Sayana® Press Self-injection Study in Malawi

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Sayana Press

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 Type: Interventional
• Enrollment (Actual): 735
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • College of Medicine, Department of Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: self-injection; Women randomized to this arm will be trained to self-inject Sayana Press at home every three months	Drug: Sayana Press; Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject; Other Names: depot medroxyprogesterone acetate (DMPA)
Active Comparator: provider injection; Women randomized to this arm will received Sayana press from a family planning provider every three months.	Drug: Sayana Press; Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject; Other Names: depot medroxyprogesterone acetate (DMPA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press	Providers' reported experiences and recommendations	12 months

Collaborators and Investigators

• Sponsor: FHI 360
• Investigators: Study Director: Holly Burke, Ph.D., FHI 360

Publications and helpful links

General Publications

• Burke HM, Chen M, Packer C, Fuchs R, Ngwira B. Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi. J Adolesc Health. 2020 Nov;67(5):700-707. doi: 10.1016/j.jadohealth.2020.03.038. Epub 2020 May 7.
• Burke HM, Chen M, Buluzi M, Fuchs R, Wevill S, Venkatasubramanian L, Dal Santo L, Ngwira B. Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial. Lancet Glob Health. 2018 May;6(5):e568-e578. doi: 10.1016/S2214-109X(18)30061-5. Epub 2018 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Actual): January 27, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous; DMPA-IM: depo medroxyprogesterone acetate intramuscular
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: 631917-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No