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ISBRA 2006 HIV and Alcohol Symposium

ISBRA 2006 HIV and Alcohol Symposium. Jeffrey H. Samet, MD, MA, MPH, Chairman Evgeny M. Krupitsky, MD, Phd, Co-Chairman. The Impact of Alcohol Consumption on HIV Disease Progression. Jeffrey H. Samet, MD, MA, MPH Chief, Section General Internal Medicine Boston Medical Center

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ISBRA 2006 HIV and Alcohol Symposium

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  1. ISBRA 2006 HIV and Alcohol Symposium Jeffrey H. Samet, MD, MA, MPH, Chairman Evgeny M. Krupitsky, MD, Phd, Co-Chairman

  2. The Impact of Alcohol Consumption on HIV Disease Progression Jeffrey H. Samet, MD, MA, MPH Chief, Section General Internal Medicine Boston Medical Center Professor of Medicine and Public Health Boston University Schools of Medicine and Public Health ISBRA 2006 HIV and Alcohol Symposium

  3. Authors Samet JH1, Cheng DM1, Libman H3, Nunes D1, Alperen J1, Faber V6, Saitz R1 1Boston Medical Center, Boston University School of Medicine, United States; 2Beth Israel Deaconess Medical Center, Harvard Medical School, United States; 3 DM-STAT, United States Funded by the National Institute on Alcoholism and Alcohol Abuse: R01-AA13216, R01-AA11785, & R01-AA10870 and USPHS M01-RR00533 (GCRC)

  4. Background • Alcohol use is common among HIV-infected persons • 36% of HIV-infected veterans (n=881) were current hazardous drinkers* • 42% of HIV-infected patients establishing primary care (n=664) had history of alcohol problems** *Conigliaro, Gordon, McGinnis, Rabeneck, Justice. JAIDS. 2003;33:521-525. **Samet, Phillips, Horton, Traphagen, Freedberg. AIDS Res Hum Retroviruses. 2004;20:151-155.

  5. Background • The impact of alcohol use on HIV disease progression is unclear. • Pre-HAART (circa 1996), no association found * • Among persons receiving antiretroviral therapy (ART) between 1997-2000 cross-sectional evidence found an association of heavy alcohol use with lower CD4 and higher HVL (HIV viral load).** *Dingle, Oei. Psychol Bull. 1997;122:56-71. **Samet, Horton, Traphagen, Lyon, Freedberg. Alcohol Clin Exp Res. 2003;27:862-7.

  6. Background • Potential mechanisms of alcohol’s impact on disease progression • Decreased medication adherence.* • Physiological impact is suspected from studies in rhesus macaques.†‡ *Cook RL, et al. J Gen Intern Med. 2001;16:83-88. † Bagby GJ, et al. Alcohol Clin Exp Res. 2003;27:495-502. ‡Stoltz DA, et al. Am J Respir Crit Care Med. 2000;161:135-140.

  7. Hypothesis • Alcohol consumption is associated with more rapid HIV disease progression: • CD4 decrease • HVL (i.e. HIV RNA) increase

  8. Participants & Design • Two consecutive prospective cohorts of HIV-infected persons with current or past alcohol problems • HIV-ALC (HIV-Alcohol Longitudinal Cohort): 7/97-7/01 • HIV-LIVE (HIV-Longitudinal Interrelationship between Viruses and Ethanol): 8/01-03/06

  9. Eligibility criteria • Inclusion Criteria • HIV infection • Two or more positive CAGE* responses • Fluent in English or Spanish • Exclusion criteria • Mini Mental State Examination** score < 21 • Plans to move from area in next year *Ewing. JAMA. 1984;252:1905-07. **Folstein et al. J Psychiatr Res. 1975;12:189-98.

