by Anna Forbes
This article was originally published at Rewire and is reposted with permission.
Does using Depo-Provera (an injectable contraceptive) increase a woman’s risk of acquiring HIV or not? On March 2, the World Health Organization (WHO) changed its messaging on this from “absolutely not” to “well, probably not, but maybe somewhat if she is at high risk of HIV exposure.”
Injected contraceptives come in two forms: Combination injectable contraceptives contain both progestogen and estrogen hormones and are administered monthly; longer-lasting injectables are progestogen-only. The best known of these is Depo, which is administered every three months. Technically known as medroxyprogesterone acetate, Depo gained Food and Drug Administration (FDA) approval in 1992, and it is still the only injectable contraceptive available in the United States. NET-EN, a newer progestogen-only injectable administered every two months, is available in 91 countries outside the United States.
After reproductive justice organizers raised concerns about Depo in the 1990s for its promotion among low-income communities and women of color, the contraceptive again drew public criticism in 2011 when a study conducted in Southern and Eastern Africa indicated that women using it might have double the risk of acquiring HIV than that of women not using hormonal contraception at all. Those results were derived from observational data (information gathered from research designed to answer another question), and the validity of this conclusion has been hotly debated.
Some additional analyses done since then, also based on observational data, suggest that HIV acquisition is possibly linked to Depo use. Others suggest that there is no connection. A recent collective, systematic review of these analyses motivated WHO to change its safety rating of progestogen-only injectables.
WHO (the public health arm of the United Nations) grades various contraceptive methods for safety on a Medical Eligibility Criteria scale called the MEC. This standardized grading, based on close analysis of the available data, is designed to ensure that health-care providers across the globe deliver accurate information to their patients.
In lay language, the MEC ratings are:
- MEC 1 – no restrictions for use, anyone can use safely
- MEC 2 – advantages of using it generally outweigh “theoretical or proven risks” of not using it
- MEC 3 – the “theoretical or proven risks” of using it generally outweigh the advantages
- MEC 4 – “unacceptable health risk if this contraceptive method is used”
Depo had been graded as a MEC 1 since the scale was created. On March 2, WHO announced that Depo and NET-EN were being moved from MEC 1 to MEC 2. This came immediately on the heels of data indicating that NET-EN may be less likely than Depo to be associated with HIV acquisition. But WHO reclassified both due to insufficient evidence on this question.
There is no new instruction yet on what U.S. health-care providers, who follow FDA and Centers for Disease Control and Prevention (CDC) guidance documents, should tell their patients about Depo. The CDC MEC scale uses the same 1-4 categories as the WHO scale. At present, the CDC scale still shows Depo as a MEC 1—indicating no risk (real or potential).
What Does This Mean for Depo Users?
Depo is currently used by millions of women in 114 countries. Of the 53 million Americans using contraception between 2006 and 2010, 23 percent—more than 12 million women—used Depo. Most of them were women of color: 34 percent of them identified as Black, 27 percent as Hispanic/Latina, 20 percent as white, and 10 percent as Asian. Over one third (36 percent) of those Depo users also lacked high school diplomas.
Low-income women of color in the United States face the highest risk of HIV acquisition among women and the least access to adequate health care. Governmental decisions to defund family planning clinics and suppress safe abortion access inevitably drive women to avoid unintended pregnancy at all costs. Under such circumstances, the use of Depo becomes both a logical choice and a potentially dangerous one.
Many reproductive justice advocates see the MEC change toward a cautionary stance as long overdue.
Valerie Rochester of the Black Women’s Health Imperative told Rewire that news of the WHO MEC change will likely “create confusion and cause mistrust” among many of the Black women and girls that BWHI serves and those who use the contraceptive; particularly since Depo’s “long-lasting effectiveness is appealing to many women.”
To prevent this, she advised that providers “make sure that women know that Depo works for birth control but NOT for protection from HIV and STIs.” That distinction expands the conversation to include discussion of how women using Depo can also meet their noncontraceptive needs.
Pre-exposure prophylaxis (PrEP), which can reduce the users risk of HIV by 90 percent or more, is an essential part of that equation, she noted, along with male and female condoms. “And these messages can’t be given in isolation,” she added. Providers need to be trained to present the full range of tools for sexual health and allowed the time required to discuss each women’s specific needs and priorities.
The ECHO Trial: Resolving the Dilemma
A randomized clinical trial called ECHO (Evidence for Contraceptive Options and HIV Outcomes) is under way to resolve, once and for all, the question of whether Depo use facilitates HIV risk. Launched in 2015, the four-year trial in Eastern and Southern Africa has enrolled to date about half of its anticipated 7,800 participants. To test the effects of Depo, a hormonal implant called Jadelle, and the copper intrauterine device on women’s HIV risk, it is randomly dividing participants into three groups and supplying each with one of the three methods. Participants are also provided with free male and female condoms and urged to use them and access to PrEP, where available.
If a woman wants to change her contraceptive method during the study, she receives counseling and treatment for any side effects she may have, to see if her problem with the assigned method can be resolved. If it can’t, she is provided with the contraceptive she requests and is welcome to stay in the study and receive study services. But she is not then counted in the final analysis of women using their assigned methods, because doing so could introduce bias that would affect the trial’s accuracy.
The ECHO trial designers had hoped to include a NET-EN arm as well, to look for any detectable differences in HIV risk between those using Depo and those using NET-EN. But the lack of funding support from the U.S. National Institutes of Health and other major donors resulted in a shortfall that could only be resolved by scrapping the NET-EN component from ECHO’s design. Trial results are expected in 2018.
And in the Meantime?
Globally, advocates are calling for increased funding to make a broad range of contraceptive methods available, particularly to women in underserved areas heavily affected by HIV.
The Civil Society Advocacy Working Group on Hormonal Contraception and HIV represents women living with and affected by HIV in nine African countries and allies in the United States and Europe. Following WHO’s announcement on March 2, it issued a consensus statement emphasizing, among other points, that “all women seeking contraception and/or protection against sexually transmitted infections (STIs) and expressing interest in injectable methods should be advised in a wholly respectful, non-judgmental routine way, of the possibility of associated risk” and how it can be reduced. The statement notes this development comes at a time when “women’s health needs are in jeopardy,” and, as WHO and other UN agencies put it, “the promotion, protection and fulfillment of sexual and reproductive health and rights are currently experiencing marked resistance around the world.”
Nevertheless, it is time to demand that women have access to all contraceptive, HIV and STI prevention information and tools, along with nonjudgmental information that equips us to make informed choices. It’s a human rights thing.