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Sayana® Press Self-injection Study in Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02293694
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Sayana Press Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 735 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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 Name: 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 Name: depot medroxyprogesterone acetate (DMPA)




Primary Outcome Measures :
  1. 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 ]
    Discontinuation of Sayana Press measured at enrollment and every three months through one year


Secondary Outcome Measures :
  1. To compare reported side effects between the two study groups [ Time Frame: up to 12 months ]
    Women's reported side effects

  2. To compare pregnancy rates between the two study groups [ Time Frame: 12 months ]
    Frequencies of pregnancies in the two groups reported during the final


Other Outcome Measures:
  1. To describe experiences of women who self-inject Sayana Press [ Time Frame: 12 months ]
    Self-injectors' reported experiences (e.g., using, storing, and disposing of Sayana Press)

  2. To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press [ Time Frame: 12 months ]
    Providers' reported experiences and recommendations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293694


Locations
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Malawi
College of Medicine, Department of Community Health
Blantyre, Malawi
Sponsors and Collaborators
FHI 360
Investigators
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Study Director: Holly Burke, Ph.D. FHI 360
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT02293694    
Other Study ID Numbers: 631917-1
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by FHI 360:
DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous
DMPA-IM: depo medroxyprogesterone acetate intramuscular
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents