Homework #5: Randomized Control Trial Reading

Homework #5: Randomized Control Trial Reading - Articles...

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www.thelancet.com Vol 369 February 24, 2007 657 Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial Ronald H Gray, Godfrey Kigozi, David Serwadda, Frederick Makumbi, Stephen Watya, Fred Nalugoda, Noah Kiwanuka, Lawrence H Moulton, Mohammad A Chaudhary, Michael Z Chen, Nelson K Sewankambo, Fred Wabwire-Mangen, Melanie C Bacon, Carolyn F M Williams, Pius Opendi, Steven J Reynolds, Oliver Laeyendecker, Thomas C Quinn, Maria J Wawer Summary Background Ecological and observational studies suggest that male circumcision reduces the risk of HIV acquisition in men. Our aim was to investigate the eF ect of male circumcision on HIV incidence in men. Methods 4996 uncircumcised, HIV-negative men aged 15–49 years who agreed to HIV testing and counselling were enrolled in this randomised trial in rural Rakai district, Uganda. Men were randomly assigned to receive immediate circumcision (n=2474) or circumcision delayed for 24 months (2522). HIV testing, physical examination, and interviews were repeated at 6, 12, and 24 month follow-up visits. The primary outcome was HIV incidence. Analyses were done on a modi± ed intention-to-treat basis. This trial is registered with ClinicalTrials.gov, with the number NCT00425984. Findings Baseline characteristics of the men in the intervention and control groups were much the same at enrolment. Retention rates were much the same in the two groups, with 90–92% of participants retained at all time points. In the modi± ed intention-to-treat analysis, HIV incidence over 24 months was 0·66 cases per 100 person-years in the intervention group and 1·33 cases per 100 person-years in the control group (estimated effi cacy of intervention 51%, 95% CI 16–72; p=0·006). The as-treated effi cacy was 55% (95% CI 22–75; p=0·002); effi cacy from the Kaplan-Meier time-to-HIV-detection as-treated analysis was 60% (30–77; p=0·003). HIV incidence was lower in the intervention group than it was in the control group in all sociodemographic, behavioural, and sexually transmitted disease symptom subgroups. Moderate or severe adverse events occurred in 84 (3·6%) circumcisions; all resolved with treatment. Behaviours were much the same in both groups during follow-up. Interpretation Male circumcision reduced HIV incidence in men without behavioural disinhibition. Circumcision can be recommended for HIV prevention in men. Introduction A number of ecological and observational studies, mainly from sub-Saharan Africa, have suggested that male circumcision reduces the risk of HIV infection in men. 1–5 A meta-analysis of cross-sectional and prospective studies estimated that the adjusted summary rate ratio of male HIV acquisition associated with circumcision in general populations was 0·56 (95% CI 0·44–0·70); in high-risk populations the adjusted summary rate ratio was 0·29 (0·20–0·41).
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Homework #5: Randomized Control Trial Reading - Articles...

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