1. Combined Pharmacological and Behavioral Therapy and HIV Risk Reduction Jennifer Schroeder, David Epstein, Katherine Belendiuk, Jessica Willner-Reid, John Schmittner, Kenzie L. Preston NIDA Intramural Research Program Supported by NIH NIDA Intramural funds

2. Substance abuse is a significant vector for HIV transmission. Transmission can occur at multiple points: drug procurement exchanging (unprotected) sex for drugs act of self-administering drugs use of infected equipment effects of the drug unprotected sex during intoxication

3. To determine the effect of combined methadone maintenance and behavioral treatments on HIV risk behaviors in heroin/cocaine users. To investigate HIV risk behaviors in a subpopulation of heroin/cocaine users - individuals infected with hepatitis C. Objectives

4. 55% Male Race:58% African American 40% White 2% Other Age:38 years old Education: 11 years 10 years of Heroin Use; 100% opioid dependent 8 years of Cocaine Use; 65% DSM IV cocaine dependent <10% HIV positive Treatment Population

5. Target heroin use - Methadone Maintenance Target cocaine use - Contingency management - reinforced cocaine abstinence Cognitive Behavioral Therapy - f our specific skills taught: Coping skills to deal with stress Relapse prevention skills to deal with craving Development of alternative (non-drug) reinforcers HIV Risk Reduction Education Combination Single Control Cognitive Behavioral Social Support Contingency Management Noncontingent Control Combination Treatment

6. Baseline Intervention Post Intervention Maintenance 5 weeks12 weeks8-12 weeks Study Time Line Counseling Behavioral Intervention Informed consent and screening Methadone stabilization 70 - 100 mg/day weekly individual Randomization HIV Risk Behavior Questionnaire every 2 weeks

7. HIV Risk Behavior Questionnaire Internally developed questionnaire modified from that used in the ALIVE study (Vlahov et al., 1991). Drug-related behaviors how often injected any kind of drug how frequently injected with shared needles Sexual behaviors how frequently had unprotected sex how frequently traded sex for money, drugs or gifts. Possible responses: none, less than 4 times per month, once per week, 2-6 times per week, daily, 2 or more times a day. Responses were dichotomized to none vs. some (i.e., any occurrence of the behavior).

8. HIV Risk Behaviors 0 20 40 60 80 100 Injection Drug Use Share Needles Unprotected Sex Trade Sex for Money or Drugs % Reporting Behavior Before Treatment 96% 57% 31% 29% N=81

9. HIV Risk Behaviors 0 20 40 60 80 100 Injection Drug Use Share Needles Unprotected Sex Trade Sex for Money or Drugs % Reporting Behavior Before Treatment After Treatment 96% 49% 57% 5% 31% 4% 29% 2% N=81

10. 0 20 40 60 80 100 CBT +CM CBTCMControl % Reporting Behavior 0 20 40 60 80 100 CBT +CM CBTCMControl % Reporting Behavior Before After 0 20 40 60 80 100 CBT +CM CBTCMControl % Reporting Behavior 0 20 40 60 80 100 CBT +CM CBTCMControl % Reporting Behavior Frequencies of self-reported HIV risk behaviors by treatment group CBT - Cognitive Behavioral Therapy; CM - Contingency Management Therapy Injection Drug UseShare Needles Unprotected SexTrade Sex for Money or Drugs * * * *

11. Methadone maintenance augmented with behavioral interventions has broad beneficial effects in reducing risky behaviors. Cognitive behavior therapy enhanced with HIV Risk education had limited added benefit over standard treatment. Are treatment effects on risky behaviors different in infected and non-infected populations?

