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AETC HIV Testing Collaborative
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Agenda
 Updates from CDC and HRSA
 Renee Freeman, Rupali Doshi
 Presentations
 The Prevalence of HIV with Rapid Testing in Mental Health Settings
Michael Blank, PhD
Associate Professor of Psychology in Psychiatry
University of Pennsylvania, Perelman School of Medicine
 Implementing Rapid HIV Testing with or without Risk-Reduction
Counseling in Drug Treatment Centers
Lisa Metsch, PhD
Stephen Smith Professor and Chair
Columbia University, Mailman School of Public Health
 Case Study: Implementing HIV testing within a Substance Abuse Center in
South Carolina
Louise F. Haynes, MSW
Adjunct Assistant Professor
Medical University of South Carolina, Dept. Psychiatry and Behavioral Sciences
 Next Call
PREVALENCE OF HIV WITH RAPID TESTING IN MENTAL
HEALTH SETTINGS: A MULTISITE STUDY
Michael B. Blank, PhD
University of Pennsylvania
November 3, 2014
GRANT SUPPORT
This project was supported by U18-PS000704 (Michael
Blank, PI) “Multi-Site Rapid HIV Testing in Urban
Community Mental Health Settings,” by P30-AI045008
(James Hoxie, PI) “Penn Center for AIDS Research”, and by
P30-MH097488 (Dwight Evans, PI) “Penn Mental Health
AIDS Research Center”.
OBJECTIVES
•
To determine HIV prevalence and risk factors among persons receiving mental health
treatment in Philadelphia, Pennsylvania and Baltimore, Maryland between January 2009 –
August 2011
•
Stratified sampling using inpatient psychiatric units, outpatient community mental health
centers (CMHCs), and outpatient intensive case management captures the three
predominant modalities of mental health service delivery in the United States
•
We were also interested in identifying any barriers to implementing routine rapid HIV
testing in mental health service settings
METHODS
•
Multisite, cross-sectional design stratified by clinical setting
•
1061 individuals tested for HIV
•
University-based psychiatric inpatient psychiatric units (n = 287)
•
Intensive case-management and ACT programs (n = 273)
•
Standard case management in Community Mental Health Centers (n = 501)
HIV STATUS AMONG PERSONS RECEIVING TREATMENT IN MENTAL
HEALTH SETTINGS BY LEVEL OF CARE AND STUDY SITE
Participants by HIV Status, No. (%)
All
Participants
(n = 1061), No. (%)
HIVPositive
(n = 51)
HIVNegative
(n = 1010)
HIV
Prevalence
(95% CI)
Inpatient
287 (27.1)
17 (33.3)
270 (26.7)
5.9 (3.7, 9.4)
ICM
273 (25.7)
14 (27.5)
259 (25.6)
5.1 (3.1, 8.5)
Outpatient
501 (47.2)
20 (39.2)
481 (47.6)
4.0 (2.6, 6.1)
Philadelphia
608 (57.3)
24 (47.1)
584 (57.8)
4.0 (2.7, 5.8)
Baltimore
453 (42.7)
27 (52.9)
426 (42.2)
5.9 (4.1, 8.6)
Variable
p
Level of Care
.46
Study Site
.13
RESULTS
•
51 individuals (4.8%) were HIV-infected
•
Confirmed HIV positive tests based on level of care:
• Inpatient units: 5.9% (95% confidence interval [CI] 3.7%, 9.4%)
• Intensive case-management programs: 5.1% (95% CI = 3.1%, 8.5%)
• Community mental health centers: 4.0% (95% CI = 2.6%, 6.1%)
•
Characteristics associated with HIV included:
•
African American
•
Homosexual or bisexual identity
•
HCV co-infection
BREAKDOWN OF CHARACTERISTICS
ASSOCIATED WITH HIV INFECTION
(RACE AND HOUSING STATUS)
Participants by HIV status, No. (%)
All
Participants
(n = 1061, No. (%)
HIVPositive
(n = 51)
