Sayana® Press Self-injection Study in Malawi

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02293694
• Date of registration: 10/11/2014
• Prospective Registration: Yes
• Primary sponsor: FHI 360
• Public title: Sayana® Press Self-injection Study in Malawi
• Scientific title: A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women
• Date of first enrolment: September 17, 2015
• Target sample size: 735
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02293694
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Holly Burke, Ph.D.
• Affiliation: FHI 360

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Sayana Press

Primary Outcome(s)

To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider [Time Frame: up to 12 months]

Secondary Outcome(s)

To compare pregnancy rates between the two study groups [Time Frame: 12 months]

To compare reported side effects between the two study groups [Time Frame: up to 12 months]

Secondary ID(s)

631917-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors