“Clinics that treat sexually transmitted infections (STIs) in a ‘real-world’ setting are promising sites to deliver PrEP for HIV,” said Michael A. Kolber, M.D., Ph.D., professor and Vice Chair for Clinical Affairs in the Department of Medicine at the University of Miami Miller School of Medicine. Kolber is also Clinical Director of HIV for Infectious Diseases, and Director of the Comprehensive AIDS Program. “Our study found a high level of engagement and compliance with the PrEP program,” he said.
The study, “Effect of Pre-exposure Prophylaxis for HIV Infection Integrated with Community Health Services,” assessed PrEP adherence, sexual practices and incidence of STIs and HIV infection among men who have sex with men, and transgender women in San Francisco, Miami and Washington, D.C. Kolber was co-Principal Investigator for the study.
Men who have sex with men account for more than two-thirds of new HIV infections in the United States, according to the researchers. While previous randomized clinical trials have demonstrated the ability of PrEP to prevent HIV infection, little has been known about adherence to the PrEP regimen, sexual practices and overall effectiveness when PrEP is implemented at community-based clinics, said Kolber.
“Our study found that 78.5 percent of the 557 participants in the three cities continued to participate throughout the 48-week PrEP demonstration project,” Kolber said. He added that the preventive treatment was highly effective, as only two of the participants developed HIV – one who did not take the medication regularly and another who tested HIV-positive four weeks after the study ended.
The PrEP clinic project enrolled participants from two municipal STI clinics in San Francisco and Miami and at a community health center in Washington from October 2012 through January 2014 with final follow-up in February 2015. PrEP was provided free of charge to participants for 48 weeks. Patients also received HIV testing, brief client-centered counseling and clinical monitoring throughout the study. Sexual behaviors were assessed by questionnaire.
Kolber noted that about 80 percent of participants in the Miami clinic were African-American or Hispanic, while a majority in San Francisco and Washington were non-Hispanic whites. “Our participants were also younger and were more likely to be uninsured than participants in the other two cities,” Kolber said. “Whatever the reason, the Miami participants were less likely to take their medication as frequently as at the other sites.”
Adherence was higher among participants with more reported risk behaviors, according to the study. “These results provide support for expanding PrEP implementation in men having sex with men in similar clinical settings and highlight the urgent need to develop effective adherence support for African-American, Hispanic and transgender populations,” Kolber said. “We are continuing to educate providers about the effectiveness of PrEP in preventing HIV transmission.”
University of Miami