BACKGROUND: The objective of this study was to estimate the effect of male circumcision (MC) on HIV acquisition estimated using HIV incidence assays and to compare it to the effect measured by survival analysis. METHODS: We used samples collected during the MC randomized controlled trial (ANRS-1265) conducted in Orange Farm (South Africa) among men aged 18 to 24. Among the 2946 samples collected at the last follow-up visit, 194 HIV-positive samples were tested using two incidence assays: Calypte HIV-EIA (BED) and an avidity assay based on the BioRad HIV1/2+O EIA (AI). The results of the assays were also combined (BED-AI). The samples included the 124 participants (4.2% of total) who were HIV-positive at randomization. The protective effect was calculated as one minus the intention-to-treat incidence rate ratio in an uncorrected manner and with correction for misclassifications, with simple theoretical formulae. Theoretical calculations showed that the uncorrected intention-to-treat effect was approximately independent of the value of the incidence assay window period and was the ratio of the number tested recent seroconverters divided by the number tested HIV-negative between the randomization groups. We used cut-off values ranging from 0.325 to 2.27 for BED, 31.6 to 96 for AI and 0.325-31.6 to 1.89-96 for BED-AI. Effects were corrected for long-term specificity using a previously published formula. 95% Confidence intervals (CI) were estimated by bootstrap resampling. RESULTS: With the highest cut-off values, the uncorrected protective effects evaluated by BED, AI and BED-AI were 50% (95%CI: 27% to 66%), 50% (21% to 69%) and 63% (36% to 81%). The corrections for misclassifications were lower than 50% of the number of tested recent. The corrected effects were 53% (30% to 70%), 55% (25% to 77%) and 67% (38% to 86%), slightly higher than the corresponding uncorrected values. These values were consistent with the previously reported protective effect of 60% (34% to 76%) obtained with survival analysis. CONCLUSIONS: HIV incidence assays may be employed to assess the effect of interventions using cross-sectional data.
RCT Entities:
BACKGROUND: The objective of this study was to estimate the effect of male circumcision (MC) on HIV acquisition estimated using HIV incidence assays and to compare it to the effect measured by survival analysis. METHODS: We used samples collected during the MC randomized controlled trial (ANRS-1265) conducted in Orange Farm (South Africa) among men aged 18 to 24. Among the 2946 samples collected at the last follow-up visit, 194 HIV-positive samples were tested using two incidence assays: Calypte HIV-EIA (BED) and an avidity assay based on the BioRad HIV1/2+O EIA (AI). The results of the assays were also combined (BED-AI). The samples included the 124 participants (4.2% of total) who were HIV-positive at randomization. The protective effect was calculated as one minus the intention-to-treat incidence rate ratio in an uncorrected manner and with correction for misclassifications, with simple theoretical formulae. Theoretical calculations showed that the uncorrected intention-to-treat effect was approximately independent of the value of the incidence assay window period and was the ratio of the number tested recent seroconverters divided by the number tested HIV-negative between the randomization groups. We used cut-off values ranging from 0.325 to 2.27 for BED, 31.6 to 96 for AI and 0.325-31.6 to 1.89-96 for BED-AI. Effects were corrected for long-term specificity using a previously published formula. 95% Confidence intervals (CI) were estimated by bootstrap resampling. RESULTS: With the highest cut-off values, the uncorrected protective effects evaluated by BED, AI and BED-AI were 50% (95%CI: 27% to 66%), 50% (21% to 69%) and 63% (36% to 81%). The corrections for misclassifications were lower than 50% of the number of tested recent. The corrected effects were 53% (30% to 70%), 55% (25% to 77%) and 67% (38% to 86%), slightly higher than the corresponding uncorrected values. These values were consistent with the previously reported protective effect of 60% (34% to 76%) obtained with survival analysis. CONCLUSIONS: HIV incidence assays may be employed to assess the effect of interventions using cross-sectional data.
Authors: J Steven McDougal; Bharat S Parekh; Michael L Peterson; Bernard M Branson; Trudy Dobbs; Marta Ackers; Marc Gurwith Journal: AIDS Res Hum Retroviruses Date: 2006-10 Impact factor: 2.205
Authors: Bharat S Parekh; M Susan Kennedy; Trudy Dobbs; Chou-Pong Pau; Robert Byers; Timothy Green; Dale J Hu; Suphak Vanichseni; Nancy L Young; Kachit Choopanya; Timothy D Mastro; J Steven McDougal Journal: AIDS Res Hum Retroviruses Date: 2002-03-01 Impact factor: 2.205
Authors: S B Gupta; G Murphy; E Koenig; C Adon; C Beyrer; D Celentano; S Khawaja; F Sifakis; J V Parry; W Straus Journal: AIDS Res Hum Retroviruses Date: 2007-12 Impact factor: 2.205
Authors: Charlotte Sakarovitch; Francois Rouet; Gary Murphy; Albert K Minga; Ahmadou Alioum; Francois Dabis; Dominique Costagliola; Roger Salamon; John V Parry; Francis Barin Journal: J Acquir Immune Defic Syndr Date: 2007-05-01 Impact factor: 3.731
Authors: R S Janssen; G A Satten; S L Stramer; B D Rawal; T R O'Brien; B J Weiblen; F M Hecht; N Jack; F R Cleghorn; J O Kahn; M A Chesney; M P Busch Journal: JAMA Date: 1998-07-01 Impact factor: 56.272
Authors: Etienne Karita; Matt Price; Eric Hunter; Elwyn Chomba; Susan Allen; Lin Fei; Anatoli Kamali; Eduard J Sanders; Omu Anzala; Michael Katende; Nzeera Ketter Journal: AIDS Date: 2007-02-19 Impact factor: 4.177
Authors: Taha E Taha; Maria M James; Donald R Hoover; Jin Sun; Oliver Laeyendecker; Caroline E Mullis; Johnstone J Kumwenda; Jairam R Lingappa; Bertran Auvert; Charles S Morrison; Lynne M Mofensen; Allan Taylor; Mary G Fowler; Newton I Kumenda; Susan H Eshleman Journal: AIDS Date: 2011-07-17 Impact factor: 4.177
Authors: Oliver Laeyendecker; Ron Brookmeyer; Matthew M Cousins; Caroline E Mullis; Jacob Konikoff; Deborah Donnell; Connie Celum; Susan P Buchbinder; George R Seage; Gregory D Kirk; Shruti H Mehta; Jacquie Astemborski; Lisa P Jacobson; Joseph B Margolick; Joelle Brown; Thomas C Quinn; Susan H Eshleman Journal: J Infect Dis Date: 2012-11-05 Impact factor: 5.226
Authors: Sikhulile Moyo; Tessa LeCuyer; Rui Wang; Simani Gaseitsiwe; Jia Weng; Rosemary Musonda; Hermann Bussmann; Madisa Mine; Susan Engelbrecht; Joseph Makhema; Richard Marlink; Marianna K Baum; Vladimir Novitsky; M Essex Journal: AIDS Res Hum Retroviruses Date: 2013-09-06 Impact factor: 2.205