Sayana® Press Self-injection Study in Malawi

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Sayana Press

• Registration Number: NCT02293694
• Lead Sponsor: FHI 360

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. 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.

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 with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.

If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa.

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-18
• Study Start: 2015-09-17
• Primary Completion: 2017-01-27
• Study Completion: 2017-08-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 735

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self-injection	Sayana Press	Women randomized to this arm will be trained to self-inject Sayana Press at home every three months
provider injection	Sayana Press	Women randomized to this arm will received Sayana press from a family planning provider every three months.

Primary Outcome Measures

Name	Time	Method
To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider	up to 12 months	Discontinuation of Sayana Press measured at enrollment and every three months through one year

Secondary Outcome Measures

Name	Time	Method
To compare reported side effects between the two study groups	up to 12 months	Women's reported side effects
To compare pregnancy rates between the two study groups	12 months	Frequencies of pregnancies in the two groups reported during the final

Trial Locations

Locations (1)

College of Medicine, Department of Community Health; 🇲🇼 Blantyre, Malawi