The photos in this PowerPoint may be freely used for educational or noncommercial purposes, provided that a photo credit is included. Expanding options and access with subcutaneous DMPA: A new type of injectable contraception [Presenting organization or individual] [Date] [Event or meeting title]

Presentation overview Introducing subcutaneous DMPA (DMPA-SC, or Sayana® Press*) Features and benefits Transformative potential Global availability Key evidence on DMPA-SC Status of DMPA-SC in [insert country] Policy gaps and opportunities Hormonal contraception and HIV This presentation will describe a new type of injectable contraception that promises to increase women’s choices and access to family planning (FP). * DMPA stands for depot medroxyprogesterone acetate. Sayana Press is registered trademark of Pfizer, Inc.

In [insert country], total unmet need for family planning (FP) is [insert percentage]. Urban areas: [insert percentage] Rural areas: [insert percentage] THE GAP/PROBLEM: In [insert country], thousands of women do not have the ability to plan whether or when they get pregnant. In fact, [insert percentage] of [married] women of reproductive age who want to prevent or space pregnancies are not using contraception, in part because options are limited or do not meet women’s needs, as well as there being barriers to access, like long distance between a woman’s home and a health facility. This can lead to poor health outcomes for a woman and financial strains for families—and even stifled economic growth for countries. PATH/Will Boase

Strengthening the environment for introduction and scale-up of a wide range of contraceptive options:  Addresses unmet need. Increases method choice. Expands access, especially in rural and underserved areas. Fulfills commitments, including FP2020. THE SOLUTION: To ensure that women [and adolescent girls] are able to make their own reproductive health decisions, it’s critical that governments create a supportive policy and financing environment for introduction and scale-up of a variety of contraceptive options. Doing so can help: Address unmet need, [especially for women who have not found existing methods to be acceptable] [OR] [to meet the reality of their lives]. Increase method choice, which can help women and adolescents find and use a method that’s right for them. Expand access, especially in rural and underserved areas, including through policies that enable community-based distribution, provision through pharmacies and accredited drug shops, and self-administration of contraception. Fulfill FP goals and commitments, including FP2020 commitments such as increasing modern contraceptive prevalence rate, reaching new users of FP, and increasing use by adolescent girls and young women. FP2020 aims to expand access to FP information, services, and supplies to an additional 120 million women and girls in 69 of the world’s poorest countries by 2020. A new injectable contraceptive can help [insert country] meet these goals.

Subcutaneous DMPA, or DMPA-SC, is a new injectable that is administered under  the skin.  Safe and highly effective at preventing pregnancy. Delivered every 3 months. Prefilled and ready to inject. Simple to use. Small and light, with a short needle. This new product, subcutaneous DMPA (DMPA-SC, or Sayana® Press)—is a new, progestogen-only (or progestin-only) contraceptive that is injected under the skin. It is safe and highly effective at preventing pregnancy for 3 months when given correctly and on time. Because Sayana Press (the DMPA-SC product manufactured by Pfizer and available today) is prefilled and easy-to-use and requires minimal training, it opens up possibilities for community-based distribution and even self-injection. This can dramatically increase contraceptive access for women [and adolescent girls].

DMPA-SC compared with DMPA-IM DMPA-SC (Sayana® Press) Comes in a prefilled, “all-in-one” injection system. Is injected underneath the skin.  Has lower dose of DMPA (104 mg). Has 2.5-centimeter needle. Both products Safe and highly effective at preventing unintended pregnancy. Delivered every 3 months.  Do not protect against HIV or other sexually transmitted infections.  Comparable in regards to side effects.  Stable at room temperature. PATH/Patrick McKern DMPA-IM (Depo-Provera® and generic options) Comes in a vial with a separate syringe.  Is injected into the muscle.  Has higher dose of DMPA (150 mg).  Has 3.8-centimeter needle.  So what makes DMPA-SC (Sayana Press) different than the widely used DMPA-IM (also known as Depo Provera)? This slide summarizes similarities and differences of “next-generation” DMPA-SC compared with the “current-generation” DMPA-IM. DMPA-SC (subcutaneous): Prefilled in the Uniject injection system Injection site: Fat just under the skin (“subcutaneous” fat) 104 mg DMPA 2.5-centimeter needle Sayana® Press Brand, Pfizer, Inc. | Patent until 2020 DMPA-IM (intramuscular): Glass vial with syringe Injection site: Deep muscle tissue 150 mg DMPA 3.8-centimeter needle Depo-Provera® brand: Pfizer, Inc. | Generic equivalents made by various manufacturers DMPA: depot medroxyprogesterone acetate. Depo-Provera and Sayana Press are registered trademarks of Pfizer, Inc. Uniject is a trademark of BD.

