Consensus Statement on ECHO Trial to NIH

Consensus statement to NIH re: ECHO Trial


To: Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health (NIH)
Anthony M. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID)
Alan E. Guttmacher, M.D., Director, National Institute of Child Health and Human Development (NICHD)


Dear Doctors Collins, Fauci and Guttmacher,

We, the undersigned, are nationally and locally based advocacy and service delivery organizations committed to achieving reproductive justice in the United States. Many of us focus on addressing the specific needs of women of color, particularly those living and raising families in poverty. Others of us focus on the needs of people of all genders who are affected by HIV and AIDS. We are all keenly aware that the needs of these populations are both overlapping and urgent in our country.

We have reached consensus that the Evidence for Contraceptive Options and HIV
Outcomes (ECHO) trial can provide data to shape vital -- and to date inadequately informed -- health policy. We believe that it must be fully funded and launched as soon as possible. The NIH has not yet joined other international donors in committing funding to this trial. We call on you to correct this omission immediately, make a strong financial commitment to ECHO in 2014, and thus enable this trial to proceed in 2015 without delay.

A DEFINITIVE ANSWER TO THE ECHO QUESTION MUST BE SOUGHT NOW - NOT LATER.

More than half of all people living with HIV globally are women. In sub-Saharan Africa, 60% of all hormonal contraceptive users are receiving progestogen-only contraceptives, most commonly Depo-Provera (also called Depo or DMPA) and less frequently NET-EN. In some observational studies, both of these products have been associated with increased risk of HIV acquisition. In other studies, no such association was found. The question of whether such methods are linked to increased HIV risk remains unanswered and this ambiguity is particularly hazardous to women in sub-Saharan Africa. But it also poses a significant threat in the US.

The CDC reports that one quarter of all US women use Depo at some point in their lives and its use is highest among disadvantaged women and women of color. Over one third (34%) of African American women use or have used Depo compared to 20% of white women. Over one third (36%) of all women lacking high school diplomas have used Depo, versus only 9% of women with graduate degrees.

Choosing Depo is a matter of practicality for many women, especially those living in poverty and/or in rural areas with inadequate access to affordable family planning care. About one third of all US women now live in counties with no legal abortion providers, making safe abortion completely inaccessible to those who cannot afford to travel. In such circumstances, it makes sense that many women choose a long-lasting, highly-effective injectable contraceptive rather that some other method that is less reliable and may require more frequent family planning visits.

It is also clear that the women most frequently using Depo are in the populations heavily impacted by HIV. The existing data on the relationship between hormonal contraceptives, particularly Depo, and HIV risk are mixed. This uncertainty makes for unclear public health messaging and anxiety among women who need to balance their risk of unplanned pregnancy against the potential risk associated with use of a product that might (or might not) increase their risk of HIV. These women have a right to know – as soon as possible –whether their contraceptive method makes them more vulnerable to HIV. The ECHO trial is designed to answer this question for Depo, the copper IUD and the Jadelle implant.

OTHER APPROACHES TO HANDLING THE AMBIGUITY AROUND THIS ISSUE ARE INSUFFICIENT.

A randomized trial with ECHO’s scope is needed to answer the question of how various methods, including progestogen-only contraceptives, impact HIV risk. The data now available on this question were gathered from observational trials and are affected by confounding factors that make them unreliable. After reviewing these data, the World Health Organization (WHO) concluded that it “strongly supports the need for further research to identify definitive answers to these issues.”

Some disagree, arguing that the resources needed to fund the ECHO trial should, instead, be used to expand the contraceptive method mix in under-served areas so that Depo can be phased out in favor of other long-lasting methods such as implants and IUDs. Given Depo’s popularity in heavily impacted regions, however, it is not at all clear that funders, policy makers or the end users, themselves, would agree to this change without strong evidence that Depo poses a substantial risk to users. Little is known about the relationship, if any, between HIV risk and IUD or contraceptive implant use.

Removing Depo, the most widely-used form of contraception in some regions, without immediately escalating access to an acceptable, accessible replacement, would result an increase in unplanned pregnancies and their associated risks of maternal illness and death. Important efforts are underway in many countries to increase women’s contraceptive choices. These, however, neither compete with nor eliminate the need for certainty regarding whether, or to what extent, injectable hormonal contraceptives and other methods affect women’s HIV risk. As advocates noted recently, “No one wants to swap illness and death associated with HIV acquisition for pregnancy-related morbidity and mortality.”

FUNDING ECHO IS A MATTER OF JUSTICE AND EQUITY.

In 2005-06, data from three major clinical trials confirmed that circumcising men reduced their risk of HIV acquisition by approximately 60%. These trials were conducted after systematic reviews and meta-analysis of observational data suggesting that circumcision might reduce HIV risk. The NIH helped to fund two of these three trials, recognizing the need to answer the question definitively so that men could make informed choices about how best to protect themselves from HIV acquisition. The WHO upheld the need for these large trials to obtain a decisive answer to the question.

We call on NIH to participate in funding the ECHO trial for the same reason it participated in funding two male circumcision trials – because people need and have a right to complete information about protecting themselves from HIV. Governmental investment on ECHO will also help to bridge the HIV and contraceptive research agendas and advance our country’s stated commitment to integrating family planning and our HIV response – a commitment boldly upheld internationally by USAID and domestically in the National HIV/AIDS Strategy and DHHS programming.

As American tax-payers, we need and expect to see our country “walk the walk” with regard to its commitment to women’s health. The funding needed for ECHO is less than NIH has invested in the male circumcision trials mentioned above and many other important HIV prevention studies. Allowing the ECHO trial to be withdrawn, especially if it is due to lack of funding that NIH should have provided, will communicate an exceedingly disappointing message about the priority that NIH actually places on women’s health and rights. As George Bernard Shaw once observed, “it is the deed that teaches, not the name we give it.”

Sincerely,

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