Sayana® Press Self-injection Study in Malawi

• Status: Completed
• Trial end date: 2017-08-30
• Target enrollment: 0
• Participant gender: Female

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. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

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 Criteria:

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