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J Clin Psychol Med Settings (2013) 20:156–163

DOI 10.1007/s10880-012-9332-1

A Comparison of Enrollees Versus Non-enrollees in a Patient/


Family HCV Psychoeducation Study
David E. Pollio • Carol S. North • Ashley M. Hudson •

Barry A. Hong

Published online: 19 September 2012


 Springer Science+Business Media, LLC 2012

Abstract Despite the seriousness of Hepatitis C (HCV), Keywords HCV  Enrollment  Addiction 
many patients do not receive treatment. One promising Psychoeducation  Group
means of addressing these issues for medically ill patients
is through participation in support group services. This
study examined individual-, treatment- and system-level Introduction
factors associated with enrolling in a support group inter-
vention (psychoeducation) for persons with HCV. A total It is estimated that nearly 4 million individuals (1.8 % of
of 235 research participants were recruited as part of a the population) in the United States are infected with the
NIAAA-funded randomized clinical trial for patients with hepatitis C virus (HCV) and that perhaps as many as 2.7
HCV and their family members, with 172 (73.2 %) million people have chronic HCV infections (Ho et al.,
agreeing to enroll in the psychoeducation trial and 63 2008). Without treatment, many of these patients will
(26.8 %) declining. Factors leading to enrollment indicated progress to cirrhosis, end-stage liver disease, and death
that individuals without employment, with certain person- (Alter et al., 1999). Despite the medical seriousness
ality structures (low cooperativeness and self-directed- of HCV, many patients do not receive treatment because of
ness), and traveling greater distance to their group were limited access to specialized healthcare services, lack of
more likely to agree to participate. Populations being seen motivation for treatment, inadequate family support, and/or
in public settings demonstrate a desire for additional sup- pre-existing or current psychiatric problems (National
port and education, but at the same time these potential Institutes of Health, 2002).
participants are faced with challenges to following through One promising means of addressing these issues for
and enrolling in the desired services. HCV patients is through participation in support group
services, which have been shown in other populations to
improve mood, coping skills, overall physical functioning,
and knowledge about the illness (Cameron et al., 2005;
Sherman et al., 2008). In general, support groups for
D. E. Pollio (&)  A. M. Hudson
medical conditions tend to attract patients who are dis-
School of Social Work, University of Alabama, Box 870314,
Tuscaloosa, AL 35487-0314, USA proportionately white, female, middle-class and employed,
e-mail: depollio@sw.ua.edu better-educated, and relatively young (Bauman, Gervey, &
Siegel, 1992; Cameron et al., 2005; Katz et al., 2002;
C. S. North
Sherman et al., 2008; Taylor, Falke, Shoptaw, & Lichtman,
The VA North Texas Health Care System, Departments
of Psychiatry and Surgery/Division of Emergency Medicine, 1986). Characteristics of those who join and do not join
University of Texas Southwestern Medical Center, support groups are likely to vary, however, according to the
Dallas, TX, USA type of support group offered and the particular health
issue it addresses (Walch, Roetzer, & Minnett, 2006). In
B. A. Hong
Department of Psychiatry, Washington University School addition to these demographic correlates, research con-
of Medicine, St. Louis, MO, USA ducted by Bauman et al. (1992) found that support group

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J Clin Psychol Med Settings (2013) 20:156–163 157

