1. Vancouver, British Columbia, Canada

2. Clinical Outcomes and Quality of Life: a preliminary look at HIV+ participants enrolled in a DOT Program
Eirikka Brandson MSc PPH
K.A. Fernandes, M.W. Tyndall, A.K. Palmer, K.C. Duncan, D. Tzemis, V.D. Lima, J.S.G. Montaner, R.S. Hogg
Drug Treatment Program
BC Centre for Excellence in HIV/AIDS, Canada
XVII International AIDS Conference 3-8 August 2008 Mexico City

3. Background Directly Observed Therapy (DOT) improves adherence
Optimizes adherence among vulnerable groups
Treatment requires high rates of adherence
DOT – MAT began in 1999, has approx 90 participants enrolled at any given time. The majority take meds daily, otherwise an outreach worker finds them. Mult-team 1 coordinator, 1 pharmacist, 1 social worker, 2RNs 1 Community LIason person. Biggest challenge is housing. 1/3 on methadone.
Talk about LISA informally - basically, LISA is looking at how we (as in health care providers and HIV positive community) are doing 10 years (give or take) after triple therapy was introduced. The introduction of HAART has the ability to change the face of the disease - has it been successful? Strengths, gaps, etc.
R – reductions in HIV morbidity & mortality associated with HAART
E – evading drug resistance requires high-level adherence
L – low level adherence found in IDU and other vulnerable groups
E – enhance adherence with Directly Administered Antiretroviral Therapy (DAART) programs
V - Visiting daily optimizes opportunities to monitor co-morbidities and introduce other treatment options
A - At the Maximally Assisted Therapy (MAT) DOT program, ARVs are provided by a multi-disciplinary team who also provide support for individuals on ARVs
N - November 1999 MAT enrollment began
C - Common first line therapies are used at MAT
E - Encouraging life skills by providing assistance with housing, health concerns, and addiction treatment options.

4. Predictors of Optimal Adherence
The Adherent patient:
Has emotional & practical life supports
Fits drug regimen into daily routine
Understands non-adherence leads to resistance
Recognizes that ALL doses must be taken
Feels comfortable taking meds in front of others
Keeps clinical appointments

5. Predictors of Optimal Adherence
Barriers to Optimal Adherence:
Drug dependency
Mental illness
Misinformation about ART
Poor access to medical care
Lack of patient education
Criminal enforcement
Hep C and other co-infections
Unstable housing

6. Objectives
1.) To evaluate the socio-demographic characteristics, quality of life, and clinical outcomes among persons enrolled in a Directly Observed Therapy (DOT) program.
2.) To examine whether there is an association between Viral Load Suppression and being in the DOT program, while accounting for potential confounders.
Participants are asked to sign a consent form, verifying their voluntary involvement in the project. All interviews are confidential and participants are compensated $20 for their time.

7. Methods
Longitudinal Investigations into Supportive and Ancillary health services (LISA) cohort is a prospective study of HIV+ persons on ART
Participants recruited from the Drug Treatment Program at the BC Centre for Excellence in HIV/AIDS
Interview administered survey that collects information
Bivariable analyses: Fisher’s Exact Test for categorial variables, Wilcoxon Rank Sum Test for continuous explanatory variables
Multivariable confounder model used to investigate the association between Viral Load Suppression and being in the DOT program,
adjusting for potential confounders

8. Results LISA Cohort (n=481)
Other Participants DOT Participants (n=417) (n=64)
101 (25%) Female (28%) Female
137 (33%) Aboriginal 23 (36%) Aboriginal
46 Median Age Median Age

