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Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

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ClinicalTrials.gov Identifier: NCT03585361
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Jhpiego

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.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Postpartum Family Planning Contraception Prenatal Care Pregnancy Behavioral: Health centers provide PPFP counseling and services Behavioral: HEWs provide PPFP counseling and services Behavioral: Volunteers (Development Army) promote PPFP Behavioral: Health centers conduct data reviews Behavioral: HEWs and volunteers track PPFP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


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.
Behavioral: Health centers provide PPFP counseling and services
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.

Behavioral: HEWs provide PPFP counseling and services
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.

Behavioral: Volunteers (Development Army) promote PPFP
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.

Behavioral: Health centers conduct data reviews
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.

Behavioral: HEWs and volunteers track PPFP
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.
Behavioral: Health centers provide PPFP counseling and services
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.

Behavioral: Health centers conduct data reviews
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Method choice [ Time Frame: 12 months after birth ]
    Proportion of interviewed postpartum women who chose a method prior to delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585361


Locations
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Ethiopia
Boru PHCU
Hitosa, Oromia, Ethiopia
Sibu PHCU
Hitosa, Oromia, Ethiopia
Aleko PHCU
Lode Hitosa, Oromia, Ethiopia
Huruta PHCU
Lode Hitosa, Oromia, Ethiopia
Ligaba PHCU
Lode Hitosa, Oromia, Ethiopia
Lode Jimata
Lode Hitosa, Oromia, Ethiopia
Sponsors and Collaborators
Jhpiego
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
  Study Documents (Full-Text)

Documents provided by Jhpiego:
Statistical Analysis Plan  [PDF] June 21, 2018
Study Protocol  [PDF] February 2, 2018


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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03585361     History of Changes
Other Study ID Numbers: IRB00007143
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jhpiego:
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