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NCT Number: NCT07301281

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

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Key information

Conditions

Contraception Side Effects

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mittin

Behavioral

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.

Primary outcomes

  1. Preference-Aligned Fertility Management (PFM) Index

    Time frame: Measured at 4 and 8 months

    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.

Secondary outcomes

  1. Agency in Contraceptive Decisions Scale

    Time frame: Measured at 4 and 8 months

    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.

  2. Method satisfaction

    Time frame: Measured at 4- and 8-months

    1-item measure where 1=very dissatisfied and 5=very satisfied

  3. Preferred Method Use

    Time frame: Measured at 4 and 8 months

    Single item assesses whether there is a contraceptive method that a person would like to use but is not currently using (Yes/No/Uncertain)

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Holt, ScD

CONTACT

[email protected]

617-455-2693

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • St. Paul's Hospital Millennium Medical College, Ethiopia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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