Oct. 05 2015

A New Day for HIV Prevention in Harlem

ICAP Study Finds At-Risk Groups Embrace PrEP

A blue pill marked with the word PrEP rests on a man’s tongue. Accompanying text reads: “This pill is changing HIV prevention.” The bus shelter advertisement on 125th Street pitches PrEPor pre-exposure prophylaxis—commonly taken as the drug Truvada®. It was approved by the Federal Drug Administration in 2012 as another tool in the HIV prevention arsenal. But in some high-risk communities, PrEP has not yet made a difference in new infection rates.

With the goal of assessing the alternative dosing schedules for taking PrEP, ICAP, a major research center located at Columbia’s Mailman School of Public Health, conducted a study in Harlem. Sharon Mannheimer, associate professor of Epidemiology and Medicine at Columbia University Medical Center, presented the results at the International AIDS Conference in Vancouver in July and at a recent community event at the African Services Committee on West 127th Street.

Mannheimer and colleagues followed 179 black men who have sex with men (MSM) and transgender women enrolled in the study through ICAP’s Harlem Prevention Center. Participants were randomized to three groups: those taking the pill daily; those taking the pill twice weekly and once after sex; and those taking it before and after sex. Researchers measured adherence through self-reporting, blood analysis, and data from electronic pillboxes that record each time the box is opened. Overall, adherence was highest with the daily regimen, with 65 percent adherence compared with 46 percent in the second group, and 41 percent in the third.

Interviews with study participants provided clues into why the daily regimen won out. They spoke about the convenience of daily dosing, and difficulties with doses after sex, especially when the intermittent regimens were sometimes met with skepticism, distrust and an unwillingness of some partners to engage in sex after learning about another partner's PrEP use.

“Despite broad consensus among public health experts about the benefits of PrEP, the qualitative study results offer a glimpse into how stigma and other social barriers may impede adherence,” said Mannheimer, site principal investigator for the Harlem study, who also serves as chief of Infectious Diseases at Harlem Hospital Center. To address the problem, programs could work to disseminate information about PrEP and try to build social support for individuals taking PrEP.     

Overall the news is very good. The study showed that PrEP was feasible and acceptable in Harlem among at-risk groups, including black MSM who make up the group most heavily impacted by HIV in the U.S. “This community is disproportionally affected by HIV,” said Mannheimer. “These results are especially important in demonstrating that this population can adhere to PrEP when given access to it.”

The Harlem study, known as HPTN 067, is part of a larger National Institutes of Health-funded Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking or ADAPT study. In the two other research sites of ADAPT, researchers looked at PrEP regimens for young heterosexual women in Cape Town, South Africa, and MSM and transgender women in Bangkok, Thailand. PrEP adherence was similar between New York and Cape Town but higher in Bangkok. Ongoing and upcoming ICAP research in Harlem and the Bronx is looking at other forms of PrEP, including an injectable option and monoclonal antibodies.

While recent studies show that PrEP can reduce HIV rates by 86 percent, it’s not quite enough to end AIDS yet, Mannheimer cautions. “There are still issues around side effects, adherence, access, and stigma,” she says. But as researchers work with community members to solve these problems, the message on the bus shelter holds true: PrEP is changing HIV prevention.