1. HIV and HCV Risk Reduction Interventions in Drug Detoxification and Treatment Settings

2. Key Players – Lead Investigator: – Robert Booth, Ph.D. – Rocky Mountain Co-Lead Investigator – Laetitia Thompson, Ph.D. – Oregon Co-Lead Investigator – Bret Fuller, Ph.D. – Co-Investigators: – Dennis McCarty (OR); Barbara Campbell (OR); Paula Riggs ; (RM); Susan Mikulich-Gilbertson (RM); Catherine Dempsey (RM)

3. 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

4. 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

5. 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

6. 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

7. Randomized Clinical Trial Design ■ NIDA Counseling & Education Intervention (C&E) ■ Therapeutic Alliance Intervention (TA) ■ Treatment As Usual (TAU)

8. 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

9. 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

10. Treatment as usual Typical clinic procedures  HIV Risk Reduction Education  Referrals for HIV testing  Linkage to continuing care

11. Subjects Consented (n = 698) Subjects Randomized (n = 632) TAU (n = 211) 33% C & E (n = 212) 33% TA (n = 209) 33% Participant Excluded (n = 66) 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% Consort Diagram

12. 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

13. Interventionist & Supervisor Selection ■ 50 staff in 8 CTPs ■ Education for interventionists: ■ Associate’s degree to masters ■ Education for supervisors: ■ Bachelor’s degree to M.D. ■ Years of experience: ■ 6 months to 25 years ■ 49 of 50 completed training and certification ■ 1 C&E interventionist failed certification

14. 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

15. 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%)

16. Drug use at baseline Lifetime UseUse in last 30 Days Injected in last 30 days N%N%n% Cocaine62795.2262660.0662545.28 Heroin62890.4562481.5762380.74 Amphetamine62664.8662433.9762326.97 Other Opiates62874.0062239.3962216.88 Speedballs63172.3862743.7062537.92

17. Days used and times injected Days used in last 30Days injected in last 30 Times injected in past 30 days MeanSDMeanSDMeanSD Cocaine6.919.754.047.6833.41110.79 Heroin17.8512.2517.2312.3390.86184.50 Amphetamine2.966.542.345.848.2029.09 Other Opiates2.976.331.224.206.5734.92 Speedballs3.927.243.256.4519.44107.38

18. Injection risk behaviors at baseline TOTAL (n=631) TAU (n = 21 2 ) 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)

19. Sexual Risk Behaviors: Safe Sex Past 30 Days TOTALTAUC&ETA N%N%N%N% Men: Abstinence/ 100% Condom Use 46651.5% (missing 7) 15248.0% (missing 3) 15753.5% (missing 3) 15752.9% (missing 1) Women: Abstinence/ 100% Condom Use 15239.5%5633.9%4643.5%5042.0%

20. Sexual Risk Behaviors: Number of Partners Past 30 Days TOTALTAUC&ETA BehaviorNMean (SD)N N N Number of partners had vaginal, oral, or anal sex with 6261.6 (3.9)2101.3 (2.1)2091.6 (3.2)2071.8 (5.5) Men having vaginal sex with women 4571.0 (2.5)1530.9 (1.5)1540.9 (1.7)1581.2 (3.6) Men having anal sex with women 4650.3 (0.7)1530.3 (0.6)1580.3 (0.6)1580.3 (0.9) Men having penetrative anal sex with men 4690.004 (0.1)1540.006 (0.1)1590.006 (0.8)1580 Men having receptive anal sex with men 4690.006 (0.1)15401590.006 (0.8)1580.01 (0.2) Women having vaginal sex with men 1472.0 (5.1)541.5 (1.7)462.0 (2.7)472.4 (8.5) Women having anal sex with men 1510.3 (0.9)560.3 (0.5)460.4 (1.4)490.2 (0.5)

21. Outcomes So Far

22. 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 self- efficacy to practice safer behaviors will be evaluated for inclusion

23. 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

24. Days Injected Past 30 Days (capped at 30) Intervention: NS, p<.79 Site: p<.0001 Time:p <.0001 Time*Intervention: NS, p<.22 Site*Intervention: NS (removed) Site*timep<.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 Intervention Days Injected by Site

25. Frequency of Injecting Past 30 Days (capped at 10x /day and 300x /month) Intervention: NS, p<.90 Site: p<.0001 Time:p <.0001 Time*Intervention: NS (removed) Site*Intervention: NS (removed) Site*timep<.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 Injected by Intervention Times Injected by Intervention Times Injected by Site