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02340 FEASIBILITY OF CONDUCTING MICROBICIDE PREPAREDNESS STUDIES IN URBAN & RURAL KWAZULU-NATAL Dladla-Qwabe Nozizwe* Background: There are several microbicide agents ready for Phase III clinical trials. Adequate population size, basic clinical and laboratory infrastructure, and estimates of HIV incidence are required. Preparedness studies are necessary for appropriate site selection. Preliminary baseline outcomes of a preparedness study are described. Method: Between May and July 2003, 251 and 250 women from an urban clinic (Durban) and a rural clinic (Hlabisa) were screened for participation in the feasibility study. Of those, 116 and 92 women from Durban and Hlabisa respectively were enrolled in the study. At screening participants were tested for HIV, STI, and pregnancy. A demographic questionnaire was administered. At enrolment, women were screened for genital abnormality (colposcopy) and were administered a behavioral questionnaire. Results: The median age of women in Durban and Hlabisa was 28 years at both clinics. 66% and 78% of the women in Durban and Hlabisa, respectively, were unmarried. 35% of the women in Hlabisa believed that their husband/partner had more than one partner. 54% of women in Durban and 42% of women in Hlabisa had incomplete secondary education. HIV prevalence was 31.3% and 35.5% in Durban and Hlabisa respectively, with a significantly higher prevalence in the 26-35 years age group in Hlabisa (p = 0.0046) Infections with T.vaginalis, candida and syphilis were significantly higher in Durban (p= 0058, 0.0141, and 0.0004 respectively). 85% and 87% of the women in Durban and Hlabisa respectively had vaginal sex without condoms in the past 3 months. Only 29% and 18% of the women in Durban and Hlabisa respectively used condoms in the last sexual act. Vaginal douching was not highly prevalent at both the sites. Conclusion: Despite the high prevalence of HIV at both sites, these sites were able to enroll a cohort of HIV negative women in a short period of time. Risky sexual behaviors are still very prevalent which will likely result in high HIV incidence in these cohorts. Therefore, these sites are ready to be part of a microbicide Phase III clinical trial. Ms Nozizwe Dladla-Qwabe |
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