Status:
COMPLETED
Sayana® Press Self-injection Study in Malawi
Lead Sponsor:
FHI 360
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. ...
Detailed Description
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered w...
Eligibility Criteria
Inclusion
- Age 18-40, inclusive
- In general good health (participant verbally reports she feels well)
- Able to understand and willing to sign an informed consent document
- Willing to give contact information for follow-up
- Agree to have follow-up visits/interviews
- Willing to be randomized to the self-injection arm or provider-administered injection arm
- Menstrual period started within the past 7 days (for new DMPA users)
- Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria (MEC)
Exclusion
- Pregnancy
- Plans to become pregnant in the next 12 months
- Plans to relocate outside the study area in the next 12 months
- Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or would interfere with adherence to study requirements or complicate data interpretation
Key Trial Info
Start Date :
September 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT02293694
Start Date
September 17 2015
End Date
August 30 2017
Last Update
September 18 2017
Active Locations (1)
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1
College of Medicine, Department of Community Health
Blantyre, Malawi