HIVNegative
(n = 1010)
HIV
Prevalence
(95% CI)
White
196 (18.6)
2 (3.9)
194 (19.3)
1.0 (0.3, 4.1)
Black
692 (65.7)
43 (84.3)
649 (64.7)
6.2 (4.7, 8.3)
Other
166 (15.8)
6 (11.8)
160 (16.0)
3.6 (0.2, 7.9)
Currently homeless
173 (16.4)
14 (27.5)
159 (15.9)
8.1 (4.9, 13.4)
Not currently homeless
880 (83.6)
37 (72.6)
843 (84.1)
4.2 (3.1, 5.8)
Variable
p
Race
.02
Housing Status
.03
BREAKDOWN OF CHARACTERISTICS ASSOCIATED WITH HIV
INFECTION
(HCV INFECTION, NIDU PAST 4 WKS, SEXUAL IDENTITY)
Participants by HIV status, No. (%)
All
Participants
(n = 1061, No. (%)
HIVPositive
(n = 51)
HIVNegative
(n = 1010)
HIV
Prevalence
(95% CI)
No
891 (85.0)
33 (66.0)
858 (86.0)
3.7 (2.7, 5.2)
Yes
157 (15.0)
17 (34.0)
140 (14.0)
10.8 (6.9, 17.0)
No
218 (20.6)
8 (15.7)
210 (20.8)
3.7 (1.9, 7.2)
Yes
843 (79.5)
43 (84.3)
800 (79.2)
5.1 (3.8, 6.8)
945 (90.8)
40 (80.0)
905 (91.3)
4.2 (3.1, 5.7)
96 (9.2)
10 (20.0)
86 (8.7)
10.4 (5.8, 18.7)
Variable
p
HCV Infection
<.001
NIDU, past 4 wks
.38
Sexual Identity
Heterosexual
Homosexual or Bisexual
.01
BREAKDOWN OF CHARACTERISTICS
ASSOCIATED WITH HIV INFECTION
(PSYCHIATRIC DIAGNOSIS)
Participants by HIV status, No. (%)
All
Participants
(n = 1061, No. (%)
HIVPositive
(n = 51)
HIVNegative
(n = 1010)
HIV
Prevalence
(95% CI)
Psychiatric
disorder only
570 (54.7)
21 (41.2)
549 (55.4)
3.7 (2.4, 5.6)
Psychiatric and
substance abuse
disorders
350 (33.6)
21 (41.2)
329 (33.2)
6.0 (4.0, 9.1)
Substance abuse
disorder only
122 (11.7)
9 (17.7)
113 (11.4)
7.4 (3.9, 13.8)
Variable
p
Psychiatric Diagnosis
.12
SPECIAL THANKS
The authors would like to thank the administrators
and clinicians at the many hospitals and mental health
clinics in Philadelphia and Baltimore who allowed them
to recruit in their settings, and especially the participants
themselves.
HIV Testing in Substance Use Treatment
Programs: Evidence-Based Opportunities
and Challenges
Lisa Metsch, PhD
Stephen Smith Professor and Chair
Department of Sociomedical Sciences
November 3, 2014
Slide 14
Today’s Talk…
▪ Identify opportunities to provide HIV testing in
substance use treatment programs
▪ Review the scientific evidence for offering HIV testing
on-site in substance use treatment programs
▪ Discuss the latest research on how to approach
counseling at the time of HIV testing
Slide 15
What about HIV Testing in Drug
Abuse Treatment Centers?
Slide 16
■
Fewer than one-third of U.S drug treatment
programs offer HIV testing and counseling.
■
Fewer than half of CTN community treatment
programs made HIV testing available either in the
community treatment program (CTP), or through
referral.
SAMSHA, 2009; Pollack and D’Aunno, 2010; Abraham et al., 2011, 2012; Brown et al. JSAT,
2006; AJPH, 2007
Slide 17
Slide 18
National Drug Abuse Treatment System
Survey (NDATSS)
■
■
■
■
Nationally representative survey
Opioid treatment programs surveyed in 2005 and
2011
93% of OTPs offered HIV testing in 2005 vs.
64% in 2011
41% of clients in these OTPS were tested for HIV
in 2005 vs. 17% in 2011
D’Aunno et al., 2014, Health Services Research
Slide 19
HIV Rapid Testing in Substance Use
Treatment Programs
CTN 0032
Lisa Metsch, Ph.D.
Grant Colfax, M.D.
Slide 20
Primary Questions
■ In
substance use treatment centers,
what is most effective HIV testing
strategy:
1. To increase receipt of HIV test
results?
2. To decrease HIV sexual risk
behaviors?
