Today the World Health Organization issued an updated guidance statement on its recommendations for the use of hormonal contraception by women at high risk of HIV. The update changes the WHO classification of long-acting injectable contraceptives like DMPA (also known as Depo) and NET-EN. WHO states "there continues to be evidence of a possible increased risk of HIV among progestogen-only injectable users." Based on this possibility and women's right to informed choice, the WHO has changed the grade for both methods from "use without restriction" to "benefits outweigh theoretical or proven risks". Click here for a plain language explanation of these grades and to register for a March 10 webinar on this topic.
The new guidance is clear that the recommendations are based on women's right to informed choice in health and that women should have information about this possibility as well as full access to the method of their choice, regardless of their HIV risk.
Here are links to key resources:
Since 1996, the WHO has used a grading system for contraceptive methods. This system is called the Medical Eligibility Criteria or MEC. (AVAC has developed a background guide to "grades" and the MEC available here.) The MEC are used to make sure that family planning programs around the world use methods in the same way. Part of the MEC is a grading system that shows how safe each method is and who can use it. Today WHO changed the grade for DMPA and NET-EN.
Both methods are now in the category for which "the benefits outweigh the theoretical or actual risks." Simply put, this means this method works well and women should feel free to use it, but they should also know about possible risks. In this case, the specific possible risk is that DMPA or NET-EN might increase risk of acquiring HIV. This risk isn't proven yet and this classification makes it clear that DMPA and NET-EN should be freely available to all women, regardless of HIV risk.
The technical term for the category is MEC 2. A method that can be used without restriction is in the MEC 1 category. Previously DMPA had been classified a MEC 1*. This meant that it could be used safely by anyone but that there were key things for women and health care workers to think about. The MEC 1* classification for DMPA stated that women at high risk of HIV should be told about the uncertainty about this method and HIV risk, and counseled to use condoms.
For the past several years, advocates for women's sexual and reproductive health and rights have urged action to ensure that all women receive clear information about possible risks and benefits of all contraceptive methods. In many settings, the 1* classification did not change counseling messages about DMPA. Today's change to a 2 could help ensure that the right to information is fulfilled. As advocates have made clear, this must be in the context of free choice among a range of contraceptive and HIV prevention methods. (Background on this issue is available here.)
Why the Change?
The change was recommended by an Expert Review Group convened by the WHO in December. The group looked at available data on the possible connection between the use of hormonal contraceptives and HIV risk in HIV-negative women. This group also looked at information on women's values and preferences and discussed the ways that the MEC 1* classification had affected what women were told about DMPA and HIV risk. Based on this and other information, the ERG recommended a change to a "2." The available information suggest a potential increased risk of risk of getting HIV among users of DMPA. The guidance notes that it is not clear whether this risk is real, but also signals that women should know about theoretical risks in their decision making. An independent WHO committee subsequently reviewed and approved the recommendation.
What Does It Mean?
The change is a strong affirmation of the sexual and reproductive health and rights of women and girls, including the right to information and informed choice. The guidance statement affirms that these rights were "at the core" of the process. It is a positive signal that all women should receive complete information about all of their family planning options. ICW Eastern Africa and other Africa-based civil society groups have documented that the MEC 1* classification did not substantively change the information most women received about Depo.
Women and adolescents need more choices for contraception and HIV prevention at the same clinic. The call for expanded "method mix" (having more contraceptive choices for women) and integration of HIV and sexual and reproductive health programs is not new. But this updated guidance must catalyze action in these key areas. Some women may not want to use DMPA or NET-EN after being counseled. Others may be motivated to take additional HIV prevention steps. Expanded access to a range of long-acting, discrete contraceptive methods is urgently needed, as is expanded access to male and female condoms and oral PrEP at family planning clinics.
Use of DMPA and NET-EN should not be restricted in any way. Any woman who wants to use DMPA or NET-EN should be able to do so, regardless of her HIV risk. Women are fully capable of weighing risks and benefits when given full information. Every woman should have the option she needs and wants and have access to the method as well as comprehensive information about the options.
This guidance affects specific contraceptives and is most relevant for specific parts of the world where injectable use and rates of HIV are both high. There are limited data on many contraceptives and their impact on HIV risk. The ongoing ECHO trial which is a randomized clinical trial designed to assess the impact of DMPA, the Jadelle implant and the copper intrauterine device on HIV risk, as well as pregnancy, side-effects, and long-term acceptability, will provide more information.
AVAC will be working with partners in the weeks and months to come to ensure the guidance is operationalized in ways that uphold women's right to informed choice and access to a wider range of contraception and HIV prevention. We will also continue to work with other stakeholders in the field to understand how the change impacts ongoing research, including the ECHO trial. Please join us for the webinar next Friday, March 10 to learn more and discuss these issues with colleagues.
Please let us know your thoughts, questions and information needs and please join us on next week's call.