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A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
A Fire in our House: Why do we not have a more effective ...
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A Fire in our House: Why do we not have a more effective ...

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  • 1. A Fire in our House: Why do we not have a more effective response to the AIDS Pandemic?
    • Timothy Flanigan MD
    • Professor of Medicine
    • Brown Medical School
  • 2.  
  • 3. Reaching out: HIV Community based interventions for active substance users. Timothy P. Flanigan, MD Professor of Medicine Brown Medical School
  • 4. Why Reaching out?
    • HIV is the leprosy of our time! Stigma is overwhelming and can never be underestimated.
    • Alienation, family disintegration, hopelessness, mental illness, violence, multiple medical ills, homelessness, spiritual desolation…in short terrible suffering is the rule not the exception
    • This can only be addressed by going to the community  the street, detox and treatment centers, jails and prisons… and this must be done by a person with care and compassion.
  • 5. HIV Testing, Prevention, and Treatment are interlinked!
    • These may be distinct academic disciplines…but that has NO relevance to the community we serve.
    • There can be no realistic prevention without testing…no treatment without testing…they are intertwined and to the community that we serve must be promoted in a holistic fashion
    • They are synergistic and support each other
  • 6. HIV treatment is prevention!
    • Among HIV + men in treatment on ART:
    •  Marked decrease in unprotected sex
    •  ART decreases HIV in the blood, semen, and other body fluids with decreased transmission
    • CDC study in Uganda estimated a >90% reduction in risk among men on ART
    • In RI among substance users on a community based ART program  very low risk taking behaviours
  • 7. PLASMA HIV RNA PREDICTS LIKELIHOOD OF TRANSMISSION 0 5 10 15 20 25 30 Viral load (HIV-1 RNA copies/ml) and HIV transmission Transmission rate per 100 Person-Years Source: Quinn N, et al, N Eng J Med 2000 All subjects Male-to-Female Transmission Female-to-Male Transmission <400 400-3499 3500-9999 10 000-49 999 >50 000 <400 400-3499 3500-9999 10 000-49 999 >50 000 <400 400-3499 3500-9999 10 000-49 999 >50 000
  • 8. HIV Testing
    • New technologies: rapid testing
    • New approach to decouple HIV testing with risk reduction counseling in many settings
  • 9.  
  • 10.  
  • 11.  
  • 12. Denial and Stigma are common and fuel the flames of HIV In the U.S., 250,000 of the 1,000,000 infected persons are unaware of their infection Kaiser Permanente Study: “1/2 of patients sought an AIDS test because they were feeling ill” African Americans and substance users are more likely to enter care later
  • 13. Spectrum of Disease at Time of Diagnosis
    • CD4 Count at Diagnosis (n=27)
  • 14. Missed Opportunities for HIV Screening
      • 65% of study patients: NO identifiable risk factors
      • How do we know who to test
      • with no identifiable risk factors?
      • Physicians, other care providers and PATIENTS all routinely underestimate the risk of HIV!
  • 15. Feasibility and Acceptability of Rapid HIV Testing in Jail Curt G. Beckwith Sarah Atunah-Jay Jonathan Cohen Michelle Lally Michael Poshkus Josiah D. Rich Timothy P. Flanigan
  • 16.  
