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

NCT07301281 | Not Yet Recruiting

• 2 other identifiers: 24-43085INV-044992
• Study Type: interventional
• Target: 2,715
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Agency in Contraceptive Decisions Scale

  Measured at 4 and 8 months

• Method satisfaction

  Measured at 4- and 8-months

• Preferred Method Use

  Measured at 4 and 8 months

Study Arms (2)

Standard of care arm

NO INTERVENTION

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).

Mittin Intervention arm

EXPERIMENTAL

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

Interventions

Mittin BEHAVIORAL

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.

Mittin Intervention arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• St. Paul's Hospital Millennium Medical College, Ethiopia: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

St. Paul's Hospital Millennium Medical College

Addis Ababa, Ethiopia

Location

Study Officials

• Kelsey Holt, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Holt, ScD

CONTACT

617-455-2693; kelsey.holt@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Arm will be masked to the principal investigators until analysis of the primary outcomes at 4 months; prior to this data will be in aggregate form and will not reveal intervention assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 6 months of publication of findings, with no end date
• Access Criteria: Anyone will be able to access publicly available deidentified data once it is uploaded to a repository.

Locations

ET (1)