Rapid Testing and Counseling Rapid Testing and Counseling Research within the CTN Research within the CTN

Lisa Metsch, Ph.D.Lisa Metsch, Ph.D.James L Sorensen, Ph.D.James L Sorensen, Ph.D.

Grant Colfax, M.D.Grant Colfax, M.D.Jose Szapocznik, Ph.D.Jose Szapocznik, Ph.D.

Susan Tross, Ph.D.Susan Tross, Ph.D.Raul Mandler, M.D.Raul Mandler, M.D.

Other CollaboratorsOther Collaborators

• Dan Feaster, Debbie Orr, Tiffany Kyle, Dan Feaster, Debbie Orr, Tiffany Kyle, Lauren GoodenLauren Gooden, Florida Node, Florida Node

• Tim MathesonTim Matheson, California and Arizona Node, California and Arizona Node• Louise HaynesLouise Haynes, South Carolina Node, South Carolina Node• Paul McLaughlinPaul McLaughlin, New England Node, New England Node• Janet Levy, JJ PanJanet Levy, JJ Pan and and Paul WakimPaul Wakim, NIDA, NIDA• Carl Pieper, Dan Blazer, Maureen Carl Pieper, Dan Blazer, Maureen

Cunningham, Craig McClendon and Cunningham, Craig McClendon and Curtis CampbellCurtis Campbell, DCRI, DCRI

• Carol Wenck Carol Wenck and and Karen Nesmith,Karen Nesmith, EMMES EMMES• Bernard BransonBernard Branson, CDC, Technical , CDC, Technical

ConsultantConsultant

HIV Rapid Test HIV Rapid Test • FDA approved FDA approved

• Only requires blood from a Only requires blood from a finger stick or oral fluid from a finger stick or oral fluid from a swabswab

• Results in 20 minutesResults in 20 minutes

• Does not require laboratory Does not require laboratory facilities and can be done by facilities and can be done by drug counselorsdrug counselors

• Positive results require Positive results require confirmatory testingconfirmatory testing

Late HIV Testing is Late HIV Testing is CommonCommonSupplement to HIV/AIDS Surveillance, 2000-Supplement to HIV/AIDS Surveillance, 2000-20032003• Among 4,127 persons with HIV/AIDS*, 45% Among 4,127 persons with HIV/AIDS*, 45%

were diagnosed AIDS within 12 months after were diagnosed AIDS within 12 months after finding out HIV positive status (“late testers”)finding out HIV positive status (“late testers”)

• Late testers, compared to those tested early Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more (>5 yrs before AIDS diagnosis) were more likely to be:likely to be:– Younger (18-29 yrs)Younger (18-29 yrs)– HeterosexualHeterosexual– Less educatedLess educated– African American or HispanicAfrican American or Hispanic

MMWR June 27, 2003 *16 states

Benefits of Widespread HIV Benefits of Widespread HIV ScreeningScreening

• Decreases spread of HIV: An HIV diagnosis Decreases spread of HIV: An HIV diagnosis is associated with reduction in high risk is associated with reduction in high risk sexual and injection behaviorssexual and injection behaviors

• Improves survival: Linkage to care and Improves survival: Linkage to care and treatmenttreatment

• May reduce the stigma that is associated May reduce the stigma that is associated with testing based on riskwith testing based on risk

Offering HIV Testing in Offering HIV Testing in Outpatient Health Care SettingsOutpatient Health Care Settings

• CDC now recommends offering routine HIV CDC now recommends offering routine HIV testing to persons regardless of risk factors:testing to persons regardless of risk factors:– Emergency DepartmentsEmergency Departments

– Sexually Transmitted Diseases (STD) ClinicsSexually Transmitted Diseases (STD) Clinics

– Labor and DeliveryLabor and Delivery

– Correctional FacilitiesCorrectional Facilities

– Offices of Primary Care PhysiciansOffices of Primary Care Physicians

– Substance Abuse Treatment ClinicsSubstance Abuse Treatment Clinics–

The Case for Drug The Case for Drug Treatment….Treatment….

• Fewer than 1/3 of U.S drug treatment Fewer than 1/3 of U.S drug treatment programs offer HIV testing and programs offer HIV testing and counseling*counseling*

• Less than ½ of CTN CTPs made HIV Less than ½ of CTN CTPs made HIV testing available either in the CTP, testing available either in the CTP, through referral or outsourced **through referral or outsourced **

• CTN provides an ideal setting to CTN provides an ideal setting to introduce routine, on-site rapid HIV introduce routine, on-site rapid HIV testing and counseling testing and counseling

* SAMSHA, 2004**Brown et al. JSAT, 2006; Pollack et al., 2006

Need for Scientific Need for Scientific StudiesStudies• CDC and new guidelines are moving away CDC and new guidelines are moving away

from HIV counseling at the time of testingfrom HIV counseling at the time of testing

• Scientific study is needed to evaluate the Scientific study is needed to evaluate the effectiveness of offering HIV rapid testing effectiveness of offering HIV rapid testing + counseling in drug treatment programs+ counseling in drug treatment programs– Effect on getting people tested Effect on getting people tested – Effect on sexual risk behaviorsEffect on sexual risk behaviors

David Holtgrave: David Holtgrave: Costs and Costs and Consequences of the New CDC Testing Consequences of the New CDC Testing GuidelinesGuidelines (June, 2007; (June, 2007; www.plosmedicinewww.plosmedicine. org). org)

• Article questions costs and consequences of new Article questions costs and consequences of new CDC guidelines regarding routine HIV testing CDC guidelines regarding routine HIV testing without risk reduction counseling (compared with without risk reduction counseling (compared with a more targeted counseling and testing strategy)a more targeted counseling and testing strategy)

• Uses scenario and cost-effectiveness analysisUses scenario and cost-effectiveness analysis

• Concludes that abandoning counseling would Concludes that abandoning counseling would have real public health consequences in terms of have real public health consequences in terms of HIV infections that could have been avertedHIV infections that could have been averted

David Holtgrave: David Holtgrave: Costs and Costs and Consequences of the New CDC Testing Consequences of the New CDC Testing GuidelinesGuidelines (June, 2007; (June, 2007; www.plosmedicinewww.plosmedicine. org). org)

• Editor’s note says that Holtgrave Editor’s note says that Holtgrave articlearticle

“ “has a major limitation in that it tried has a major limitation in that it tried to predict what might happen in the to predict what might happen in the future – it did not study the actual future – it did not study the actual impact of the two different types of impact of the two different types of testing on a group of people.”testing on a group of people.”

Research QuestionsResearch Questions

Among persons who attend substance abuse treatment Among persons who attend substance abuse treatment and report being HIV negative or not knowing their and report being HIV negative or not knowing their status…status…

(1) What is the more effective testing (1) What is the more effective testing strategy to ensure they get HIV tested strategy to ensure they get HIV tested and receive their results?and receive their results?

(2) What is the more effective testing (2) What is the more effective testing strategy to decrease their risk behaviors?strategy to decrease their risk behaviors?

Three Testing Strategies to Three Testing Strategies to be evaluated in 3 arm RCTbe evaluated in 3 arm RCT

• Offer on-site HIV rapid testing (via Offer on-site HIV rapid testing (via oral fluid) with brief participant-oral fluid) with brief participant-tailored prevention counselingtailored prevention counseling

• Offer on-site HIV rapid testing (via Offer on-site HIV rapid testing (via oral fluid) with information onlyoral fluid) with information only

• Offer referral for HIV testing in the Offer referral for HIV testing in the communitycommunity

CTN 0032 PROTOCOL CTN 0032 PROTOCOL DEVELOPMENTDEVELOPMENT

HIV Rapid Testing and CounselingHIV Rapid Testing and Counseling• Protocol Concept approved by CTN, then Protocol Concept approved by CTN, then

by Dr. Volkow in November, 2006by Dr. Volkow in November, 2006• Protocol Development is in progressProtocol Development is in progress• Informal surveys of CTPs, February – May, Informal surveys of CTPs, February – May,

2007 2007 – Amount of testing? On site? How recent?Amount of testing? On site? How recent?

• Protocol was reviewed by DSMB in July, Protocol was reviewed by DSMB in July, 20072007

• Revisions expected to be made in Revisions expected to be made in August/September, 2007August/September, 2007

Interest in Health Services Interest in Health Services Research Ancillary StudiesResearch Ancillary Studies

• Feasibility of implementing HIV rapid Feasibility of implementing HIV rapid testing and counseling in drug tx testing and counseling in drug tx

• Acceptability by drug counselors of Acceptability by drug counselors of conducting HIV rapid testing in drug conducting HIV rapid testing in drug txtx

• Durability of providing HIV rapid Durability of providing HIV rapid testing and counseling after CTN testing and counseling after CTN study is completed.study is completed.

IN SUMMARYIN SUMMARY• Significant changes in HIV testing and Significant changes in HIV testing and

counselingcounseling– Technology, Policy, and Ethical ChallengesTechnology, Policy, and Ethical Challenges

• Study of HIV Rapid Testing and Counseling Study of HIV Rapid Testing and Counseling being plannedbeing planned

• Need information (need research)Need information (need research)– Impact on drug use, other risk factorsImpact on drug use, other risk factors– Feasibility of large-scale testing in Feasibility of large-scale testing in

treatment programstreatment programs– Best-practice solutions to ethical quandriesBest-practice solutions to ethical quandries

• These are Vital Issues in need of attentionThese are Vital Issues in need of attention

We welcome your questions We welcome your questions and suggestionsand suggestions

Lisa Metsch, Ph.D.Lisa Metsch, Ph.D.

Lmetsch@med.miami.eduLmetsch@med.miami.edu