Toronto I-II 8:30 pm
Taking an adherence intervention from efficacy to
effectiveness
Jeffrey Parsons
Editor of Sexuality Research
and Social Policy, Associate
Editor of Archives of Sexual
Behavior and AIDS and
Behavior, past member of
the White House Office on
National AIDS Policy HIV and
Aging Working Group and
Chair of the Behavioral and
Social Consequences of HIV
(BSCH) Study Section of the
National Institutes of Health
Moderator: Trevor A. Hart
Associate Professor in the
Department of Psychology at
Ryerson University and
Adjunct Faculty at the Dalla
Lana School of Public Health
at the University of Toronto
Taking an adherence intervention
from efficacy to effectiveness
Jeffrey T. Parsons, Ph.D.
Distinguished Professor, Department of Psychology
Director, Center for HIV/AIDS Educational Studies & Training (CHEST)
Hunter College and the Graduate Center of the City University of New York (CUNY)
Presented at the OHTN 2013 Research Conference: November 19, 2013
My goals
Present on the first (and thus far only) behavioral
intervention focused on HIV medication adherence to
result in positive immunologic and virologic outcomes.
Discuss evolution of this project into a 2nd RCT and a
planned effectiveness trial
Highlight the problems and mistakes we made along
the way.
Background & Significance
Alcohol use negatively impacts the health of people who
are HIV+.
Alcohol has been commonly identified as a factor related
to HIV medication adherence.
Even recreational alcohol use has been shown to be
associated with non-adherence.
Background & Significance
Optimal HAART adherence is less often achieved in
patients with alcohol problems due to:
• beliefs and misunderstandings about potential negative
interactions between alcohol and HAART (interactions which are
typically not true!)
• exacerbations of side effects by alcohol use
• immediate cognitive and behavioral changes from alcohol use
(e.g. perceptions of time and maintenance of routines)
Study Description
Project PLUS was aimed at simultaneously
improving adherence to HIV meds and
reducing drinking among heavy drinking HIV+
men and women in NYC.
Project PLUS: Medication Adherence Among
HIV-Positive Alcohol Abusers
Principal Investigator:
Project Director:
Assistant Project Director:
Clinical Supervisor:
Education Supervisor:
Data Analyst:
Recruitment Director:
Graphic Designer:
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Jeffrey T. Parsons, PhD
Elana Rosof, PhD
Joseph C. Punzalan
Brad Thomason, PhD
Jose Nanin, EdD
Sarit Golub, PhD
Christian Grov, PhD
Chris Hietikko, MFA
Funded by the National Institute on Alcohol Abuse and Alcoholism
R01 AA13556
Going backwards in time …
Recruitment in 1997-2000
Recruitment in
2002-2006
Clinic Brochure
Methods
Eligibility
 Confirmed HIV Seropositive Status
 On HAART
 AUDIT score >= 8
 Heavy drinking >16 drinks/week for men; > 12/week for women
 Alcohol problems > Other Drug Problems (MAJOR PROBLEM)
 At least 18 years old
Random Assignment
 Using urn randomization
 Matching on gender, AUDIT score and CD4 count
 Two arms
• intervention
• education (attention control) (PARTIAL MAJOR PROBLEM)
Assessment

Adherence:
• Biological measures: viral load and CD4 count
• Self-report measures: Time Line Follow Back
(TLFB) calendar for the past 14 days
 Alcohol use:
• Self-report measures: TLFB for the past 14 days
▫
▫
•
Number of Standard drinks – summed number of standard drinks across the 14-day
period.
Drinks per drinking day - total number of standard drinks in the past 14 days divided
by the number of days during that period in which the participant had at least one
alcoholic drink
NOTE – No biological measures of alcohol use
The Intervention

First two sessions focus exclusively on
Motivational Interviewing (MI).
• Client picks which behavior to focus on
first
• Structured computer-generated
personalized feedback on both
behaviors is provided
• Also covers the Information component
of the IMB model
Motivational Interviewing
 A change plan is formulated with the
participant:
• The changes I want to make are:
• The most important reasons why I want
to make these changes are:
• The steps I plan to take in changing are:
The Intervention

Last six sessions use MI and Cognitive
Behavioral Skills Building
• A menu-approach is used.