  10. Subject Assessment • Interview, medical record, and/or phlebotomy at 6-month intervals for up to 7 years (1997-2006) for the following: • CD4 • HVL • ART • ART adherence • alcohol and drug use

  11. Primary Outcome Measures • CD4 cell count per µL • log10 HVL (HIV RNA copies per mL) • Obtained within 3 months of assessment interview

  12. Primary Independent Variable • Past 30-day alcohol use: • Heavy • > 4 drinks on any day or >14 drinks/week in men • >3 on any day or >7 drinks/week in women • Moderate (alcohol use less than “heavy”) • Abstinent

  13. Other Independent Variables • Gender • Age • Race (black, white, or other) • HIV risk factor (injection drug use, men having sex with men, or heterosexual behavior) • Homelessness (> 1 night in past 6 months) • 3-day adherence to ART (100% adherence, [yes/no]) • Time since study enrollment • Year of study entry • Cohort study participation (HIV-ALC vs. HIV-LIVE)

  14. Analysis • Generalized linear mixed effects models • Stratified by ART use (on/off) to account for possible effect modification • The data were restricted to observations beginning at baseline until a change in ART usage occurred (i.e., went on or off ART) • Regression analyses controlled for baseline CD4 counts

  15. Results: Cohort (N=595) In HIV ALC & HIV LIVE N=154 Only in HIV LIVE N=246 Only in HIV ALC N=195

  16. Baseline Characteristics (N=595)

  17. Baseline Characteristics(N=595)

  18. Baseline Characteristics (N=595)

  19. Results: Observations (N=595) • CD4 analyses observations = 1495 • HVL analyses observations = 2031

  20. Results: Multivariable Analyses †p=0.09 *p=0.02

  21. Limitations • Participants in the no ART group may have been exposed to these medications in the past but were no longer receiving them at the time of study entry. • Observational cohort: possible uncontrolled confounding • Inconsistent time frames: alcohol assessed 30 days prior to the interview; CD4 & HIV RNA within 3 months

  22. Conclusion • In those on ART, heavy drinking was possibly associated with higher HVL. • In those not on ART, heavy drinking was associated with lower CD4 cell counts.

  23. Implications • Avoiding alcohol consumption at heavy levels may have a beneficial effect on HIV disease progression. • Determining the behavioral and/or biological basis for these effects and addressing alcohol use in HIV-infected patients are important research and clinical issues.

  24. Reduction of risky sexual behavior among hospitalized Russian substance dependent patients The Russian Partnership to Reduce the Epidemic Via Engagement in Narcology Treatment (Russian PREVENT)Study ISBRA-2006 Symposium "Alcohol and HIV" Supported by National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH: R21-AA014821

  25. Krupitsky E.1, Cheng D.M.2, Raj A.2, Egorova V.1, Levenson S.2, Bridden C.3, Zvartau E,1 Samet J.H.2,3 1St. Petersburg State Pavlov Medical University, Russian Federation; 2Boston University School of Public Health, United States; 3 Boston University School of Medicine, Boston Medical Center, United States

  26. HIV positive individuals Leningrad Regional HIV/AIDS Center Data i. v. drug users alcoholics 100% 100% 100% 100% 100% 100% 100% 100% 100% 6 6 51 780 1912 1503 1046 100% 94.2% 91.2% 90% 82.2% 80% 66% 66.7% 70% 66.7% 60% 60% 47.4% 50% 45% 40% 30% 20% 10% 3.8% 4.5% 3.6% 4.6% 4% 0.6% 0% 0% 0% 0% 1997 1998 1999 2000 2001 2002 2003 2004 2005 937 993

  27. Background • Russia has one of the highest per capita alcohol consumption rates in the world. • The Russian HIV epidemic is propelled by injection drug use. • Alcohol use may increase high-risk sexual behaviors and promote spreading of HIV from IDUs into the general population.

  28. Background • Regional narcology hospitals play a central role in Russia’s efforts to address alcohol and drug dependence but have not aggressively addressed HIV. • Risky sexual behaviors need to be addressed with effective and feasible interventions among Russian substance dependent persons.

  29. Purpose • To assess the effectiveness of a sexual risk reduction intervention in the Russian narcology hospital setting

  30. Hypothesis • Subjects receiving the intervention will report fewer risky sexual behaviors.

  31. Design and Setting • Randomized controlled trial (RCT) • Recruited 10/04 through 4/05 • Two narcology hospitals in the Leningrad Region of Russia • Leningrad Region Center for Addictions (LRCA) • Medical Narcology Rehabilitation Center (MNRC) • Narcology hospitals provide 1 week detoxification and 2-3 weeks stabilization.

  32. Participants • 181 subjects with alcohol and/or heroin dependence • Eligibility criteria: • age > 18 • unprotected sex in last 6 months • willing to undergo HIV testing • abstinent from substances for > 48 hours

  33. Behavioral Intervention • Culturally and contextually adapted CDC-endorsed RESPECT brief counseling designed to reduce sex-risk behaviors* • Received 30 condoms at baseline • 2 intervention sessions at medical center plus 3 monthly booster sessions via telephone

  34. Behavioral Intervention • Session 1 (30-40 min) • Personal assessment of HIV risk • Increasing HIV risk perceptions • Negotiating a personalized risk reduction plan • Session 2 (60 min) • Provision and discussion of HIV test results; review plan • Promotion of safer sex: condom skills; self-efficacy; emphasizing relationship between alcohol and sexual risk • For HIV-infected subjects: skills building to reduce violence and stigmatization when disclosing to partners • For injection drug users: education and skills building to promote new needle usage and cleaning of needles/works

  35. Behavioral Intervention • 3 monthly booster sessions (10-20 min) • Provision of ongoing case management tailored to the individual’s stage of readiness to engage in sexual or drug use risk reduction

  36. Control Program • Usual addiction treatment, which includes no sexual behavior counseling • Received 30 condoms at baseline • HIV-infected controls received brief post-test counseling • Provision and discussion of HIV test results; creation of risk reduction goals • Referral to an HIV care program • 3 monthly study check-in phone calls (3 min)

  37. Subject Assessment • Assessed at baseline, 3, and 6 months • Baseline and 6 month assessment via face-to-face interviews with the Risk Assessment Battery and Time Line Follow Back survey. • HIV risk behaviors additionally assessed by Audio Computer-Assisted Self Interviewing (ACASI) System (to promote truth telling) • 3-month assessment interviewer- administered via the telephone

  38. Outcomes • Assessed at 6 months*: • Primary: • percentage of safe sex episodes • consistent safe sex (yes/no) • Secondary: • any condom use • number of unsafe sex episodes • Assessed at 3 months (all secondary)†: • percentage of safe sex episodes • consistent safe sex (yes/no) • any condom use *In the past 3 months, ACASI †In the past 3 months, telephone interview

  39. Primary Outcomes(assessed at 6-month follow-up visit by ACASI) • Percentage of safe sex episodes (continuous variable) • number of times condoms were used out of the number of sexual episodes (anal and vaginal intercourse) • Consistent safe sex (yes/no) • 100% condom use during anal and vaginal intercourse or abstinence from sex

  40. Secondary Outcomes • 6 months: • Any condom use (yes/no) • Number of unsafe sex episodes • no condom use during anal or vaginal sex • 3 months: • percentage of safe sex episodes • consistent safe sex (yes/no) • any condom use (yes/no)

  41. Analysis • Intent-to-treat • Descriptive statistics (e.g., medians, interquartile ranges [IQR], and proportions) were used to characterize the sample by treatment group. • Chi-square, Fisher’s exact, or Wilcoxon rank sum tests used as appropriate for dichotomous and continuous variables. • Additional analyses using logistic regression and median regression models to adjust for possible group differences at baseline

  42. Results

  43. Follow-Up Follow-up was 90% (162/181) at 3 months and 80% (144/181) at 6 months, with no differential follow-up between intervention groups

  44. Results - PrimaryPercentage of Safe Sex *In the past 3 months, ACASI †In the past 3 months, telephone interview

  45. 100 90 80 70 60 Intervention 50 episodes Control Median percentage of safe sex 40 30 20 10 0 0 3 6 Months The Effect of the PREVENT Intervention on Median Percentage of Safe Sex Episodes

  46. Results - PrimaryConsistent Safe Sex

  47. Results – SecondaryAny Condom Use

  48. Results- SecondaryUnsafe Sex Episodes

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