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

Sponsor
University of California, San Francisco
Study ID
NCT07301281
Status
Not Yet Recruiting

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Conditions

  • Contraception
  • Side Effects

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 49 Years
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Dec 24, 2025
Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
2,715 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Preference-Aligned Fertility Management (PFM) Index [ Time Frame: Measured at 4 and 8 months ]

Central Contacts

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