participation appeared to be more appealing to those who was hypothesized that enrollees would differ on demo-
have unhealthy or maladaptive personality traits, who in graphic factors (more likely to be white, female, employed,
general have been found to lack emotional support and/or better-educated, relatively younger) and temperament and
social networks (Josefsson et al., 2011; Cloninger & Zohar, character indicators of disordered personality (likely to
2011; Beadle, Brown, Keady, Tranel, & Paradiso, 2012; have higher scores on these characteristics); treatment-
Williams & Wingate, 2012). Fassino and colleagues found related factors (higher levels of treatment satisfaction,
that lower scores on specific temperament and character greater length of time in treatment, and lack of additional
traits of cooperativeness and self-directedness were asso- medical conditions and negative life events); and residen-
ciated with dropout from groups and other type treatments tial location (easier spatial access to groups).
in several different populations (Fassino, Abbate-Daga,
Piero, Leombruni, & Rovera, 2003; Mongini et al., 2005;
Leombruni, Fassino, Picardi, & Morosini, 2005). Methods
Involvement in a support group may further be affected
by various treatment- and system-level factors. Examining Psychoeducation Trial
the illness-related perceptions of patients with other kinds
of chronic illness, both Cameron et al. (2005) and Sherman The data collected for this article were collected as part of a
et al. (2008) found that support group participation NIAAA-funded randomized psychoeducation trial for
reflected patients’ perceptions of illness severity, disease- patients with HCV and their family members. The proposed
related distress, and perceived benefits of participation. project enrolled HCV patients in various stages of illness
These findings suggest that problem-specific support group and disease progression for randomization into either a
services may not be utilized by patients who have greater multifamily group psychoeducation program (described
concerns over a second unrelated but overriding medical subsequently) or to an education only group control con-
issue (i.e., psychiatric or substance abuse issues). Finally, dition of equal service intensity. The study was approved in
lack of reliable transportation and/or living in distant or advance of recruitment by the Institutional Review Board of
rural areas where fewer group services are readily available the Washington University School of Medicine.
or accessible is the most commonly cited barrier (Bauman
et al., 1992; Sherman et al., 2009; Voerman et al., 2007). HCV-PERF and Comparison Condition
Further support for this finding emerged from research by
Voerman et al. (2007) indicating that level of interest in The PsychoEducation Responsive to Families for patients
support group participation was positively associated with with HCV and their family members (HCV-PERF) pro-
patients’ perceived control—especially control involving gram is an adaptation of a PERF model developed spe-
the physical distance they were willing and able to travel to cifically for families with a member with a severe mental
participate in the groups. Another cited hindrance to sup- illness (North et al., 1998; Pollio, North, & Osborne, 2002;
port group participation is lack of physician recommen- Pollio et al., 2012). HCV-PERF is a six-month-long mul-
dation (Cameron et al., 2005; Sherman et al., 2009; Taylor, tiple family group program of HCV patients and any of
Falke, Shoptaw, & Lichtman, 1986). their family members who would like to participate. The
Understanding the individual-, treatment-, and system- family groups meet for 90 min twice a month. The sessions
level factors associated with participating in support group are semi-structured and problem-oriented, focusing on
services is vital for maximizing recruitment of HCV providing information, support, and sharing. HCV-PERF
patients to this intervention. Therefore, the purpose of this provides illness education and a forum to discuss problems
study was to examine factors associated with enrolling in a in daily living and coping with the illness within a sup-
study to participate in a support group intervention (psy- portive, proactive, and problem-focused agenda. Topics
choeducation) for persons with HCV. The two specific covered in the psychoeducation groups are systematically
research questions addressed in this study were: (1) which generated by the group members themselves. This format
individual-level (demographic, risk behavior, recent life permits discussions to be participant-specific, emphasizing,
events, and temperament and character), treatment-level and reinforcing personalized solutions to the problems of
(other medical conditions, treatment involvement), and living with a chronic illness and its complicated treatment
system-level (residential location) factors contribute to regimen. The groups are led by two professionals, one with
likelihood of enrollment into a randomized clinical trial of HCV medical knowledge and the other with a mental
a group psychoeducation intervention for HCV patients and health background.
their families, and (2) considered together, how do these The control group provides patient education in a group
factors predict likelihood of enrollment into a clinical trial format with the same time commitment as the active HCV-
of a multifamily group psychoeducation program? It PERF family psychoeducation groups, with opportunities

