1. Evaluation of Presumptive Treatment Recommendation for Asymptomatic Anorectal Gonorrhoea and Chlamydia Infections in At-Risk Kenyan MSM IAS 24 July 2012 Washington DC, USA Okuku HS, Wahome E, Duncan S, Thiongo’ A, Mwambi J, Shafi J, Smith AD, Graham SM, Sanders EJ Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya; Un. of Washington, Seattle, US; Un. of Oxford, UK

2. Background Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are important public health problems – NG enhances HIV-1 acquisition and transmission in men who have sex with men (MSM); NG/CT cause considerable morbidity Little is known about anorectal NG and CT infections among African MSM

3. STI treatment is challenging in most of sub-Saharan Africa Syndromic treatment not always effective STD Treatment guidelines do not mention anal sex Front line health workers not trained to discuss sexual behaviour, including anal sex with their clients BIG TABOO! …. anal sex !

4. WHO recommendation 2011 At-risk MSM – reporting unprotected anal receptive intercourse in the last 6 months – PLUS: partner with STI or multiple partners Should be presumptively treated for asymptomatic anorectal NG or CT infections in absence of NAAT NAAT-screening not available at routine care clinics

5. Study objectives and design I: Evaluate WHO’s recommendation in on-going cohort studies of MSM in Coastal Kenya II: Assess new cases of NG and CT infections over 3-months follow-up MSM are followed in: 1. HIV negative high risk cohort 2. HIV positive cohort All men had 3-monthly follow up – Recall of sexual behaviour, medical history, physical examination – Risk reduction counselling & provision of free condoms/lubricants/treatment of STI KEMRI-clinic, Mtwapa

6. Study Procedures At month 0 and 3: urine and anal swab samples collected for NAAT screening Men with STI symptoms; NG culture taken & treated with cefixime (400 mg stat) and doxycycline (100 mg, bd, 7 days) Those with NAAT results positive for NG or CT traced back to receive organism specific treatment

7. Baseline Characteristics – 275 MSM N (%) Age [Median – IQR] 28 (24 - 33) Education Primary or None 146 (53) Transactional sex past 6 months 232 (84) Symptomatic STI Urethral discharge (n=1), dysuria (n=1) Rectal discharge(n=1), rectal pain (n=1) 4 (2) 2 Receptive anal intercourse past 6 months (Asymptomatic) 207 (76) Risk assessment positive past 6 months Multiple sex partners Unprotected anal intercourse Sex partner with STI 204 (99) 203 196 10

8. WHO Algorithm for presumptive treatment of anorectal infections RAI past 6 months N = 211 Symptomatic? * N = 4 N = 207 Risk assessment positive N = 204 Presumptive treatment * including 3 that were NAAT-confirmed (2 NG and 1 NG/CT co-infection)

9. NAAT-diagnosed infections in 275 MSM, Coastal Kenya CTNGCT + NG UrethraRectumUrethraRectumU + R95% CI All MSM 182041441 (15%)11 - 20 RAI142041437 (18%)13 – 23 IAI40004 (6%)2 – 15 RAI – Receptive anal intercourse IAI – Insertive anal intercourse

10. NAAT-diagnosed infections in 275 MSM, Coastal Kenya CTNGCT + NG UrethraRectumUrethraRectumU + R95% CI All MSM 182041441 (15%)11 - 20 RAI142041437*(18%)13 – 23 IAI40004 (6%)2 – 15 * Including 28 (14%) men with asymptomatic anorectal infections

11. Sensitivity & specificity of WHO Presumptive treatment algorithm NAAT-diagnosed Asymptomatic anorectal NG or CT infections Total PositiveNegative RAI + positive risk assessment 28 *176204 No RAI071 Total28247275 Sensitivity (28/28) = 100%, Specificity (71/247) = 29% Of 204 MSM meeting WHO criteria, 28 (14%) men had all anorectal infections (8 NG; 17 CT and 3 NG/CT)

12. 238 MSM were re-screened at a median 103 days (Inter quartile range: 91-131) 19 (8.0%) had an asymptomatic anorectal NG or CT infection, including 8 men who were treated at baseline, and 17 met WHO criteria for presumptive treatment The estimate incidence of any anorectal NG or CT infection after 3 months - 25.1 (95% CI: 16.0 - 39.4) per 100 person years NG infection 11.9 (95% CI: 6.2-22.9) CT infection 15.9 (95% CI: 9.0-27.9) Results – aim II

13. Study limitations Sample / setting – High risk MSM cohort (most reported sex work in past 6 months) – Counsellors / clinicians experienced to discuss RAI STI treatment policy in Kenya – Syndromic treatment [norfloxacin/doxycycline] not effective for NG

14. Only 4 (2%) of 275 men had symptomatic infections High burden of anorectal CT and NG infections in at- risk MSM in Coastal Kenya For every 7 at-risk MSM meeting WHO criteria for presumptive treatment, 1 asymptomatic anorectal infection would be treated in this population Conclusions

15. Upon re-screening at 3 months, 1 out of 13 at-risk MSM had asymptomatic NG or CT infections, and 89% met WHO treatment criteria Periodic presumptive treatment every 3 months should be considered for at-risk MSM in the absence of NAAT screening Conclusion & recommendation

16. Acknowledgements University of Washington – Scott McClelland International AIDS Vaccine Initiative – Matthew Price – Pat Fast – Bonnie Bender – Jill Gilmour NASCOP - Anisa Omar, Peter Cherutich Brown University -Don Operario KEMRI, Kilifi – Elise van der Elst – Peter Mugo – Norbert Peshu – Counsellors – Clinicians MSM & FSW communities