• Following a functional analysis, specific
skills building sessions are chosen based
on individual needs of each client and
are assessed through a case
conceptualization
Functional Analysis
Conducted for
each behavior in
order to best
select skillbuilding sessions
most appropriate
for each client
Cognitive Behavioral Skills Building
Provider chooses 3 modules for each behavior based on
client’s skills deficits
ADHERENCE
ALCOHOL
 Coping with Triggers to Drink
 Managing Thoughts to Drink
 Refusal Skills
 Moderated Drinking
 Managing Side Effects
 Communication with Health
Care Providers
 Managing Cravings to Skip
Medication
 Managing Thoughts to Skip
Medication
EITHER
 Increasing Pleasant Activities
 Managing Negative Moods
 Making Time For Self
Control Condition
 The control condition consists of eight individual
sessions with health educators, using videotapes
which provide education around HIV, adherence, and
alcohol use, followed by a structured discussion of the
information covered.
 DANGER, DANGER, DANGER!!!!
Non-Hazardous Drinkers
(n = 167, 53.87%)
Baselined and Randomized
Hazardous Drinkers
(n = 143, 46.13%)
Treatment Condition
(n = 65, 45%)
Mean (SD) sessions = 6.45 (2.31)
3 Month Follow Up
not completed
(n = 12)
6 Month Follow Up
not completed
(n = 12)
Control Condition
(n = 78, 55%)
Mean (SD) sessions = 6.95 (2.18)
Completed
3 Month
Follow Up
(n = 53, 84%)
Completed
3 Month
Follow Up
(n = 68, 87%)
Completed
6 Month
Follow Up
(n = 53, 84%)
Completed
6 Month
Follow Up
(n = 62, 83%)
3 Month Follow Up
not completed
(n = 10)
6 Month Follow Up
not completed
(n = 16)
Adherence Results
 The primary outcome measures were changes in log viral load
and CD4 count from baseline to 3-month follow-up.
 At baseline, the two groups did not differ significantly in their
viral load or CD4 counts.
 At 3-months, there was a significant time x condition interaction
– such that intervention participants demonstrated significant
decreases in viral load, and significant increases in CD4 count,
compared to those in the control condition.
Log Viral Load
4
3.5
Intervention
Control
3
2.5
2
Baseline
3-Months
CD4 Count
500
480
460
440
420
400
380
360
Intervention
Control
Baseline 3-Months
Drinking Results
 Participants in both conditions reported significant decreases in both
the number of standard drinks they consumed from baseline to 3
months, F (1, 112) = 62.7, p < .001.
 Similarly, all participants reported significant decreases in number of
drinks per drinking day from baseline to 3 months, F(1, 112) = 35.1, p <
.001.
 There were no significant time by condition interaction effects for
these variables.
Attention control conditions may change behavior due to
assessment effects or just the effects of being in a study.
Or it may be that they work!
No good biologic measures for alcohol exist.
Results at 6 months
At the 6-month follow-up visit, there were no significant
differences between individuals in the intervention and
control condition on any outcome variable for
adherence or drinking
Average log viral load and CD4 counts remained better
among participants in the intervention condition, but
the time-by-condition interaction effect did not achieve
statistical significance.
Drinking remained lower in both groups, but the
interaction effect was not significant.
PROBLEM: NO BOOSTERS
Summary
This is the first published behavioral intervention to
document efficacy across viral load, CD4 count, and
self-reported adherence.
Both the intervention and the educational control
sessions were equally efficacious in reducing
drinking behaviors.
The reduction in the magnitude of the intervention’s
efficacy at 6-month follow-up indicates the
importance of intervention booster sessions.
Moving beyond PLUS
The Meth “Epidemic”
 In the first several months of
2004, increasing attention
began to focus on the
“epidemic” of crystal
methamphetamine among
gay/bisexual men in NYC and
other urban areas.
The Meth Epidemic
 Gays' Use of Viagra and Methamphetamine Is Linked to Diseases
(NY Times 03.11.04)
 Crystal Meth Linked to AIDS in New York: “Party” drug increases
HIV risk among gays (Reuters 06.07.04)
 Rare and Aggressive H.I.V. Reported in New York (NY Times
02.12.05)
The Meth Epidemic
 Party, Play—And Pay: Multiple
partners. Unprotected sex. And
crystal meth. It's a deadly
cocktail that has stirred new
fears about the spread of HIV
(Newsweek 02.28.05)
Our own research
Through our community-based surveys, we
identified a large increase in methamphetamine
use among MSM.
Use was significantly higher among HIV+ MSM.
Also identified clear relationships between meth
use and sexual risk behaviors.
Meth and Adherence
Meth use and dependence were associated with
poor adherence and increased viral load.
Meth use has many negative effects on the health
of people living with HIV.
Because of the “epidemic” we felt an urgent need
to take PLUS and apply it to meth-using MSM
ACE: Intervention Targeting Medication
Adherence and Methamphetamine Use for
HIV+ MSM
Principal Investigator:
Co-Investigator:
Project Director:
Clinical Supervisor:
Education Supervisor:
Neuropsych Coordinator:
Senior Data Analyst:
Recruitment Director:
Graphic Designer:
Jeffrey T. Parsons, PhD
Sarit Golub, PhD
Julia Tomassilli, PhD
John Pachankis, PhD
Catherine Holder
William Kowalczyk, PhD
Tyrel Starks, PhD
Kevin Robin
Chris Hietikko, MFA
Funded by the National Institute on Drug Abuse
R01-DA023395
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Study Description
 Project ACE is aimed at simultaneously improving HIV medication
adherence and reducing meth use among HIV+ MSM in NYC.
 Eight-session, manual-driven, individual intervention using a
combination of Motivational Interviewing (MI) and Cognitive
Behavioral Skills Building (CBST), adapted from Project PLUS.
 Driven by the IMB Model of Fisher & Fisher
Methods
Eligibility
 Confirmed HIV+ and taking HAART
 >3 missed med days in the last 30
 >3 days of Meth use in the last 90 days
 Past sex with men
 At least 18 years old
Random Assignment
 Using urn randomization
 Two arms: intervention or education (attention control)
WTF?! You didn’t learn the first time???
Clinic Brochure
Recruitment
Cards and Ads
Timing sucks
 The meth “epidemic” identified in 2004.
 First ACE grant submission in late 2005.
 Second ACE grant submission in early 2007.
 ACE was funded in Sept, 2007
 By 2008, rates of meth use dramatically decreased among MSM in
NYC!
 In 2008, only 6% of gay men in New York City reported using meth
during the previous 12 months.
 That's a 57% drop from the percentage reported in 2004.
ACE
 We completed recruitment and enrollment, and just finished our last
round of follow-ups.
 We ended up with a sample size of 210 – after YEARS of recruitment,
and trying virtually every approach in the book – active, passive,
internet-based, RDS, etc.
 Analyses have begun …. More later.
Where do we go from here
 PLUS and ACE were tested in a very controlled environment (CHEST).
 There were numerous inclusion/exclusion criteria that led to a less
generalizable sample.
 Therapists delivering PLUS were highly trained, and received
extensive supervision.
 PROBLEM: Would we get the same results in actual HIV clinic
settings, using the actual staff?
Where do we go from here
 So, we submitted an application to NIAAA for a comparative
effectiveness trial to test PLUS in 3 clinics in NYC.
 Will train existing clinic staff in MI, CBT, and the intervention itself,
but will provide limited on-going supervision.
 Limited eligibility criteria, few exclusion criteria.
 The fact that patients come to clinic regularly for care will permit
natural booster sessions.
 Funded, and the trial will begin in 2014.
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Thank you!
For further questions or a copy of these slides, please email me:
Jeffrey.Parsons@hunter.cuny.edu
Or visit:
www.chestnyc.org