NCT02293694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

September 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

November 10, 2014

Last Update Submit

September 15, 2017

Conditions

Contraception

Keywords

DMPA-SC: depo medroxyprogesterone acetate sub-cutaneousDMPA-IM: depo medroxyprogesterone acetate intramuscular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • To compare reported side effects between the two study groups

    up to 12 months

  • To compare pregnancy rates between the two study groups

    12 months

Other Outcomes (2)

  • To describe experiences of women who self-inject Sayana Press

    12 months

  • To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press

    12 months

Study Arms (2)

self-injection

ACTIVE COMPARATOR

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

Drug: Sayana Press

provider injection

ACTIVE COMPARATOR

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

Drug: Sayana Press

Interventions

Sayana PressDRUG

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

Also known as: depot medroxyprogesterone acetate (DMPA)
provider injectionself-injection

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, Department of Community Health

Blantyre, Malawi

Location

Related Publications (2)

  • 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.

    PMID: 32389457DERIVED

  • 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.

    PMID: 29526707DERIVED

Study Officials

  • Holly Burke, Ph.D.

    FHI 360

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 18, 2014

Study Start

September 17, 2015

Primary Completion

January 27, 2017

Study Completion

August 30, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)