1 / 17

H. Hunter Handsfield, M.D. Battelle Centers for Public Health Research and Evaluation

Evidence Summary and CDC Guidance for Expedited Partner Therapy 2006 National STD Prevention Conference Jacksonville, Florida May 9, 2006. H. Hunter Handsfield, M.D. Battelle Centers for Public Health Research and Evaluation Center for AIDS and STD University of Washington.

ivria
Download Presentation

H. Hunter Handsfield, M.D. Battelle Centers for Public Health Research and Evaluation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Evidence Summary and CDC Guidance for Expedited Partner Therapy 2006 National STD Prevention ConferenceJacksonville, FloridaMay 9, 2006 H. Hunter Handsfield, M.D. Battelle Centers for Public Health Research and Evaluation Center for AIDS and STD University of Washington

  2. Partner Management for GC and CT in the United States: Summary • Provider referral by public health generally isn’t available, especially outside public clinics • Few providers contact their patients’ partners • Almost all providers advise their patients to inform and refer partners (patient referral) • Many pts notify some (most?) of their ptrs • Through these methods, probably ~50% of partners at risk get treated • How timely? What effect on overall incidence? • General consensus of inadequacy

  3. EPT Terminology • Expedited partner therapy: Bypassing obligatory clinical evaluation and professional counseling • Several possible approaches • Patient-delivered partner therapy (PDPT): Delivery of medication or prescription to partner(s) by index patients • Pharmacy arrangements • Field delivery of drug to partners by public health personnel • Drug pick-up by partners from providers’ offices • Other

  4. Use of EPT by Health Care Providers for Gonorrhea and Chlamydia • Five surveys N • National 2,538 Hogben et al, Sex Transm Dis 2005 • King Co, WA 150 Golden et al, Sex Transm Dis 2004 • RI and CT 111 Niccolai et al, Sex Transm Dis 2005 • California 1,513 Packal et al, NSTDPM 2004; ms in prep • NYC ~350 Rogers et al, ISSTDR 2005 • Consistent results across all most surveys • Never use 45-50% • Sometimes 45-50% • Usually or always 10-15% (NYC 27%, CA 50%)

  5. RCT of PDPT for CT in Women Schillinger J et al Sex Transm Dis 2003;30:49-56 • Women age 14-34 with uncomplicated CT in 6 metropolitan areas • PDPT (azithromycin) versus patient referral • Outcome: recurrent/persistent infection at 1 mo & 3-6 mo • Follow-up: 90% at 1 month, 55% at 3-6 months; urine NAAT N CT 1 month CT 3-6 mo Cumulative total PDPT 890 37 (5.1%) 50 (11%) 87 (12%) Control 905 54 (7.4%) 54 (12%) 108 (15%) OR (95% CI) 0.80 (0.62-1.05)

  6. RCT of EPT for Men and Women with GC or CT, SeattleGolden MR, et al. N Engl J Med 2005;352:676-85 • N = 2751, M & F, GC or CT; 42% public, 58% private care • EPT (mostly PDPT) vs patient- or provider-referral • Azithromycin + cefixime • Follow-up 3-19 weeks; urine NAAT P=0.17 P=0.04 Percent P=0.02 N=358 N=1595 N=1860

  7. Multivariate AnalysisReduced rate of infection at follow-up remained independently associated with EPT (OR 0.75, 95% CI 0.57 - 0.97) after adjustment for: • Age • Sex • Diagnosis (GC, CT, both) • Source (STD, FP, pvt, etc) • Race/ethnicity • No. sex partners 60 days • Sex since Rx • New partner since Rx • No. partners sex w/o condom • Sex w/ ptr who had other ptrs • Sex with untreated partner • All partners treated Golden et al. NEJM 2005;352:676-85

  8. Summary of Results STD EPT Standard RR (95% CI) • GC or CT 92/929 (10) 121/931 (13) 0.76 (0.59-0.98) • Male 13/194 (7) 24/202 (12) 0.56 (0.30-1.08) • Female 79/735 (11) 97/729 (13) 0.81 (0.61-1.07) • Gonorrhea 6/179 (3) 19/179 (11) 0.32 (0.13-0.77) • Male 3/72 (4) 8/85 (9) 0.44 (0.12-1.61) • Female 3/107 (3) 11/94 (12) 0.25 (0.07-0.83) • Chlamydia 86/797 (11) 105/798 (13) 0.82 (0.62-1.07) • Male 10/132 (8) 17/135 (13) 0.60 (0.29-1.27) • Female 76/665 (11) 88/663 (13) 0.86 (0.65-1.15) Golden et al. NEJM 2005;352:676-85

  9. Recurrent or Persistent Chlamydial Infection in Two Trials Number Completing study 1454 1595 3049 Schillinger Golden Total Patient referral 108 (15) 105 (13.2) 213 (14.0) OR 95% CI 0.80 (0.62-1.05) 0.82 (0.62-1.07) 0.81 (0.67-0.97) PDPT 87 (12) 85 (10.8) 172 (11.2)

  10. Differential persistence: Infection at Follow-up among Women Who Any Sex Since Treatment CT Rx Failure 8.6% (95% CI 5-12%) P=0.34 Percent 15/147 22/289 11/156 1/17 0/21 1/38 Study Arm

  11. RCT of PDPT for Urethritis in Men Kissinger P, et al Clin Infect Dis (in press) • 977 men with urethritis: 54% GC, 15% CT, 6% both, 25% neither • PDPT (AZM + cefixime/cipro) vs pt referral vs enhanced pt ref • Follow-up: Interview 720 (79%), urine NAAT 289 (38%) • Study Arm Infected at FU (%) Odds ratio (95% CI) • Pt referral 35/82 (43) Referent • Enhanced pt referral 16/112 (14) 0.22 (0.11 - 0.44) • PDPT 20/87 (23) 0.38 (0.19 - 0.74) • Gonorrhea 0.34 (0.13 - 0.86) • Chlamydia 0.46 (0.13 - 0.87)

  12. Behavioral Outcomes • Partner notification • Partner treatment • Sexual behavior

  13. Behavioral Outcomes P<0.001 P<0.001 Percent P = 0.001 Golden et al NEJM 2005;352:676-85

  14. EPT: Guidance Development • Systematic evidence review Autumn 2004 • Expert consultation Oct 28-29, 2004 • Scientific evidence • Elements of guidance • Secondary evidence review Nov ’04 – Feb ‘05 • Programmatic consultation Mar 2-3, 2005 • Program, stakeholders • Implementation issues • Dear Colleague Letter May, 2005 • General support • Start to address barriers • DSTDP deliberations etc Mar ’05 – Feb ‘06 • Guidance released, posted Feb ‘06

  15. EPT: CDC Guidance • Overview • EPT is as least equivalent to patient referral in preventing persistent/recurrent infection in het M&F with GC or CT, and in several desirable behavioral outcomes • EPT should be available as an option • EPT does not supplant other strategies • GC and CT in heterosexual men and women • Effective in preventing persistent/recurrent infection and in several desirable behavioral outcomes • Recommended as an option • Routinely recommend personal evaluation • Especially for women; advise re PID symptoms • Men with symptoms • Warn about adverse effects

  16. EPT: CDC Guidance • GC and CT in MSM • No data • High likelihood of co-morbidity, especially HIV • Use selectively and with caution, only when standard PN impractical or unsuccessful • Trichomoniasis in women • Despite historic use, a single RCT showed no benefit vs standard management • High STD co-morbidity in partners (10-15% GC or CT) • Metronidazole adverse effects • Not recommended for routine use • “Permission” to use if partner treatment is otherwise impractical or unsuccessful • Infectious syphilis • Not recommended for routine use

More Related