Transcript Open slides - CTN Dissemination Library

HIV and HCV Risk Reduction
Interventions in Drug Detoxification
and Treatment Settings
Key Players
–
Lead Investigator:
–
–
Rocky Mountain Co-Lead Investigator
–
–
Laetitia Thompson, Ph.D.
Oregon Co-Lead Investigator
–
–
Robert Booth, Ph.D.
Bret Fuller, Ph.D.
Co-Investigators:
–
Dennis McCarty (OR); Barbara Campbell (OR);
Paula Riggs ; (RM); Susan Mikulich-Gilbertson
(RM); Catherine Dempsey (RM)
Participating Nodes and Treatment Centers
■Rocky
Mountain
❑ Denver
Health and Hospital
❑ Island Grove Regional Treatment
■Northern
New England
❑ SSTAR:
Rhode Island
❑ SSTAR: Fall River
■Great
Lakes
Jim Gilmore Community Healing Center
Oregon/Hawaii
Willamette Family Treatment
■Washington
❑Recovery Centers of King County: Seattle
❑Recovery Centers of King County: Kent
Target Population
■Adult
(18+ years) injection drug users
■In residential detoxification
■Engaging in unsafe needle and/or sex
behaviors
■At risk for transmitting HIV and HCV
Study Objectives
■Primary Aim:
❑ Reduce injection-related HIV and HCV risk
behaviors
■Secondary Aims:
❑ Decrease sexual risk behaviors
❑ Decrease drug injection
❑ Increase treatment entry
❑ Increase treatment retention
Dependent Variables
■Primary Outcome (past 30 days)
❑ Sum of the above risky injection behaviors
❑ Sharing
needles
❑ Sharing cotton/cooker/water
❑ Splitting drug solution
■Secondary Outcomes
❑ 30 day abstinence or 100% condom use
❑ 30 day frequency of drug injecting
❑ Number
of days injected (capped at 30 days)
❑ Number of times injected (capped at 10 times per day
and 300 times per month)
❑ Treatment
entry (yes, no)
❑ Weeks treatment attended
Randomized Clinical Trial Design
■ NIDA Counseling
& Education Intervention (C&E)
■ Therapeutic Alliance Intervention (TA)
■ Treatment As Usual (TAU)
Counseling &Education Intervention
■
■
■
HIV & HCV Education
Drug risk & sex risk reduction education
Protective skills training
■
teaching needle sterilization
■ use of condoms
■
■
Voluntary HIV &/or HCV testing
Encouragement to stop drug injection/drug
use & enter treatment
Therapeutic Alliance Intervention
■Single
■
■
■
■
■
session with outpatient counselor
Identify life and treatment goals
Agree on treatment tasks and expectations
Develop confidence about treatment success
Build a positive relationship bond
Schedule voluntary outpatient appointment
Treatment as usual

