ContraceptionNCT07301281
Trial of the "Mittin" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia
A study testing Mittin in people with Contraception and Side Effects, run by University of California, San Francisco at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Contraception, Side Effects
- What is being tested?
- Mittin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,715 participants
- Where
- 1 siteEthiopia
- Study dates
- 23 Feb 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
St. Paul's Hospital Millennium Medical College
Addis Ababa
Ewenat Gebrehanna, PhD MPH, +251911154262, gewenat@gmail.com
Hanna Feleke, MPH, +251910337708, hannafeleke33@gmail.com
About this study
Official title: Cluster Randomized Controlled Trial of the "Mittin" Intervention in Addis Ababa, Ethiopia
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.
Read more
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
- Conditions
- Contraception, Side Effects
- Being tested
- Mittin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MittinBehavioural
Mittin intervention consists of the following components:
- Educational posters and handouts to raise awareness of the right to contraceptive choice and to switch methods if side effects become intolerable
- Decision support tools for providers to aid women in weighing the risks and benefits of potential side effects during in-person counseling
- On-demand and proactive virtual side effects counseling and referrals via a call center.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mittin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 4 and 8 months
Secondary outcomes (3)
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: Measured at 4 and 8 months
Method satisfaction
1-item measure where 1=very dissatisfied and 5=very satisfied
Measured: 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: Measured at 4 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start23 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,715 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- St. Paul's Hospital Millennium Medical College, Ethiopia, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Kelsey Holt, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301281
- Sponsor's protocol ID
- 24-43085
- Other IDs
- INV-044992
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No later than six months after publication of the initial findings of the study, we will make deidentified individual participant data that underlie the results available through a reasonable request submitted to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial of the "Mittin" Intervention in Addis Ababa, Ethiopia
- ClinicalTrials.gov ID
- NCT07301281
- Acronym / sponsor ID
- 24-43085
- Conditions
- Contraception, Side Effects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,715 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- St. Paul's Hospital Millennium Medical College, Ethiopia, Bill and Melinda Gates Foundation
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: MittinHealth 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not planning to live in Addis Ababa for the next eight months
- Can not verbally communicate
- Not willing to provide consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MittinMittin 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. | Behavioural | Mittin Intervention arm |
Primary outcome
Preference-Aligned Fertility Management (PFM) Index
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. No later than six months after publication of the initial findings of the study, we will make deidentified individual participant data that underlie the results available through a reasonable request submitted to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelsey Holt, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mittin in people with Contraception and Side Effects, run by University of California, San Francisco at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Holt, ScD (617-455-2693, kelsey.holt@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference-Aligned Fertility Management (PFM) Index (time frame: Measured at 4 and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.