Trial of the "Mittin" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia
NCT ID: NCT07301281
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2715 participants
INTERVENTIONAL
2026-02-28
2027-06-30
Brief Summary
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Researchers will compare women's outcomes in health centers providing the Mittin intervention to women's outcomes in health centers that offer standard care to see if Mittin improves women's ability to act in line with their contraceptive preferences.
Participants will
* Receive either standard contraception services (control arm) or enhanced services (intervention arm)
* Participate in a survey at the beginning of the study
* Participate in surveys 4 and 8 months later
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Standard of care arm
Health centers randomized to the standard of care arm will continue offering standard of care contraceptive counseling as per Ethiopian Ministry of Health guidelines. After completion of the c-RCT, the control arm health centers will receive Mittin materials for use on-site (counseling tools, waiting room posters, and educational handouts).
No interventions assigned to this group
Mittin Intervention arm
Health centers randomized to receive the Mittin intervention will receive staff training and materials (counseling tools, waiting room posters, and educational handouts) necessary to offer Mittin's side effects counseling and support model in their facilities. Women enrolled in the study in intervention health centers will receive proactive follow-up calls from call center agents to offer support after initiating a new contraceptive method. The call center will also be available on-demand to any person who desires support related to contraceptive options or side effects.
Mittin
Mittin intervention consists of the following components:
1. Educational posters and handouts to raise awareness of the right to contraceptive choice and to switch methods if side effects become intolerable
2. Decision support tools for providers to aid women in weighing the risks and benefits of potential side effects during in-person counseling
3. On-demand and proactive virtual side effects counseling and referrals via a call center.
Interventions
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Mittin
Mittin intervention consists of the following components:
1. Educational posters and handouts to raise awareness of the right to contraceptive choice and to switch methods if side effects become intolerable
2. Decision support tools for providers to aid women in weighing the risks and benefits of potential side effects during in-person counseling
3. On-demand and proactive virtual side effects counseling and referrals via a call center.
Eligibility Criteria
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Inclusion Criteria
* Started or continued using hormonal contraceptive method or copper IUD on day of recruitment
* Ages 15-49 years
* Willing to provide phone number and receive follow-up phone call
Exclusion Criteria
* Can not verbally communicate
* Not willing to provide consent for the study
15 Years
49 Years
FEMALE
No
Sponsors
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St. Paul's Hospital Millennium Medical College, Ethiopia
OTHER
Bill and Melinda Gates Foundation
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kelsey Holt, ScD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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St. Paul's Hospital Millennium Medical College
Addis Ababa, , Ethiopia
Countries
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Central Contacts
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Facility Contacts
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Ewenat Gebrehanna, PhD MPH
Role: primary
Hanna Feleke, MPH
Role: backup
Other Identifiers
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INV-044992
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-43085
Identifier Type: -
Identifier Source: org_study_id