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A Setback for HIV Prevention Trial: Getting People To Take the Medicine

Women didn’t take their preventative medications, even those proven to work, for fear of side effects

One of the HIV-prevention medications, a pill called Truvada (Lacy Atkins/San Francisco Chronicle/Corbis)
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In the fight against HIV, as with any complex disease, there are no miracles. There are advances that bring hope, but there are also struggles to keep up with the virus’ changes and to find strategies that truly work. Case in point: A trial among women in Zimbabwe, Uganda and South Africa to test medications that prevent HIV infection has failed, reports Elizabeth Lopatto for the Verge—and not because of the medication tested.

In this trial, the researchers were looking at preventative pills—Truvada and Viread, as well as a vaginal gel formulation of Viread. Truvada can reduce infection rates by more than 90 percent when people take the pill daily, as prophylaxis, reports Arielle Duhaime-Ross for the Verge. But even while recognizing the drug’s potential, experts were worried about how to get it to the right people. When the U.S. government’s encouraged doctors to offer prescriptions to all people at risk of infection, Duhaime-Ross wrote:

"We know that the medicine works, it's proven," says Jay Laudato, executive director of the Callen-Lorde Community Health Center, which provides healthcare to New York City's LGBTQ communities. "But what was shockingly missing from the government's announcement was ‘how do we integrate this drug into peoples' lives?' and into HIV prevention plans in general." He thinks the drug is a good fit for some people, but Laudato says it's not right for everyone who might be part of an "at-risk" group.

People who take injection drugs, for example, might not be able to take the drug every day. "If you're in the throes of substance use, you might not be a reliable person to receive a medication that requires daily adherence." And Laudato wonders where the homeless kids that frequent the center, many of whom partake in sex work, might keep a bottle of Truvada.

Those concerns were justified in the failed trial. Five thousand women were involved, and the researchers were surprised to find that the rate of new infection hit 5.7 percent — nearly twice as high as they expected, reports Jessica Berman for Voice of America. Blood tests for 650 women revealed that three months into the study most were not using their medication. The researchers published their findings in the New England Journal of Medicine.

For the Verge, Lopatto writes:

Those least likely to have used their medicine were single women under 25 — those who were at greatest risk. At some study sites, 10 of these women out of 100 were infected every year.

Women in sub-Saharan Africa are at a higher risk for HIV infection than women in other parts of the world, in part due to the high prevalence of infection there, difficulty negotiating condom use and vulnerability to non-consensual sex. More women than men are living with HIV in the region. Lopatto again:

[W]omen went to great lengths to pretend they were taking their pills, bringing back medicine for a practice called "reconciliation," where researchers count unused pills. In that process, 86 percent of medicine was "taken," though again, that didn't match with the blood plasma samples.

"This means that a large number of participants actively removed unused medications from their allotment before returning to the study site in order to create the appearance of compliance with the protocol," [Michael Saag, of the University of Alabama at Birmingham wrote in an editorial]. "The question that emerges is this: why did the participants go to such lengths to create the appearance that they were taking medications when they were not?"

The reasons for the puzzling deception appears to be fear—of the researchers and of the possibility of harmful side effects from the medicines, reports the New York Times. While the intent of the trial was not successfully realized, the study is a success in one regard: Researchers have now learned that trust is a problem they must address in these countries before they can properly fight the virus. The implications extend even farther than the geography of sub-Saharan Africa. People already hate taking pills, and daily medication can seem unnecessary.

“It’s really changed the way prevention studies, I think, are going to be done," the study’s lead author, Jeanne Marrazo of the University of Washington in Seattle, told Voice of America, "and it’s not just going to be for HIV, it’s going to be for anything that’s in very healthy people. Because really healthy people — you know how it is, you don’t really think bad things are going to happen to you until it’s too late, right?”

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