Browsing by Author "Ntombela, Fanelesibonge."
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Item How ethical is your clinical trial?(John Wiley & Sons., 2010) Miller, Lori.; Folayan, Morenike.; Allman, Dan.; Nkala, Busisiwe.; Kasirye, Lilian Mutengu.; Mingote, Laia Ruiz.; Calazans, Gabriela.; Mburu, Rosemary.; Ntombela, Fanelesibonge.; Ditmore, Melissa Hope.Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level.Item Prevalence of HIV, HSV-2 and pregnancy among high school students in rural KwaZulu-Natal, South Africa: a bio-behavioural cross-sectional survey.(BMJ., 2014) Abdool Karim, Quarraisha.; Kharsany, Ayesha Bibi Mahomed.; Leask, Kerry.; Ntombela, Fanelesibonge.; Humphries, Hilton Richard.; Fröhlich, Janet Ann.; Samsunder, Natasha.; Grobler, Anna Christina.; Dellar, Rachael Claire.; Abdool Karim, Salim Safurdeen.Abstract available in pdf.Item The preventive misconception: experiences from CAPRISA 004.(Springer., 2014) Dellar, Rachael Claire.; Abdool Karim, Quarraisha.; Mansoor, Leila Essop.; Grobler, Anna Christina.; Humphries, Hilton Richard.; Werner, Lise.; Ntombela, Fanelesibonge.; Luthuli, Londiwe R.; Abdool Karim, Salim Safurdeen.Abstract available in pdf.Item Stabilizing HIV prevalence masks high HIV incidence rates amongst rural and urban women in KwaZulu-Natal, South Africa.(Oxford University Press for the International Epidemiological Association., 2010) Abdool Karim, Quarraisha.; Kharsany, Ayesha Bibi Mahomed.; Fröhlich, Janet Ann.; Werner, Lise.; Mashego, May.; Mlotshwa, Mukelisiwe.; Madlala, Bernadette T.; Ntombela, Fanelesibonge.; Abdool Karim, Salim Safurdeen.Objective: To determine the HIV incidence rate among rural and urban women in KwaZulu-Natal, South Africa. Methods: We conducted a prospective cohort study from March 2004 to May 2007. Volunteers were recruited from a rural family-planning clinic and an urban clinic for sexually transmitted infections. Consenting, HIV-uninfected women aged 14–30 years were enrolled. Demographic, clinical, sexual and behavioural data were collected using standardized questionnaires with HIV risk reduction counselling and HIV testing. Pelvic examinations were completed at quarterly visits. Results: The HIV prevalence at screening was 35.7% [95% confidence interval (CI) 32.7–38.8] amongst rural women and 59.3% (95% CI 56.5–62.0) amongst urban women. A total of 594/2240 (26.5%) enrolled women contributed to 602 person-years (PYs) of follow-up. The median age was 22 years [inter-quartile range 18–23 years]. HIV incidence rate was 6.5/100 PY (95% CI 4.4–9.2) amongst rural women and 6.4/100 PY (95% CI 2.6–13.2) amongst urban women. HIV incidence rate of 17.2/100 PY (95% CI 2.1–62.2) was highest amongst urban women <20 years of age and 10.2/100 PY (95% CI 4.1–20.9) amongst rural women ≥25 years of age. Conclusion: HIV incidence rates are devastatingly high in young women in rural and urban KwaZulu-Natal, despite reports of stabilized HIV prevalence observed in current surveillance data. The diffuse nature of the HIV epidemic underscores the urgent need to enhance HIV prevention and treatment modalities.