Clinical trial NCT03585361: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia
Official title: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Postpartum Family Planning
Contraception
Prenatal Care
Pregnancy
Keywords: Contraceptive Usage
Pregnancy
Postpartum Family Planning
Contraception
Prenatal Care
Postnatal Care
Postpartum Care
Family Planning
Ethiopia
Community Health Workers
Community Based Care
Health Extension Workers
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Bill and Melinda Gates Foundation
First posted: 2018-07-13
Enrollment: 776
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Women

   * Pregnant at time of enrollment
   * Willing to give informed consent
2. Provider interviews

   * Providers providing PPFP messages or services in study area
   * Willing to give informed consent

Exclusion Criteria:

1. Women

   * Not pregnant at time of enrollment
   * Living outside study area
2. Provider interviews

   * Not working in antenatal, labor \& delivery, postnatal, or immunization care

Primary outcomes:
measure: PPFP uptake
timeFrame: 12 months after birth
Secondary outcomes:
measure: Method choice
timeFrame: 12 months after birth
Other outcomes:
Locations:
city: Hitosa
country: Ethiopia
facility: Boru PHCU
state: Oromia
city: Hitosa
country: Ethiopia
facility: Sibu PHCU
state: Oromia
city: Lode Hitosa
country: Ethiopia
facility: Aleko PHCU
state: Oromia
city: Lode Hitosa
country: Ethiopia
facility: Huruta PHCU
state: Oromia
city: Lode Hitosa
country: Ethiopia
facility: Ligaba PHCU
state: Oromia
city: Lode Hitosa
country: Ethiopia
facility: Lode Jimata
state: Oromia
Study officials:
References: