An intervention to increase engagement with treatment among African-American/black and Hispanic people living with HIV has been funded by the National Institute on Drug Abuse, a part of the National Institutes of Health. The study will target people who are neither taking antiretroviral therapy nor consistently engaged in HIV primary care.
Linda M. Collins, director of The Methodology Center at Penn State, and Marya Gwadz, New York University Rory Meyers College of Nursing Senior Research Scientist, have received a five-year $5.8 million grant to design this intervention using a pioneering engineering-inspired framework - the Multiphase Optimization Strategy (MOST) -- developed by Collins.
"At least half of people living with HIV in the U.S. are neither sufficiently engaged in HIV primary care nor taking antiretroviral therapy," said Gwadz. "In particular, African-American/black and Hispanic people are less likely to be well engaged along the HIV care continuum than their white peers, and as a result, have lower rates of HIV viral suppression, greater morbidity, and earlier mortality from HIV."
The MOST framework is a means of assessing the performance of individual intervention components and their interactions, in contrast to the "classical" approach of testing a packaged multi-component intervention against a control.
This is the first study to apply the MOST framework in the field of adult HIV treatment and prevention, and also the first study to include a cost-effectiveness analysis as one aspect of the optimization process.
To this end, the goals of the proposed intervention are threefold. First, the researchers seek to identify which of five intervention components contribute meaningfully to improvement in the primary outcome, viral suppression, and in secondary outcomes: absolute viral load, antiretroviral therapy adherence, and engagement in HIV primary care. All outcomes will be assessed via objective biomarkers or through the medical record.
Second, they look to identify mediators and moderators of the efficacy of each intervention component (e.g., substance use history, sexual minority status), and also of interaction effects between components.
And finally, by using a mathematical modeling approach led by Scott Braithwaite, director of the division of comparative effectiveness and decision science at New York University Langone School of Medicine, they seek to build the most cost-effective and efficient intervention package from the components found to be efficacious in the first goal.
"These gaps in the HIV care continuum signal the need for culturally targeted interventions to reduce racial/ethnic health disparities, eliminate forward transmission of HIV, and decrease healthcare costs, consistent with the high-priority research areas recently designated by the NIH Office of AIDS Research," said Collins, also a Distinguished Professor of Human Development and Family Studies at Penn State. "But we need new methodological approaches to these serious problems."
The necessity of potent interventions for this cohort has become increasingly apparent to public health researchers and other stakeholders over the last several decades, particularly for people of color living with HIV who suffer a unique set of barriers to engagement in the current HIV care continuum.
"The reasons that people of color are less likely to be well engaged along the HIV care continuum stem from a variety of factors -- alcohol or drug use problems, distrust of medical settings and medications, fear of side effects, stigma associated with HIV, and others -- both historical and cultural," said Gwadz. "Further, these barriers are grounded in and complicated by low socio-economic status."
Gwadz is also affiliated with NYU Meyers' NIDA-funded Center for Drug Use and HIV Research. Braithwaite is also Tenured Professor of Population Health and Medicine.
The study includes co-investigators Charles M. Cleland and Noelle R. Leonard, affiliated with NYU Meyers' Center for Drug Use and HIV Research; and Leo Wilton, professor of human development, Binghamton University.