Can HIV incidence testing be used for evaluating HIV intervention programs? A reanalysis of the Orange Farm male circumcision trial (ANRS-1265)

Autor: Pascale Lissouba, Bertran Auvert, Thomas C. Quinn, Agnès Fiamma, Beverley Singh, Oliver E Amy, Oliver Laeyendecker, Dirk Taljaard
Přispěvatelé: Department of Medicine, University of California [Los Angeles] (UCLA), University of California (UC)-University of California (UC), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), The Johns Hopkins University School of Medicine-Division of Infectious Diseases, National Institute of Allergy and Infectious Diseases [Bethesda] (NIAID-NIH), National Institutes of Health [Bethesda] (NIH), National Institute for Communicable Diseases [Johannesburg] (NICD), Progressus Research and Development, BMC, Ed., University of California-University of California, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Male
Biomedical Research
Cross-sectional study
HIV Infections
Window period
Rate ratio
law.invention
South Africa
0302 clinical medicine
Randomized controlled trial
MESH: South Africa
law
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases
030212 general & internal medicine
MESH: Incidence
Randomized Controlled Trials as Topic
MESH: Treatment Outcome
0303 health sciences
education.field_of_study
Incidence
MESH: HIV Infections
Infectious Diseases
Treatment Outcome
MESH: Young Adult
MESH: Survival Analysis
[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases
MESH: Circumcision
Male

Research Article
medicine.medical_specialty
Randomization
Adolescent
Population
Sensitivity and Specificity
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Young Adult
Internal medicine
medicine
Humans
lcsh:RC109-216
education
Survival analysis
030304 developmental biology
MESH: Adolescent
MESH: Humans
business.industry
MESH: Biomedical Research
Survival Analysis
Confidence interval
MESH: Male
MESH: Sensitivity and Specificity
MESH: Randomized Controlled Trials as Topic
Circumcision
Male

Immunology
business
Zdroj: BMC Infectious Diseases
BMC Infectious Diseases, 2010, 10 (1), pp.137. ⟨10.1186/1471-2334-10-137⟩
BMC Infectious Diseases, BioMed Central, 2010, 10 (1), pp.137. ⟨10.1186/1471-2334-10-137⟩
Fiamma, Agnès; Lissouba, Pascale; Amy, Oliver E; Singh, Beverley; Laeyendecker, Oliver; Quinn, Thomas C; et al.(2010). Can HIV incidence testing be used for evaluating HIV intervention programs? A reanalysis of the Orange Farm male circumcision trial (ANRS-1265). BMC Infectious Diseases, 10(1), 137. doi: http://dx.doi.org/10.1186/1471-2334-10-137. Retrieved from: http://www.escholarship.org/uc/item/1fz4f29z
BMC Infectious Diseases, Vol 10, Iss 1, p 137 (2010)
ISSN: 1471-2334
DOI: 10.1186/1471-2334-10-137⟩
Popis: 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.
Databáze: OpenAIRE