Slide 21
Study Intervention Groups
■
Group 1 - Rapid HIV Testing with RESPECT
Counseling
■
Group 2 - Rapid HIV Testing and Information
Only
■
Group 3 - Referral Only
Slide 22
Counseling Intervention
■
Group 1 intervention is based on CDC’s RESPECT 2*
counseling model
■
RESPECT 2 is an individually tailored but focused
(counselor directed) HIV prevention counseling format
used in conjunction with rapid HIV testing which aims
to:
– Increase the individual’s awareness of personal risk for HIV
– Assist the individual in creating an HIV risk reduction plan
*Metcalf, Douglas, Malotte et al; 2005
Overview of CTN 0032
Study Design
Slide 23
Recruitment and Enrollment
Brief Baseline
Assessment
Random Assignment
Offer Rapid Testing
with brief
participanttailored prevention
Counseling
Offer Rapid
Testing with
Information Only
Post-intervention
data collection
Offer Standard
Referral for
Testing
in Community
Slide 24
Participating Sites
CODA
MCCA
Wheeler
Life
Link
La Frontera
Gibson
Recovery
CPCDS
Glenwood
Chesterfield
Daymark
LRADAC
Morris
Village
Slide 25
Study Population
■
1281 drug treatment clients enrolled at 12 CTPs in
the U.S. in less than 5 months
■
12 sites randomized an average of 106 participants
(ranging from 59 to 126 per site)
■
Randomized participants were demographically
similar (age, gender, race/ethnicity) to CTP
demographics
Slide 26
Notable Inclusion Criteria
Participant must have:
■ Been seeking or currently receiving drug
(inclusive of alcohol) abuse treatment services at
the CTP
■ Reported being HIV-negative or HIV status
unknown
■ Reported no receipt of results from an HIV test
performed in the prior 12 months
Slide 27
Efficacy Assessments
■
Primary Outcomes:
– Self-reported receipt of HIV test results at one
month follow-up
– Self-reported sexual risk behavior at 6 month followup
■
Data collected on web-based ACASI an
Electronic Data Collection Form (eCRF)
■
Emphasis on intervention fidelity and quality
assurance
Slide 28
Follow-Up Visit Attendance
Randomized
(n=1281)
n
%
Month 1
1257/1281
98.1
Month 6
1193/1281
93.1
Slide 29
Summary of Treatment Exposure
Treatment
n
%
Off-site referral
429/429
100
On-site HIV test
with RESPECT-2
427/433
98.8
On-site HIV test
with information only
419/419
100
Slide 30
Counseling Fidelity
Pre-results session
Adherence Rating
Unsatisfactory
Acceptable/Good
Excellent
Counseling content
beyond treatment arm
Overall
(n=198)
n
0/198
10/198
188/198
%
0.0
5.1
94.9
5/131
3.8
Slide 31
Demographics (n=1281)
■
Gender
■
– 60.7% Male
– 39.3% Female
■
–
–
–
–
–
Age Range
–
–
–
–
24.1% 18-29
24.4% 30-39
32.3% 40-49
19.1% ≥ 50
Race
■
2.6% American Indian
20.5% Black/African American
64.5% White
7.7% Multiracial
4.7% Other*
Ethnicity
– 11.5% Hispanic
*Includes Asian, Native Hawaiian/Pacific Islander, and other
Slide 32
Baseline Drug Use
Baseline
%
Injected Drugs in Lifetime
48.6
Injected Drugs in Last 6 Mo
20.6
Used Opiates in Last 6 Mo
37.0
Used Stimulants in Last 6 Mo
43.6
High Drug Use Severity
53.6
Binge Drinking
71.8
Baseline Sex Risk and HIV Testing
History
Risky Sexual Behavior
Median Number of Risky
Sexual Acts
Ever Tested for HIV
Median Times HIV Tested
61.7%
5
69.3%
2
Slide 33
Slide 34
Primary Hypothesis Test:
Risky Sexual Behavior
Slide 35
Number of risky sexual behaviors at 6 month post-randomization
Treatment
n Mean (SD)
Comparison Groups
387 20.5 (49.8)
■
On-site HIV test:
385 21.3 (47.6)
RESPECT-2
■
On-site HIV test:
371 21.3 (44.8)
Info Only
■
Off-site Referral
Overall:
– p = . 6596
Off-site vs. On-site:
– p = . 4348
RESPECT-2 vs. Info Only:
– p = . 8697
Slide 36
HIV Diagnoses
■
3 (0.4%) participants had reactive tests
confirmed HIV positive by Western Blot
– 2 in counseling
– 1 in information only
Slide 37
Change in Needle Sharing from Baseline
to Six Months
Discontinued No Change Initiated
Counseling
32
369
1
Information Only
24
355
6
Referral
17
384
3
Full Sample: Fisher’s Exact p < .046
Slide 38
Summary of Findings – CTN 0032
■
■
■
HIV testing in substance use treatment centers
increased testing and receipt of test results.
