Increasing and Supporting the Participation of Persons
of Color Living with HIV/AIDS in AIDS Clinical Trials
Marya Viorst Gwadz & Pablo Colon & Amanda S. Ritchie & Noelle R. Leonard &
Charles M. Cleland & Marion Riedel & DeShannon Bowens & Angela D. Banfield &
Patricia Chang & Robert Quiles & Donna Mildvan
Published online: 25 August 2010
# Springer Science+Business Media, LLC 2010
Abstract Persons living with HIV/AIDS (PLHA) of color
are under-represented in AIDS clinical trials (ACTs), which
may limit the generalizability of research findings and denies
many individuals access to high levels of care and new
treatments available through ACTs. Disproportionately low
a major barrier to ACTs for this group. Moreover, PLHA of
color are more likely than their white peers to decline to
participate, mainly due to fear and mistrust (although
willingness is also high), negative social norms about ACTs,
and difficulty navigating the unfamiliar ACT system. We
describe a small number of successful behavioral and
structural interventions to increase the participation of PLHA
of color in screening for and enrollment into ACTs. HIV care
settings, clinical trials sites, and trial sponsors are uniquely
positioned to develop procedures, supports, and trials to
increase the proportion of PLHA of color in ACTs.
Keywords Clinical trials.HIV/AIDS.Racial/ethnic
Racial/Ethnic Disparities in HIV/AIDS
The HIVepidemic increasingly affects African-American and
Latino/Hispanic individuals in the United States. African-
Americans make up 13% of the US population, but 48% of
prevalent HIV/AIDS cases . Latinos/Hispanics are also
over-represented among HIV/AIDS cases: they comprise
12% of the population, but 17% of prevalent HIV/AIDS
cases. Moreover, persons living with HIV/AIDS (PLHA)
from African-American and Latino racial/ethnic back-
grounds, referred to in this article as “PLHA of color,” are
more likely to suffer the ill effects of HIV/AIDS than their
white peers, including greater morbidity and earlier mortality
. Further, racial/ethnic disparities in HIV/AIDS incidence,
prevalence, morbidity, and mortality are increasing [1, 3]
Racial/Ethnic Disparities in AIDS Clinical Trials
AIDS clinical trials (ACTs) are research studies to evaluate
promising therapies to fight HIV infection, treat the
complications of antiretroviral therapy, prevent and treat
the opportunistic infections and cancers associated with
HIV/AIDS, and reconstitute HIV-damaged immune systems
. ACTs are critical to the development of new medi-
cations and treatment regimens. Through involvement in
M. V. Gwadz (*):P. Colon:A. S. Ritchie:N. R. Leonard:
A. D. Banfield:P. Chang:R. Quiles
New York University College of Nursing,
726 Broadway, 10th Floor,
New York, NY 10003, USA
C. M. Cleland
National Development and Research Institutes, Inc (NDRI),
71 West 23rd St., 8th Floor,
New York, NY 10010, USA
Columbia University School of Social Work,
1255 Amsterdam Ave.,
New York, NY 10027, USA
ILERA Counseling & Education Service,
PO Box 876,
Yonkers, NY 10704, USA
Division of Infectious Diseases, Beth Israel Medical Center,
350 East 17th Street,
New York, NY 10003, USA
Curr HIV/AIDS Rep (2010) 7:194–200
ACTs, individuals living with HIV/AIDS can gain access to
promising new treatments, and access a level of care and
support services that may not otherwise be available to
those of limited resources . While Latinos have
historically been modestly under-represented in trials ,
the greatest disproportionality is found among African-
Americans, who comprise approximately 48% of all PLHA
but only 30% of ACT participants [1, 4]. Further, these
disparities have not improved over the past two decades .
Indeed, the Underrepresented Populations Committee of the
Adult AIDS Clinical Trials Group at the National Institute
of Allergy and Infectious Diseases has made substantial
progress in exposing and reducing ACT disparities [6•, 7].
Yet barriers to ACTs are complex and persistent for PLHA
of color, as we describe below.
The Importance of ACTs in the Treatment of HIV/AIDS
The disproportionately low inclusion of PLHA of color in
ACTs has been criticized on at least two levels. First,
insufficient involvement of PLHA of color may limit the
generalizability of research findings to these populations
[8, 9]. The disproportionately low representation of PLHA
of color has led to concerns about the precision of estimates
of clinical efficacy and adverse effects of many therapies
for HIV/AIDS and related complications in these popula-
tions [9, 10]. For example, patients in clinic settings often
fail to achieve the high initial or sustained virologic
response to highly active antiretroviral therapy (HAART)
typically seen in patients who participate in ACTs .
Second, at the level of the individual patient, persons with
poor access to ACTs are denied supplementary attention
and care available through ACTs as well as access to new
treatments and prophylaxis [5, 9, 10, 12, 13]. For some
patients, ACTs may represent their best opportunity for life-
extending, state-of-the-art therapies, particularly for indi-
viduals with poor access to services . In addition to an
ethical mandate to reduce disparities in ACTs, increasing
the numbers of PLHA of color in ACTs is vital to advance
scientific knowledge and improve diagnosis, development
of preventive strategies, and treatment for PLHA of color
Description of the Multi-level Barriers to ACT Screening
and Enrollment Experienced by PLHA of Color
PLHA enter ACTs through a screening process. Screening
typically begins with a medical history interview and
physical examination, followed by a small number of
additional visits for evaluation and testing to determine
eligibility. Those found eligible for ACTs, typically the
minority of those screened because of the strict inclusion
and exclusion requirements (an estimated 13–49% of those
screened [11, 16]), then have an opportunity to enroll. In
the following section we describe the barriers that PLHA of
color experience to ACTs through the process of screening
Barrier #1: Low Rates of Recruitment and Referral
A major reason why PLHA of color are under-represented
in ACTs is that they are unlikely to ever be recruited for or
referred to ACTs, and much less likely to be recruited or
referred compared to their white peers [17, 18, 19•],
including by HIV/AIDS primary care providers, who are
typically the main source of referrals to ACTs [8, 9]. A
growing literature suggests that provider beliefs about
patients, including patients of color, influence their behavior
with these patients, and this plays a role in racial/ethnic
disparities in health. Medical providers who deliver HIV
primary care have been found to assume that PLHA of color
are less interested in joining ACTs than whites, and in turn,
are less likely to refer them to ACTs [8, 18].
Second, as research studies, the success of ACTs is
dependent on patients’ rigorous adherence to study require-
ments. Providers are often hesitant to refer PLHA of color
to ACTs because they are concerned about their patients’
abilities to adhere to protocols [8, 21, 22]. While in many
cases PLHA may indeed not be appropriate for ACTs, this
pre-screening by providers raises questions. First, it is
difficult for clinicians to predict an individual’s future
adherence with accuracy, and demographic characteristics
are not good predictors of adherence [23, 24]. Further,
adherence can vary over time, by treatment, and by context
. In our own research to reduce racial/ethnic disparities
in ACTs, for example, we found that adherence to health
care appointments is at least in part a reaction to the
organizational setting where the patient receives care. In the
case of PLHA of color who receive care at busy
community-based organizations and clinics in hospitals,
appointments typically begin late and patients are often
double-booked. Therefore, patients have found they can
arrive late or not show at all without penalty. However,
when it comes time to consider ACTs, providers may
assume that patients will not be adherent to ACTs because
they are poorly adherent to medical visits. Yet patients
indicate that their adherence to medical appointments is in
large measure a rational response to the clinic’s practices.
Although we have not examined adherence to HAART and
its potential relationship to adherence to ACTs, we do know
that very little research has been conducted on how to
maximize adherence to ACTs for PLHA of color.
The same concerns regarding adherence that appear to
influence the referral decisions of primary health care
providers and the organizations serving PLHA of color
Curr HIV/AIDS Rep (2010) 7:194–200195
may also come into play for AIDS clinical trials units
(ACTUs). As part of study inclusion/exclusion criteria,
ACT investigators are given discretion by trial sponsors to
use clinical judgement to exclude patients who they believe
are not good study candidates. These criteria include
investigators’ judgment of substance use and loosely
defined “social conditions” that lead investigators to believe
that patients may not comply with the study protocol. For
example, in an anonymous survey, ACTU research nurses
and study coordinators expressed concerns about the
capacity for PLHA of color to adhere to trial dosing
schedules and required follow-up visits (investigators were
not surveyed) [6•]. Moreover, these research clinicians
reported being more comfortable enrolling white men in
clinical trials than PLHA of color. This raises the possibility
that ACTUs may exclude potentially eligible PLHA of
color because of assumptions about social and behavioral
barriers to adherence.
HIV/AIDS and substance use are “twin epidemics”
, and substance use appears to play a significant role
in ACT disparities in ways that may not always be
apparent. Active alcohol and/or drug abuse are associated
with poor adherence to HAART , but there is
substantial variability among substance-using populations
regarding their ability to achieve high adherence .
Providers are understandably hesitant to refer individuals
with substance use problems to ACTs, as they may not
benefit from trials nor achieve the high levels of adherence
necessary in trials. However, in contrast to the problematic
use of substances (that is, high frequency and/or quantity
use that causes mental, physical, or social harm to the
user), the non-problematic use of substances (that is, low-
to-moderate frequency and/or quantity of use that does not
cause mental, physical, or social harm to the user) does
not necessarily present a barrier to trial participation and
high levels of adherence. Yet providers may be ill
equipped to make a determination of an individual’s
suitability for an ACT with respect to substance use,
particularly during short health care visits . Moreover,
providers may not have the time or training to distinguish
between past and current substance use or abuse, the
former not being a reason to exclude an individual from
ACTs . This suggests that health care providers may
benefit from support and resources to better pre-screen
patients for substance use problems that would interfere
with ACT participation, including assessments using
structured validated instruments or tools.
Barrier #2: When Invited to Participate in Trials, PLHA
of Color May Be More Likely to Decline
Even when approached for trials, PLHA of color are more
likely than their white peers to decline to participate [19•].
It is well documented that PLHA of color, particularly
African-Americans, have great distrust of and hold negative
attitudes toward ACTs, stemming partly from a legacy of
past research studies in which patients were mistreated
[8, 30, 31]. At the same time, PLHA of color also express
high levels of interest in and willingness to participate in
ACTs [17, 32, 33], particularly if a study is recommended
by a primary care provider [34•, 35•]. Furthermore,
knowledge of ACTs tends to be poor, particularly for those
with inconsistent health care utilization patterns, and this
serves as an additional barrier to ACTs . Practical
barriers and life circumstances may also interfere with ACT
screening and enrollment, including lack of access to
transportation and other pressing life problems related to
poverty [9, 10, 36]. Over half of HIV-infected women have
minor-age children, and family responsibilities and child-
care may be experienced as greater priorities than ACTs
. As noted above, substance use is also a barrier. Until
recently, ACTs have had restrictive criteria for substance
use, whether the individual used in the past or present
[9, 10]. Although individuals with historical substance use
and current non-problematic substance use are now actively
recruited into ACTs, PLHA are not typically aware of this
shift in inclusion criteria, and avoid ACTs as a result,
fearing stigma and exclusion .
Social influences impede access to ACTs among PLHA of
color. Peer norms, social comparisons, modeling and rein-
forcement, and social interactions have powerful effects on
individuals’ behaviors, including health behaviors [38, 39].
Among PLHA of color, social networks comprised of other
PLHA of color, family, and friends also evidence a lack of
information about and negative or mixed attitudes toward
ACTs, contributing to negative social norms regarding
ACTs. This results in a lack of support for ACTs among
social network members, and concerns that one will
experience social stigma related to ACT participation, which
interfere with participation in ACTs .
Barrier #3: PLHA of Color May Be Less Likely
to Be Found Eligible for Trials
Data are emerging that suggest that when screened, PLHA
of color may be less likely to be found eligible for ACTs
than their white peers , although this aspect of ACT
disparities is understudied. Restrictive eligibility criteria of
many ACTs, particularly therapeutic trials, has been cited as
contributing to the lower likelihood of trial eligibility
among PLHA of color . In our own work with a
mixed-gendered sample of predominantly PLHA of color
presenting for screening to an ACTU, patients who were
not prescreened by physicians for eligibility as is typical,
we found an eligibility rate of only 13% for 30 ACTG and
industry-sponsored trials . The main reasons for
196 Curr HIV/AIDS Rep (2010) 7:194–200
ineligibility were mismatches between patients’ laboratory
values (such as viral load, CD4), HAART and medical
histories, and the requirements stipulated by the trials’
protocol enrollment criteria. Further, a recent analysis of the
Women’s Interagency HIV Study (WIHS), the largest
representative sample of HIV-infected women in the United
States (including the proportional representation of women
of color and those with past and current substance use),
found that over half of the women in the WIHS cohort
would have been excluded from participating in 20 key
ACTG studies based on protocol enrollment criteria .
Barrier #4: PLHA of Color May Find the ACT System
Foreign and Hard to Navigate
PLHA often experience structural barriers to ACT
screening and enrollment . Clinical trials units may
be located in settings that are separate from clinics, and
may have policies and procedures that differ from clinics,
and thus may be difficult for PLHA to navigate . The
location, atmosphere, and procedures of a clinical trials
unit may also be experienced as unfamiliar, which
contributes to fear and mistrust [5, 40]. As noted by
researchers in other disease categories (eg, stroke, cancer),
misunderstandings between the patient and clinical trials
units are common, particularly among populations less
familiar with and less trusting of medical research .