The transformative power of DMPA-SC Features and Benefits All-in-one presentation Simplified injection Shorter training Easier to transport and store Less waste to dispose Improved injection safety Opportunities Increased acceptability and use by lower-level health care workers Well-suited for private-sector provision Uniquely suited to self-injection Value Expanded access Increased method choice Together, the unique features of DMPA-SC unlock the potential to expand access and method choice for women and adolescent girls. Many women currently travel long distances to health facilities in order to access contraception. But DMPA-SC can be delivered through channels that are closer to where women live. This includes community-based distribution through lower-level health care workers, provision at pharmacies and accredited drug shops, and even self-injection. Many women also like and value injectable contraception because it is safe, highly effective at preventing unintended pregnancy, private, and convenient.

The current DMPA-SC product: Sayana Press regulatory approval* Approved by regulatory authorities in the European Union and more than 25 countries worldwide. Registered for self-injection in the United Kingdom, several European countries, and an increasing number of FP2020 countries including Ghana, Myanmar, Niger, Nigeria, Uganda, and Zambia. Availability* Available in more than 15 FP2020 countries. Pricing* Product can be procured by qualified, public-sector purchasers at US$0.85 per dose. *Information current as of May 2017. The currently available DMPA-SC product, Sayana Press, has been approved by regulatory authorities in more than 25 countries, including the European Union. Increasingly, it has been registered for self-injection. This includes registration in the United Kingdom, several European countries, and an increasing number of FP2020 countries, such as Ghana, Myanmar, Niger, Nigeria, Uganda, and Zambia. DMPA-SC can be purchased at US$0.85 per dose by qualified public-sector buyers, such as ministries of health in FP2020 countries and United Nations agencies (like United Nations Population Fund [UNFPA]). The price that a woman may pay to access DMPA-SC will vary by country and where she obtains the method. If she receives a dose through the public sector, she will likely get it for free or at a highly reduced price. If she obtains a dose through the private sector (for example, through social marketing or a pharmacy or accredited drug shop), she will likely need to pay an amount determined by local market conditions.

Evidence: What we know about DMPA-SC Is highly acceptable Expands access for women and adolescent girls through channels closer to where they live: Community Self-injection Pharmacies and accredited drug shops Most evidence collected to date has been specific to Pfizer’s branded DMPA-SC product, Sayana Press.

FP providers and clients like DMPA-SC [Include data points from notes section that are relevant for your country.] [Add your own local data, if available.] EVIDENCE In the Democratic Republic of Congo, a recent study of community-based distribution found that more than 90 percent of women who accepted DMPA-SC and were followed up three months later chose to receive a second injection (Tulane University). In Nigeria, more than 70 percent of users sampled have either continued to use DMPA-SC or say they plan to continue (University of California, San Francisco [UCSF]). In Senegal and Uganda, acceptability studies in 2012 found that 80 percent of women in Senegal and 84 percent in Uganda who received DMPA-SC said they would select it over intramuscular DMPA if both types were available (FHI 360). “It was easy to use. I like the size, and also it has a good needle.” —Adolescent FP user, Uganda

Community health workers can administer DMPA-SC [Include data points from notes section that are relevant for your country.] [Add your own local data, if available.] EVIDENCE Many women and adolescent girls in [insert country] with unmet need for contraception live in rural and remote areas and could benefit from being able to obtain injectable contraception right in their communities—rather than at distant health clinics. According to the High Impact Practices in the Family Planning Initiative, community health workers are a proven source of FP products and information. Experience and evidence suggest that community-based distribution of DMPA-SC is feasible and has the potential to greatly expand access. In Uganda, around 2,000 trained community health workers (called Village Health Teams in Uganda) administered all 130,000 doses of DMPA-SC during the pilot introduction between late 2014 and mid-2016 (PATH). When both DMPA-SC and DMPA-IM are available from CHWs, DMPA-SC tends to make up the majority of injectables administered—72 percent in Senegal and 75 percent in Uganda (PATH). In the Democratic Republic of Congo, 97 percent of research participants who received DMPA-SC from medical or nursing students through community-based distribution said they were very comfortable receiving the injection that way (Tulane University).

DMPA-SC can reach new users, especially through remote channels [Include data points from notes section that are relevant for your country.] [Add your own local data, if available.] EVIDENCE In Burkina Faso, Niger, Senegal, and Uganda, a two-year pilot introduction reached 135,000 women who had never used FP before (PATH/UNFPA). In Niger, where DMPA-SC was the first injectable contraception offered at remote health posts, 70 percent of doses administered were to new users of FP at the outset of introduction (PATH/UNFPA). In clinics in Mozambique (Population Services International) and private outlets in Nigeria (DKT/UCSF), nearly one-third of DMPA-SC users were new contraceptive users.

Women can self-inject with DMPA-SC [Include data points from notes section that are relevant for your country.] [Add your own local data, if available.] [Choose a quote to include on this slide, if preferred] “It's really very easy; I had no problem doing so. I see only advantages mainly that contribute to staying healthy." —Self-injection research participant, Senegal "If I have the knowledge and the health worker has told me to come back in case I get a problem, then I would prefer to inject myself." —Adolescent qualitative research participant, Uganda EVIDENCE  In Uganda, a recent study found that nearly 90 percent of women could self-inject competently and on time three months after being trained, and 98 percent of women who tried self-injecting wanted to continue self-injecting (PATH). Also in Uganda, a qualitative study found that many adolescents interviewed could envision trying self-injection themselves. However, some still preferred having providers administer injections due to factors like fear of needles or provider expertise (PATH). In Senegal, a recent study found that nearly 90 percent of women could self-inject competently after being trained, and the vast majority of women (93 percent) who tried self-injecting wanted to continue self-injecting (PATH).