Risk-reduction counseling did not reduce
participants’ sexual risk behaviors or increase
their acceptance of HIV testing.
Secondary analysis found counseling reduced
needle/syringe sharing risk.
Slide 39
Drug and Alcohol Dependence (2012)
Slide 40
“There is no additional
benefit from HIV
sexual risk reduction
counseling.”
Slide 41
Project AWARE
■
This study will evaluate
the effect of counseling
on 1 primary outcome:
– STI incidence
– Secondary outcomes:
– Reduction of sexual risk
behaviors
– Reduction of substance
use during sex
– Cost and costeffectiveness of
counseling
SITES
Columbia, SC
Jacksonville, FL
Los Angeles, CA
Miami, FL
San Francisco,
CA
Pittsburg, PA
Portland, OR
Seattle, WA
Washington, DC
Slide 42
5012 participants randomized across
9 STD clinics in the U.S.
STUDY DESIGN
Recruitment and Enrollment
STI Testing
Baseline Assessment
Randomization
RESPECT-2 counseling
with on-site rapid HIV
test
Information with on-site
rapid HIV test
STI testing and ACASI repeated at 6
months
Primary Outcome Analysis:
New STIs – Project AWARE
Slide 43
*Excludes participants who were positive for this STI at baseline.
Slide 44
Slide 45
“…the Division of
HIV/AIDS
Prevention (DHAP) is
discontinuing its support
for RESPECT, one of
CDC’s long-standing
behavioral interventions
for people at high risk
for HIV infection.”
Slide 46
Where do we go from here?
Both CTN 0032 and Project AWARE provide no
evidence to support brief risk reduction counseling
in conjunction with HIV rapid testing
■ Post-Test counseling still critical
■ Targeted counseling for some?
■ Raises questions as to dosage of counseling
delivered?
■ Taking the counseling workforce and reorienting
them
■
Slide 47
www.attcnetwork.
org/rapid testing
Slide 48
Acknowledgements…
 National Institute on Drug Abuse Clinical Trials
Network
 National Institute on Drug Abuse AIDS
Research Program
 12 Community-Based Treatment Programs and 9
Community-Based STD Programs in CTN 0032
and Project AWARE
Implementing HIV Testing in Community
Substance Abuse Treatment Programs: A Case Study
Louise Haynes, MSW
Medical University of South Carolina
AETC HIV Testing Collaborative
Webinar
November 3, 2014
Today
• Experience of one community treatment
program that decided to implement HIV
testing on-site
• Background
• Why they made that decision
• No roadmap for implementation beyond
the research
• Lessons learned
• Ongoing challenges
“The Bridge”
Research to Practice
NIDA Clinical Trials Network
Building the Bridge
• The idea: treatment programs will be more likely to adopt
evidence based practices, if they have participated in the
research supporting the intervention
• Participation in research jump started the process of
implementation of HIV testing on-site
• Some of the lessons learned generalize to implementation
without research
• Participating in research allowed providers to gain experience
in HIV testing and led to decision to adopt an intervention
• Partnering with providers allowed the investigators to learn
how to promote and support adoption
• Bi-directional learning
From the perspective of the
treatment program, the decision to
adopt an intervention is an
essential first step, BUT
deciding how to organize and
deliver testing services is
complex
When the agency’s mission is
Substance Abuse Treatment,
54
the integration of HIV Testing
can be very challenging.