Typical clinic procedures
 HIV
Risk Reduction Education
 Referrals for HIV testing
 Linkage to continuing care
Subjects
Consented
(n = 698)
Consort
Diagram
Participant
Excluded
(n = 66)
Subjects
Randomized
(n = 632)
TAU
(n = 211)
33%
C&E
(n = 212)
33%
TA
(n = 209)
33%
2 Month
TAU
(n = 134)
64%
2 Month
C&E
(n = 132)
62%
2 Month
TA
(n = 130)
62%
4 Month
TAU
(n = 124)
59%
4 Month
C&E
(n = 131)
62%
4 Month
TA
(n = 126)
62%
6 Month
TAU
(n = 129)
61%
6 Month
C&E
(n = 141)
67%
6 Month
TA
(n = 127)
61%
Assessment Instruments
■
■
■
■
■
■
■
■
■
■
■
■
HIV Risk Behavior Survey (RBS) Audio CASI
Urine Drug Screen (UDS)
Saliva Alcohol Test (ST) (Baseline)
Demographics Questionnaire (DEM) (Baseline)
Drug Use Screening Questionnaire (DUS) (Baseline)
Services Received Questionnaire (SRQ)
Addiction Severity Index -Lite (ASL)
CIDI-2 (SUD) (Baseline)
Timeline Follow-back Assessment of Treatment Participation (TFB)
Stages of Change (SOC)
Self Efficacy (SEF)
Locator Form
Interventionist & Supervisor Selection
■
■
50 staff in 8 CTPs
Education for interventionists:
■
■
Education for supervisors:
■
■
Bachelor’s degree to M.D.
Years of experience:
■
■
Associate’s degree to masters
6 months to 25 years
49 of 50 completed training and certification
■
1 C&E interventionist failed certification
Fidelity Monitoring Procedure
■
■
■
■
Sessions audiotaped
Local certified supervisors select and rate
25% to 50%
National expert reviews 1/3 of rated tapes
Experts rated supervisors
Gender and Race/Ethnicity
■
Gender
❑478
men (75.6%)
❑154 women (24.4%)
■
■
■
■
■
Hispanic: 58 (9.4%)
African American: 67 (10.6%)
American Indian: 62 (9.8%)
Asian and other: 38 (6.0%)
White: 465 (74.3%)
Drug use at baseline
Lifetime Use
Use in last 30
Days
Injected in last 30
days
N
%
N
%
n
%
Cocaine
627
95.22
626
60.06
625
45.28
Heroin
628
90.45
624
81.57
623
80.74
Amphetamine
626
64.86
624
33.97
623
26.97
Other Opiates
628
74.00
622
39.39
622
16.88
Speedballs
631
72.38
627
43.70
625
37.92
Days used and times injected
Days used in last 30
Mean
Days injected
in last 30
SD Mean
Times injected in
past 30 days
SD
Mean
SD
Cocaine
6.91
9.75
4.04
7.68
33.41
110.79
Heroin
17.85
12.25
17.23
12.33
90.86
184.50
Amphetamine
2.96
6.54
2.34
5.84
8.20
29.09
Other Opiates
2.97
6.33
1.22
4.20
6.57
34.92
Speedballs
3.92
7.24
3.25
6.45
19.44
107.38
Injection risk behaviors at baseline
TOTAL
(n=631)
TAU
(n = 212)
C&E
(n = 211)
TA
(n = 209)
% using a previously
used needle in past 30
days
38.29%
(n=619)
38.28%
(n=209)
37.75%
(n=204)
38.83%
(n=206)
% using a previously
used needle at all in 30
days without bleaching
25.41%
(n=614)
25.48%
(n=208)
24.63%
(n=203)
26.11%
(n=203)
% using dirty
cotton/cooker/water in
30 days
46.39%
(n=623)
47.62%
(n=210)
44.93%
(n=207)
46.60%
(n=206)
% splitting drug
solution in 30 days
53.93%
(n=623)
54.29%
(n=210)
53.40%
(n=206)
54.11%
(n=207)
% reporting any of the
three risk factors
61.34%
(n=626)
61.61%
(n=211)
63.32%
(n=207)
60.10%
(n=208)
Sexual Risk Behaviors: Safe Sex Past 30 Days
TOTAL
N
Men:
Abstinence/
100%
Condom
Use
466
Women:
Abstinence/
100%
Condom
Use
152
TAU
%
N
51.5%
152
(missing 7)
39.5%
C&E
%
N
48.0%
157
(missing 3)
56
33.9%
TA
%
N
53.5%
157
(missing 3)
46
43.5%
%
52.9%
(missing 1)
50
42.0%
Sexual Risk Behaviors: Number of Partners Past 30 Days
TOTAL
Behavior
TAU
C&E
TA
N
Mean (SD)
N
Mean (SD)
N
Mean (SD)
N
Mean (SD)
Number of partners
had vaginal, oral,
or anal sex with
626
1.6 (3.9)
210
1.3 (2.1)
209
1.6 (3.2)
207
1.8 (5.5)
Men having vaginal
sex with women
457
1.0 (2.5)
153
0.9 (1.5)
154
0.9 (1.7)
158
1.2 (3.6)
Men having anal sex
with women
465
0.3 (0.7)
153
0.3 (0.6)
158
0.3 (0.6)
158
0.3 (0.9)
Men having
penetrative anal
sex with men
469
0.004 (0.1)
154
0.006 (0.1)
159
0.006 (0.8)
158
0
Men having
receptive anal sex
with men
469
0.006 (0.1)
154
0
159
0.006 (0.8)
158
0.01 (0.2)
Women having
vaginal sex with
men
147
2.0 (5.1)
54
1.5 (1.7)
46
2.0 (2.7)
47
2.4 (8.5)
Women having anal
sex with men
151
0.3 (0.9)
56
0.3 (0.5)
46
0.4 (1.4)
49
0.2 (0.5)
Outcomes So Far
Longitudinal Analyses of Primary
Outcomes



Each continuous outcome assessed with the
same mixed model design including fixed
intervention, time, site, and interaction effects
Specified random effects allowed both the
intercept and curve (e.g., slope) of the lines to
vary by subject
Pre-specified covariates (gender, treatment
entry, type of drug injected, and perceived selfefficacy to practice safer behaviors will be
evaluated for inclusion
Sum of Risky Injection Behaviors in
the Past 30 Days
Intervention: NS, p<.34
 Site:
NS, p<.17
 Time:
p <.0001
 Time*Intervention: NS,p<.17
 Site*Intervention: NS
(removed)

Significant decrease in risky
injection behaviors across
interventions and sites
Days Injected Past 30 Days
Days Injected by Intervention
(capped at 30)
Intervention:
NS, p<.79
 Site:
p<.0001
 Time:
p <.0001
 Time*Intervention: NS, p<.22
 Site*Intervention: NS
(removed)
 Site*time
p<.007
Relationship with time
differed by sites but all
showed a decrease in days
injected
Overall, significant decrease in
days injected in the past 30
days across interventions
and sites

Days Injected by Site
Frequency of Injecting Past 30 Days
(capped at 10x /day and 300x /month)
Times Injected by Intervention






Intervention:
NS, p<.90
Site:
p<.0001
Time:
p <.0001
Time*Intervention: NS
(removed)
Site*Intervention: NS
(removed)
Site*time
p<.0001
Relationship with time differed
by sites but all showed a
decrease in days injected
Overall, significant decrease in
times injected in the past 30
days across interventions and
sites
Days
TimesInjected
InjectedbybyIntervention
Site