Pharmacies/drug shops may be a promising channel for DMPA-SC [Include data points from notes section that are relevant for your country.] [Add your own local data, if available.] EVIDENCE Private retail outlets, such as pharmacies and drug shops, are often an important source of contraceptives, especially for adolescents and young people. In Nigeria, DKT International, a social marketing organization, introduced the product in 2014 through private-sector outlets, including pharmacies. In Senegal, the social marketing organization ADEMAS has begun to offer the product through pharmacists. In Uganda, the government is in the process of changing its policies to enable provision of injectable contraception by pharmacies and drug shops. About half of adolescents in sub-Saharan Africa, Asia, and Latin America obtain contraception from private sector sources, including private pharmacies (Strengthening Health Outcomes Through the Private Sector Project).

Status of DMPA-SC in [insert country] Approved for use in [insert date]. [Registered for self-injection in (insert date).] [OR] [Under review for self-injection.] Introduction or scale-up ongoing in [insert delivery channel(s)]. Studies on [insert study topic/purpose] underway in [insert geographic areas]. [Insert number of doses] procured or distributed to date.

When [introducing] [OR] [scaling up] DMPA-SC consider… How can DMPA-SC help our country increase FP access and meet national goals and FP2020 commitments? How do we ensure DMPA-SC introduction takes place in context of informed choice and women’s health and rights? How do we integrate DMPA-SC in the broader FP system and not create a parallel track? How do we plan for a total market approach from the outset? Are women and adolescent girls interested in self-injection? How do we pave the way for this innovative practice? What policies, guidelines, and funding would facilitate introduction and scale up?

Policy gaps restricting access in [insert country] [Choose from the following, or insert your own.] No coordinated plan for introduction or scale-up. Community health workers not authorized to give injections. No formal policy approving self-injection of DMPA-SC. Pharmacies and accredited drug shops cannot legally sell injectable contraceptives. Limited domestic financing for FP.

Policy opportunities to increase access in [insert country] [Choose from the following, or insert your own.] Create a national road map or scale-up plan for DMPA-SC. Update task-shifting guidelines to allow community-based distribution of injectables, including DMPA-SC. Grant policy approval for self-injection and develop related guidelines or protocols on the practice. Revise regulations to allow pharmacies and accredited drug shops to stock and sell DMPA-SC. Increase domestic budget allocation for FP, including DMPA- SC.

Hormonal contraception and HIV The World Health Organization (WHO) states that women at high risk of HIV can use progestogen-only injectables, including those that contain DMPA. New WHO 2017 guidance emphasizes that any woman considering use of DMPA should be counseled on the uncertainty of an increased risk of HIV acquisition and how to protect herself from HIV. For discussion: How does this affect policies and programs in [insert country]? Important background/talking points: For decades there has been mixed evidence on the risk of HIV infection and the use of progestogen-only injectable contraceptive products containing depot medroxyprogesterone acetate (DMPA). Some studies suggest that women using DMPA injectable contraception might be more likely to get HIV if they are exposed to the virus. However, other studies do not show this association. In March 2017, based on a review of available evidence, WHO released new guidance on hormonal contraception and HIV for women at high risk of HIV. The guidance conveys that women at high risk of HIV can use progestogen-only injectables, including products that contain DMPA-IM, DMPA-SC, or norethisterone enanthate (NET-EN), because the advantages of these methods generally outweigh the possible increased risk of HIV acquisition. Practically speaking, WHO has shifted progestogen-only injectables from category 1 to category 2 for women at high risk of HIV in its Medical eligibility criteria for contraceptive use (MEC). The MEC provides guidance to country policymakers and FP program managers on developing their national policies, programs, protocols, and guidelines. There are some important points about the evidence on progestogen-only injectables and HIV. First, the evidence we have today is inconclusive. For example, all available data have been from observational studies. This means data were derived from studies designed primarily to answer other questions. This type of information is hard to analyze because there are many other variables that could have influenced the results. In addition, all data to date are on DMPA-IM. There are no data available on the lower-dose DMPA-SC. Because the products have the same safety and efficacy profile, WHO applies the same guidance to both types of products. Second, additional research will provide new information on contraception and HIV. A randomized clinical trial called the ECHO Study is evaluating whether there is a link between use of three contraceptives—DMPA-IM, the levonorgestrel implant, and the copper intrauterine device—and increased risk of acquiring HIV infection. Data from the ECHO study will be available in 2019. For more information, see: http://echo-consortium.com/ The bottom line is that comprehensive sexual and reproductive health programming that provides women with a full range of contraceptive options to prevent unintended pregnancy, HIV, and other sexually transmitted infections (STIs) is more important now than ever, and policies and financing need to support this.

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