Less than half of community
substance abuse treatment
programs offer HIV testing
Why integration of testing is
important, despite the
challenges
• Substance abuse continues as a major factor in transmission
of HIV/AIDS, via injection and sexual risk behavior
• One out of five people infected with HIV is unaware of the
infection
• Encouraging people at risk to be tested is a main HIV
prevention strategy in the USA
• On-site testing removes barriers and is a service to clients
The Setting
• Lexington Richland Alcohol and Drug Abuse
Council in Columbia, South Carolina
• Large publicly-funded, not-for-profit agency
• Outpatient, medical detox, DUI, prevention
services
• Traditional 12-step philosophy of treatment
• Prior to clinical trial, not offering HIV testing
• Despite SAMHSA initiative, SC struggled to bring
HIV testing into substance abuse treatment
programs
Questions Prior to Conducting HIV
Testing Study at LRADAC
• Would LRADAC clients be willing to participate?
Problem with earlier study.
• Would the staff support HIV testing at LRADAC?
Problem with earlier study.
• Original plan to train all of the counselors in the
agency to provide testing. Never got beyond
planning stage.
• Confidentiality
• Best format for introducing offer of HIV test – group
or individual?
4 Phases of Implementation of HIV
Testing at LRADAC: A Process
1. Clinical trial: enrollment Jan-May 2009
2. Pilot (detox program): Sept 2009March 2010
3. Full implementation (detox and
outpatient): ongoing (with breaks in
availability)
4. Ongoing adaptation
Phase 1
Clinical Trial
•
•
•
Enrolled 1281 participants from 12
outpatient sites across US
LRADAC enrolled 115 participants
Two research questions:
1. Best strategy for offering testing?
2. Impact of counseling on risk
behaviors?
Phase 1 Outcomes
• Effectiveness of on-site testing vs.
referral (evident throughout trial)
• No change in sexual risk behavior as
a result of counseling (not evident to
study staff)
• Very few positive tests
Phase 1 (Clinical Trial)
Lessons Learned that Influenced
Implementation
• Acceptability of testing
• Value of integrating research practices
with established patient flow in agency:
routine part of intake
• Value of specialty counselors to offer
and provide testing
Phase 2
Pilot in Detox Program
•
•
•
16 bed medical detox
Agency decision to implement HIV
testing, agency management support,
state level support
Transition from research to practice
1. Adaptation of procedures: approach, finger
stick
2. Training of agency staff
•
•
Support by research infrastructure
Buy-in of front line staff
Pilot (detox)
September 2009 through April 2010
• 183 patients tested
• 62% acceptance rate
• Most common reason for refusal:
recently tested
• Research staff conducted testing and
counseling – no cost to agency
Phase 2 Pilot
Lessons Learned
• Acceptability of testing without
compensation
• Acceptability of finger stick
• Research procedures could be
adapted
• Value of individual vs. group initial
offer
Phase 3
Full Implementation
April 2010 to 2012
•
•
•
•
•
Testing offered in detox and outpatient
Need for new sources of funding
Health Department grant received
New SAMHSA grant
Procedures must change to comply with requirements of
sponsor (grant)
• Transition to agency staff
• Need for QA and supervision
Phase 4
Continued Adaptation
• Funding streams – ideally finding a stable source of
funds
• Documentation – data requirements from multiple
agencies
• Staffing/certification challenges
• Frequent changing of staff - lessons learned from
past experience can get lost
• Counseling
• Adding HCV and STI testing
Summary
CLINICAL Implementation of
HIV Risk Reduction Intervention
• HIV testing was integrated into routine clinic
practices
• Philosophical changes
• Acceptability to clients
• Leadership support
• Incentive to agency: peer recognition,
financial support
• Champion
• Adaptation over time
• On-going problem solving
State Level Update
• FY11 – Total HIV Rapid Tests performed in SC
was 1253 with LRADAC reporting 487 of the total.
• FY12 – Total HIV Rapid Test performed is 2125
with LRADAC reporting 970 of the total.
• FY14 – 16 of 33 providers in state system receive
funding to conduct testing, level of testing varies
by site
Overcoming Barriers
• Funding –Has required creativity. Health care
reform may make funds for testing more
accessible.
• Credentialing of staff – Refining training and
credentialing to be more focused on substance
abuse treatment providers.
• Staff buy in – imbed testing in routine treatment.
• Focus on value to patient
For more information
contact:
• Louise Haynes: [email protected]
Questions?
Next Call
 Monday, February 2nd, from 2:00pm-3:30pm
ET/ 11:00am-12:30pm PT
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