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for interactive question-and-answer periods with the group Asian, and other races), age in years, gender, marital status
leader. The didactic curriculum covered in these groups do (married, divorced/separated, widowed, or never married),
not focus on HCV or any particular disease, instead pro- and specific medical illnesses and number of medical ill-
moting general health and wellbeing, such as the impor- nesses. Additionally, participants were asked to identify
tance of dental care (e.g., instruction on correct brushing risk behaviors (dichotomous variables representing specific
and flossing and the importance of regular dental visits), risky sexual activities, needle use, and substance use, and
first aid, nutrition, and effective time management. total number of these risk behaviors) (Partnership Steering
Committee, Special Projects of National Significance
Recruitment and Assessment of Research Participants Program, 2000). Negative recent life events in the last
6 months were identified by the patient from a checklist of
Study participants were recruited from the hepatitis service 13 events: loss of job or income, moving, breakup of a
of a large Midwestern university medical center. All study- romantic partner or good friend, long separation from a
eligible patients attending this service were invited to par- loved one, major car trouble, house robbery or break-in,
ticipate in the research by the study’s hepatitis nurse coor- being assaulted, bad debts, serious illness or injury, arrest
dinator or physician assistant. Written informed consent to or other legal problems, death of a relative or close friend,
participate in the study was obtained from all participants and pressure to shelter an undesired house guest (Wachtel
after the research was explained to them, prior to study et al., 1992). A dichotomous variable was created from this
enrollment. As part of this process, the full requirements for list to reflect the occurrence of any recent negative life
study participation were detailed. Participants were event. Temperament and character were assessed using the
informed that the groups would be held at a time convenient Temperament and Character Inventory (TCI), a self-
to them, usually on the day of their HCV medical administered self-report questionnaire of 240 items scored
appointment. Inclusion criteria were a diagnosis of HCV on a 5-point Likert scale (Cloninger, 1987; Cloninger,
confirmed by serology and documented viral load, and age Svrakic, & Przybeck, 1993; Svrakic, Whitehead, Przybeck,
18 years or above. Exclusion criteria include inability to & Cloninger, 1993). The TCI has been described in greater
provide informed consent, current homicidality of suici- detail previously; inter-rater reliability and validity in
dality, or active psychosis. None of the patients in this study relation to structured interview diagnoses of personality
were in active HCV antiviral treatment at the time of study disorder have been demonstrated. The TCI measures three
recruitment. Patients who provided permission to contact dimensions of character (self-directedness, cooperative-
them and agreed to complete research assessments but who ness, and self-transcendence) and four dimensions of
declined to enroll in the psychoeducation trial were asked to temperament (harm avoidance, novelty seeking, reward
complete a brief instrument providing data on key variables dependence, and persistence). The combination of low
obtained from baseline interviews of psychoeducation en- cooperativeness and low self-directedness is conceptual-
rollees. A total of 235 research participants were recruited ized by Cloninger and colleagues as representing an
to the study between November 2007 and May 2010, with unhealthy personality structure that is characteristic of
172 (73.2 %) agreeing to enroll in the psychoeducation trial personality disorders.
and 63 (26.8 %) declining the intervention. Study partici-
pants were given assessments to collect data for the study
variables described below, with 173 (73.6 %) providing Treatment-Level Variables
data. The analyses for this study are based on the 140 par-
ticipants with complete data. To assess the presence of medical conditions, individuals
completed a checklist of 10 individual types of chronic
Variables in the Analysis illnesses experienced in their lifetime, including heart dis-
ease, cancer, stroke, arthritis, asthma, diabetes, tuberculosis,
Dependent Variable ulcer, epilepsy, and other illness; a variable reflecting a
count of the number of medical conditions was created.
The dichotomous dependent variable in the study was Treatment satisfaction was assessed through a scale con-
whether patients with HCV recruited into the clinical trial sisting of 12 items on a 5-point Likert scale. Because the
elected to enroll or not. individual treatment satisfaction variables collectively
demonstrated strong intercorrelations (alpha = .95), an
Individual-Level Variables aggregate measure representing the sum of the satisfaction
variables was created. Length of time in HCV treatment by
Demographic variables in the analysis included race self-report since first episode of treatment was coded as
(categorically representing Caucasian, African-American, number of months.

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System-Level Variables structure measured by TCI scale scores reflecting the


