Community outreach with weekly delivery of anti-retroviral drugs
compared to cognitive-behavioural health care team-based approach to
improve adherence among indigent women newly starting HAART
F. VISNEGARWALA1, M. C. RODRIGUEZ-BARRADASS1,4, E. A. GRAVISS1, M. CAPRIO2,
M. NYKYFORCHYN3, & L. LAUFMAN1
1Baylor College Of Medicine, Houston, Tex,2Harris County Hospital District, Houston, Texas,3University Of Texas Health
Science Center, Houston, Tex and4Veterans Administration Medical Center, Houston, Tex
Sustained virological suppression requires adherence to ? /95% of doses of therapy. Overall there is paucity of data on
adherence interventions among women and post-intervention outcomes. In this pilot study, we evaluated a novel strategy of
weekly delivery of medications (Directly Delivered Therapy: DDT) for six months using an outreach worker (ORW), among
ARV naı ¨ve indigent women starting HAART and compared the ‘during intervention’ and ‘post-intervention’ outcomes to
the health care team (a nurse educator, a case worker, a pharmacist and social worker/drug addictions counsellor) based
approach termed Adherence Coordination Services (ACS) and the Standard of Care (SoC) historical referent group. The
baseline characteristics of the three groups were comparable. The proportion of women who achieved sustained virologic
suppression in 4?/8 month period for DDT; ACS and SoC groups were 86% (18/21); 54% (6/11); and 36% (8/22) (P B /
0.004); and in the 10?/14 month period were 80% (12/15); 54% (6/11) and 45%(10/22) (P? /0.036 for DDT vs. SoC).
Retention rate in the DDT was 87%, and 92% of 307 ORW visits were kept, and post-intervention satisfaction was high.
Short-term weekly delivery of medications using a community based liaison is a feasible, acceptable and a cost-effective
strategy for improving both short-term and perhaps long-term adherence among women initiating their first HAART
The success of HAART is dependent upon close
adherence to prescribed medication regimens (Car-
penter et al., 1997; Hogg et al., 1998; Mocroft et al.,
1998; Palella et al., 1998). When adherence is
optimal, there is a high likelihood of virologic and
immunologic success, and less likelihood of spread
of drug resistant virus (Bangsberg et al., 2000;
Cingolani et al., 2002; Little, 2001; Paterson et al.,
2000). However, in resource-rich countries, the
benefits of successful HIV therapy have not been
realized by all persons living with HIV/AIDS (An-
derson & Mitchell, 2000; Bozzette et al., 2001;
Cunningham et al., 1999; Hader et al., 2001;
Shapiro et al., 1999). We and others have shown
that only half of the urban indigent patients can
maintain virologic suppression at one year largely
due to non-adherence (Lucas et al., 1999; Visne-
garwala et al., 2004).
More than 20 studies have been published evalu-
ating different strategies for adherence improvement
(Murphy et al., 2002). These are classified as:
health-care team based behavioural-cognitive ap-
proach, patient-oriented behavioural approach; af-
fective strategies; and modified directly observed
therapy (DOT) (Murphy et al., 2002). The most
widely used strategy is cognitive-behavioural inter-
vention, with health care team. Data from controlled
and uncontrolled studies show a modest improve-
ment in short-term adherence in predominantly
ARV experienced male populations (Holzemer et
al., 2000; Martin et al., 2001; McPherson-Baker et
al., 2000; Murphy et al., 2002; Safren et al., 2001;
Tuldra et al., 2000). There is little data addressing
specific adherence interventions among women.
Women are often caregivers for young, old and
sick, thus adherence becomes more burdensome
(Hader et al., 2001;‘Update: trends in AIDS in-
cidence ?/ United States, 1996’, 1997). In addition,
the post-intervention outcomes and data on long-
term impact are limited (Rogers et al., 2001).
