A clinical trial looking at the relationship between hormonal contraception and HIV risk might not proceed unless it receives funding from the National Institutes of Health (NIH), according to reproductive justice advocates.
The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial promises to determine whether using the injectable hormonal birth control Depo-Provera has any effect on a woman's risk of acquiring HIV. Despite already receiving support from international donors such as the Bill and Melinda Gates Foundation and the South African Government, a funding shortfall may prevent the trial from going ahead, the advocates warn.
The 7800 women volunteering for the study in East and Southern Africa would be randomly divided into three groups. One group would use Depo-Provera, another would use a hormonal implant called Jadelle, while a third group would use a copper intrauterine device (or IUD).
The trial would measure HIV incidence (new infections) among women using each of these contraceptive methods, and determine whether a particular method was associated with increased HIV risk.
While the trial is to be conducted in sub-Saharan Africa, where Depo-Provera is most commonly used, advocates emphasize it is also important for women living in the United States.
About 23% of American women who have used contraception have used Depo-Provera at some point, according to the United States Centers for Disease Control and Prevention (CDC). Its use is higher among women of color and women with limited formal education:
- Approximately 34% of African-American women and 27% of Hispanic women have used the injectable hormonal contraceptive, compared with 20% of white women and 10% of Asian Women.
- 36% of women without high school diplomas have used Depo-Provera, versus 9% of women with graduate degrees.
Despite widespread usage, some studies have suggested Depo-Provera might affect cervical and vaginal tissue and increase the likelihood of HIV entering the blood stream.
However, results have been conflicting and inconclusive.
"The small amount of data available comes from observational studies -- meaning the information was collected 'on the side' from studies designed to look at other questions. But a trial has never been done specifically to answer the question of whether hormonal contraception affects a woman's HIV risk, and the observational data have produced very mixed results," explains Anna Forbes, a consultant working with the AIDS Vaccine Advocacy Coalition (AVAC) and SisterLove. "Some of the trials have suggested that it does and some of the trials have suggested that it doesn't. To get a definitive answer on Depo -- one way or the other -- we need research that is designed to look specifically at this question."
Forbes notes that the NIH supported research on male circumcision and HIV risk.
"It just seems ludicrous that NIH would contribute to two randomized controlled trials, which are the large-scale, very expensive trials, to determine whether or not circumcision was protective for men -- which it turns out to be, and that's very good news -- and not contribute to ECHO to find out if Depo increases women's HIV risk," Forbes said. "That was life-saving information for men. The ECHO trial -- whatever its results -- would provide life-saving information for women."
A coalition of organizations, including AVAC, Black Women's Heath Imperative, Center for Health and Gender Equity, HIV Prevention Justice Alliance, National Women's Health Network, Positive Women's Network - USA, SisterLove, Inc., and SisterSong Women of Color Reproductive Justice Collective are calling for the NIH to allocate funding for the ECHO trial before the end of the year.
"We really need to move fast on this because existing donors have indicated that they will take their money off the table and reprogram it for other things if we don't get this together and get this moving," Forbes said.
"This trial was proposed two years ago and it's just been too long. So we need to put pressure on NIH as quickly as possible to get them to come up with the money they need to come up with for their share."
She invites organizations to support the advocacy effort by signing a letter addressed to the NIH, requesting funding for the study.
Katherine Moriarty is a consultant and freelance writer, based in Vancouver. She has 10 years of experience in the intersecting fields of public health and community development, with a focus on bloodborne virus policy and programming.