Interventions to Reduce Barriers to ACTs for PLHA
While the persistent racial/ethnic disparities in ACTs, and
the factors that underlie these disparities, have been well
described, the science of behavioral interventions to
ameliorate these barriers is in its infancy. The multi-level
and complex nature of barriers to ACTs for PLHA of color
signal the need for interventions at a range of levels of
influence, including policy, structural, organizational, social
network, and individual-level strategies, as well as for
interventions that operate simultaneously at multiple levels
Two clinic-based interventions are described in the
literature. Freedberg and colleagues  developed a brief
structural intervention. In this study, based in an inner-city
hospital-based HIV clinic, all PLHA (regardless of the
patient’s sociodemographic characteristics or potential
eligibility) were provided with culturally sensitive informa-
tion about ACTs during the patient’s first visit. While the
intervention has not been evaluated in a randomized
controlled trial, the brief intervention reduced disparities
in ACT participation by race, risk behavior, and gender
when compared to a historical cohort at the same clinic
. El-Sadr and colleagues  developed a multi-level
outreach program to increase recruitment, enrollment, and
adherence to study protocols among PLHA of color and
women. The program included culturally sensitive infor-
mational materials about ACTs, outreach workers who
made home visits when needed, transportation for patients
for study visits, social work services for referrals to
necessary, ancillary services (eg, mental health, housing),
and peer support groups to assist patients with adherence to
study protocols . While El-Sadr and colleagues did not
report efficacy data, the multi-level nature of the program
directly targeted the types of barriers to recruitment and
retention of PLHA of color to ACTs described above and
therefore has promise as an intervention approach.
Our own work has focused on peer-driven intervention
strategies to increase the participation of PLHA of color in
ACTs in an urban environment. In response to the multi-
level barriers experienced to ACTs among this group, the
intervention (with the field name “the ACT2 Project”) was
designed to target barriers at the levels of individuals (such
as poor knowledge and high mistrust of ACTs, co-existing
with great willingness to explore ACTs), their social
networks (namely, peer norms regarding avoidance of
medical research), and also social and structural impedi-
ments associated with health care providers and ACT
settings. As described above, screening is a critical gateway
to gaining access to ACTs. Further, screening yields
indirect benefits to PLHA of color, including improvements
in HIV health knowledge and the opportunity to contribute
to research. This minimal-risk exchange may also reduce
PLHA’s fears of ACTs, and establish a relationship between
the PLHA and ACT unit. Yet, as reviewed above, PLHA of
color are screened for ACTs at disproportionately low rates
[43•]. Thus, the ACT2 Project’s primary outcome was ACT
screening. Enrollment in trials is also being explored as a
secondary outcome. However, enrollment patterns are
complicated by the fact that the number and type of ACTs
vary over time, and therefore to enter a trial, a participant’s
health status, readiness to participate (and endorsement of
the primary care provider in most cases), and an available
and appropriate trial must all match at the same point in
Peer-driven intervention (PDI) is an effective, culturally
appropriate, and low-cost intervention methodology that taps
into six critical elements of behavior change: knowledge, skill
building, motivation, peer influence, social norms, and
repetition . In the PDI model, individuals participate in
facilitated intervention activities targeting critical mediators
of behavior change (eg, knowledge, self-efficacy, motiva-
tion) and then independently educate up to three peers, for
which compensation is provided. The PDI model hypothe-
sizes that through peer education an individual’s own
commitment to engage in the targeted health outcome
Curr HIV/AIDS Rep (2010) 7:194–200 197
behavior is strengthened because the act of educating peers is
a public affirmation of the behavior. Peer education also
entails repetition of the intervention’s core messages and
may result in internalization of them. Thus, peer education
increases individuals’ mastery of the intervention content
. Further, PDI attempts to alter network social norms
through successive waves of recruitment and peer education
. PDI has been used successfully with PLHA to increase
medication adherence  and reduce HIV-related sexual
and drug use risk behavior .
The ACT2 intervention’s theoretical mechanisms of
action (that is, how behavior change is hypothesized to
come about) are grounded in the theory of normative
regulation , which positsthatthe behaviors ofindividuals
are amplified through their social groups, as well as
motivational interviewing, a method for enhancing intrinsic
motivation to change by exploring and resolving ambivalence
, andsocial cognitivetheory, whichemphasizes individual
and social-contextual influences on behavior . The
intervention is comprised of three group sessions (5.5 h
total), three peer education experiences, and a brief (30 min)
individual session conducted on the AIDS clinical trials unit
to overcome structural barriers to ACTs. The study is
currently in the final stages of evaluation in a randomized
controlled trial, where participants in the control arm received
a time-matched and attention-matched health education
intervention. The study’s primary outcome is screening for
ACTs to the point of determining eligibility. Importantly, the
screening end point is modeled on the typical “real world”
experience: PLHA must take initiative for screening and do
not receive a financial incentive for screening, suggesting
they attend because motivation to explore screening and
ACTs is high.
