1. Welcome! AETC HIV Testing Collaborative For the audio portion of this meeting: Dial 1-866-814-9555, Enter participant code: 826 798 4863 Please turn off your computer speakers

2. 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

3. Michael B. Blank, PhD University of Pennsylvania November 3, 2014 PREVALENCE OF HIV WITH RAPID TESTING IN MENTAL HEALTH SETTINGS: A MULTISITE STUDY

4. 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”.

5. 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

6. 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)

7. HIV STATUS AMONG PERSONS RECEIVING TREATMENT IN MENTAL HEALTH SETTINGS BY LEVEL OF CARE AND STUDY SITE Participants by HIV Status, No. (%) Variable All Participants (n = 1061), No. (%) HIV- Positive (n = 51) HIV- Negative (n = 1010) HIV Prevalence (95% CI) p Level of Care Inpatient 287 (27.1)17 (33.3)270 (26.7)5.9 (3.7, 9.4).46 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) Study Site Philadelphia 608 (57.3)24 (47.1)584 (57.8)4.0 (2.7, 5.8).13 Baltimore 453 (42.7)27 (52.9)426 (42.2)5.9 (4.1, 8.6)

8. 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

9. BREAKDOWN OF CHARACTERISTICS ASSOCIATED WITH HIV INFECTION (RACE AND HOUSING STATUS) Participants by HIV status, No. (%) Variable All Participants (n = 1061, No. (%) HIV- Positive (n = 51) HIV- Negative (n = 1010) HIV Prevalence (95% CI) p Race White 196 (18.6)2 (3.9)194 (19.3)1.0 (0.3, 4.1).02 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) Housing Status Currently homeless 173 (16.4)14 (27.5)159 (15.9)8.1 (4.9, 13.4).03 Not currently homeless 880 (83.6)37 (72.6)843 (84.1)4.2 (3.1, 5.8)

10. BREAKDOWN OF CHARACTERISTICS ASSOCIATED WITH HIV INFECTION (HCV INFECTION, NIDU PAST 4 WKS, SEXUAL IDENTITY) Participants by HIV status, No. (%) Variable All Participants (n = 1061, No. (%) HIV- Positive (n = 51) HIV- Negative (n = 1010) HIV Prevalence (95% CI) p HCV Infection No 891 (85.0)33 (66.0)858 (86.0)3.7 (2.7, 5.2) <.001 Yes 157 (15.0)17 (34.0)140 (14.0)10.8 (6.9, 17.0) NIDU, past 4 wks No 218 (20.6)8 (15.7)210 (20.8)3.7 (1.9, 7.2).38 Yes 843 (79.5)43 (84.3)800 (79.2)5.1 (3.8, 6.8) Sexual Identity Heterosexual 945 (90.8)40 (80.0)905 (91.3)4.2 (3.1, 5.7).01 Homosexual or Bisexual 96 (9.2)10 (20.0)86 (8.7)10.4 (5.8, 18.7)

11. BREAKDOWN OF CHARACTERISTICS ASSOCIATED WITH HIV INFECTION (PSYCHIATRIC DIAGNOSIS) Participants by HIV status, No. (%) Variable All Participants (n = 1061, No. (%) HIV- Positive (n = 51) HIV- Negative (n = 1010) HIV Prevalence (95% CI) p Psychiatric Diagnosis Psychiatric disorder only 570 (54.7)21 (41.2)549 (55.4)3.7 (2.4, 5.6).12 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)

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.

13. 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

14. Slide 14 ▪ 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 Today’s Talk…

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16. 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. What about HIV Testing in Drug Abuse Treatment Centers? SAMSHA, 2009; Pollack and D’Aunno, 2010; Abraham et al., 2011, 2012; Brown et al. JSAT, 2006; AJPH, 2007

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18. Slide 18 ■ 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 National Drug Abuse Treatment System Survey (NDATSS) D’Aunno et al., 2014, Health Services Research

19. Slide 19 HIV Rapid Testing in Substance Use Treatment Programs CTN 0032 Lisa Metsch, Ph.D. Grant Colfax, M.D.

20. Slide 20 ■ 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? Primary Questions

21. Slide 21 ■ Group 1 - Rapid HIV Testing with RESPECT Counseling ■ Group 2 - Rapid HIV Testing and Information Only ■ Group 3 - Referral Only Study Intervention Groups

22. Slide 22 ■ 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 Counseling Intervention *Metcalf, Douglas, Malotte et al; 2005

23. Slide 23 Overview of CTN 0032 Study Design Recruitment and Enrollment Brief Baseline Assessment Offer Rapid Testing with brief participant- tailored prevention Counseling Random Assignment Post-intervention data collection Offer Rapid Testing with Information Only Offer Standard Referral for Testing in Community

24. Slide 24 Participating Sites CODA La Frontera Life Link Gibson Recovery MCCA Wheeler CPCDS LRADAC Morris Village Glenwood Chesterfield Daymark

