Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| INV-044992 | Other Grant/Funding Number | Gates Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| St. Paul's Hospital Millennium Medical College, Ethiopia | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care arm | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mittin | Behavioral | Mittin intervention consists of the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at 4 and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at 4 and 8 months |
| Method satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Holt, ScD | Contact | 617-455-2693 | kelsey.holt@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kelsey Holt, ScD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital Millennium Medical College | Addis Ababa | Ethiopia |
No later than six months after publication of the initial findings of the study, we will make individual participant data that underlie the results available in a public repository after deidentification.
Not provided
Within 6 months of publication of findings, with no end date
Anyone will be able to access publicly available deidentified data once it is uploaded to a repository.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
1-item measure where 1=very dissatisfied and 5=very satisfied
| Measured at 4- and 8-months |
| 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) | Measured at 4 and 8 months |