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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-49
SponsorUniversity of California, San Francisco

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,715 Participants
are divided into 2 treatment groups
Group A: Standard of care armNo intervention 0 interventions
Group B: Mittin Intervention armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Measured at 4 and 8 months

Secondary outcomes

1

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.

Time frame
Measured at 4 and 8 months
2

Method satisfaction

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

Time frame
Measured at 4- and 8-months
3

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)

Time frame
Measured at 4 and 8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

St. Paul's Hospital Millennium Medical College, Ethiopia

Collaborator

Bill and Melinda Gates Foundation

Collaborator