TY - JOUR
T1 - Male circumcision for HIV prevention in men in Rakai, Uganda
T2 - a randomised trial
AU - Gray, Ronald H.
AU - Kigozi, Godfrey
AU - Serwadda, David
AU - Makumbi, Frederick
AU - Watya, Stephen
AU - Nalugoda, Fred
AU - Kiwanuka, Noah
AU - Moulton, Lawrence H.
AU - Chaudhary, Mohammad A.
AU - Chen, Michael Z.
AU - Sewankambo, Nelson K.
AU - Wabwire-Mangen, Fred
AU - Bacon, Melanie C.
AU - Williams, Carolyn FM
AU - Opendi, Pius
AU - Reynolds, Steven J.
AU - Laeyendecker, Oliver
AU - Quinn, Thomas C.
AU - Wawer, Maria J.
N1 - Funding Information:
The study was supported by a grant (UO1 AI11171-01-02) from the National Institutes of Allergy and Infectious Disease (NIAID), Division of AIDS, National Institutes of Health (NIH), and in part by the Division of Intramural Research, NIAID, NIH. This publication was supported, in part, by a fellowship/grant from the Fogarty International Center/USNIH: grant number 2 D 43 TW000010-19-AITRP. We thank the members of the NIH data safety monitoring board who monitored this trial, as well as the institutional review boards that provided oversight (the scientific and ethics committee of the Uganda Virus Research Institute, the committee for human research at Johns Hopkins, and Western Institutional Review Board). We are also grateful for the advice provided by the Rakai community advisory board. Finally, we wish to express our gratitude to study participants whose commitment and cooperation made the study possible.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2007/2/24
Y1 - 2007/2/24
N2 - Background: Ecological and observational studies suggest that male circumcision reduces the risk of HIV acquisition in men. Our aim was to investigate the effect 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 modified 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 modified 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 efficacy of intervention 51%, 95% CI 16-72; p=0·006). The as-treated efficacy was 55% (95% CI 22-75; p=0·002); efficacy 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.
AB - Background: Ecological and observational studies suggest that male circumcision reduces the risk of HIV acquisition in men. Our aim was to investigate the effect 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 modified 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 modified 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 efficacy of intervention 51%, 95% CI 16-72; p=0·006). The as-treated efficacy was 55% (95% CI 22-75; p=0·002); efficacy 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.
UR - http://www.scopus.com/inward/record.url?scp=33847104829&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33847104829&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(07)60313-4
DO - 10.1016/S0140-6736(07)60313-4
M3 - Article
C2 - 17321311
AN - SCOPUS:33847104829
SN - 0140-6736
VL - 369
SP - 657
EP - 666
JO - Lancet
JF - Lancet
IS - 9562
ER -