25. Slide 25 ■ 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 Study Population

26. Slide 26 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 Notable Inclusion Criteria

27. Slide 27 ■ Primary Outcomes: – Self-reported receipt of HIV test results at one month follow-up – Self-reported sexual risk behavior at 6 month follow- up ■ Data collected on web-based ACASI an Electronic Data Collection Form (eCRF) ■ Emphasis on intervention fidelity and quality assurance Efficacy Assessments

28. Slide 28 Randomized (n=1281) n% Month 11257/128198.1 Month 61193/128193.1 Follow-Up Visit Attendance

29. Slide 29 Treatmentn% Off-site referral429/429100 On-site HIV test with RESPECT-2 427/43398.8 On-site HIV test with information only 419/419100 Summary of Treatment Exposure

30. Slide 30 Pre-results session Overall (n=198) Adherence Ratingn% Unsatisfactory0/1980.0 Acceptable/Good10/1985.1 Excellent188/19894.9 Counseling content beyond treatment arm 5/1313.8 Counseling Fidelity

31. 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

32. Slide 32 Baseline Drug Use Baseline% Injected Drugs in Lifetime48.6 Injected Drugs in Last 6 Mo20.6 Used Opiates in Last 6 Mo37.0 Used Stimulants in Last 6 Mo43.6 High Drug Use Severity53.6 Binge Drinking71.8

33. Slide 33 Baseline Sex Risk and HIV Testing History Risky Sexual Behavior61.7% Median Number of Risky Sexual Acts 5 Ever Tested for HIV69.3% Median Times HIV Tested2

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35. Slide 35 Primary Hypothesis Test: Risky Sexual Behavior Number of risky sexual behaviors at 6 month post-randomization TreatmentnMean (SD) Off-site Referral38720.5 (49.8) On-site HIV test: RESPECT-2 38521.3 (47.6) On-site HIV test: Info Only 37121.3 (44.8) Comparison Groups ■ Overall: – p =. 6596 ■ Off-site vs. On-site: – p =. 4348 ■ RESPECT-2 vs. Info Only: – p =. 8697

36. Slide 36 ■ 3 (0.4%) participants had reactive tests confirmed HIV positive by Western Blot – 2 in counseling – 1 in information only HIV Diagnoses

37. Slide 37 Change in Needle Sharing from Baseline to Six Months DiscontinuedNo ChangeInitiated Counseling323691 Information Only243556 Referral173843 Full Sample: Fisher’s Exact p <.046

38. Slide 38 ■ 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. Summary of Findings – CTN 0032

39. Slide 39 Drug and Alcohol Dependence (2012)

40. Slide 40 “There is no additional benefit from HIV sexual risk reduction counseling.”

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42. Slide 42 ■ 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 cost- effectiveness of counseling Project AWARE 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 STUDY DESIGN 5012 participants randomized across 9 STD clinics in the U.S. 9 STD clinics in the U.S. ARRA Funded! SITES Columbia, SC Jacksonville, FL Los Angeles, CA Miami, FL San Francisco, CA Pittsburg, PA Portland, OR Seattle, WA Washington, DC SITES Columbia, SC Jacksonville, FL Los Angeles, CA Miami, FL San Francisco, CA Pittsburg, PA Portland, OR Seattle, WA Washington, DC

43. Slide 43 Primary Outcome Analysis: New STIs – Project AWARE *Excludes participants who were positive for this STI at baseline.

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45. 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.”

46. Slide 46 ■ 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 Where do we go from here?

47. Slide 47 www.attcnetwork. org/rapidwww.attcnetwork. org/rapid testing

48. Slide 48  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 Acknowledgements…

49. AETC HIV Testing Collaborative Webinar November 3, 2014 Implementing HIV Testing in Community Substance Abuse Treatment Programs: A Case Study Louise Haynes, MSW Medical University of South Carolina

50. 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

51. “The Bridge” Research to Practice NIDA Clinical Trials Network

52. 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

53. 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

54. When the agency’s mission is Substance Abuse Treatment, 54

55. the integration of HIV Testing can be very challenging. Less than half of community substance abuse treatment programs offer HIV testing

56. 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

57. 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

58. 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?

59. 4 Phases of Implementation of HIV Testing at LRADAC: A Process 4 Phases of Implementation of HIV Testing at LRADAC: A Process 1.Clinical trial: enrollment Jan-May 2009 2.Pilot (detox program): Sept 2009- March 2010 3.Full implementation (detox and outpatient): ongoing (with breaks in availability) 4.Ongoing adaptation

60. 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?

61. 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

62. 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

63. 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

64. 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

65. 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

66. 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

67. 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

68. 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

69. 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

70. 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

71. For more information contact: Louise Haynes: hayneslf@musc.eduhayneslf@musc.edu

72. Questions?

73. Next Call  Monday, February 2 nd, from 2:00pm-3:30pm ET/ 11:00am-12:30pm PT  Please mark your calendars

74. Quick Evaluation  https://www.surveymonkey.com/s/3HGCYJ5 https://www.surveymonkey.com/s/3HGCYJ5  5 minutes to complete

75. Thank you!