Trial of the "Mittin" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mittin.
- Who it may be relevant to
- Registry conditions: Contraception, Side Effects. Basic parameters: 15 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cluster Randomized Controlled Trial of the "Mittin" Intervention in Addis Ababa, Ethiopia
Overview
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
Interventions
- Behavioral Mittin
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.
Primary outcome measures
- Preference-Aligned Fertility Management (PFM) Index [Time frame: Measured at 4 and 8 months]
Secondary outcome measures (3)
- Agency in Contraceptive Decisions Scale [Time frame: Measured at 4 and 8 months]
- Method satisfaction [Time frame: Measured at 4- and 8-months]
- Preferred Method Use [Time frame: Measured at 4 and 8 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Ethiopia · 1 center
- St. Paul's Hospital Millennium Medical College — Addis Ababa
Identifiers
NCT: NCT07301281 · 24-43085 · INV-044992