Therapy-experienced patients have already devel-
oped a comfort level with the health care system
(Martin et al., 2001; McPherson-Baker et al., 2000;
Murphy et al., 2002; Rogers et al., 2001; Safren
Correspondence: F. Visnegarwala M.D., Baylor College of Medicine, Department of Medicine, Section of Infectious Diseases, One Baylor
Plaza, Room # 465 EC, Houston, TX 77030. Tel: 713 798 3942. Fax: 713 798 5134. E-mail: firstname.lastname@example.org
AIDS Care, May 2006; 18(4): 332?/338
ISSN 0954-0121 print/ISSN 1360-0451 online # 2006 Taylor & Francis
et al., 2001). However, about 25% of indigent
patients who newly access care do not return after
the first few visits (Giordano et al., 2004). The latter
may be due to intimidation by the health care
system’s processes, especially among indigent, min-
ority who have differing attitudes, trust, and health
care beliefs (Begley et al., 2002; Singh et al., 1999;
Smith et al., 1997). Thus it may be naı ¨ve to believe
that only institutionally based strategies will improve
adherence among such patients. Novel strategies,
with a de-institutionalized approach and community
outreach that are cost effective, acceptable and
feasible need to be tested.
We evaluated the strategy of weekly delivery of
anti-retroviral therapy for six months in a pilot
program. Our goal was not to observe the delivery
of all HAART doses, but to assure continuous
availability of drugs and provide positive re-enforce-
ment. We hypothesized that: a) consistent drug
availability will improve short-term adherence; b)
the relationship formed between the peer HIV sero-
positive outreach worker and the patient would
empower the patient, and thus improve overall
The Thomas Street Clinic (TSC) is free-standing
HIV clinic in Houston, Texas, providing care to
primarily uninsured, HIV/AIDS infected indivi-
Standard of Care (SoC). The referent group included
historical controls from an observational database
before the interventions began. A contemporaneous
comparison group was not chosen, since the two
programmes were offered to ALL women accessing
care for the next two years, thus only those refusing
to participate would have been selected thus intro-
ducing a selection bias. We included consecutive
women who were ARV naı ¨ve, and initiated HAART
between September 1999 and August 2001, with 12
months of follow up. The procedures were: medical;
social history; baseline laboratory tests; urine tox-
icology screen at the first visit by a nurse/patient
advocate. Once patients were placed on HAART,
HIVand drug specific education was provided by the
primary care provider. The content and duration of
this education was provider-specific.
Adherence ?/ Coordination Services (ACS) ?/ a health-
care team based strategy. Patient enrolment began in
September 2001 and a total of 50 women were
recruited. The eligible subjects included all women
newly accessing care, as well as those who were in-
care, with virologic failure and were changing
HAART with two new drugs in the regimen. Of
these 26 were ARV naı ¨ve.
The following intervention was administered for
six months by a health-care team consisting of care
manager/nurse educator, social worker/addictions
counsellor, HIV? / peer caseworker, and pharmacist.
After obtaining informed consent, the care manager
assessed general functioning, provided HIV 101
education for a total of 4?/5 hours over four weeks.
The social worker/addictions counsellor assessed
metric tests, and provided appropriate referrals for
drug rehabilitation. Assistance was provided for
housing, food, phone, transportation, child-care
needs. Reminder calls for pharmacy refills and clinic
appointments were provided. The case worker per-
formed on average 1?/4 home visits.
Directly Delivered Therapy (DDT). Enrolment period
was April 2003?/September 2003. All ARV naı ¨ve
women newly entering care, and who were off
HAART for ? /2 years, restarting with two or more
new drugs in their regimen were eligible. After
obtaining informed consent, the baseline psychoso-
cial measures including the Zung Depression Scale,
Interpersonal Support Evaluation List (ISEL), and
Medical Outcome Study Health Survey Form-12.
(MOS-SF 12), and drug/alcohol assessment were
done by a research coordinator. If the participant
was found to be depressed, the primary care provider
was informed using a form letter.
The intervention included delivery of all HAART
doses (in a bubble pack) by an outreach worker for
six months (every week for first four months then bi-
weekly for two months). The outreach worker’s role
was to both deliver the drugs and provide positive
reinforcement. She was a peer, an HIV positive
women who was recruited from the clinic, whose
training included certification in basic life support,
HIV 101 education, environmental safety, manage-
ment of social problems using local case manage-
medical problem, by referral to the research coordi-
nator who would then inform the primary care
provider with a ‘form letter’.
Bubble packing with protective aluminum foil was
utilized for acceptability and ease of carrying single
doses for prolonged periods at room temperature
(Health Care Logistics.).
In addition to the above services from the DDT
programme, the participant could access all the
other services of the clinic, including filling non-
ARV drugs from the clinic pharmacy.
At each visit, the ORW completed a brief ques-
tionnaire for adverse effects, self-reported adherence
and collected the empty bubble packs. At the end of
Community-based weekly ARV delivery in naı ¨ve women
the intervention, during an exit interview, partici-
pants were asked to complete a ‘programme-evalua-
tion survey’ by the research coordinator.