12. Risky Behaviors in HCV-infected Polydrug Users Participants: 647 polydrug (heroin/cocaine) users tested for HCV antibodies on admission 55% HCV positive (n = 356); 45% HCV negative (n = 291) most were unaware of their HCV status at the time of testing Treatment: Methadone Maintenance Contingency management - reinforced cocaine/heroin abstinence. HIV risk reduction education was incorporated in individual counseling for all participants. HIV Risk-taking Behavior Scale (HRBS; Darke, et al., 1991) Two subscales: Drug-related risk behavior; Sexual risk behavior Completed every two weeks

13. 0 2 4 6 8 10 12 048 16202428 HIV Risk-taking Behavior Scale Total Score Treatment Week * HCV negative HCV positive Maximum possible score = 60; higher score = more risky behavior HIV Risk-taking Behaviors and Hepatitis C Infection Intake: F 1, 645 = 86.6, p<.001

14. 0 2 4 6 8 10 12 048 16202428 HIV Risk-taking Behavior Scale Total Score Treatment Week * * * HCV negative HCV positive Maximum possible score = 60; higher score = more risky behavior HIV Risk-taking Behaviors and Hepatitis C Infection HCV status: F 1, 645 = 10.3, p<.001 HCV status X Time: F 15, 6229 = 10.3, p<.0001

15. Treatment Week 0 1 2 3 4 5 6 7 8 04812162024 28 Drug Risk Subscale Subscale Score * * * * * * 0 1 2 3 4 Times Injected 0 1 2 3 4 051015202530 Did Not Clean Needles Week Representative Individual Items HIV Risk-taking Behavior Scale HCV negative HCV positive Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior N = 647 HCV status: F 1, 645 = 552.5, p<.0001 N = 418 HCV status: F 1, 412 = 11.3, p<.0008 HCV status: F 1, 645 =23.9, p<.001 Time: F 15, 6147 =76.9, p<.0001 HCV stat X Time: F 15, 6147 =23.9, p<.0001

16. 051015202530 Week 0 1 2 3 4 5 6 7 8 0481216202428 Sex Risk Subscale Subscale Score Sex with How Many Partners 0 1 2 3 4 No Condoms with Casual Partners Week Representative Individual Items HCV negative HCV positive HIV Risk-taking Behavior Scale Treatment Week Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior N = 647 HCV status: NS N = 480 HCV status: F 1, 477 = 19.9, p<.0001 HIV status: F 1, 645 = 9.8, p<.01 Time: F 15, 6144 = 18.9, p<.0001 HIV status X Time: NS 0 1 2

17. Conclusions HIV-risk behaviors decreased in polydrug users receiving combined pharmacological and behavioral treatments. Polydrug users who were already infected with hepatitis C reported a steeper decline in risky behaviors than non-infected patients.

18. 051015202530 Week 0 1 2 3 4 5 6 7 8 0481216202428 Sex Risk Subscale Subscale Score 0 1 2 3 4 No Condoms with Regular Partners 0 1 2 3 4 No Condoms with Casual Partners Week Representative Individual Items HCV negative HCV positive HIV Risk-taking Behavior Scale Treatment Week Maximum possible score: subscale = 30; individual items = 6; higher score = more risky behavior N = 480 HCV status: F 1, 477 = 17.2, p<.0001 N = 480 HCV status: F 1, 477 = 19.9, p<.0001 HIV status: F 1, 645 = 9.8, p<.01 Time: F 15, 6144 = 18.9, p<.0001 HIV status X Time: NS

19. Cognitive Behavioral Therapy Four specific skills taught: Coping skills to deal with stress Relapse prevention skills to deal with craving Development of alternative (non-drug) reinforcers HIV Risk Reduction Education Delivered by masters-level counselors in 12 manualized group sessions, monitored for adherence. $0 $10 $20 $30 $40 $50 $60 $70 Consecutive Drug-Negative Urine Specimens 1357 91113151719 21 23252729313335 Potential Earnings For Each Drug-Negative Urine Specimen Contingency Management Voucher given for each cocaine- negative urine specimen. Values - increase with each consecutive negative. - reset at each positive or miss - maximum total $1155 over 12 wks Exchangeable for goods and Services.