Patty Kissinger 1 Norine Schmidt 1 Bernadette Meadors 2 Jami S Leichliter 3 Cheryl Sanders 1

1. A randomized trial of three different strategies to treat partners of women with Trichomonas vaginalis Patty Kissinger1 Norine Schmidt1 Bernadette Meadors2 Jami S Leichliter3 Cheryl Sanders1 Hamish Mohammed1 Thomas A Farley1 1Tulane University School of Public Health and Tropical Medicine 2Louisiana State University Health Sciences Center 3 Centers for Disease Control and Prevention

2. Background • Trichomonas is an understudied STI that has been linked to poor obstetrical outcomes and increased transmission of HIV. • Partners are rarely treated and consequently high recurrence rates are reported (8%-36%). • Better methods of treating partners of women with trichomonas are needed.

3. Objective • This randomized trial was to determine if booklet enhanced partner referral (BR) or patient delivered partner medicine (PDPM) was better than the standard partner referral (PR) for reducing recurrent trichomonas vaginalis (TV) infection among women.

4. Outcomes measured • Outcomes measured were: • Index woman’s report that partner(s) told her they took the medicine • TV Recurrence at one-month follow-up

5. Inclusion • Women attending a Family Planning clinic in New Orleans: • Aged 16-44 • Attending clinic from 12/01 to 1/04 • In Pouch culture positive • Report having one or more sex partners in past 60 days • Not presumptively treated for trichomonas and had not taken metronidazole in the last two weeks • Pregnant women in their second or third trimester. • Provide informed consent to be re-contacted by telephone or in person in 21-56 days for a follow-up interview and T vaginalis rescreening

6. Methods • Randomized to either PR, BR or PDPM. • At baseline and one month each woman underwent: • audio computer assisted (ACASI) self-administered survey eliciting information about each partner • Testing for TV via InPouch culture • Women were given $10 for baseline and $10-$40 for follow-up interviews • IRB approval was obtained from Tulane, Office of Public Health and CDC • Women in all arms received counseling about the importance of partner treatment before they were randomized (not usually done in the clinic)

7. The interventions • Standard partner referral (PR) – women were given information about TV and counseled on the importance of telling their partners about the infection and about the need to go to either the public STD clinic or the clinic of their choice for TV treatment • Booklet-enhanced partner referral (BR) – women were given a booklet that contained 4 tear out cards with information for the partner and the provider regarding TV and partner treatment. • Patient delivered partner medication (PDPM) – 2 grams of metronidazole were provided for up to 4 partners with instructions, warnings and a 24 hour nurse pager number

8. Results • 391 women reported information on 443 partners • Women were mostly: • African American (99.2%) • > 24 years of age (52.4%) • Had one partner (86.2%) • Had < high school education (58.1%) • Reported having a symptom at baseline (62.1%): • Discharge (49.1%) • Burning (10.2%) • Itching (38.9%)

9. Baseline characteristics by Arm No statistical differences were found

10. Outcomes • Of 391 women enrolled, 84.9% completed a follow-up interview and follow-up cultures were also completed for 79.3% • Of 310 who were retested: • 8.1% were TV culture positive at one-month • 19.5% had unprotected sex in the follow-up period • There was no difference in TV+ rates for those who had unprotected sex compared to those who did not have sex or had protected sex

11. Outcomes con’t • Of 443 partnerships, index women reported that: • 87.9% of indexes talked to the partner about the TV • 81.7% of indexes gave the intervention to the partner • 67.1% of the partners told the index they took the medicine • 35.3% saw them take the medicine • 13.9% had unprotected sex before the partner took medicine • 41.7% re-initiated sex with the partner • 57.6% used condoms all the time during follow-up • 4.8% acquired a new partner

12. Not statistically different

13. *P< 0.05, **P<0.001

14. Not statistically different

15. P=0.30 57% of sex was reported to be protected sex

16. *P < 0.01

17. Characteristics associated with index report of partner taking medicine (N=443) * P < 0.05, **P < 0.001

18. Characteristics associated with a TV positive culture at one-month follow-up (N=307)

19. Discussion • Randomization worked well • No side effects among partners were reported • We did not anticipate such a low overall recurrence rate (8.1%) and such a high compliance rate among the standard of care group (88.2%) • Sample size still too small for accurate comparisons

20. Surprising findings • We expected a trend in the biological outcome, but did not find one. • There is some evidence that recurrence at follow-up was persistence rather than re-infection because: • high rates of compliance with the intervention on all arms • Similar rates of recurrence between those who had unprotected sex, protected sex and no sex • While PDPM arm had higher rates of unprotected sex during follow-up, they also had high rates of partner treatment and did not have higher rates of re-infection • The finding that BR reduces report of partner taking medicine was surprising and may be due to the passive nature of this intervention

21. Conclusion • In women, while PDPM results in more partners taking the medicine than the standard or booklet enhanced methods, recurrence rates were similar. • Lack of difference in recurrence rates could be attributed to lack of exposure to re-infection or high rates of persistence.

22. Implications • PDPM may be effective for TV, but future studies should follow women longer. • The distinction between re-infection or persistence for follow-up test positives needs to be made.