One of the participants in powerful new research into how clinicians can better serve highly marginalized individuals with HIV gave NYU researchers a sense of their everyday struggles: He punctures the foil top on his medication bottle as soon as he gets it, making it worthless in the black market for pharmaceuticals. While he could have used the $125 or so that he could get from a disreputable pharmacy, he was determined not to impede his goal of achieving an undetectable HIV viral load level.
“Most of those who enrolled in our research projects live on the razor’s edge of poverty,” explains Professor Marya Gwadz associate dean for research at NYU Silver and director of the school’s Intervention Innovations Team who led the study—called Heart to Heart—aimed at increasing overall HIV medication uptake among those living with HIV who face serious impediments to doing so. “They are not always in a place where HIV can be their priority.”
Gwadz, a psychologist, and her team of master’s-level mental health professionals and researchers were still able to recruit hundreds Black and Latino persons of low socioeconomic status and unsuppressed HIV viral levels into the research study, conducted from a clinic in Manhattan’s Union Square. The goal was to determine the best behavioral-therapeutic components for increasing rates of HIV viral suppression in this population, with the knowledge that not all persons living with HIV are able or may even wish to do so.
Six different intervention components were tested, based on existing evidenced-based strategies; they were modified using a conceptual model Gwadz’s team developed, tailored to this hard-to-reach and understudied cohort’s particular impediments to HIV care and medication use. The model, called the Intervention Innovations Team Integrated Conceptual Model—or the IIT-ICM, for short—blends critical race theory and harm reduction and self-determination approaches, showing that a person’s health issues, such as falling short of HIV viral suppression, are the downstream effects of upstream structural factors such as poverty, according to Gwadz. That is a fundamentally de-stigmatizing message, she says, along with being more accurate than placing the source of health problems at the feet of the individual.
The results of Heart to Heart are so far encouraging, according to Gwadz, with 40% of the 512 study participants showing suppressed HIV viral loads during the course of their approximately one-year enrollment in the study. The team does not expect that all the components are needed to increase the rates of HIV viral suppression. So, compatible studies are planned to uncover the most cost-effective combination of intervention components for clinicians to use in clinical and social service settings.
“The US public health system wants to end the HIV epidemic by 2030,” noted Gwadz. “We can’t do that without bringing these people who face the greatest barriers onto the HIV care continuum.”
NYU News spoke with her about her research with respect to the national goal:
Why did you focus on this particular subpopulation?
Experts have shown that HIV travels along the “fault lines” of society—mainly related to poverty, racial and other forms of discrimination, and stigma. So, currently most people living with HIV or who contract HIV are Black and Latino, with sexual minorities overrepresented compared to their numbers in the general population. The reasons for this are not due to risky individual behavior, but rather to societal factors. I’m interested in understanding and disrupting that glaring problem.
You went as far as to set up a research clinic to facilitate this study, “Heart to Heart”?
Studies that test behavioral interventions are found at a community-based social services organization or a health center typically—or they can be located in their own space where both the research and clinical intervention components are carried out. Our project was in a shared space in an NYU-operated building near Union Square. It was the result of a pragmatic decision, as a wing was available where we could create an environment that communicated our study’s ethos of supporting personal decisions, dignity, and respect.
People with HIV who are not taking medication face a lot of pressure to do so, and may feel shame and stigma when they don’t. Generally, they do not feel their personal health decisions are heard or respected in service settings. We knew we needed to address these types of issues to engage people in the study and do good work together to help them achieve their best possible health status, whether that meant taking HIV medication or not. Our research staff ensured the participants got the message from the minute they walked in the door that their personal choices would be respected and they would not be pressured to make certain decisions about medications or their health.
Further, members of this population tend to be wary of research for a number of reasons including past mistreatment of populations of color in medical research, which resonates with present-day structural racism and inequality. We wanted to counteract that through the ethos of the study, in addition to the specific intervention components we tested.
Even so, many participants were unable to reach HIV viral suppression while enrolled in the study, or chose not to, but this was never a bar to their participation. Many participants in Heart to Heart have since told us that they wished their time in the project did not have to end. For me personally, the experience of carrying out the study was one of the most profound of my life.
How did this study come about?
We designed it to measure the effects of individual behavioral intervention components designed for African American/Black and Latino persons who were not taking HIV medication at high levels and did not have HIV viral suppression at enrollment. In all, we enrolled 512 participants, who engaged with us for a year and were assessed at four points in time--a quantitative study, or optimization trial grounded in the multiphase optimization strategy framework. We looked for what most is cost-effective with respect to increasing HIV viral suppression in this subpopulation.
