Novel behavioral intervention improves treatment outcomes for HIV-infected individuals who have previously delayed, declined, or discontinued antiretroviral therapy

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Novel behavioral intervention improves treatment outcomes for HIV-infected individuals who have previously delayed, declined, or discontinued antiretroviral therapy

Up to 60% of persons living with HIV (PLHA) in the U.S. are neither taking antiretroviral therapy (ART) nor well engaged in HIV primary care, with racial/ethnic minorities more likely to experience barriers to engagement along this HIV continuum of care than their White counterparts. In fact, only 30% of persons living with HIV/AIDS (PLHA) in the United States have achieved “viral suppression,” the ultimate goal of HIV treatment. Indeed, PLHA poorly engaged in HIV primary care and/or who are not on ART are at elevated risk for a host of poor outcomes, including more frequent hospitalizations, lower quality of life, and even earlier mortality, and also run a greater risk of transmitting HIV to their partners. Further, poor engagement in HIV care and lack of ART initiation with good adherence are major drivers of high health care costs among PLHA.

However, for a substantial proportion of the population of PLHA in the United States, barriers to ART initiation with good adherence and HIV care are complex and serious. Among African American/Black and Latino PLHA, these barriers include fear of side effects from ART, medical mistrust, difficulties managing the emotional aspects of HIV/AIDS treatment, low self efficacy regarding the ability to manage adherence, “competing priorities” arising from substance use problems and mental health distress, and fear of social stigma – all complicated by low socioeconomic status. There is an urgent need, therefore, for potent and sustainable behavioral interventions to improve outcomes along the HIV continuum of care for the nation’s most vulnerable PLHA.

To this end, researchers from the Center for Drug Use and HIV Research (CDUHR) at New York University College of Nursing (NYUCN) explored a novel behavioral intervention targeted to PLHA from African American/Black and Latino racial/ethnic backgrounds who were not taking ART and often not well engaged in HIV care, recruited mainly though peers, as this group is not found in substantial numbers in hospital-based HIV clinics.

The study,”Behavioral intervention improves treatment outcomes among HIV-infected individuals who have delayed, declined, or discontinued antiretroviral therapy: A randomized controlled trial of a novel intervention,” published in the journal AIDS and Behavior, explored the feasibility, acceptability, and evidence of efficacy of a new multi-component intervention for these groups. Through the framework of the Theory of Triadic Influence, a multi-level social-cognitive theory focused on three “streams of influence” (individual-, social-, and structural-levels of influence), researchers developed a set of components to ameliorate the barriers to HIV care and ART use most commonly experienced by these groups. The intervention’s main counseling approach was Motivational Interviewing (MI), a flexible, collaborative counseling method that actively engages, focuses, and guides participants in order to elicit and strengthen intrinsic motivation for behavior change. The intervention, called “Heart to Heart,” was culturally targeted to this population, and intervention components were also individually tailored to the needs of each participant. The study was conducted by the New York University College of Nursing (NYUCN), Mount Sinai Beth Israel Medical Center, and Mount Sinai St. Luke’s-Roosevelt Hospital Center.

“This is a novel ‘pre-adherence’ intervention designed for those who are not appropriate for most adherence programs and services, because they have refused or do not believe they are ready for ART. Heart to Heart is unique in its focus on the underlying emotional, social, and attitudinal barriers to ART and HIV care, including fear and mistrust, which act simultaneously to reduce initiation and adherence to ART and engagement in HIV care,” said Marya Gwadz, PhD, Senior Research Scientist at NYUCN and the study’s Principal Investigator. “These individuals are generally opposed to the idea of going on ART, and even afraid to do so, and as a result they avoid HIV care because they don’t want to discuss ART with their health care providers, or have to explain, once again, why they are not on these life-preserving regimens.”

“The challenge for us as interventionists was to develop an approach to engage participants in an examination of this important decision they were making, and to have them on the one hand unpack the barriers and fears they experience, and on the other hand, the fact that for most people ART is their best chance for a long and healthy life,” said Liz Applegate, MPH, the project’s coordinator. “The Motivational Interviewing approach was a vital part of engaging participants in this challenging personal evaluation. The overall goal of the intervention was to develop durable, high quality intrinsic motivation for behavior change. In keeping with that approach, the project’s tagline was ‘No pressure, no judgments,’ which set a positive tone for wary participants.”

The intervention was comprised of three individual sessions; up to five focused support groups with other participants, co-led by a trained facilitator and a “successful” peer who was taking ART with good adherence and well engaged in HIV care; and individualized patient navigation for 12-24 weeks depending on the participant’s need. “Participants wanted to hear about these issues from their peers who had been there, who had struggled with this decision themselves, gone through the same apprehensions, and who had gotten over the mountain and were doing well on ART and making their HIV care appointments regularly,” said Dr. Noelle R. Leonard, a study Co-Investigator. “This was one of the most successful aspects of the intervention.”

