Contraception, Side Effects
Conditions
Brief summary
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
BEHAVIORALMittin
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.
Sponsors
University of California, San Francisco
St. Paul's Hospital Millennium Medical College, Ethiopia
Bill and Melinda Gates Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
Arm will be masked to the principal investigators until analysis of the primary outcomes at 4 months; prior to this data will be in aggregate form and will not reveal intervention assignment.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference-Aligned Fertility Management (PFM) Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Agency in Contraceptive Decisions Scale | 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. |
| Method satisfaction | Measured at 4- and 8-months | 1-item measure where 1=very dissatisfied and 5=very satisfied |
| Preferred Method Use | 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) |
Countries
Ethiopia
Contacts
CONTACTKelsey Holt, ScD
PRINCIPAL_INVESTIGATORKelsey Holt, ScD
University of California, San Francisco
Outcome results
None listed