Dr. Marya Gwadz' NIDA-Funded HIV Intervention Optimization Study Finds New Home at NYU Silver
When Dr. Marya Gwadz joined the NYU Silver faculty as Associate Dean for Research and Professor in September 2018, she brought with her a $5.8 million National Institute of Drug Abuse-funded study (R01DA040480) using the multiphase optimization strategy (MOST) framework to optimize an intervention for vulnerable populations living with HIV (PLWH). The five-year study, now in its third year, aims to develop a highly efficacious, efficient, scalable, and cost-effective intervention to foster engagement along the HIV care continuum for Black and Latino PLWH who rarely attend HIV primary care appointments and are not taking HIV antiretroviral therapy (ART).
The study, developed with Co-Principal Investigator Dr. Linda M. Collins, the original developer of MOST, is the first application of the MOST framework in the field of HIV treatment and prevention. “MOST is one of the first major innovations in intervention science in 30 years,” explained Dr. Gwadz. “MOST is an engineering-inspired framework for developing efficient interventions that can be ‘optimized’ to meet certain constraints, such as time and cost. We can also create multi-component interventions with no inactive, poorly performing, or counter-productive elements. Unlike the classical approach to intervention evaluation, where a multi-component intervention is tested as a package in a randomized controlled trial, MOST optimization trials identify the most efficacious combination of components, so there is no waste of time or resources when the optimized multi-component intervention is later implemented in clinical settings.”
The study is evaluating five distinct components drawn from an intervention called “Heart to Heart” (HTH), which Dr. Gwadz and her research team developed to mitigate the individual-, social-, and structural-level barriers to HIV care and ART use that Black and Latino PLWH most commonly experience. Dr. Gwadz previously evaluated HTH in a developmental randomized controlled trial, funded by the National Institute of Mental Health, which found that the intervention was not only acceptable and feasible but also highly efficacious, yielding substantial improvement in ART adherence and reductions in HIV viral load, even after the intervention concluded.
According to Dr. Gwadz, Black and Latino PLWH who avoid HIV care and have declined to take ART “have a really potent confluence of barriers” to doing so. “Just at the individual level,” she said, “there are often substance use and/or mental health challenges that make HIV less of a priority for them. Poverty also plays a role; systems are hard to navigate when you are poor. And then, for many, medical distrust is a huge factor. Furthermore, I think we lose sight of the fact that it’s hard for anyone to take medication for a chronic, stigmatized condition on a daily basis.”
She added that unintended consequences of public health policy also appear to be playing out for the study population. “The good news is that everyone who is HIV-positive in New York State now has access to HIV medication and there are robust systems to get people to take that medication. But the bad news is that some people who aren't ready, or have mental health issues or substance use issues, feel pressured out of HIV care because there is not much room for those who aren't taking medication.” To communicate to participants that the study is specifically designed for those struggling with HIV care and ART, she said, the study’s tagline is “no pressure, no judgment.”
The five components Drs. Gwadz and Collins are studying to address barriers to HIV care and treatment are: individual counseling sessions; pre-adherence preparation to build strong adherence habits; peer mentorship; focused support groups; and patient navigation to ancillary services. All study components are culturally salient and grounded in the motivational interviewing counseling approach. The study uses an innovative fractional factorial design to evaluate the components, with participants being randomly assigned to one of 16 conditions. Each condition is comprised of an empirically chosen permutation of the components, and most of the conditions offer three or four components. Dr. Gwadz noted, “factorial and fractional factorial designs are highly efficient, and the sample size needed for studies using the MOST framework are similar to a two-arm randomized controlled trial.”
While having a design with 16 intervention conditions is new for this research team, Dr. Gwadz said it is manageable for the research study staff members. “Using the MOST framework is exciting to us as interventionists. I love that we are advancing intervention science and also developing the most efficient and efficacious intervention possible for this challenged population.”.
Dr. Gwadz said the components are designed to ask participants questions they may never have been asked before, and to think about their relationships with HIV and ART in new ways. “For example, in one-on-one counseling sessions, we have videos that put issues on the table about race/ethnicity and social class and how they might influence healthcare engagement. We let them know it is okay to express counter-narratives about the causes of HIV. We have them explore their relationships to HIV and to antiretroviral therapy to get at the emotions that underlie healthcare decisions, because for many, the factors driving these decisions and behaviors are not rational, but emotional.”
In the focused support group component, Dr. Gwadz said, participants get to be in a room with other people not taking medication and talk about why. “This is useful,” she explained, “because PLWH experience stigma associated with not taking antiretroviral therapy from friends, family, and health care providers. There is a lot of pressure and a lot of shame. Further, they are often lonely and isolated, so we encourage them to make connections and build relationships with peers who can understand and support them. And, the groups talk about why PLWH don’t take medications, which is not a major topic of most support groups in social service and clinical settings. We find that talking openly about the factors that impede taking medications can often free people up to examine their health care decisions and make different decisions. Last, across all components, we don’t presume to know whether taking antiretroviral therapy is right for that person, but respect them as the ultimate expert on their own health.”
Dr. Gwadz noted that one of the reasons she and the study team are so excited that the study is now at NYU Silver is that the school and the study both interface with problems at the larger, structural level. “We want to be in a community of people who understand what it means to live in poverty, who understand that individual health behavior is embedded within and influenced by social networks and systems, and also how hard it is to change behavior. Other disciplines, I think, don't grapple with those issues as much as social work does. Our team is also influenced by the thinking of the anti-racist movement, which I was introduced to by social workers, and that is led by social workers. NYU Silver and social work as a profession have a lot to offer public health in terms of bringing the complexities of human behavior change and systems to bear in the research questions we address.” Dr. Gwadz added that she is optimistic that the NYU Silver environment and her new colleagues there will help advance the impact of her work, by supporting her to identify ways that research findings can influence or change the policies, practices, and structures that create health inequalities in HIV and other health and mental health conditions.