The study’s primary aim was to examine the acceptability and feasibility of procedures and the intervention components, and explore evidence of intervention efficacy on two primary endpoints: ART adherence, evaluated via ART concentrations in hair samples, and viral load suppression from medical records. “The assessment of adherence based on ART concentrations in hair samples is an innovative and feasible way of taking a look at patterns of medication-taking over a period of time, lending a greater deal of precision and detail to behavioral studies such as this,” said Dr. Monica Gandhi, a study collaborator.

This was a small study designed to explore intervention components and refine procedures. The study’s participants (N=95) were African American/Black and Latino adult PLHA with CD4 <= 500 cells/mm3 not taking ART, randomized 1:1 to intervention or control arms, the latter receiving treatment as usual.

The intervention was found to be feasible and acceptable. Eight months post-baseline, intervention participants tended to be more likely to evidence “good” (that is, 7 day a week) adherence assessed via hair sample analysis (60% among intervention arm participants vs. 26.7% among controls), and also had lower HIV viral load levels based on the medical record than controls, at a statistically significant level (a difference of 0.88 log10 viral load), both large effect sizes. Thus the intervention components were highly promising, and merit further study with this vulnerable population.

“Interventions to support ART initiation and continuation are vital, for individual PLHA, their loved ones, and the public health,” notes Dr. Charles Cleland, a study Co-Investigator. “Although this was a small study, the intervention demonstrated efficacy with a large effect size on the most critical HIV endpoint, viral load suppression, assessed with objective biomarker data. We believe this study sheds light on new approaches to addressing ART adherence - the ‘Achilles’ heel’ of HIV treatment.”

**Paper Title: “Behavioral intervention improves treatment outcomes among HIV-infected individuals who have delayed, declined, or discontinued antiretroviral therapy: A randomized controlled trial of a novel intervention.”

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Researchers and Affiliations: Marya Gwadz1; Charles M. Cleland1; Elizabeth Applegate1; Mindy Belkin1; Monica Gandhi2; Nadim Salomon3; Angela Banfield1; Noelle Leonard1; Marion Riedel4; Hannah Wolfe5; Isaiah Pickens1; Kelly Bolger1; DeShannon Bowens1; David Perlman6; Donna Mildvan6; and the Heart to Heart Collaborative Research Team

1Center for Drug Use and HIV Research (CDUHR), New York University College of Nursing, New York, NY; 2Division of HIV/ AIDS, Department of Medicine, University of California San Francisco (UCSF), San Francisco, CA; 3Peter Krueger Center for Immunological Disorders, Department of Infectious Diseases, Mount Sinai Beth Israel, New York, NY; 4School of Social Work, Columbia University, New York, NY; 5Spencer Cox Center for Health, Mount Sinai St. Luke’s-Roosevelt Hospital Center, New York, NY; 6Department of Infectious Diseases, Mount Sinai Beth Israel, New York, NY

We wish to thank the men and women who participated in the study, the Peter Krueger Center for Immunological Disorders at Mount Sinai Beth Israel, Spencer Cox Center for Health at Mount Sinai St. Luke's- Roosevelt Hospital Center, and Gay Men's Health Crisis for making this study possible. Special thanks to Rob Shiau at the Peter Krueger Center and Zach Hennessey, MA at Spencer Cox for facilitating study implementation. This work would not have been possible without Lisa Sanfilippo, RN; Andrea Wagner, RN; Christopher Hilliard, MPH; Amy Braksmajer, Ph.D.; and Victoria Sharp, MD.

The study was supported by: the National Institutes of Mental Health (R34MH093352) and the Center for Drug Use and HIV Research (CDUHR; P30 DA011041). We particularly wish to acknowledge our Program Officer at the National Institute of Mental Health (NIMH), Michael Stirratt, Ph.D., Program Chief at the NIMH Division of AIDS Research.

The mission of the Center for Drug Use and HIV Research (CDUHR) is to end the HIV and HCV epidemics in drug using populations and their communities by conducting transdisciplinary research and disseminating its findings to inform programmatic, policy, and grass roots initiatives at the local, state, national and global levels. CDUHR is a Core Center of Excellence funded by the National Institute on Drug Abuse (Grant #P30 DA011041). It is the first center for the socio-behavioral study of substance use and HIV in the United States and is located at the New York University College of Nursing. For more information, visit

About New York University College of Nursing
NYU College of Nursing is a global leader in nursing education, research, and practice. It offers a Bachelor of Science with major in Nursing, a Master of Science and Post-Master’s Certificate Programs, a Doctor of Nursing Practice degree and a Doctor of Philosophy in Research Theory and Development. For more information, visit

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