NYU researchers dramatically improve ART adherence for minority PHLA
Novel behavioral intervention improves treatment outcomes for HIV-infected individuals
who have previously delayed, declined, or discontinued antiretroviral therapy
New York University
2-Apr-2015 - 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
**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."
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,
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 in Nursing, a Master of Science and Post-Master's Certificate Programs, a
Doctor of Philosophy in Research Theory and Development, and a Doctor of Nursing Practice
degree. For more information, visit https://nursing.nyu.edu/
http://www. nyu. edu
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