Description of Sample and Preliminary Results
We present here data on the first 342 participants enrolled
in the study. Participants ranged in age from 26 to 74 years
with a mean of 49 years (SD=7.3 years), and 43.9% were
female. Almost all (91.5%) were people of color (64.9%
African-American, 26.6% Latino/Hispanic). About two
thirds recruited or recruited/educated at least one peer
(64.9%). The majority was on antiretroviral therapy
(66.1%) and reported their viral load levels as undetectable
(67.4%). Only 19.6% had been screened for ACTs in the
past. Preliminary data indicate that the ACT2 intervention
is potent: approximately half (46.0%) of participants in the
ACT2 intervention arm were screened, compared to less
than 2% of those in the control arm. Enrollment results are in
process but also promising. To date, of those screened,
approximately 45% have been found eligible for a biomedical
observational research study and almost all (approximately
90%) have entered the study. Approximately 9% have been
found eligible for a therapeutic trial, and half have entered the
trial. Thus, the ACT2 intervention approach is highly
efficacious in increasing rates of screening for ACTs among
PLHA of color, the critical gateway to enrollment in ACTs
and an important outcome even independent of enrollment.
Furthermore, preliminary data indicate that the ACT2
intervention also has a potent effect on increasing rates of
participation in biomedical studies and clinical trials among
PLHA of color.
PLHA of color evidence high willingness to participate in
ACTs combined with numerous serious barriers to ACTs
operating at the levels of individual PLHA, their social
networks, their health care providers, the organizations that
serve them, clinical trials units, and the types of trials and
studies’ inclusion criteria. The small but growing literature
on interventions to address racial/ethnic disparities in ACTs
suggests some promising avenues for reducing these
barriers through behavioral/social and structural interven-
tions. Increasing access to screening through outreach in
communities and service settings, and conducting behav-
ioral intervention to reduce barriers to screening, are
critical aspects of eliminating ACT racial/ethnic disparities,
as screening is the gateway to ACT participation, a low-
risk activity, and also has numerous indirect benefits to
PLHA. The fact that barriers to ACTs are long-standing,
complex, rooted in culture and social norms for PLHA of
color, and also in the perceptions and practices of HIV care
providers and ACT study clinicians, suggests that screening
for ACTs should be regular, routine, and involve health
care providers. Further, given the complex barriers to ACTs
experienced by PLHA of color, support and assistance
through screening, enrollment, and trial participation is
recommended to foster positive outcomes including the
high levels of adherence to trial protocols . Further,
ACTs and clinical trials units can also play a role in
reducing ACT racial/ethnic disparities. As noted by Gandhi
and colleagues , reducing subjective eligibility criteria
may have the effect of broadening demographic and clinical
representativeness of trials participants. Further, reducing
the penalties to trial sites for losses to follow-up and less
than perfect adherence would very likely increase the
willingness of clinical trials units to recruit and enroll a
more diverse population [6•]. Similarly, there is a need to
develop trials targeting PLHA of color by such means as
oversampling PLHA of color , modifying eligibility
requirements , focusing on the clinical entities that are
over-represented in PLHA of color, including HIV-associated
nephropathy, and examining for racial/ethnic differences in
drug metabolism and adverse events of anti-HIV treatments.
198Curr HIV/AIDS Rep (2010) 7:194–200
We acknowledge that these recommendations are challenging.
However, interventions that target organizations and/or multi-
ple levels of influence simultaneously, including the types of
the representation of diverse racial/ethnic groups in ACTs.
National Institute of Allergy and Infectious Diseases, National Institutes
of Health (1 R01 AI070005) and the Center for Drug Use and HIV
Research (P30DA011041), funded by the National Institute on Drug
Abuse at theNational InstitutesofHealth.Wewouldliketoacknowledge
the men and women who participated in the ACT1 and ACT2 Projects,
and Dr. Usha Sharma (Program Officer) and Dr. Vanessa Elharrar
(Medical Officer), Division of AIDS, National Institute of Allergy and
Infectious Diseases. The project is dedicated to the memory of Keith
Cylar, Co-founder and Co-CEO of Housing Works (1958–2004), and
former Housing Works PI, The ACT1 Project.
Funding for this study was provided by the
No potential conflicts of interest relevant to this article
Papers of particular interest, published recently, have been
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