combination of low cooperativeness and low self-direct-
To examine the contribution of residential location, home edness, treatment-level variables (treatment satisfaction,
addresses were coded by zip code. Individuals residing individual medical illnesses and number of medical ill-
within the city of St. Louis and with zip codes directly nesses reported, negative life events and total number of
contiguous to the city were coded as nearby residents. recent life events reported in the last 6 months), and resi-
(Because the HCV clinic and location of the group were in dential location. Variables significant in bivariate equations
the far western part of the city, inclusion of the residential were included in a logistic regression model predict-
zip codes contiguous to the city was considered to repre- ing psychoeducation trial enrollee versus non-enrollee
sent approximately the same range of travel.) Patients groups.
residing more than 60 miles away were not included in the
study as part of the recruitment exclusion criteria.
Results
Non-enrollee Data
Individual-Level Findings
Psychoeducation non-enrollees were asked to indicate from
a checklist their reasons for choosing to not participate in Demographics
the intervention.
Table 1 presents demographics of the psychoeducation trial
Data Analysis enrollees and non-enrollees. The sample was about one-
half male and nearly two-thirds (57.6 %) were of ethnic
Data analysis was conducted in two stages, bivariate and minority groups (predominantly black, 54.7 %). The mean
multivariate analyses based on the hypothesis. The age was 51.7 ± 8.9 years. Enrollees and non-enrollees
bivariate analyses commenced with v2 tests and t tests were equivalent in sex ratios and age. Only 25.7 % were
based on the operationalization of the variable. Psycho- currently married. More than one-fourth were unemployed
education enrollees and non-enrollees were compared for (27.7 %) and nearly one-half (47.4 %) were disabled. Non-
demographic variables (age in years, gender, race, marital enrollees were significantly more likely than enrollees to be
status, employment status) and disordered personality non-minorities and employed.

Table 1 Comparisons between


Enrollees (%) Non-enrollees (%) Significance
psychoeducation enrollees
(n = 113)* (n = 59)*
and non-enrollees
Male gender 49.6 50.4 NS
Race
Caucasian 32.7 61.0 v2 = 13.00,
df = 1, p \ .001
Black 63.7 37.3 v2 = 10.49,
df = 1, p = .001
Asian 0.9 1.7 NS
Other 2.7 0.0 NS
Marital status
Married 29.2 36.2 NS
Divorced/separated 46.0 31.0 NS
Widowed 7.1 3.5 NS
Never married 26.6 29.3 NS
Current employment
status
Employed 18.4 37.3 v2 = 7.41,
df = 1, p = .007
Unemployed 30.7 22.0 NS
*n varies across variables based Disabled 50.9 40.7 NS
on sporadic missing data (\1 % Residing in city or 50.5 28.8 v2 = 7.32,
for all but one variable, which is adjacent zip code areas df = 1, p = .007
missing \5 %)

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Risk Behaviors two groups did not differ in the proportions with any
lifetime medical illness or in the total number of lifetime
High lifetime rates of multiple risk behaviors were found medical illnesses.
across the sample, including cocaine use (49.4 %), heroin
use (83.5 %), other hard drug use (71.8 %), injection drug Treatment Satisfaction
use (52.7 %), sharing needles (41.4 %), prostitution
(20.4 %), and smoking (74.8 %). Compared to non-enrol- The treatment satisfaction summary variable was not sig-
lees, a higher proportion of enrollees reported having nificantly different between the two groups (mean = 47.5,
engaged in prostitution (25.5 vs. 10.5 %; v2 = 5.16, SD = 9.1, n = 143, p [ .05). No individual satisfaction
df = 1, p = .023, n = 167). The two groups did not differ item significantly differentiated enrollees and non-
in lifetime history of the other risk behaviors. enrollees.

