Sayana® Press Self-injection Study in Malawi

Contraception Clinical Trial

Official title:

A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293694
• Other study ID #: 631917-1
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: September 15, 2017
• Start date: September 17, 2015
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: August 30, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Sayana Press
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject

Locations

Country	Name	City	State
Malawi	College of Medicine, Department of Community Health	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To describe experiences of women who self-inject Sayana Press	Self-injectors' reported experiences (e.g., using, storing, and disposing of Sayana Press)	12 months
Other	To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press	Providers' reported experiences and recommendations	12 months
Primary	To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider	Discontinuation of Sayana Press measured at enrollment and every three months through one year	up to 12 months
Secondary	To compare reported side effects between the two study groups	Women's reported side effects	up to 12 months
Secondary	To compare pregnancy rates between the two study groups	Frequencies of pregnancies in the two groups reported during the final	12 months