A comparison of three different strategies to treat partners of men with urethritis

1. A comparison of three different strategies to treat partners of men with urethritis Patty Kissinger1 Gwangi Richardson-Alston1 Jami S Leichliter4 Hamish Mohammed1 Stephanie N Taylor2,3 David H Martin2 Thomas A Farley1 1Tulane University School of Public Health and Tropical Medicine 2Louisiana State University Health Sciences Center 3New Orleans Health Department Delgado STD/HIV Clinic 4 Centers for Disease Control and Prevention

2. Background: • Studies of Chlamydia trachomatis among women demonstrate that only 25-40% of named male partners were treated • Alternative methods of partner treatment are needed • Evidence that patient-delivered partner medicine (PDPM) is superior to partner referral (PR) for reducing STI recurrence is mounting, but not yet definitive • Less is known about patient-delivered partner medicine among men

3. Studies with biological outcomes demonstrating PDPM is better

4. Studies with biological outcomes either absent or not demonstrating statistical significance

5. Objectives • To compare patient-delivered partner medication (PDPM) with booklet enhanced partner referral (BR) and standard partner referral methods (PR) among men with urethritis • Outcomes were: • Percentage of partners who told their partners they took the medicine (per index man’s report) • Re-infection by CT or GC

6. The interventions • Standard partner referral (PR) – men were told to tell their partners to go to either the public STD clinic or the clinic of their choice for STI testing and treatment • Booklet-enhanced partner referral (BR) – men were given a booklet which contained 4 tear out cards with information for the partner and the provider for partner treatment • Patient delivered partner medication (PDPM) - azithromycin 1 gram/cefixime 400 mg or ciprofloxacin 500 mg with instructions, warnings and a nurse pager number

7. Inclusion • Inclusion criteria: • Men who attended the Delgado public STD Clinic in New Orleans • 16 years of age or older • With a presumptive diagnosis of urethritis • Between 1/02 and 12/03 • Who had at least one or more female sex partner(s) • Whose partner(s) did not accompany them to the clinic • Were treated for gonorrhea and/or chlamydia at baseline and had not taken cefixime, ciprofloxacin or azithromycin in last two weeks prior to baseline • Provided informed consent to be re-contacted by telephone or in person in 14-28 days for a follow-up interview • 85.1% accepted to participate

8. Methods • Intervention allocation was randomly assigned by month rather than by individual • Information about each partner was elicited from the index men at baseline and one-month using a audio computer-assisted self-administered interview (ACASI) • Genprobe urethral swabs were performed at baseline and PCR urine testing and/or Genprobe urethral swabs were performed at one month • Men were given $10-$40 for follow-up visits • IRB approval was obtained from Tulane, Office Of Public Health, the N. O. Health Dept. Research Review Committee and CDC

9. Results • 887 men reported information on 1808 partners at baseline • Men were mostly: • African American (96.2%) • > 24 years of age (55.8%) • Had < high school education (78.1%) • Had > 2 partners (68.1%) • 97.7% of partners were women • Had dysuria/discharge at baseline (85.9%) • Baseline GenProbe test positive (N=760) • GC 61.6% • CT 19.6% • Either CT or GC 69.3% • CT and GC 6.1%

10. Baseline characteristics by Arm *P < 0.05

11. Outcomes • Of 887 men enrolled: • 84.1% completed a follow-up interview • 31.6% provided a follow-up STI test • Information was reported on 1313 partners at follow-up • Of 280 who provided follow-up STD tests: • 25.9% had CT or GC • 17.6% had CT • 12.4% had GC • 25% had symptoms at follow-up

12. Outcomes • Of 1313 partnerships reported on at follow-up, index men reported that: • 55.8% of indexes talked to the partner about the STI • 58.9% of indexes gave the intervention to the partner • 44.9% of the partners took the medicine • 35.7% saw them take the medicine • 27.0% had unprotected sex before the partner took medicine • 51.6% used condoms all the time during follow-up • 36.8% re-initiated sex with the partner • 13.1% of index men acquired a new partner

13. PDPM vs. PR, P< 0.001 for both

14. PDPM vs. PR, P< 0.001 for all

15. P> 0.05 for both

16. Characteristics associated with index report of partner taking medicine (N=1313) * P < 0.05, **P < 0.001

17. Multivariable GEE results of factors associated with index report of partner taking medicine (N=1313) * P < 0.05, **P < 0.001

18. Characteristics associated with a CT or GC positive urine test at one-month follow-up (N=280) * P < 0.05, **P < 0.001

19. Discussion • Randomization worked well • Very large sample size • No partner side effects were reported • PDPM consistently better than PR for all outcomes • Biological outcome: while we had high follow-up rates for interviews, many men refused to give urine specimens. But those who gave urines were similar to those who did not

20. Characteristics of those followed and those who gave urine • Those who were LTF (n=138) were more likely than those who were followed (n=729) to be: • < 24 years of age (54.3% vs. 41.9%, P < 0.01) • to have > 2 partners (74.6% vs. 66.8%, P < 0.07) • They were similar by race, education and symptoms at baseline • Among those who were followed, those who gave a urine test (n=213) were similar to those who did not (n=516) by race, education, age, symptoms at baseline and number of partners

21. Conclusion • In men, PDPM was better than both BR and PR in treatment of partners and for the prevention of recurrence of CT or GC.

22. Implications: • PDPM and BR can be useful public health interventions to prevent the spread STDs among men.