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Sayana® Press Self-injection Study in Malawi

NCT ID: NCT02293694

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

735 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-17

Study Completion Date

2017-08-30

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.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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self-injection

Women randomized to this arm will be trained to self-inject Sayana Press at home every three months

Group Type ACTIVE_COMPARATOR

Sayana Press

Intervention Type DRUG

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

provider injection

Women randomized to this arm will received Sayana press from a family planning provider every three months.

Group Type ACTIVE_COMPARATOR

Sayana Press

Intervention Type DRUG

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

Interventions

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Sayana Press

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

Intervention Type DRUG

Other Intervention Names

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depot medroxyprogesterone acetate (DMPA)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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FHI 360

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Burke, Ph.D.

Role: STUDY_DIRECTOR

FHI 360

Locations

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College of Medicine, Department of Community Health

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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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.

Reference Type DERIVED
PMID: 32389457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29526707 (View on PubMed)

Other Identifiers

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631917-1

Identifier Type: -

Identifier Source: org_study_id