Seattle, November 16, 2016 --Self-injection of the contraceptive Sayana® Press is both feasible and highly acceptable among women participating in the first such research study conducted in sub-Saharan Africa, according to results published online by the journal Contraception.
Sayana Press is an all-in-one injectable contraceptive that puts control of women's health in their hands. It is a subcutaneous formulation of the widely used injectable contraceptive depot medroxyprogesterone acetate (DMPA-SC) delivered in the PATH-developed Uniject™ injection system.
"This pioneering research is important not only for the women of Uganda, but for all women," says Professor Dr. Anthony K. Mbonye, Acting Director General, Health Services, Ministry of Health, and co-investigator of the study. "The evidence that women can self-inject safely and successfully can help inform family planning program decision-making in countries around the world."
In low- and middle-income regions of the world, nearly 225 million women want to plan their pregnancies but don't have access to a method that meets the reality of their lives. Expanding access to new contraceptive options such as Sayana Press can improve health and save lives by allowing women to delay or space their births.
"Many women don't have the power to plan their families, because health centers are far away or partners refuse to support them to use contraceptives," explains Fiona Walugembe, PATH's Sayana Press coordinator in Uganda. "Self-injection gives women an additional option that increases both convenience and privacy."
Sayana Press combines one dose of the contraceptive and a single-use needle in the Uniject device. Its streamlined design makes it small, light, and easy to use. It requires minimal training to use, making it especially suitable for community-based distribution--and for women to administer themselves through self-injection.
Provider-administered Sayana Press is being offered as a family planning option in several countries around the world, including Uganda. Sayana Press is manufactured by Pfizer Inc. and Uniject is manufactured by BD. PATH first developed the Uniject injection system in the 1980s to make injections simpler and safer in low-resource settings.
PATH and the Uganda Ministry of Health collected the newly published results to determine if Ugandan women liked the option and could inject themselves successfully, remember their reinjection dates, and safely store and dispose of the device--evidence critical for family planning decision-makers in low-income countries considering integration of self-injection in their programs.
In the Uganda study, 380 women between the ages of 18 and 45 were trained by licensed nurses to self-inject Sayana Press, guided by a client instruction booklet. Those considered to be competent (98 percent) were given a Sayana Press device, instruction booklet, and reinjection calendar for self-injection at home three months later.
Shortly after the participants' scheduled reinjection dates, nurses visited participants at home to learn whether they had reinjected on time and to observe their self-injection technique on a model. At this follow-up, 88 percent of participants demonstrated injection competence and 98 percent of those who self-injected expressed the desire to continue self-injecting.
A similar study in Senegal was just completed. The studies build on previous self-injection research conducted in the United States and Europe.
Self-injection of Sayana Press has been approved by the United Kingdom Medicines & Healthcare products Regulatory Agency and is under regulatory review in several other countries. While these approvals open the door for introduction of self-injection, further evidence is needed to guide family planning program decisions.
Dr. Jane Cover, PATH Sayana Press Research Manager, puts the new Uganda study results in context: "Regulatory approval is necessary but not sufficient to make a new product or practice available to people in communities," she explains. "We have heard clearly from ministries of health in several African countries that they want more evidence on whether and how self-injection would work in their contexts. That evidence is starting to emerge with these first promising results from Uganda."
Sayana Press injections are already widely available from family planning providers in many countries. For example, since 2014, nearly 500,000 doses of Sayana Press have been provided by health workers through country-led pilot introductions in Burkina Faso, Niger, Senegal, and Uganda, coordinated by PATH. These four countries are now moving forward with scale-up of provider-administered Sayana Press in their national family planning programs.
Given the successful introduction of Sayana Press administered by community health workers and these promising self-injection research results, the Uganda Ministry of Health has begun offering Sayana Press self-injection as an option for women in Uganda's Mubende District--the first time the practice has been available in sub-Saharan Africa outside of a research setting.
This month, PATH and the Mubende District Health Team trained approximately 100 health care providers at public-sector facilities to teach clients how to self-inject. The providers will offer Sayana Press as one family planning option, either by administering the injection or supporting clients to self-inject, according to their preference. The Uganda Ministry of Health and PATH hope to expand self-injection in the country in 2017.
Sayana Press and Depo-Provera are registered trademarks of Pfizer Inc. Uniject is a trademark of BD.
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