Rapid Testing and Counseling Research within the CTN

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Rapid Testing and Counseling Research within the
CTN

• Lisa Metsch, Ph.D.
• James L Sorensen, Ph.D.
• Grant Colfax, M.D.
• Jose Szapocznik, Ph.D.
• Susan Tross, Ph.D.
• Raul Mandler, M.D.

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Other Collaborators

• Dan Feaster, Debbie Orr, Tiffany Kyle, Lauren
  Gooden, Florida Node
• Tim Matheson, California and Arizona Node
• Louise Haynes, South Carolina Node
• Paul McLaughlin, New England Node
• Janet Levy, JJ Pan and Paul Wakim, NIDA
• Carl Pieper, Dan Blazer, Maureen Cunningham,
  Craig McClendon and Curtis Campbell, DCRI
• Carol Wenck and Karen Nesmith, EMMES
• Bernard Branson, CDC, Technical Consultant

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HIV Rapid Test

• FDA approved
• Only requires blood from a finger stick or oral
  fluid from a swab
• Results in 20 minutes
• Does not require laboratory facilities and can be
  done by drug counselors
• Positive results require confirmatory testing

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Late HIV Testing is CommonSupplement to HIV/AIDS
Surveillance, 2000-2003

• Among 4,127 persons with HIV/AIDS, 45 were
  diagnosed AIDS within 12 months after finding out
  HIV positive status (late testers)
• Late testers, compared to those tested early (gt5
  yrs before AIDS diagnosis) were more likely to
  be
• Younger (18-29 yrs)
• Heterosexual
• Less educated
• African American or Hispanic

MMWR June 27, 2003
16 states
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Benefits of Widespread HIV Screening

• Decreases spread of HIV An HIV diagnosis is
  associated with reduction in high risk sexual and
  injection behaviors
• Improves survival Linkage to care and treatment
• May reduce the stigma that is associated with
  testing based on risk

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Offering HIV Testing in Outpatient Health Care
Settings

• CDC now recommends offering routine HIV testing
  to persons regardless of risk factors
• Emergency Departments
• Sexually Transmitted Diseases (STD) Clinics
• Labor and Delivery
• Correctional Facilities
• Offices of Primary Care Physicians
• Substance Abuse Treatment Clinics

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The Case for Drug Treatment.

• Fewer than 1/3 of U.S drug treatment programs
  offer HIV testing and counseling
• Less than ½ of CTN CTPs made HIV testing
  available either in the CTP, through referral or
  outsourced
• CTN provides an ideal setting to introduce
  routine, on-site rapid HIV testing and counseling
  

SAMSHA, 2004 Brown et al. JSAT, 2006 Pollack
et al., 2006
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Need for Scientific Studies

• CDC and new guidelines are moving away from HIV
  counseling at the time of testing
• Scientific study is needed to evaluate the
  effectiveness of offering HIV rapid testing
  counseling in drug treatment programs
• Effect on getting people tested
• Effect on sexual risk behaviors

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David Holtgrave Costs and Consequences of the
New CDC Testing Guidelines (June, 2007
www.plosmedicine. org)

• Article questions costs and consequences of new
  CDC guidelines regarding routine HIV testing
  without risk reduction counseling (compared with
  a more targeted counseling and testing strategy)
• Uses scenario and cost-effectiveness analysis
• Concludes that abandoning counseling would have
  real public health consequences in terms of HIV
  infections that could have been averted

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David Holtgrave Costs and Consequences of the
New CDC Testing Guidelines (June, 2007
www.plosmedicine. org)

• Editors note says that Holtgrave article
• has a major limitation in that it tried to
  predict what might happen in the future it did
  not study the actual impact of the two different
  types of testing on a group of people.

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Research Questions

• Among persons who attend substance abuse
  treatment and report being HIV negative or not
  knowing their status
• (1) What is the more effective testing strategy
  to ensure they get HIV tested and receive their
  results?
• (2) What is the more effective testing strategy
  to decrease their risk behaviors?

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Three Testing Strategies to be evaluated in 3 arm
RCT

• Offer on-site HIV rapid testing (via oral fluid)
  with brief participant-tailored prevention
  counseling
• Offer on-site HIV rapid testing (via oral fluid)
  with information only
• Offer referral for HIV testing in the community

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CTN 0032 PROTOCOL DEVELOPMENTHIV Rapid Testing
and Counseling

• Protocol Concept approved by CTN, then by Dr.
  Volkow in November, 2006
• Protocol Development is in progress
• Informal surveys of CTPs, February May, 2007
• Amount of testing? On site? How recent?
• Protocol was reviewed by DSMB in July, 2007
• Revisions expected to be made in
  August/September, 2007

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Interest in Health Services Research Ancillary
Studies

• Feasibility of implementing HIV rapid testing and
  counseling in drug tx
• Acceptability by drug counselors of conducting
  HIV rapid testing in drug tx
• Durability of providing HIV rapid testing and
  counseling after CTN study is completed.

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IN SUMMARY

• Significant changes in HIV testing and counseling
• Technology, Policy, and Ethical Challenges
• Study of HIV Rapid Testing and Counseling being
  planned
• Need information (need research)
• Impact on drug use, other risk factors
• Feasibility of large-scale testing in treatment
  programs
• Best-practice solutions to ethical quandries
• These are Vital Issues in need of attention

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• We welcome your questions and suggestions
• Lisa Metsch, Ph.D.
• Lmetsch_at_med.miami.edu