  • 17. Results
    • Participation:
      • 113 inmates were asked to participate
      • 100 (88%) participated
    • Demographics:
        • Median age 29 (18-60)
        • Race:
          • 46% White
          • 25% Black
          • 17% Hispanic
          • 10% Native American
    • Incarceration History:
      • Median # lifetime incarcerations = 5 (range 1-43)
      • Median # incarcerations in previous 12 months = 2 (range 1-7)
  • 18. HIV Risk Assessment 10 (1-500) Median # Lifetime sex partners 33% (33/99) Self-reported History of STD 23% (23/99) Almost always/Always 21% (21/99) Sometimes 52% (52/99) Never/Rarely Condom Usage 44% (44/99) Multiple sex partners within six months prior to incarceration Sexual History 76% (75/99) Do not consider themselves at risk for HIV infection
  • 19. Study Enrollment and Rapid Test Results 100% Received risk reduction counseling 100% Received rapid test results 1% (1/95) Positive 99% (94/95) Negative Rapid Test Results 95% (95/100) OraQuick ® testing 88% (100/113) Participated 113 Selected to participate
  • 20. Attitudes Toward Routine HIV Testing and Partner Notification 92% (83/90) In follow-up question, agreed that counselor could be a health counselor from the State Dept. of Health 95% (90/95) In hypothetical situation, if HIV test was positive, subject agreed to talk with counselor in order to inform contacts of the need for HIV testing 96% (96/100) Agreed RIDOC is a good place to offer routine HIV testing
  • 21. RI DOH & Miriam Databases
  • 22. Project Bridge: Retaining Ex-Offenders in Care The Miriam Hospital Supported by grant #H97HA00190 from the Health Services and Resources Administration (HRSA) Special Projects of National Significance (SPNS) Program
  • 23. The Road Home
  • 24. Program Design
    • Community based
    • 2 person teams of social workers assigned to each case
    • Daily contact first month
    • Weekly contact weeks 5-12
    • Monthly contact thereafter
    • Accompany during medical exams
  • 25. Evaluation Findings
    • 95% of eligible people enroll in program
    • 90% have clinic visit in first month
    • Increase in CD4 and decrease in PVL
    • Continuity: 87% clinic visits at 24 months
    • 84% complete 18-month enrollment
  • 26. Adherence
    • Treatment can be simply and effective  now 1 pill/day…”Atripla”
    • Adherence of 95% is not absolutely necessary  excellent viral suppression is achieved with rates of 80%
    • Prior substance use does not predict poor adherence  current substance use, missed appointments, etc predict poor adherence
  • 27. Background
    • Directly observed therapy (DOT), which has been so successful in the treatment of tuberculosis (TB) is currently being adapted for the treatment of HIV in multiple diverse settings
    • These community based programs are called “modified DOT” “MDOT” “Directly administered ART” “DAART” “Accompagneur”…they all use a community based person or family member to deliver ART.
    • The goal of these interventions is to decrease the long term morbidity and mortality from HIV/AIDS and limit the development and transmission of resistant virus, particularly in high risk communities
  • 28. MDOT at The Miriam Hospital
    • Provision of observed therapy with once daily medications since 1999
      • MDOT intervention
        • Single arm pilot projects
        • Randomized controlled trial (AARTS)
    • Qualitative work with special populations
      • Pregnant and post-partum women
      • Individuals leaving prison
  • 29. MDOT intervention – methods
    • Participants were recruited from both community and hospital-based clinics in Rhode Island and southeastern Massachusetts
    • Primary care providers (PCPs) referred patients to the MDOT program if:
      • patients had persistent viremia despite multiple attempts at clinic-based adherence counseling; or
      • patients reported active substance use within the previous 6 months
  • 30. MDOT intervention – methods
    • Participants were placed on a once-daily antiretroviral regimen recommended by the study team and their PCP after considering toxicity profiles, genotype results, and prior HIV medications
    • All participants kept at least a one-week supply of medications with them so that they could self-administer their medications if an outreach visit was missed
  • 31. MDOT intervention – methods
    • Initially, a “near-peer” outreach worker (ORW) delivered medications to participants 5-7 days per week (intensive MDOT stage)
    • After the intensive MDOT stage, outreach worker visits were gradually tapered to 1-3 days per week
  • 32. The Experience of 69 Participants Receiving MDOT
    • Analysis of first 69 participants who have received MDOT using a once-daily regimen
    • 80% had a history of substance use in the last 3 months and 71% had been incarcerated.
