Research by recent USC clinical fellow Jessica Maria Atrio, MD, has demonstrated that a safe but less-frequently prescribed birth control "mini-pill" is effective for women taking HIV medications. This data may help U.S. and global health authorities update their influential recommendations about contraception for women with HIV.

HIV-positive women need birth control for family planning and health considerations, but antiretroviral drugs that suppress the HIV infection can also block the contraceptive function of the most commonly used type of birth control pill. This may increase the risk of unplanned pregnancy, said Atrio, a former fellow in the Department of Obstetrics and Gynecology at the Keck School of Medicine of USC.

Jessica Maria Atrio, MD

The more widely used type of birth control pill combines the hormones estrogen and progestin, while the less common mini-pill contains only progestin. The single-hormone pill is considered to be extremely safe and nearly as effective, but doctors around the world have been reluctant to prescribe it, following guidelines by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC).

Both health authorities currently recommend use of the mini-pill only in very limited circumstances for HIV-positive patients, based on concerns that HIV medications might also interfere with the mini-pill, said Atrio.

But the drug interaction concerns had not been fully researched. "It wasn't a matter of them having data suggesting problematic drug interactions," said Atrio, now assistant professor at Montefiore Hospital & Albert Einstein College of Medicine. "They simply didn't have the data to be able to say it was safe to take these drugs together."

Support for an early-career researcher

Atrio decided to provide the needed data. But as a clinical fellow not long out of her medical residency, she had never conducted a prospective study with human participants before.

"It was a tremendous undertaking for me at that point," she said. "I had only done retrospective research up to then, so this would be my first foray as a principal investigator in research that was more rigorous and translational in nature."

"I couldn't have conducted the study without the support of the SC CTSI," said Atrio. "It required a degree of sophistication I simply had no ability to do on my own."

Atrio's mentors in Keck's Department of Obstetrics and Gynecology steered her to the Southern California Clinical and Translational Science Institute (SC CTSI), which supports health and medical researchers at USC, Children's Hospital of Los Angeles, and their regional partners through a broad range of services.

"I couldn't have conducted the study without the support of the SC CTSI," said Atrio. "It required a degree of sophistication I simply had no ability to do on my own."

For example, she said, Anthony El-Khoueiry, MD, director of Clinical Translation at SC CTSI, advocated for the project and addressed ethical considerations. Wendy Mack, PhD, director of SC CTSI Biostatistics and Bioinformatics Resources and professor of biostatistics in the Department of Preventive Medicine at the Keck School of Medicine of USC, advised Atrio on sample size calculations.

SC CTSI also provided regulatory review as well as informed consent and HIPPA forms for the project. In addition, nurses in the Clinical Trials Unit at USC assisted with the hands-on work with study participants, including blood sample draws and laboratory analysis. 

Protecting the health of women with HIV

Atrio's project studied the interactions between the progestin-only pill and two of the antiretroviral drugs, such as protease inhibitors, that HIV patients take to stay healthy. The research showed that the HIV medications not only don't lower the amount of birth control hormones, but may actually enhance the mini-pill's effectiveness by increasing hormone levels.

Worldwide, HIV is the number one cause of death among women 18 to 45, according to the WHO. Because of their serious and complex health concerns, HIV-positive women must take particular care with the decision to have children.

The majority of women who have HIV live in countries where their access to medical care is limited, particularly sub-Saharan Africa, where women and girls comprise 58% of people with HIV.

"These women face a large burden of mortality from pregnancy and childbirth, so they don't want to risk an unplanned pregnancy," said Atrio. "A lot more HIV-positive women could potentially benefit from the mini-pill."

Atrio hopes her findings will help the WHO and CDC broaden their future recommendations on use of the progestin-only pill, enabling health care providers to prescribe it to more women on HIV medications.

Atrio's article on the study, titled, "Effect of protease inhibitors on steady state pharmacokinetics of oral norethindrone contraception in HIV infected women," was recently published in the Journal of Acquired Immune Deficiency Syndromes.

View the research poster

SC CTSI is part of the 62-member of the Clinical and Translational Science Awards (CTSA) network funded through the National Center for Advancing Translational Sciences (NCATS) at the NIH (Grant Number UL1TR000130). Under the mandate of “Translating Science into Solutions for Better Health,” SC CTSI provides a wide range of services, funding, and education for researchers and promotes online collaboration tools such as USC Profiles.related