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Disproportionate HIV and HSV-2 Prevalence and Incidence among Women and Adolescent Girls in Western Kenya: Preparation for Female-Centred Prevention Trials. Otieno, Fredrick ; Ndivo, R; Zeh, C; LeBaron, C; McLellan- Lemal , E; Gust, D; Shinde, S; Pals, S; Chege, W; Chen, RT ; Mills, LA.
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Disproportionate HIV and HSV-2 Prevalence and Incidence among Women and Adolescent Girls in Western Kenya: Preparation for Female-Centred Prevention Trials Otieno, Fredrick; Ndivo, R; Zeh, C; LeBaron, C; McLellan-Lemal, E; Gust, D; Shinde, S; Pals, S; Chege, W; Chen, RT ; Mills, LA International Conference on AIDS and STIs in Africa (ICASA) Millennium Conference Centre, Addis Ababa December 4rd to 8th 2011
KEMRI/CDC Field Research Station • KEMRI/CDC Field Station established 1979 • HIV Research Branch established in 2001 • Prevention and treatment studies • Supported by CDC Division of HIV/AIDS Prevention (DHAP) • Division of Global HIV/AIDS (Global AIDS Program) since 2003 • Technical assistance and funding for Prevention, Care and Treatment, Laboratory, Epidemiology, Surveillance and Informatics To promote public health in Kenya and East Africa
Kisumu Incidence Cohort Studies (KICoS) • Motivation: • To conduct longitudinal community-based HIV incidence cohorts in preparation for future HIV prevention trials in Kisumu, western Kenya • Considerations: • Need to develop and evaluate new biomedical and behavioural interventions • Recent successes and puzzles in treatment as prevention, pre-exposure prophylaxis, microbicides and vaccines • Sites with well-characterized populations, high incidence, and good retention are necessary
Study Design • Prospective cohort studies of 851 HIV-negative sexually-active individuals • Accrual for 8 months and follow-up for 12 months • Study site: • KEMRI/CDC Clinical Research Center (CRC) within New Nyanza Provincial General Hospital • Study population: • KICoS 1: General Adults (18-34 years of age) • n=625; Jan ’07 – Mar ‘09 • KICoS 2: Adolescents (16-17 years of age) • n=206; Apr ‘09 – June ’10
Screening Study Procedures • Pre-screening assessment to determine basic eligibility • Age, resident of Kisumu catchment area, and sexually active ≥1 in past 3 months • Informed consent with parental permission for minors • Demographic, sexual and behavioural data collected • Medical evaluation with specimen collection and testing • Rapid point-of-care HIV testing with pre- and post-test counselling • Quality control of HIV rapid test results in Research Laboratory • KalonIgG ELISA for Herpes Simplex Virus -2 (HSV-2)
Enrolment and Follow-up Study Procedures • Enrolment visit • 2 weeks later, eligibility determined from screening data • Follow up visits • Quarterly for 12 months • Same procedures as screening visit (including HIV testing) • Seroconverters followed for additional 24 mo • Characterize circulating prevalent and incident HIV-1 subtypes • Describe cellular immunologic responses by characterizing trends in CD4 counts over time • Describe plasma HIV viral load set-points
Study Population aPersons aged 18-34 years bPersons aged 16-17 years
Conclusion • HIV and HSV-2 prevalence and incidence were higher among women than men and girls than boys • Strikingly, HIV incidence in adolescents was nearly 4.0 per 100 person-years in girls and null in boys. • Gender differences in behavioural and biologic factors are being evaluated to explain these disparities • Cohort studies are ideal preparation for HIV prevention trials
Acknowledgements • KICoS Participants • Kisumu Community Advisory Board • KICoS Staff • KEMRI/CDC Field Station • DHAP, CDC Atlanta