Trial of the "Mittin" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia

Cluster Randomized Controlled Trial of the "Mittin" Intervention in Addis Ababa, Ethiopia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception; Side Effects
• Intervention / Treatment: Behavioral: Mittin

• Study Type: Interventional
• Enrollment (Estimated): 2715
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelsey Holt, ScD; Phone Number: 617-455-2693; Email: kelsey.holt@ucsf.edu

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • St. Paul's Hospital Millennium Medical College
    • Contact: Ewenat Gebrehanna, PhD MPH; Phone Number: +251911154262; Email: gewenat@gmail.com
    • Contact: Hanna Feleke, MPH; Phone Number: +251910337708; Email: hannafeleke33@gmail.com
    • Principal Investigator: Ewenat Gebrehanna, PhD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Woman
• 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:

• Not planning to live in Addis Ababa for the next eight months
• Can not verbally communicate
• Not willing to provide consent for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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.	Behavioral: Mittin; Mittin intervention consists of the following components: Educational posters and handouts to raise awareness of the right to contraceptive choice and to switch methods if side effects become intolerable; Decision support tools for providers to aid women in weighing the risks and benefits of potential side effects during in-person counseling; On-demand and proactive virtual side effects counseling and referrals via a call center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference-Aligned Fertility Management (PFM) Index	The PFM Index measures whether use or non-use of contraception aligns with one's preferences. It is a binary measure where 0=no alignment, and 1=alignment.	Measured at 4 and 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agency in Contraceptive Decisions Scale	This 15-item scale includes individual items scored on a scale 0-3. The composite score is an average of scores on all items. 3=highest agency.	Measured at 4 and 8 months
Method satisfaction	1-item measure where 1=very dissatisfied and 5=very satisfied	Measured at 4- and 8-months
Preferred Method Use	Single item assesses whether there is a contraceptive method that a person would like to use but is not currently using (Yes/No/Uncertain)	Measured at 4 and 8 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; St. Paul's Hospital Millennium Medical College, Ethiopia
• Investigators: Principal Investigator: Kelsey Holt, ScD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-43085; INV-044992 (Other Grant/Funding Number: Gates Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No later than six months after publication of the initial findings of the study, we will make individual participant data that underlie the results available in a public repository after deidentification.
• IPD Sharing Time Frame: Within 6 months of publication of findings, with no end date
• IPD Sharing Access Criteria: Anyone will be able to access publicly available deidentified data once it is uploaded to a repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No