    • 9% were employed and 93% were ART experienced
  • 33. PVL and CD4 Changes Among Participants Receiving MDOT
    • PVL (log 10 )
      • 1 month: median individual decrease of 1.56
      • 3 months: median individual decrease of 2.34
      • 6 months: median individual decrease of 2.7
    • CD4
      • 1 month: median individual increase of 42 cells/mm 3
      • 3 months: median individual increase of 57 cells/mm 3
      • 6 months: median individual increase of 64 cells/mm 3
      • 2/3 on MDOT at 3 months and 1/2 at 6 months…high instability
      • JAIDS 2005
  • 34. MDOT Randomized Controlled Trial (AARTS)
    • Specific Aims
      • To determine whether directly observed once-daily HAART (intervention) is more effective than self-administered once-daily HAART (control) in the suppression of plasma HIV RNA among current drug users
      • To evaluate and compare patterns of adherence in the DOT arm and the standard of care (SOC) arm during all phases of the study
      • To compare the development of antiretroviral resistance between the DOT and standard of care arms
  • 35. Proportion of participants achieving viral load suppression (PVL<=50 or >2 log decrease from baseline) at 3 months, by baseline HAART experience Deaths were considered unsuppressed viral loads – remaining missing data not included (n=11) p=1.00 p=0.02 p=0.07 5 0.56 20 0.67 25 0.64 DOT 5 0.63 10 0.34 15 0.41 SOC n success Proportion n success Proportion n success Proportion HAART naive HAART experienced All participants Trial arm
  • 36. Conclusions
    • MDOT works for HAART experienced individuals with active substance users as shown in an intent to treat analysis.
  • 37. Conclusions
    • Patients with active substance use disorders are able to successfully engage in MDOT with significant viral load responses
    • However, MDOT is not acceptable for everyone; by 6 months, almost half of those enrolled dropped out
    • A sizable percentage of the attrition was due to structural changes, such as movement to a correctional facility, hospital, drug treatment facility, or assisted living facility
  • 38. DAART in New Haven
    • Altice et al - IAS Conference on Pathogenesis and Treatment 2003
    • Randomized controlled trial of DAART among 130 HIV+ individuals with active heroin or cocaine use
    • Medications were administered on a community Health Care Van which travels in tandem with Syringe Exchange Program
    • Pager device to remind participants of visits and unobserved doses
    • Training Program for outreach workers
  • 39. DAART in New Haven - results
    • 64% male, 79% racial minorities
    • 66% of participants reported both cocaine and heroin use at baseline
    • 57% had major depression
    • Intention to treat analysis among 86 participants, looking at changes from baseline to 6 month
      • viral load log
        • DAART – decrease of 2.08
        • SOC – decrease of 0.17
        • p=.01
      • CD4
        • DAART – increase of 107
        • SOC – increase of 12
        • p=.01
  • 40. Lucas GM et al (CID 2006)
    • Four year clinical trial of DAART, in which treatment outcomes are compared with outcomes of concurrent cohort comparison patients who took self-administered HAART
    • DAART participants were recruited at 3 methadone clinics (n=82)
      • Participants received supervised doses of HAART each morning they attended the methadone clinic, and other doses were self-administered
      • Median duration of DAART – 10.3 months
    • Comparison group
      • Individuals who self-administered HAART were selected from the Johns Hopkins HIV Cohort
        • IDU-methadone group (n=75)
        • IDU-nonmethadone group (n=244)
        • non-IDU group (n=490)
  • 41. Lucas GM et al (CID 2006)
  • 42. Lucas GM et al (CID 2006)
    • DAART, when given in conjunction with methadone therapy, was feasible and was associated with improved virologic and immunologic outcomes compared with results from 3 groups of cohort comparison patients self-administering HAART
  • 43.
    • THE END!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
  • 44. Acknowledgements
    • Jody Rich
    • Grace Macalino
    • Joe Hogan
    • Jennifer Mitty
    • Helen Loewenthal
    • Cindy MacLeod
    • Curt Beckwith
    • Xiomara Paulino
    • Marie Varella-Taylor
    • Pam Varella
    • Stephanie Zuba
    • Lauri Bazerman
    • Chuck Carpenter
    • Immunology Center
    Special thanks to all of the individuals who have participated in MDOT projects at The Miriam Hospital
  • 45. Financial support
    • National Institute of Drug Abuse (R01DA013767 and K23DA017622)
    • Lifespan-Tufts-Brown Center for AIDS Research (NIH grant AI42853)
    • Tufts Nutrition Collaborative, a Center for Drug Abuse and AIDS Research (NIH grant DA13868)
    • Gilead Sciences
    • Bristol-Myers Squibb
  • 46.  

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