Trial of the "Mittin" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia
NCT07301281 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2715
Last updated 2025-12-24
Summary
The goal of this clinical trial is to learn if the "Mittin" intervention can improve women's ability to manage their fertility in line with their preferences among women aged 15-49 using hormonal contraceptives or intrauterine devices and attending public health centers in Addis Ababa, Ethiopia. The main question it aims to answer is: Does the Mittin intervention increase preference-aligned fertility management, contraceptive method satisfaction, and preferred contraceptive method use among participants compared to standard care?
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
Conditions
- Contraception
- Side Effects
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
St. Paul's Hospital Millennium Medical College, Ethiopia
collaborator OTHER -
Bill and Melinda Gates Foundation
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Kelsey Holt, ScD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
Countries
- Ethiopia
Study Locations
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