In a new National Institutes of Health study, most gay and bisexual men who had fallen out of care were willing to re-engage in care. Furthermore, 91% were still in care at 12 months, and 48% of them were virally suppressed at 12 months. The new study, part of the HIV Prevention Trials Network (HPTN), was presented at the International AIDS Society (IAS) Conference on HIV Science in Mexico City on Monday, opening the door to a potential intervention that could be implemented to increase engagement in care and viral suppression among men who have sex with men (MSM) -- particularly in black communities.
"HPTN 078 highlights the willingness of people with unsuppressed HIV to engage in treatment when connected with HIV care services," said Dianne Rausch, Ph.D., director of the NIMH Division of AIDS Research. "The lack of difference in viral suppression between the standard care and case management arms underscores the effectiveness of the current standard of HIV care in the United States, but additional interventions appear necessary to further increase the proportion of people who maintain viral suppression."
Initially, there were 1,305 MSM screened for the study, and the vast majority, 80%, were in fact virally suppressed. But in order to meet the study criteria of MSM who were living with HIV and with detectable viral loads, the study enrolled 144 MSM participants in four U.S. cities (Atlanta, Baltimore, Boston, and Birmingham, Alabama). Eighty-four percent were black, 7% Latinx, and the average age was 39. Ninety percent had a high school diploma or more, 81% had health insurance, and 67% were unemployed; 64% had incomes below $20,000.
“We thought we were going to find a lot of people living with the virus who had not been previously diagnosed,” said Chris Beyrer, M.D., M.P.H., protocol chair of this study and professor of public health with Johns Hopkins University. “That is not the case.”
Eighty-six percent had been on antiretroviral therapy at some point in their diagnosis. The researchers noted that while they only sought to enroll MSM in this study, there were a few transgender women who responded to recruitment efforts and enrolled. But being only a few, there were not enough to make any conclusions regarding transgender women in this study. Researchers said they’d be exploring a similar study in trans women in the near future.
The participants were randomly assigned to one of two arms: a standard-of-care arm and an enhanced-case-management arm. The standard-of-care participants received existing supportive services, antiretroviral therapy initiation, and treatment/adherence support. The participants in the enhanced-case-management arm received three components: access to case management and referral services, motivational interview-based counseling, and automated adherence and motivational messages. Participants were able to choose the frequency of their engagement with case management, counseling, and automated messaging.
At the end of 12 months, 91% of all participants in both arms were retained in care, and 48% were virally suppressed -- and there was no difference between the standard-of-care and enhanced-case-management arms. Researchers also noted that it took a while to get to viral suppression -- only 28% had achieved viral suppression in three months, while slowly climbing to 48% by month 12.
During the presentation at IAS, Beyrer said that there may be several reasons why the enhanced-case-management arm did not perform better than the arm of participants who enrolled in standard of care. He cited that the case management intervention may not have provided enough distinct interventions over standard of care or perhaps was not enough to overcome structural barriers. He also noted that perhaps this group of MSM -- who faced challenges to engaging in care and getting virally suppressed -- may need medical case management by nurses as opposed to nonmedical case managers.
"We are encouraged to see that nearly half of participants whose HIV was unsuppressed at the beginning of the study had achieved and maintained viral suppression after one year. However, additional issues -- such as high levels of poverty, social factors like stigma, and individual-level factors including mental health and substance use -- must be addressed to achieve higher rates of viral suppression among disenfranchised men who have sex with men and transgender women in the United States," said Beyrer.
Beyrer also said the research team noticed high rates of antiretroviral drug resistance among MSM who did not achieve viral suppression, and the team will be publishing a paper in the future on these results after completing more data analysis.