TY - JOUR
T1 - Can HIV incidence testing be used for evaluating HIV intervention programs? A reanalysis of the Orange Farm male circumcision trial (ANRS-1265)
AU - Fiamma, Agnès
AU - Lissouba, Pascale
AU - Amy, Oliver E.
AU - Singh, Beverley
AU - Laeyendecker, Oliver
AU - Quinn, Thomas C.
AU - Taljaard, Dirk
AU - Auvert, Bertran
N1 - Funding Information:
Supported by ANRS-1265 and ANRS-12126, Agence Nationale de Recherches sur le Sida et les hépatites virales (France), the US National Institute of Mental Health as a cooperative agreement, through contracts U01MH066687 (Johns Hopkins University), U01MH066688 (Medical University of South Carolina), U01MH066701 [University of California, Los Angeles (UCLA)], and U01MH066702 (University of California, San Francisco). In addition, this work was supported by the HIV Prevention Trials Network (HPTN Protocol 043) of the Division of AIDS of the US National Institute of Allergy and Infectious Diseases and by the Office of AIDS Research of the US National Institutes of Health. Additional support provided by the HIV Prevention Trials Network (HPTN) sponsored by the NIAID, National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), and Office of AIDS Research, of the NIH, DHHS (U01-AI-068613) and with the support of IFAS, the French Institute of South Africa (UNMIFRE CNRS n°25). Additional support was provided by the Division of Intramural Research, NIAID.
PY - 2010/5/27
Y1 - 2010/5/27
N2 - 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.
AB - 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.
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U2 - 10.1186/1471-2334-10-137
DO - 10.1186/1471-2334-10-137
M3 - Article
C2 - 20507545
AN - SCOPUS:77952737404
SN - 1471-2334
VL - 10
JO - BMC infectious diseases
JF - BMC infectious diseases
M1 - 137
ER -