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IAS 24 July 2012 Washington DC, USA

Evaluation of Presumptive Treatment Recommendation for Asymptomatic Anorectal Gonorrhoea and Chlamydia Infections in At-Risk Kenyan MSM. Okuku HS, Wahome E, Duncan S, Thiongo’ A, Mwambi J, Shafi J, Smith AD, Graham SM, Sanders EJ. IAS 24 July 2012 Washington DC, USA.

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IAS 24 July 2012 Washington DC, USA

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  1. Evaluation of Presumptive Treatment Recommendation for Asymptomatic Anorectal Gonorrhoea and Chlamydia Infections in At-Risk Kenyan MSM Okuku HS, Wahome E, Duncan S, Thiongo’ A, Mwambi J, Shafi J, Smith AD, Graham SM, Sanders EJ IAS 24 July 2012 Washington DC, USA 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 recommendation2011 • 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 CTtraced back to receive organism specific treatment

  7. Baseline Characteristics – 275 MSM

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

  9. NAAT-diagnosed infections in 275 MSM, Coastal Kenya RAI – Receptive anal intercourse IAI – Insertive anal intercourse

  10. NAAT-diagnosed infections in 275 MSM, Coastal Kenya * Including 28 (14%) men with asymptomatic anorectal infections

  11. Sensitivity & specificity of WHO Presumptive treatment algorithm • Of 204 MSM meeting WHO criteria, 28 (14%) men had all anorectal infections (8 NG; 17 CT and 3 NG/CT) Sensitivity (28/28) = 100%, Specificity (71/247) = 29%

  12. Results – aim II • 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)

  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. Conclusions • 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

  15. Conclusion & recommendation • 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

  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

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