Recent Life Events System-Level Findings/Residential Location

The majority (81.4 %) had at least one recent negative life More than one-half of the sample (57.1 %) resided within
event, with a mean (SD) of 2.4 (2.0) events. The most the city or immediately adjacent suburbs, near the medical
frequent negative life events involved a serious illness or center. Enrollees were more than twice as likely to be
injury (36.6 %), death of a relative or close friend residents of the city or contiguous neighborhoods (see
(33.7 %), long separation from a loved one (18.6 %), and Table 1).
job loss or substantial loss of income (20.4 %). The only
specific type of life event related to the likelihood of not Reasons for Psychoeducation Non-enrollment
enrolling in the psychoeducation trial was bad debts
(28.8 % of non-enrollees vs. 15.9 % of enrollees; v2 = 3.9, For the 54 non-enrollees who provided data on reasons for
7df = 1, p = .046, n = 172). The total number of life non-enrollment, the two most common reasons provided
events was not associated with enrollment in the psycho- for choosing not to participate in the psychoeducation
education trial. program were transportation issues (44.4 %) and the
amount of time required for participation (40.7 %). Other
Temperament and Character responses were that the individual had prioritized another
health condition (9.3 %) or family concerns (9.3 %) ahead
One-third of the sample (35.3 %) had a disordered per- of psychoeducation. Lack of interest was reported by
sonality structure (i.e., low cooperativeness and low self- 5.6 %, feeling too upset to participate by 5.6 %, perception
directedness as measured by the TCI). Fewer non-enrollees that it wasn’t worth the effort by 3.7 %, and concerns about
(23/63, 36.5 %) than enrollees (101/172, 58.7 %) had this privacy by 1.9 % as reasons for non-enrollment.
personality structure (v2 = 9.13, df = 1, p = .003).
Multivariate Modeling
Treatment-Level Findings
A final model was created using only variables that
Medical Conditions significantly predicted enrollment group in the bivariate
analyses (see Table 2). Variables entered into the final
Besides HCV, a medical condition experienced by all study model included African American race, current employ-
participants, two-thirds (69.4 %) of the sample reported ment status, residing within the city or immediately
having experienced one or more of the lifetime medical adjacent zip code area, and disordered personality struc-
illness from the list of specific conditions (heart disease, ture (low cooperativeness and low self-directedness).
cancer, stroke, arthritis, asthma, diabetes, tuberculosis, The model as a whole was significant (model likelihood
ulcer, or epilepsy), and 26.0 % reported a lifetime history ratio v2 = 29.88, df = 4, p \ .001, n = 168). Individuals
of some other medical illness. The mean (SD) number of residing in the city or adjacent areas were almost two
lifetime major medical illnesses reported from the list for and a half times as likely to enroll as those residing in
the entire sample was 1.2 (1.1). The most prevalent lifetime non-adjacent areas (Wald v2 = 5.07, df = 1, p = .024,
medical conditions were arthritis (37.6 %), diabetes CI 1.12–5.22), individuals who were employed were less
(20.3 %), asthma (16.8 %), heart disease (15.6 %), and than half as likely to enroll as those not employed (Wald
cancer (9.3 %). Psychoeducation enrollees were more v2 = 4.99, df = 1, p = .026, CI 0.19–0.90), and indi-
likely than non-enrollees to report a lifetime history of viduals with disordered personality structure were more
asthma (21.1 vs. 8.5 %; v2 = 4.41, df = 1, p = .036). The than three times as likely to enroll as those with healthy

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Table 2 Multiple logistic regression model predicting psychoeducation enrollee status


df Estimate Standard error Wald v2 p Odds ratio point 95 % Wald confidence
estimate limits

Parameter
Intercept 1 -0.68 0.22 9.31 .002
Residing in city or adjacent suburbs 1 0.44 0.20 5.07 .024 2.42 1.12 5.22
Black 1 0.31 0.19 2.60 .107 1.86 0.88 3.97
Employed 1 -0.44 0.20 4.99 .026 0.41 0.19 0.90
Low cooperativeness/low self-directedness 1 0.57 0.20 8.13 .004 3.15 1.43 6.93

