Viewing Study NCT03585361


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Study NCT ID: NCT03585361
Status: COMPLETED
Last Update Posted: 2018-07-18
First Post: 2018-06-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia
Sponsor: Jhpiego
Organization:

Study Overview

Official Title: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
Status: COMPLETED
Status Verified Date: 2018-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.
Detailed Description: This implementation research study used a quasi-experimental, mixed method design with two arms. Two districts in Arsi Zone in Ethiopia's Oromia Region (Hitosa and Lode Hitosa) were selected for the study. In each district, one primary health care unit (PHCU) - a public health center and its satellite health posts - was randomly assigned to the intervention arm and one to the comparison arm.

PPFP counseling, services, and documentation were strengthened through training and supervision at health centers in both intervention and comparison PHCUs, consistent with Government of Ethiopia policies and guidelines. Only the intervention arm received the community-based intervention. The community-based intervention involved training Health Extension Workers (HEWs) who staff health posts, make outreach home visits, and support volunteers under the government's Development Army. HEWs were trained on PPFP with a refresher on implant insertion. The community invention also involved giving tools to HEWs and volunteers to help them track women's PPFP preferences and pregnancy risk.

The study objectives are to:

1. Assess the effect of systematically integrating PPFP messages into contacts with the health system on uptake of PPFP through 12 months postpartum using a 'dose-response' analysis based on the number of contacts
2. Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites
3. Explore the acceptability and feasibility of tracking PPFP and reviewing data at health centers and HEWs and volunteers using record keeping and review processes to track women's decision-making and contraceptive use from pregnancy through 12 months postpartum
4. Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: