | Puskesmas Ketanggungan | Brebes | Jawa Tengah |
| Indonesia | RSU Alam Medika Bumi Ayu | Brebes | Jawa Tengah |
| Indonesia | RSUD Brebes | Brebes | Jawa Tengah |
| Lead Sponsor | Collaborator |
|---|---|
| Jhpiego | Bill and Melinda Gates Foundation, Merck for Mothers |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | 3 years | |
| Secondary | 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 | 3 years | |
| Secondary | Assessment of individual intervention quality | Using a quality improvement framework, assess individual pieces of the intervention package using multi-level modeling | 3 years |