ICAP’s Harlem Prevention Center (HPC) is launching two studies that address the HIV epidemic in the population most deeply affected in the US—men who have sex with men (MSM). More than half of new HIV infections in the US occur in MSM, and black MSM are disproportionately impacted, with an HIV prevalence in some studies of 28 percent as compared to 19 percent in MSM overall.

The STAR Study—short for “Seek, Test, and Retain: Linkages for Black HIV+, Substance-Using Men Who Have Sex with Men”—is a randomized controlled trial led byICAP Director Wafaa El-Sadr, and Sharon Mannheimer, Chief of Infectious Diseases at Harlem Hospital. STAR sets out to test innovative methods to engage Black MSM in HIV testing and, for those found to be HIV-infected, to assess two methods for linking them to HIV primary care. STAR plans to recruit an estimated 2,200 men through a method called respondent-driven sampling, in which participants receive an incentive to refer a limited number of other men for possible enrollment in the study. “This strategy mobilizes the power of social influence to engage people who would benefit from HIV counseling and testing, but are not reached by conventional recruitment methods,” explained Dr. El-Sadr.

Two hundred STAR participants identified as HIV-infected will then be randomly assigned to one of two interventions—peer navigation and financial incentives—to link and retain them in HIV primary care. Both interventions have been shown to improve patient engagement at different points along the continuum of HIV primary care, but neither has been evaluated as a linkage and retention strategy for Black MSM. STAR will compare the relative effectiveness of the two interventions and their cost effectiveness.

The second study at the Harlem Prevention Center aims to further the understanding and best practices of a pre-exposure prophylaxis (PrEP) regimen to prevent HIV infection. On May 10, the Antiviral Drug Advisory Committee to the US Federal Drug Administration recommended that the antiretroviral Truvuda® be approved in the US as a pre-exposure prohphylaxix (PrEP) that prevents HIV infection in adults at high risk for sexual acquisition of HIV including at-risk MSM. The promise of an effective biomedical tool to strengthen approaches to HIV prevention raises the persistent question of how best to support medication adherence, upon which the effectiveness of PrEP depends.

In the HPTN 067 ADAPT Study (“Alternative Dosing to Augment PrEP pill-Taking”), supported by the NIH-funded HIV Prevention Trials Network (HPTN), researchers at the Harlem Prevention Center will evaluate the pharmacokinetics and feasibility of different dosing schedules of Truvada® for PrEP to prevent HIV infection. As an important step towards answering questions about supporting medication adherence, the HPTN 067 ADAPT Study will evaluate PrEP coverage in instances of possible exposure to HIV; reported symptoms and side effects of PrEP; medication adherence; and HIV-risk behaviors under three different dosing schedules: daily, twice-weekly, and around the time of sex. The study will also provide important new information about how tests for drug in the blood may be used to monitor use of PrEP, and how to improve the reliability of self-reporting of pill taking. The Harlem Prevention Center aims to enroll 180 MSM from New York City in this study.

“ADAPT presents a unique opportunity to gain a deeper understanding of the complexities and barriers to remain adherent to PrEP. We hope this study will shed light on ways to address adherence challenges in this critical population,” said Dr. Sharon Mannheimer, the primary site investigator.

Both the HPTN ADAPT and STAR Studies are conducted in partnership with community-based organizations in Harlem, and will take place over the next year.

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