We also wanted to know about participants’ perspectives on the components—what was helpful to each of them and why—and hear individuals’ perspectives on their lives, which were dominated by issues such as poverty, unstable or poor-quality housing, social isolation, and mental health and drug use problems. So, we used qualitative research methods to address those questions and carried out in-depth, semi-structured interviews with of 46 of the 512 participants. The result was our most recent published paper.
You wrote that individuals who are not well-engaged in HIV care face major barriers.
These barriers to HIV care and medication can include chronic poverty, structural inequality, life stress, social isolation, unstable or poor-quality housing, mental health distress, substance use challenges, and distrust of medical settings, among others. Transportation, even just affording public transportation, is a common impediment to care.
Understandably, such factors also make it difficult for research studies to locate and engage them. Being part of a research study is not necessarily a priority for people struggling with these types of serious challenges. Under our eligibility criteria, subjects needed to be between 18 and 65 years of age, African American/Black or Latino, have a diagnosis of HIV within at least six months and a pattern of poor engagement with HIV care. They also did not evidence HIV viral suppression, based on a lab report. The participants also had to live in New York City and be able to carry out activities in English or Spanish. We used a range of recruitment strategies. In the end, participation rates in assessments and intervention activities were very good. Once participants knew us, they kept coming back. This was supported in part by financial compensation for study activities. But the study’s ethos and the intervention components, both of which participants said were different from what they experienced in other settings they engaged in, contributed to the high retention rates as well.
What behavioral intervention components specifically were tested?
The components consisted of: health education; navigation to health care and mental health care and substance use treatment; motivational counseling (i.e., a discussion of health beliefs, goal-setting, and how to foster intrinsic motivation for behavior change); focused support groups; peer-to-peer mentorship; and adherence skill-building and habit formation.
Each component addressed a specific obstacle to reaching HIV viral suppression, grounded in our conceptual model, the IIT-ICM, and intended to be both culturally and structurally salient. Each also used a specific set of evidence-based behavior change strategies. While the strategies were not new, the IIT-ICM allowed us to tailor the components to African American/Black and Latino persons living with HIV.
In the design of the quantitative study, participants were randomly assigned to one of 16 experimental conditions, comprised of a unique combination of components. Most participants received 2-to-4 components over a 4-to-8-month period, in a fractional factorial design that was an innovation used in our research..
Another innovation was the use of the multiphase optimization strategy or MOST framework. MOST is an engineering-inspired way to test the effects of individual intervention components, in contrast to the classical approach of testing multi-component interventions against a control in a randomized controlled trial. The person who first developed MOST, Linda Collins, is a professor at the NYU School of Global Public Health, and her moonshot goal is to make MOST the way interventions are developed by 2030. Dr. Collins is also a co-Principal Investigator with me on Heart to Heart. I am involved with her Center for Advancement and Dissemination of Intervention Optimization at NYU.
When you look for a way to reach these and other marginalized populations, might it mean trying to ensure that more social service providers focus on structural and cultural barriers to encourage clients to reflect on their lives and consider change?
Our conceptual model enabled us attend to some of the fears, feelings of distrust, and beliefs that African American/Black and Latino participants brought to their HIV management. When we can understand why people feel, say, a distrust of their medication, it informs our efforts. So, we encouraged people to talk about thoughts and feelings about HIV management—the good, the bad, and the ugly. It prompted us to support participants’ autonomy and decisions, and cleared the way for delivery of services that were ultimately dignity-enhancing. Participants told us that our approach and ethos were different than what they experienced in typical social service settings where, as one put it, they felt treated “like a number.”
We think most efforts to encourage people to take HIV medication, adhere to medication, and achieve viral suppression may focus too much on how to take medication, and not enough on the structural and contextual factors, as well as attitudes and emotions, that get in the way of doing so.
Health centers probably do an excellent job for most persons living with HIV, and more than half of people living with HIV in this country engage in care and have viral suppression. We are focused on the group of individuals whose needs are not well met in these settings. We think the reasons their needs are insufficiently met are largely due to structural and organizational challenges, such as large caseloads or inadequate numbers of providers, not because providers are not well-trained, capable, and willing to provide the highest quality care. Our interventions are designed for the subpopulation with these particular barriers to HIV care, and to complement the medical encounter.
Yet participants, you write, sometimes show deep distrust of systems of public care and research. How do you deal with that?
We handle distrust by being explicit about our stance—we believe HIV medication is one’s best chance for a healthy life but we are willing and able to discuss counter-narratives (sometimes called “conspiracy theories”) and hear from participants about their fears and concerns, without agreeing or disagreeing with them. Also, people can hold counter-narratives and still engage in HIV care and take HIV medication.