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

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Contraception; Side Effects

Treatments: Behavioral: Mittin

Study type: Interventional

Funder types: Other

Identifiers

NCT07301281

24-43085

INV-044992 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 2,715 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,715 participants in 2 patient groups

Standard of care arm

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Mittin