Sayana Press Pilot Introduction and Research
Sayana Press project key fact sheets
These fact sheets are also available in French.
Access to modern contraception can save lives. About one in three maternal deaths could be avoided by delaying motherhood, spacing births, preventing unintended pregnancies, and avoiding unsafely performed abortions.
Injectable contraceptives are among the world’s most popular methods for preventing pregnancy, offering women safe and effective protection, convenience, and privacy. Until now, however, they have not been widely available outside clinic settings. Sayana® Press, a lower-dose formulation and presentation of Depo-Provera®, offers the potential to improve contraceptive access for women worldwide. In order to help address unmet need for contraception, PATH and partners are coordinating country-led pilot introductions of Sayana Press in sub-Saharan Africa and conducting research on the impact of Sayana Press provided through a range of delivery channels, including self-injection.
Sayana Press is a three-month, progestin-only injectable contraceptive product packaged in the Uniject™ injection system, a small prefilled autodisable device. It contains 104 mg per 0.65 mL dose of depot medroxyprogesterone acetate (DMPA) and is administered via subcutaneous injection.
Sayana Press is small, light, easy to use, and requires minimal training, making it especially suitable for community-based distribution—and potentially for women to administer themselves through self-injection.
Commitment to increasing access
In July 2012, the London Summit on Family Planning launched a new coordinated effort to ensure that voluntary family planning services reach an additional 120 million women and girls in the world’s poorest countries by 2020. An estimated 222 million women and girls worldwide want to prevent unintended pregnancy but are not using modern contraception.
As part of this event, a group of public and private partners announced plans to work with national programs to offer Sayana Press to women in sub-Saharan Africa and South Asia between 2013 and 2016. The original Sayana Press pilot introduction partnership included the Bill & Melinda Gates Foundation, the US Agency for International Development (USAID), the UK Department for International Development (DFID), the United Nations Population Fund (UNFPA), Pfizer Inc., and PATH. In mid-2014, the Children’s Investment Fund Foundation (CIFF) also joined the partnership.
A few months later, in November 2014, Pfizer Inc., the Bill & Melinda Gates Foundation, and CIFF agreed to a new public-private collaboration through which Sayana Press will be sold for US$1 per dose to qualified purchasers. The agreement will help ensure that women in the world’s 69 poorest countries have access to this new contraceptive option at reduced or no cost.
Pilot introduction overview
Building on these public-private global collaborations, PATH and partners are supporting country-led pilot introductions of Sayana Press in Burkina Faso, Niger, Senegal, and Uganda through 2016. Sayana Press is being introduced through established family planning delivery channels in the public, nongovernmental, and commercial sectors. Donors involved in the Summit on Family Planning have procured the introduction units of Sayana Press.
Ministries of health in the four African nations introducing Sayana Press are leading the pilot introductions. PATH is working closely with the ministries and other key partners including UNFPA, USAID, nongovernmental organization service delivery partners, and social marketing groups.
With the pilot introduction of Sayana Press, injectable contraceptives will for the first time be a routine part of community-based health care in Burkina Faso, Niger, and Senegal, giving women convenient access in their own villages. In Uganda, the Sayana Press pilot introduction activities are building on the Ministry of Health’s commitment to expand community-based delivery of injectable contraceptives and are making specific efforts to increase family planning access for younger women. In order to track the progress of Sayana Press introduction, PATH, UNFPA, ministries of health, and other implementing partners will collect and report monitoring data throughout the project period.
Research on self-injection and other delivery channels
Looking beyond the current Sayana Press introductions, PATH is also working closely with ministries of health in Senegal and Uganda to conduct research on self-injection. Studies to assess the feasibility of self-injection in Senegal and Uganda will begin in 2015, followed by studies in 2016 to assess whether women who self-inject with Sayana Press continue using injectable contraceptives longer than women who use intramuscular DMPA administered by a provider—as well as the relative costs of each approach. A qualitative acceptability study in Uganda in 2015 will also assess the interest of younger women in injectable contraception and in self-injection specifically.
In Burkina Faso and Uganda, PATH and partners will also conduct research on the effectiveness and cost-effectiveness of Sayana Press administered by clinic-based (Burkina Faso) and community-based (Uganda) health providers. The studies, set to begin in 2015, will assess whether women who receive Sayana Press injections from a provider continue using injectable contraceptives longer than women who receive intramuscular DMPA injections from a provider, as well as the relative costs.
This research on self-injection complements the ongoing pilot introductions, which only involve provider-administered Sayana Press. Sayana Press is currently not labeled for self-injection.
Evidence for decision-making
PATH and partners anticipate that evidence generated through all Sayana Press project activities will enable stakeholders to make informed decisions on whether and how to include this contraceptive option in family planning programs in the future—including delivery through self-injection.
Sayana Press has regulatory approval in the European Union and several countries around the world, including the four pilot introduction countries.† The formulation of DMPA used in Sayana Press is also approved in the United States.
†Sayana Press was approved in the European Union via procedure number UK/H/0960/002UK/H/0960/002. The UK was the Reference Member State. A Public Assessment Report is available at the Heads of Medicines Agency website and the Medicines and Healthcare Products Regulatory Agency web page.