Primary outcome measures:
a) During the Intervention Period: proportion
of subjects with sustained virologic suppres-
sion (SVR) B /400 copies of HIV RNA/ml at
b) Post-Intervention Period: proportion of
subjects with SVR at 10?/14 months.
Virologic failure was defined as two or more
consecutive viral loads ? /400 copies of HIV
RNA/ml after achieving viral load B /400
Secondary outcomes measures. The following variables
were evaluated: a) 7-day self- reported adherence for
the ACS and DDT subjects (Mannheimer et al.,
2002); b) the number of empty bubble packs for the
DDT study; c) proportion of scheduled provider
visit appointments kept for the ACS study; and d)
acceptability of the DDT programme was measured
by the programme-evaluation survey.
Statistical analysis. Descriptive statistics were used to
summarize the baseline characteristics. Two-sample
t-test for independent sample with equal variances
for continuous variables, and Chi-square test of
Fisher’s Exact test for general associations between
two categorical variables. The analysis of the dichot-
omous variables for primary outcomes (virological
success yes/no) was done by means of contingency
tables (Chi-square test or Fisher’s Exact test).
Intent-to-treat for the ‘during intervention’ period,
and as-treated analysis for ‘post-intervention’ period
was performed among all those who started the
intervention. Since the DDT and ACS groups were
both compared with the control group, the alpha
level or rejection of the null hypothesis was set at
0.025 instead of the traditional 0.05.
The baseline characteristics of the three groups are
described in Table I.
. ACS. Over a period of six months, 50 women
were enrolled in the program. Twenty-six of
these were newly accessing care were ARV
naı ¨ve. Of these, 13 were started on HAART, 1
expired before the first follow up visit, and 1
moved with no time for intervention initiation.
We present the data on the 11 on whom we have
follow-up data in Table I.
. DDT. A total of 26 women were enrolled over a
period of six months. Two did not receive
HAART as per the primary care provider’s
discretion. Of the 24 who received HAART,
and thus the intervention, 21 were ARV naı ¨ve.
The baseline characteristics of these 21 women
are described in Table I, and did not differ
significantly from those in the ACS and SoC
Virological and immunological outcomes
Table II describes the virological outcomes for the
three groups. In short-term (4?/8 months) or ‘dur-
ing’ intervention outcomes, the DDT group had a
significantly higher proportion (85%) of subjects
with sustained virologic suppression as compared to
ACS (54%), and SoC (36%), (OR 1.6; 95% CI,
4.8,15.7 and P? /0.003 for three-way comparison).
In two-way comparisons, DDT was superior to
SoC (10.5; 1.97, 63.9; P B /0.001) and ACS, but
the latter had borderline significance (0.4; 0.17,
0.96; P? /0.08). The rates of virologic suppression
between ACS and SoC were not significantly differ-
ent (2.1; 0.39, 11.9; P? /0.3).
The post-intervention outcomes at 10?/14 months
of follow-up are also presented in Table II. Of the 21
ARV naı ¨ve women in the DDT group, four expired
before the post-intervention window period and two
had not reached the window period at the time of
current analysis. Thus fifteen subjects who were alive
and had reached the window period were included in
this analysis. In the post-intervention follow-up
period, 54% in ACS, 80% DDT, and 45% in SoC
had sustained virological suppression (2.7; 0.85, 8.4,
P? /0.1). In the two-way comparison, DDT was
superior to the SoC (4.8; 0.9, 29.5; P? /0.03).
The mean CD4 change during the intervention
period in the ACS group was ? /262 (9 /SD 94) cells/
cumm, the DDT group ? /193(9 /176), and in the
SoC referent group was ? /115(9 /98) P? /0.05. The
mean change in the post-intervention follow up
period was for the ACS group ? /153(9 /61); DDT
242 (9 /223) and SoC was 122(9 /178).
Retention and acceptability and measures of adherence
for the intervention programmes
. DDT. Of 38 qualifying patients, 26 (68%) gave
informed consent. Of 26 enrolled, 24 began
HAART and the intervention. Of these 24, 4
expired, 3 while enrolled in the programme,
and one was lost to follow-up before her death.
Two women died of non-HIV related causes.
All four had sustained virologic suppression in
F. Visnegarwala et al.
the 4?/8 month window. Overall, the average
level of adherence as measured by the empty
bubble packs and self-reports was 85% during
the intervention period. Of the 307 intervention
visits by the ORW 282, (92%) were kept by the
participants. Overall 76% of participants did
not miss a single visit with the ORW. Among 19
participants who completed the post-interven-
tion survey, 63% felt there was no invasion of
privacy by ORW, 16% had no opinion, and 11%
felt there was some invasion of privacy. Seventy
six percent felt ready to take HAART indepen-
dently at the end of their intervention. The
comments were, the ORW was a ‘friend’,
provided ‘confidence’, ‘hope’, ‘HIV specific
education’, and resulted in ‘less depression’.
Among 11 ARV naı ¨ve women on
HAART, 81% had 100% self-reported adher-
ence. Overall, among the 50 women enrolled,
75% of scheduled provider appointments were
kept, as compared to the 54% by the SoC
referent group (P? /ns). In the post-intervention
follow-up period 45% of scheduled appoint-
ments were kept as compared to 50% in the
referent group (P? /ns). Four women expired
and 12 were lost to follow-up.
Among the two intervention groups, a total of 74
women participated. Of these, 8 (11%) expired, 13
(18%) were lost to follow up and there were 38
hospitalizations most in the first 6 months.
There is accumulating evidence that HIV-infected
women, are less likely to access care and/or be
prescribed HAART and more likely to succumb to
the HIV related complications, and higher numbers
of indigent, minorities, and women are newly
infected with the HIV virus in the US (Anderson &
Mitchell, 2000; Giordano et al., 2003; Hader et al.,
2001; Hellinger, 2004; Karon et al., 2001;‘Update:
trends in AIDS incidence ?/ United States, 1996’,
1997). Despite this, there is paucity of data evaluat-
ing strategies to improve HAART adherence among
this group of women. We have evaluated a novel
strategy among women newly accessing care, using
weekly delivery of drugs by an out reach worker and
our pilot data show that this intervention in the short
term and in the post-intervention six-month period
has an impact which is comparable and perhaps
better than the well-established cognitive beha-
vioural health-care team based approach and the
referent standard of care practice.
Unlike TB DOT which involves a finite course of
treatment, the goal of HIV DOT, for HAART is to
assure immediate adherence while attempting to
instil a patient commitment for long-term change
in behaviour. Based on data from incarcerated
patients, it is evident that directly observed therapy
(DOT) for HAART has been successful (Fischl
et al., 2000). Successful DOT has two elements;
education /encouragement of the patient, and ob-
served delivery of medications. However, for non-
incarcerated ambulatory patients in the community,
daily DOT of complex ARV regimens may not be
cost-effective or even feasible (Bozzette & Gifford,
2003), (Kirkland et al., 2002; Lanzafame et al.,
2000; Mitty et al., 2002; Stenzel et al., 2001). The
published programmes for DOT for HAART are
predominantly uncontrolled pilot programs, with a
modest effect (5?/40%), and no post-intervention
data. (Kirkland et al., 2002; Lanzafame et al., 2000;
Mitty et al., 2002; Simoni et al., 2003; Stenzel et al.,
To our knowledge, this is the first pilot study,
describing the post-intervention effects of a modified
drug delivery programme. We show a 35% reduction
in failure rate in the post-intervention period as
compared to the referent group. It is likely that the
observed effect may be due to a change in the
standard of care, or change in the characteristics of
the cohort, or the small sample size, and/or perhaps
temporal trends in adherence due to ARV therapy
Table I. Baseline characteristics of ARV naı ¨ve women enrolled in ACS, DDT intervention programmes compared to the Standard of Care
VariableACS (n? /11) DDT (n? /21) SOC (n? /22)
Age, median, years
Race: African American, n (%)
Baseline CD4 cells/cumm, median (IQR)
Baseline Viral Load log10HIV RNA copies/ml, median (IQR)
Active Substance Use, n (%)
Clinical Depression, n (%)
Student’s t-test for continuous variables, and Chi-square or Fischer’s Exact test for categorical variables.
z Zung Depression Scale for DDT and Hamilton Depression Scale of ACS
IQR: Inter Quartile Range; ACS: Adherence Co-ordination Services: cognitive-behavioral health-care team based intervention; DDT:
Directly Delivered Therapy: weekly delivery of anti-retroviral therapy; SOC: Standard of Care
Community-based weekly ARV delivery in naı ¨ve women
simplification. During the study periods, there were
no changes in the procedures for the standard of
care, and the baseline characteristics of the cohort
were not significantly different, and the comparison
periods included the period of heavy NNRTI, and
boosted PI use. Thus we postulate that the observed
effect may be due to a long-term impact on the
behaviour of these participants.
Our goal was to instil independence in adherence
and prescription refills, thus we delivered only ARV
drugs, requiring the use of the existing clinic-
pharmacy to fill other prescriptions. Overall, we
believe that the community-based outreach using a
peer-positive person helped empower the women for
independent adherence. The latter is especially true,
when one considers that the post-intervention effect
of a more labour-intensive, clinic-based, cognitive-
behavioural approach was not different from that of
the standard of care. Because there was no ‘unlearn-
ing’ of a previous adherence behaviour among the
women who were newly starting HAART, these
results may or may not be generalized to non-naı ¨ve
We offered this programme to all women initiating
HAART, not necessarily those who had declared
themselves as ‘high-risk’ for non-adherence. There-
fore to keep a balance between an effective interven-
tion and not being intrusive in patients’ lives, we
chose once-a-week delivery of drugs. From the
proportion of successful visits by the ORW and the
post-program survey, the acceptability and satisfac-
tion were high. Moreover, the transportability of a
single dose bubble pack increased the acceptability
and convenience for the participants during the
Depression and substance use have been consis-
tently identified as markers of poor adherence (Bing
et al., 2001; Chesney et al., 2000; Elliott et al., 2002;
Ferrando et al., 1996; Gordillo et al., 1999; Lucas et
al., 2002; Ng et al., 2000; Simoni et al., 2003).
About half the women were clinically depressed in
both the ACS and DDT programmes, and they
received similar types of interventions (i.e. referral to
Even though, the number of women identified with
active substance use was less in the DDT group,
there was no targeted intervention for drug use in
this group as compared to the ACS group. We
acknowledge that the latter may have been biased
toward a more favourable outcome in DDT group.
However, despite the intervention for substance use,
the outcomes in the ACS group were not signifi-
cantly different from the SoC.
Interestingly, in both the ACS and DDT arms,
those who had virological failure in the first 4?/8
months, also remained unsuppressed in the follow
up period. This confirms that non-adherent beha-
viour is declared early (Carrieri et al., 2003; Lepri et
al., 2001). Thus adherence interventions during
therapy initiation may have substantial long-term
In a recent analysis, Goldie et al. projected the
cost-effectiveness of adherence interventions in a
simulation model (Goldie et al., 2003). The cost of
home based, 5?/7 days a week modified DOTranged
from $500?/$1500 per person per month. The cost-
effectiveness ratio for an adherence intervention was
below the average $50,000 per quality-adjusted life-
year (QALY) for programmes costing less than $500
per person per month, when the failure rates were
reduced by more than 40% as compared to the
standard of care. The total cost incurred for our
DDT project was $50,000. The adherence interven-
tion was provided to 24 women over 6 months, thus
costing $347 per person per month. The reduction
in failure rate was more than 40% in the first six
months and most importantly maintenance of 35%
reduction in the failure rate in the post- intervention
period. On the other hand, the cost-effectiveness
ratio does not compare favourably for the ACS
intervention. Whereas, the ACS intervention in-
volved a total cost of $200,000 for 50 women thus
Table II. The proportion of subjects with sustained virological suppression in each intervention group and the referent standard of care
OR (95% Confidence Interval) P Value
ACS vs. DDT
vs. SOCACS vs. DDTACS vs. SOC DDT vs. SOC
Response at 4?/8
months of follow up
Response at 10?/14
months of follow up
Only 15 patients have post-intervention follow up data available at the time of analysis, 4 had expired and 2 had not reached the window-
period; ACS: Adherence Co-ordination Services: cognitive-behavioural health-care team based intervention; DDT: Directly Delivered
Therapy: weekly delivery of anti-retroviral therapy; SOC: Standard of Care
F. Visnegarwala et al.
incurring an expense of $667 per person per month.
Thus in this study of our population, the DDT
intervention is not only effective, but also economic-
We have shown that using a novel strategy of a
community liaison with weekly delivery of ARV
therapy impacts both short term and post-interven-
tion adherence among women initiating their first
HAART regimen. Randomized clinical trials are
needed to substantiate the results of this pilot study.
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