9. Results (2) Social Factors DOT less likely to be currently employed
Others (n=417)
DOT (n=64)
P-value
High School Education or Greater
224 (57%)
31 (48%)
0.140
Currently Employed
105 (23%)
7 (11%)
<0.010
Provincial Income Assistance
301 (75%)
58 (91%)
<0.001
Unstable Housing
125 (34%)
39 (61%)
Food Insecure
270 (70%)
52 (83%)
0.030
Ever Violence
Last 6 months
311 (74%)
66 (17%)
45 (70%)
15 (23%)
0.440
0.290
Ever Incarcerated
209 (55%)
20 (7%)
56 (88%)
12 (19%)
DOT more likely to receive provincial income assistance
DOT more likely to have unstable housing
DOT more likely to be food insecure
DOT more likely ever incarcerated
DOT more likely incarcerated last 6 months

10. Results (3) Quality of Life (Holmes) DOT less HIV Mastery
Other (n=417)
DOT (n=64)
P-value
Overall Function
“pain has limited my ability to be physically active” “my health has limited my social activities”
46.4 ( )
0.790
Life Satisfaction
“I’ve felt in control of my life” “I’ve been pleased with how healthy I’ve been”
71.9 ( )
68.8 ( )
0.100
Health Worries
“I’ve been worried about my CD4 count” I’ve been worried about when I’m going to die”
55.0 ( )
52.5 ( )
0.720
Financial Worries
“I’ve been worried about how to pay my bills” “I’ve been worried about having to live on a fixed income”
43.8 ( )
46.9 ( )
0.400
Medication Worries
“Taking my medicine has made it hard to live a normal life”
68.8 ( )
0.950
HIV Mastery
“I’ve had regrets about the way I lived my life before knowing I had HIV”
58.3 ( )
58.3 ( )
0.010
Disclosure Worries
“I’ve limited what I tell others about myself” “I’ve been worried that I’ll lose my source of income if others..”
55.0 ( )
65.0 ( )
0.150
Provider Trust
“I’ve felt as if my doctor was someone who listens to me”
91.7 ( )
75.0 ( )
0.001
Sexual Function
“I’ve been satisfied with my sexual life” I’ve been interested in sex”
0.320
DOT less HIV Mastery
DOT less Provider Trust

11. Results (4) Drug Use DOT less likely to have heavy alcohol use
Others (n=417)
DOT (n=64)
P-value
Heavy Alcohol Use
239 (58%)
27 (43%)
<0.010
Never Drugs
Yes, Not current
Current
69 (15%)
171 (38%)
177 (47%)
3 (5%)
12 (19%)
49 (76%)
<0.001
Methadone
107 (28%)
29 (45%)
DOT less likely to have heavy alcohol use
DOT more likely to currently use drugs
DOT more likely to use methadone

12. Results (5) Clinical Variables
Others (n=417)
DOT (n=64)
P-value
CD4 >200
296 (78%)
55 (87%)
0.14
Viral Load Suppression
240 (61%)
43 (68%)
0.21
On ART
372 (90%)
59 (92%)
0.66
>95% Adherence
228 (61%)
36 (61%)
0.87
Depression
228 (56%)
41 (64%)
0.18
Hepatitis C
242 (62%)
<0.001
DOT more likely co-infected with Hepatitis C

13. Not included in final model
Results (6)
Multivariable Confounder Model
Association between Viral Load Suppression and being in the DOT program (N=421)
Unadjusted
Adjusted
Odds Ratio (95% CI)
P-Value
In the DOT program
(Yes vs. No)
1.46 (0.83 – 2.58)
0.19
1.35 (0.70 – 2.60)
0.36
Age (per year increase)
1.02 (1.00 – 1.04)
0.02
Not included in final model
Gender (Female vs. Male)
0.53 (0.34 – 0.83)
0.006
0.71 (0.43 – 1.17)
0.18
CD4
<200
>=350
1.00 (--)
3.43 (1.97 – 5.99)*
7.26 (4.29 – 12.31)*
<
3.31 (1.84 – 5.97)*
5.86 (3.31 – 10.4)*
Num. Drugs Currently Taking 1 2+
0.60 (0.38 – 0.96)*
0.48 (0.30 – 0.78)*
0.86 (0.50 – 1.48)
0.64 (0.37 – 1.11)
0.29
Number of years on therapy
(per one year increase)
1.24 (1.15 – 1.33)
1.22 (1.13 – 1.32)
Estimated Overall Adherence (>=95% vs <95%)
0.71 (0.52 – 0.97)
0.03

14. Not included in final model
Results (6)
Multivariable Confounder Model
Association between Viral Load Suppression and being in the DOT program (N=421)
Unadjusted
Adjusted
Odds Ratio (95% CI)
P-Value
In the DOT program
(Yes vs. No)
1.46 (0.83 – 2.58)
0.19
1.35 (0.70 – 2.60)
0.36
Age (per year increase)
1.02 (1.00 – 1.04)
0.02
Not included in final model
Gender (Female vs. Male)
0.53 (0.34 – 0.83)
0.006
0.71 (0.43 – 1.17)
0.18
CD4
<200
>=350
1.00 (--)
3.43 (1.97 – 5.99)*
7.26 (4.29 – 12.31)*
<
3.31 (1.84 – 5.97)*
5.86 (3.31 – 10.4)*
Num. Drugs Currently Taking 1 2+
0.60 (0.38 – 0.96)*
0.48 (0.30 – 0.78)*
0.86 (0.50 – 1.48)
0.64 (0.37 – 1.11)
0.29
Number of years on therapy
(per one year increase)
1.24 (1.15 – 1.33)
1.22 (1.13 – 1.32)
Estimated Overall Adherence (>=95% vs <95%)
0.71 (0.52 – 0.97)
0.03
No evidence of association between DOT program and Viral Load Suppression
Viral Load Suppression associated with number of years on therapy and CD4

15. Conclusion
Preliminary findings demonstrate the success of this program, as DOT participants showed similar clinical outcomes when compared to their peers in the cohort.

16. Recommendations The Adherent patient: The Adherent patient:
Has emotional & practical life supports
Fits drug regimen into daily routine
Understands non-adherence leads to resistance
Recognizes that ALL doses must be taken
Feels comfortable taking drugs in front of others
Keeps clinical appointments
The Adherent patient:
Has emotional & practical life supports
Fits drug regimen into daily routine
Understands non-adherence leads to resistance
Recognizes that ALL doses must be taken
Feels comfortable taking drugs in front of others
Keeps clinical appointments
Barriers to ART Adherence:
Drug dependency
Mental illness
Misinformation about ART
Poor access to medical care
Lack of patient education
Criminal enforcement
Hep C and other co-infections
Unstable housing

17. Recommendations
1.) Programs that help enable high adherence can successfully result in healthy clinical outcomes, but are not a long term solution.
2.) The self-adherent patient can only exist when the social factors and other ‘root cause’ barriers are addressed.
3.) Supportive services are fundamental to the success of any adherence intervention.
The Adherent patient:
Has emotional & practical life supports
Fits drug regimen into daily routine
Understands non-adherence leads to resistance
Recognizes that ALL doses must be taken
Feels comfortable taking drugs in front of others
Keeps clinical appointments
The Adherent patient:
Has emotional & practical life supports
Fits drug regimen into daily routine
Understands non-adherence leads to resistance
Recognizes that ALL doses must be taken
Feels comfortable taking drugs in front of others
Keeps clinical appointments
Barriers to ARV Adherence:
Drug dependency
Mental illness
Misinformation about ARV therapy
Poor access to medical care
Lack of patient education
Criminal enforcement
Hep C and other co-infections
Unstable housing
Barriers to ART Adherence:
Drug dependency
Mental illness
Misinformation about ART
Poor access to medical care
Lack of patient education
Criminal enforcement
Hep C and other co-infections
Unstable housing

18. For more information: ebrandson@cfenet.ubc.ca
Thank you
LISA participants
Canadian Institute of Health Research
BC CFE staff and statisticians
Interview sites & physicians
For more information: