- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585361
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia
Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
Study Overview
Status
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:
- 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
- Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites
- 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
- Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oromia
-
Hitosa, Oromia, Ethiopia
- Boru PHCU
-
Hitosa, Oromia, Ethiopia
- Sibu PHCU
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Lode Hitosa, Oromia, Ethiopia
- Aleko PHCU
-
Lode Hitosa, Oromia, Ethiopia
- Huruta PHCU
-
Lode Hitosa, Oromia, Ethiopia
- Ligaba PHCU
-
Lode Hitosa, Oromia, Ethiopia
- Lode Jimata
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women
- Pregnant at time of enrollment
- Willing to give informed consent
Provider interviews
- Providers providing PPFP messages or services in study area
- Willing to give informed consent
Exclusion Criteria:
Women
- Not pregnant at time of enrollment
- Living outside study area
Provider interviews
- Not working in antenatal, labor & delivery, postnatal, or immunization care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization).
Also, health centers conduct data reviews of PPFP counseling, intra-facility referrals and uptake data.
At community level, HEWs provide PPFP counseling and services throughout continuum of care, volunteers (Development Army) promote PPFP, and HEWs and volunteers track PPFP method choice and uptake.
|
Providers trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants.
Training also included how to use tools to document PPFP services and referrals.
Follow up supervision ensured skill mastery and retention.
HEWs trained in PPFP counseling with a refresher on implant insertion skills.
Training also included how to use tools to document PPFP services, method choice, and pregnancy risk at every contact during pregnancy and up to 12 months after birth.
Follow up supervision ensured skill improvement and retention.
HEWs orient volunteers on promoting PPFP and how to use a pictoral tool to remind women to access ANC, immunization, and PPFP services and to document women's method preferences and pregnancy risk at every contact during pregnancy and up to 12 months after birth.
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.
HEWs and volunteers track PPFP counseling, choice of method, receipt of methods, and pregnancy risk starting in pregnancy through 12 months postpartum.
HEWs and volunteers meet and review data.
|
Active Comparator: Comparison
Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization).
Health centers conduct data reviews.
|
Providers trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants.
Training also included how to use tools to document PPFP services and referrals.
Follow up supervision ensured skill mastery and retention.
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PPFP uptake
Time Frame: 12 months after birth
|
Proportion of interviewed postpartum women who used a modern family planning method within 12 months after giving birth
|
12 months after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Method choice
Time Frame: 12 months after birth
|
Proportion of interviewed postpartum women who chose a method prior to delivery
|
12 months after birth
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00007143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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