Sayana® Press Self-injection Study in Malawi

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Sayana Press


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMPA-IM: depo medroxyprogesterone acetate intramuscular, DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous