Study Explores New HIV Linkage to Care Model

According to the U.S. Centers for Disease Control and Prevention, MSM continue to be the group most heavily affected by HIV in the US; while they represent only two percent of the U.S. population, MSM account for nearly 67% of newly diagnosed HIV infections. That burden is even heavier for gay and bisexual African American men. The CDC reports that from 2005 to 2014, the number of new HIV diagnoses among young African American gay and bisexual men increased 87%. These troubling numbers highlight the need for a variety linkage to care models to ensure that these men regularly take their medication, see doctors, and ultimately, suppress their viral loads. In response to this need, The Fenway Institute is now recruiting for Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex with Men (MSM) in the United States, an innovative new study aimed at improving HIV treatment plans.

Study candidates are cisgender MSM who are living with HIV and are not virally suppressed. That may include people who have received a positive HIV diagnosis and have not followed up with a doctor, those who don’t know their HIV status, or people who have seen a doctor but not yet started taking HIV meds or following a care plan, explained Julian Dormitzer, Biomedical Project Manager at The Fenway Institute.

The study, also known as HPTN 078, is taking place in Boston, Baltimore, Atlanta, and Birmingham. It is designed to develop and determine the effectiveness of a combined HIV prevention strategy that includes a method to identify, recruit, and link MSM to HIV care, and an intervention to help HIV-infected MSM lower the level of HIV in their bodies to achieve and maintain viral suppression.

At the beginning of the study, participants will be randomly assigned to either a traditional HIV standard of care track or to the study intervention arm. Participants in the study intervention arm will work with a case manager trained to help the participant link to and remain engaged and active in HIV care, including health services navigation, pharmacy accompaniment, and antiretroviral therapy (ART) adherence counseling. To offer resources for assisting with care plans, participants will have the option to receive automated reminders for ART adherence and appointments through texts, phone calls, or email. The case managers will also be offering flexible meeting schedules to better fit care into each participant’s schedule.

“This model of case management intervention is more relaxed, client-driven, and nonintrusive,” Dormitzer said. “We’re looking to see if, when a patient is working more closely with a case manager equipped to meet their particular needs, they are more successful in suppressing their viral load.”

Two years after enrollment, researchers will compare how well the study of care groups and the intervention arm groups were able to achieve viral suppression.

“We already know that treatment as prevention works,” Dormitzer said. “It’s a win-win: the individual can remain healthy by staying on medication, and they’re making their community a little healthier by not unknowingly passing the virus on to someone else. We know we can end this epidemic and we know that we have the tools to do it.”

If you are interested in joining this study, please call or text 857.206.5178 to reach the study team.

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