Browsing by Author "Cohen, Gabriel M."
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Item Contraception and pregnancy in microbicide trials.(Elsevier., 2012) Sibeko, Sengeziwe.; Cohen, Gabriel M.; Moodley, Jagidesa.The distinctive feature of the human immunodeficiency virus (HIV) epidemic in Sub-Saharan Africa is the burden on women, in particular young women of reproductive age. Consequently, most late-phase effectiveness microbicide clinical trials are conducted in sub-Saharan Africa where fertility rates are high. Because late-phase clinical trials are conducted over prolonged periods of time, women participating in these trials may fall pregnant during the trial. Their unborn babies may be exposed to a drug whose teratogenic potential is unknown if the investigational drug is not withdrawn. High pregnancy rates in such trials may compromise statistical integrity, as women will be withdrawn from the study drug for the duration of the pregnancy. It is therefore imperative for microbicide trials to implement effective contraceptive and pregnancy management programmes that maintain low pregnancy rates and the safety of unborn babies while not compromising the conduct and statistical integrity of the trial.Item Role of education in HIV clinical outcomes in a tuberculosis endemic setting.(Sage., 2013) Cohen, Gabriel M.; Werner, Lise.; Gengiah, Santhanalakshmi.; Naidoo, Kogieleum.This study evaluated how educational attainment impacts clinical outcomes of HIV-positive patients in Durban, South Africa. The authors conducted a prospective study of 466 adult HIV-positive patients initiating antiretroviral therapy (ART) at an urban TB-HIV clinic from October 2004 to June 2007. The level of educational attainment (highest grade completed) was assessed at ART initiation. The authors measured tuberculosis treatment outcomes as well as death, lost to follow-up, viral suppression (HIV RNA <400 copies/mL), and immunologic response (CD4 ≥ 200 cells/mm³) at 6, 12, and 24 months after ART initiation. After 24 months of ART initiation, there were 43 deaths; viral suppression and immunologic response were observed in 88% and 83% of the remaining patients, respectively. The authors found no association between level of educational attainment and mortality (P = .12), loss to follow-up (P = .85), virologic response (P = .51), or immunologic response (P = .63). Similar findings were observed at 6 and 12 months post-ART initiation.