personality structure (Wald v2 = 8.13, df = 1, p = .004, functioning (with disordered personality structure) and
CI 1.43–6.93). unemployed and to reside in geographical proximity to the
trial site. The primary concerns of transportation issues and
time commitment required to attend the psychoeducation
Discussion groups suggest that those choosing not to enroll in the
psychoeducation trial are concerned with the difficulties of
The results of this investigation of factors leading to both time and travel, rather than reasons previously
enrollment into a clinical trial of a multifamily psychoed- reported in the literature around prioritizing other health
ucation group for patients with HCV indicates that, taken conditions or family (Cameron et al., 2005; Sherman et al.,
as a whole, individuals with greater access to the groups, 2009). It appears that individuals who are busy, have other
lack of employment, and less adaptive personality char- existing support networks, and experience systemic issues
acteristics (low cooperativeness and self-directedness) around attending the groups are less likely to enroll in the
were more likely to agree to participate in the clinical trial. clinical trial. It may also have been the case that the dis-
Recruitment primarily through the university hepatology cussion of the burden revealed in the consenting process
service led to a patient sample with significant lifetime risk influenced the decision whether or not to enroll in the
behaviors, including a high proportion with a history of study.
substance use and abuse, as well as multiple medical and The findings on the relationship between race/ethnicity
life challenges. In characterizing those who enrolled in the and residential proximity to the medical center bear further
psychoeducation trial relative to those who chose not to, discussion. In individual-level analyses, the finding that
enrollees had fewer external resources and were in greater racial/ethnic minorities were more likely to enroll in the
need of an intervention to help provide support and edu- study was exactly opposite the general conclusion from
cation about HCV. previous research (Walch et al., 2006; Bauman et al.,
The findings from the hypothesis on individual-, treat- 1992). However, in the final model, this difference disap-
ment- and system-level factors’ impact on enrollment in peared. The most likely explanation for this change in
psychoeducation are both similar and different from pre- significance when multiple variables were included in the
vious research on support groups. Unlike previous studies model has to do with the neighborhood characteristics
of individual-level characteristics for support group par- surrounding the recruitment and treatment site, where the
ticipation for persons with HIV (Walch et al., 2006) and areas in close proximity were more likely to dispropor-
other medical conditions (Bauman et al., 1992; Cameron tionately consist of racial minority groups than those of
et al., 2005; Katz et al., 2002; Sherman et al., 2008; Taylor, areas further away. It appears possible that structural
Falke, Shoptaw, & Lichtman, 1986), and as opposed to the issues, such as location of treatment, may be explanatory of
hypothesized direction, participants were less likely to be some of the racial/ethnic differences noted in the literature.
Caucasian and demonstrated lower functioning. In terms of Minimally, this finding affirms the need to conceptualize
treatment-level variables, no significant relationships were racial/ethnic composition more thoroughly, and to endea-
found in the analyses. It may be the case that treatment- vor to examine other factors for which individual minority
level variables are more important predictors of treatment membership may be serving as a proxy—and vice versa,
engagement. Finally, in terms of system-level variables, the where other factors may be serving as proxies for race/
findings very much echo those found by Voerman et al. ethnicity.
(2007) in that distance to the treatment location appears to The methods of this study are not without significant
serve as a major barrier to enrollment. limitations. Individuals who chose not to enroll in the
In examining results from the multivariate analysis, psychoeducation trial were asked to complete brief
psychoeducation trial enrollees are more likely to be lower assessments. A small proportion of those approached

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elected not to complete this assessment, providing an versus those who attended at least one session, as well as
unknown bias. Additionally, although the comparison was those who attended one session versus those who attended
between individuals choosing to enroll in the trial and those consistently. Taking these three comparisons together
electing not to, it is beyond the scope of the current (enrollee/non-enrollee, attender/non-attender, attender/
exploration to examine the actual participation of those active participant) would allow a deeper understanding of
enrolling in the study. The sample is also limited in that it different types of barriers facing participants in this par-
is drawn from a hepatology service associated with a uni- ticular type of clinical trial. Further, similar comparisons
versity medical service. Although attempts were made by with recruitment in other, similar trials would allow
the research team to outreach to private practice settings, researchers to assess whether the barriers detected gener-
virtually none of the participants in the current trial were alize broadly, or are specific to certain types of clinical
recruited from locations other than the primary site. It is intervention trials.
also likely that the current study over-recruited individuals
with limited resources and treatment options, not uncom- Acknowledgments This research was supported by the National
Institute on Alcohol Abuse and Alcoholism, grant RO1-015201 to
mon for university medical centers. This suggests that the Dr. North. Points of view in this document are those of the authors
current sample may over-represent those with addiction, as and do not necessarily represent the official position of NIAAA, the
well as those for whom proximity might represent a greater Department of Veterans Affairs, or the U.S. Government.
perceived barrier. Finally, the variable for distance served
Disclosures Dr. North discloses employment by VA North Texas
as a proxy for amount of effort required to participate in the Health Care System, Dallas, TX, USA. Dr. North also discloses
study. Details of travel time, transportation method, and research support from NIAAA, NIDDK, the Department of Veterans
burden of travel were not available in the data collected. Affairs, the American Psychiatric Association, and the Orthopaedic
Findings from this exploration of psychoeducation trial Trauma Association, consultant fees from the University of Okla-
homa Health Sciences Center and from the Tarrant County, TX
enrollment have some broader implications for HCV Department of Health, and speaker’s fees from the Pueblo City/
treatment and psychoeducation and support groups. In County, CO Department of Health.
terms of HCV treatment, populations being seen in public
settings demonstrate a clear need for additional support and
education, but at the same time these potential participants References
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