Update: Women at high HIV risk can continue hormonal contraceptives
Update: Women at high HIV risk can continue hormonal contraceptives
Advise those choosing progestin-only shot on condom use
The World Health Organization (WHO) has reaffirmed its guidance that women living with HIV or at high risk of HIV infection can safely use all hormonal contraceptives without restriction following a recent review of links between the contraceptives and HIV acquisition. However, WHO clarified its previous classification of progestin-only injectable contraception [d epot medroxyprogesterone acetate (DMPA)/norethisterone enantate (NET-EN)] for women at high risk of HIV infection: While the method is recommended for use without restriction, women at high risk of HIV who choose this method should be strongly advised to also use condoms and other HIV-preventive measures.1
The clarification comes after the agency convened a 2012 technical consultation among 75 experts from 18 countries to review findings from all recent epidemiological studies regarding hormonal contraception and HIV risk. The meeting was prompted after the 2011 publication of research that indicated that hormonal contraceptives, such as the pill or injectable contraceptives, might increase a woman's risk of HIV infection.2 Those findings suggested that women living with HIV and using hormonal contraception might be more likely to transmit the virus to their partner than women who did not use hormonal contraception.2
The expert group concluded that WHO should recommend no restriction on use of any hormonal contraceptive method, including oral contraceptive pills, injectables, patches, rings, and implants, for women living with HIV or at high risk of HIV. It also recommended the following clarification be added to the recommendation: "Some studies suggest that women using progestin-only injectable contraception may be at increased risk of HIV acquisition; other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestin-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures. Expansion of contraceptive method mix and further research on the relationship between hormonal contraception and HIV infection is essential. These recommendations will be continually reviewed in light of new evidence."1
How about U.S. criteria?
How does the WHO updated guidance impact the U.S. Medical Eligibility for Contraceptive Use (US MEC)? The US MEC provides recommendations for the safe use of contraceptive methods by women with medical conditions or risk factors, including those at high risk for HIV and those living with HIV. This guidance is adapted from WHO's global guidance, explains Kathryn Curtis, PhD, an epidemiologist and women's health and fertility branch fellow in the WHO Collaborating Center in Reproductive Health at the Division of Reproductive Health in the Centers for Disease Control and Prevention (CDC).
When the WHO issues updates about the WHO global recommendations, CDC has a process in place to evaluate whether any changes to current US MEC guidance are warranted, says Curtis.
"We have initiated that process and, once it is complete, we will release a statement either confirming existing guidance or announcing any updated recommendations," states Curtis. [To receive e-mail updates on the US MEC, go to the CDC web page, http://1.usa.gov/y6alkp. Click on "Sign up to receive U.S. Medical Eligibility Criteria (USMEC) e-mail updates."]
Why add clarification?
Why was the clarification added? According to information from FHI 360, a Durham, NC-based global development organization, the evidence on whether the use of progestin-only injectable contraception influences contracting HIV is of limited quality and is not conclusive.3
"While recognizing these limitations, members of the WHO expert meeting remain concerned and want to ensure that women receive as much guidance as possible to prevent them from acquiring HIV," the FHI 360 information states. "Thus, they added a clarification to the current medical eligibility criteria rating of '1' (meaning that the product is approved without restriction), highlighting the importance of enhanced counseling on concurrent condom use and other HIV preventive measures for women at high risk of HIV infection."
Women at high risk of HIV can continue to use progestin-only injectables for contraception; however, providers must provide enhanced counseling to these women on the importance of correct, consistent condom use and other HIV preventive measures, such as knowing one's HIV status, knowing one's sex partner's status, diagnosis and treatment of other sexually transmitted infections, and reduction in number of sexual partners.
While about 3.2% of U.S. women who use birth control choose the shot, the method is widely used in Africa, where the risks for HIV are much greater.4 "In many sub-Saharan African countries, progestin-only injectable contraceptives, principally depot medroxyprogesterone acetate (DMPA), are the most commonly used contraceptive methods," states information from FHI360. "Injectables are widely used because they are effective, simple to administer, and available by community-based distribution."3
Better research needed
Much of the existing data on the subject of hormonal contraception and HIV risk is inconclusive, which leaves public health officials without a definitive answer to this important health issue. In its recommendation, the technical consultation states, "In considering the totality of available evidence, the group determined that currently available data neither establish a clear causal association with injectables and HIV acquisition, nor definitively rule out the possibility of an effect."1
The experts participating in the WHO consultation used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system to look at existing research, explains Ward Cates, MD, MPH, distinguished scientist and president emeritus at FHI 360, who chaired a session at the WHO meeting. Better studies with stronger designs are urgently needed, he notes.
"Observational studies are not going to be able to answer the question definitively. We need higher-quality studies, such as randomized controlled trials," says Cates. "Also, we need to continue to pursue multipurpose technology methods that can address protection against both unplanned pregnancy and sexually transmitted infections."
The New York City-based Population Council joins in the call for increased research on the multipurpose technology front. In a statement issued following the release of the WHO consultation, the Population Council said, "Today's announcement underscores the need for new, multi-purpose products that prevent both HIV and unintended pregnancy, and for new contraceptive methods that better meet the family planning needs of women in developing countries. The Population Council's Center for Biomedical Research is working on both."5
References
- World Health Organization. Hormonal contraception and HIV. Geneva, Switzerland, 2012. Accessed at http://bit.ly/x8icBb.
- Heffron R, Donnell D, Rees H, et al; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis 2012;12:19-26.
- FHI 360. Q&A — Hormonal Contraception and HIV. Fact sheet. Durham, NC, 2012. Accessed at http://bit.ly/z1UjvX.
- Guttmacher Institute. Facts on Contraceptive Use in the United States. Fact sheet. New York City, June 2010. Accessed at http://bit.ly/2Bzdq6.
- Population Council. WHO announcement on injectable contraception and HIV a responsible step forward. Press release. Accessed at http://bit.ly/w3Lswf.
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