2. Prevalence of Chlamydia and Gonorrhea Among Patients With Genital Ulcer Disease in Zimbabwe: Potential Implications for Syndromic Management More Mungati: MBChB, MPH Zimbabwe Ministry of Health and Child Care University of Zimbabwe, Department of Community Medicine

3. Introduction Laboratory testing for Sexually Transmitted Infections (STIs) is not routinely available in Zimbabwe Therefore syndromic approach used in Zimbabwe and other developing countries Surveillance and sentinel lab testing are vital for developing treatment guidelines

4. Introduction Syndromic treatment for genital ulcer disease (GUD) includes Benzathine penicillin, erythromycin, and acyclovir Patients with co-existent gonorrhoea or chlamydia infections are not adequately treated unless they have concomitant genital discharge Chlamydia and gonorrhoea are frequently asymptomatic CT in women (70%) and men (30%) NG in women (80%) and men (10%)

5. Introduction How common are chlamydia and/or gonorrhoea infections in patients with GUD? What is the likelihood that these patients are not treated for these co-infections when using the syndromic approach?

6. Broad Objectives To determine the current etiology of sexually transmitted syndromes (STIs) in Zimbabwe

7. Specific Objectives  To determine the prevalence of different micro-organisms among men with urethral discharge syndrome in Zimbabwe  To determine the prevalence of different micro-organisms among women with vaginal discharge syndrome in Zimbabwe  To determine the prevalence of bacterial vaginosis among women with vaginal discharge syndrome in Zimbabwe  To determine the prevalence of different micro- organisms among men and women with genital ulcer disease in Zimbabwe

8. Specific Objectives  To assess the prevalence of HIV among patients presenting with sexually transmitted syndromes in Zimbabwe.  To assess the prevalence of positive syphilis serology among patients with sexually transmitted syndromes in Zimbabwe.  To assess the prevalence of urethral/vaginal N. Gonorrhoeae and C. trachomatis co-infection in men and women diagnosed with genital ulcer disease

9. Methods This study was part of a larger cross sectional study to determine the etiology of STI syndromes in Zimbabwe –Men with urethral discharge (n=200) –Women with vaginal discharge (n=200) –Men and women with genital ulcer disease (n=200)

10. Location of Zimbabwe

11. Gutu

12. Methods Data Collection Interviewer administered questionnaire Clinical examination Sample collection Data Analysis SAS Permission and Ethical Considerations Written informed consent Ethical review by Ministry of Health and Child Care, Medical Research Council of Zimbabwe, Research Council of Zimbabwe and Centers for Disease Control and Prevention, Atlanta

13. Methods Laboratory Testing Blood samples HIV testing: First Response; Determine; Chembio Treponemal (SD-DUO rapid) and non-treponemal serology (RPR) Samples from genital discharge for Gram-staining Men: urethritis Women: vaginal discharge

14. Methods Nucleic acid amplification tests (NAAT) for: Genital discharge : N. gonorrhoeae (NG): Probetec; Gene Xpert, M-PCR C. trachomatis (CT): Probetec, Gene Xpert, M-PCR M. genitalium (MG): M-PCR T. vaginalis (TV): M-PCR Genital ulcers : T. pallidum (TP): M-PCR H. ducreyi (HD): M-PCR C. trachomatis (LGV): M-PCR Herpes simplex virus (HSV): M-PCR Urine and vaginal swabs: for gonorrhoea and chlamydia by Probetec and Gene Xpert

15. Results

16. Enrollment completed, 600 enrolled Of 100 men and 100 women with GUD Full results available for 100 women and 98 men Specimens for 2 men inadequate

17. Study participants Enrolled by Syndrome, Zimbabwe: 2014-2015 (N=600)

18. Aetiology of Genital Discharge Syndromes, Zimbabwe: 2014-2015

19. Aetiology of Genital Ulcer Disease, Zimbabwe: 2014-2015

20. Prevalence of Gonorrhoea and Chlamydia among Different Syndromes, Zimbabwe: 2014-2015

21. Infection with Gonorrhoea and/or Chlamydia by Syndrome, Zimbabwe: 2014-2015

22. Infection with Gonorrhoea and/or Chlamydia, Zimbabwe: 2014-2015

23. Eligibility for Simultaneous Genital Discharge Syndrome Management, Zimbabwe: 2014-2015

24. Results Of the 52 men and women with GUD who were co- infected with chlamydia and gonorrhoea 36 (69%) were not eligible for genital discharge syndrome management This represents 18.2% of all patients with GUD in our study

25. Discussion Syndromic management of STIs effectively Treats symptomatic patients Treats mixed infections Avoids expensive tests High prevalence of CT/NG in asymptomatic patients 31-100% (Detels et al 2011); Causes PID, subfertility 8.7% (Nwankwo et al 2014) Prevalence of CT/NG in women with vaginal discharge is similar to men/women with GUD

26. Discussion Chlamydia and gonorrhoea are largely asymptomatic Most costly non-viral STI Syndromic approach deemed neither sensitive nor specific Romoren at al (2007); Tann et al (2006); Hylton-Kong et al (2006) Need to screen asymptomatic individuals Affected by prohibitive cost Combine with simple cheap lab tests (Prabha et al 2004)

27. Limitations Only patients with symptomatic STIs studied Possible over-sampling of high risk patients

28. Conclusions Gonococcal and chlamydia infections present in 26% of GUD cases. 69% would not have been treated Results raises concerns on the syndromic approach for genital ulcer disease

29. Next Steps So what are the alternatives: Ignore this high prevalence of CT/NG among patients with GUD? Screen all patients with GUD for chlamydia and gonorrhoea? Treat all patients with GUD for chlamydia and gonorrhoea?

30. Public Health Actions so far… GUD participants with NG/CT were followed up and treated All participants with unknown status but HIV+ followed up 63 (77%) RPR positive participants treated 38 (75%) Results prompted discussions

31. Zimbabwe STI Aetiology Study Research Team DCM/SEAM/ZiCHIRE –Prof. Mufuta Tshimanga –Dr. Gerald Shambira –Mr. Vitalis Kupara –Ms. Luanne Rodgers Ministry of Health and Child Care –Dr. Owen Mugurungi –Dr. More Mungati –Ms. Anna Machiha –Mr. Justice Nyakura U.S. Centers for Disease Control and Prevention –Dr. Peter Kilmarx –Ms. Elizabeth Gonese –Dr. Amy Herman-Roloff Consultants –Prof. David Lewis University of Sydney, Western Sydney Sexual Health –Prof. Hunter Handsfield University of Washington –Prof. Kees Rietmeijer Rietmeijer Consulting, USA

32. Collaboration Zimbabwe Ministry of Health and Child Care University of Zimbabwe, Department of Community Medicine Centers for Disease Control and Prevention

33. Funding This project has been supported by the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through Cooperative Agreement between the Centers for Disease Control and Prevention and the University of Zimbabwe Department of Community Medicine SEAM Project under the terms of Cooperative Agreement Number: 1U2GGH000315-01

34. Thank You