SEATTLE — There is no substantial difference in HIV risk among three highly effective methods of contraception, the results of a randomized clinical trial conducted in four African nations show. But the findings reveal high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention with family planning services.
The results of the Evidence for Contraceptive Options and HIV Outcomes, or ECHO, study — which ran from December 2015 through October 2018 — were announced today at the South African AIDS Conference in Durban.
“We’re very reassured by the results. But this is a wake-up call that we should be doing much more in family planning services for HIV treatment and prevention.”— Rachel Baggaley, coordinator of HIV testing and prevention, WHO
The ECHO study, conducted by a consortium led by FHI 360, the University of Washington, Wits Reproductive Health and HIV Institute, and the World Health Organization, compared the risk of HIV acquisition among 7,829 women in 12 sites throughout Eswatini, Kenya, South Africa, and Zambia. The women, between the ages of 16-35 and HIV-negative at the start of the trial, were randomly assigned to use one of three different methods of contraception: injection of progestin-only depot-medroxyprogesterone acetate, or DMPA-IM; a nonhormonal copper intrauterine device, or IUD; and a progestin-based implant containing the hormone levonorgestrel, or LNG.
The study sought to determine the comparative risks and benefits of three contraceptive options, none of which stood out as a higher risk for HIV infection. ECHO found that of the 397 HIV infections that occurred among 7,829 women, 143 were among women in the DMPA-IM group, 138 were in the copper IUD group and 116 were in the LNG implant group.
Reassuring — and sobering
The study comes after decades of uncertainty surrounding the relationship between several types of contraceptives and increased risk of HIV.
“Many of us have been pursuing this for a long part of our careers, trying to get an answer,” Dr. Timothy Mastro, chief science officer at FHI 360, said at a press briefing ahead of the report’s release.
Evidence from observational studies conducted over the past 30 years suggested that use of hormonal contraception — particularly DMPA-IM, used widely in countries with high rates of HIV among women — could increase a woman’s risk of HIV acquisition by 40 to 50%. But this data was subject to the biases associated with observational studies, Helen Rees, executive director at Wits RHI, said at the briefing.
The family planning community had feared that, depending on the results of the study, governments or health care providers might panic and restrict access to a highly effective method of contraception. The findings of the ECHO trial, therefore, have provided the sector and wider global health community with a sense of reassurance and cautious relief, members of the ECHO consortium told the press briefing.
The high continued use throughout the study of contraception not readily available in these settings, such as the progestin-based implant and the copper IUD shows that women would benefit from having increased and improved family planning options, noted FHI 360’s Mastro.
“We hope that the ECHO results will be used to expand, not restrict, women’s options for contraception,” Mastro said.
Still, despite the fact that women received individualized counselling, condoms, and other HIV prevention services during every study visit, the results also spotlight an “unacceptably high HIV incidence among young African women irrespective of which contraceptive method they were assigned to,” Wits RHI’s Rees said.
The total of 397 HIV infections that occurred, or 3.81% per year, are results that WHO Coordinator of HIV Testing and Prevention Rachel Baggaley said should be used “to spearhead much greater HIV services in family planning settings.”
There is an immediate need to step up HIV prevention efforts in high-burden countries, particularly for young women, Baggaley said. And settings where family planning is already offered is an ideal opportunity for women to not only to receive contraception choices but also to be provided HIV testing and a range of prevention services, she elaborated.
“We’re very reassured by the results. But this is a wake-up call that we should be doing much more in family planning services for HIV treatment and prevention,” Baggaley said. “We need to get much more information out there in communities about [pre-exposure prophylaxis], Baggaley said. “PrEP is really not widely understood and known about in communities.”
In the meantime, WHO will immediately begin synthesizing the evidence and sharing results with WHO’s Guideline Development Group, which WHO will convene at the end of July 2019.
This group will consider the ECHO trial results along with other recent research to determine whether any changes are needed to the global guidance on contraceptive use, explained James Kiarie of WHO’s Department of Reproductive Health and Research. Recommendations will be issued by the end of August 2019.