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Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial

Summary 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 testi... Full description

Journal Title: The Lancet (British edition) 2007, Vol.369 (9562), p.657-666
Main Author: Gray, Ronald H, Prof
Other Authors: Kigozi, Godfrey, MBChB , Serwadda, David, MBChB , Makumbi, Frederick, PhD , Watya, Stephen, MBChB , Nalugoda, Fred, MHS , Kiwanuka, Noah, MBChB , Moulton, Lawrence H, Prof , Chaudhary, Mohammad A, PhD , Chen, Michael Z, MSc , Sewankambo, Nelson K, MBChB , Wabwire-Mangen, Fred, PhD , Bacon, Melanie C, MPH , Williams, Carolyn FM, PhD , Opendi, Pius, MBChB , Reynolds, Steven J, MD , Laeyendecker, Oliver, MSc , Quinn, Thomas C, Prof , Wawer, Maria J, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
Men
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/17321311
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title: Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
format: Article
creator:
  • Gray, Ronald H, Prof
  • Kigozi, Godfrey, MBChB
  • Serwadda, David, MBChB
  • Makumbi, Frederick, PhD
  • Watya, Stephen, MBChB
  • Nalugoda, Fred, MHS
  • Kiwanuka, Noah, MBChB
  • Moulton, Lawrence H, Prof
  • Chaudhary, Mohammad A, PhD
  • Chen, Michael Z, MSc
  • Sewankambo, Nelson K, MBChB
  • Wabwire-Mangen, Fred, PhD
  • Bacon, Melanie C, MPH
  • Williams, Carolyn FM, PhD
  • Opendi, Pius, MBChB
  • Reynolds, Steven J, MD
  • Laeyendecker, Oliver, MSc
  • Quinn, Thomas C, Prof
  • Wawer, Maria J, Prof
subjects:
  • Abridged Index Medicus
  • Adolescent
  • Adult
  • Circumcision
  • Circumcision, Male - adverse effects
  • Condoms - utilization
  • HIV
  • HIV infection
  • HIV Infections - epidemiology
  • HIV Infections - prevention & control
  • Human immunodeficiency virus
  • Human papillomavirus
  • Humans
  • Incidence
  • Internal Medicine
  • Male
  • Men
  • Middle Aged
  • Poisson Distribution
  • Postoperative period
  • Prevention
  • Studies
  • Uganda - epidemiology
  • Wound healing
ispartof: The Lancet (British edition), 2007, Vol.369 (9562), p.657-666
description: Summary 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.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleMale circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
sourceAlma/SFX Local Collection
creatorGray, Ronald H, Prof ; Kigozi, Godfrey, MBChB ; Serwadda, David, MBChB ; Makumbi, Frederick, PhD ; Watya, Stephen, MBChB ; Nalugoda, Fred, MHS ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Chaudhary, Mohammad A, PhD ; Chen, Michael Z, MSc ; Sewankambo, Nelson K, MBChB ; Wabwire-Mangen, Fred, PhD ; Bacon, Melanie C, MPH ; Williams, Carolyn FM, PhD ; Opendi, Pius, MBChB ; Reynolds, Steven J, MD ; Laeyendecker, Oliver, MSc ; Quinn, Thomas C, Prof ; Wawer, Maria J, Prof
creatorcontribGray, Ronald H, Prof ; Kigozi, Godfrey, MBChB ; Serwadda, David, MBChB ; Makumbi, Frederick, PhD ; Watya, Stephen, MBChB ; Nalugoda, Fred, MHS ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Chaudhary, Mohammad A, PhD ; Chen, Michael Z, MSc ; Sewankambo, Nelson K, MBChB ; Wabwire-Mangen, Fred, PhD ; Bacon, Melanie C, MPH ; Williams, Carolyn FM, PhD ; Opendi, Pius, MBChB ; Reynolds, Steven J, MD ; Laeyendecker, Oliver, MSc ; Quinn, Thomas C, Prof ; Wawer, Maria J, Prof
descriptionSummary 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.
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languageeng
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subjectAbridged Index Medicus ; Adolescent ; Adult ; Circumcision ; Circumcision, Male - adverse effects ; Condoms - utilization ; HIV ; HIV infection ; HIV Infections - epidemiology ; HIV Infections - prevention & control ; Human immunodeficiency virus ; Human papillomavirus ; Humans ; Incidence ; Internal Medicine ; Male ; Men ; Middle Aged ; Poisson Distribution ; Postoperative period ; Prevention ; Studies ; Uganda - epidemiology ; Wound healing
ispartofThe Lancet (British edition), 2007, Vol.369 (9562), p.657-666
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13Williams, Carolyn FM, PhD
14Opendi, Pius, MBChB
15Reynolds, Steven J, MD
16Laeyendecker, Oliver, MSc
17Quinn, Thomas C, Prof
18Wawer, Maria J, Prof
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0Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
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descriptionSummary 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.
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11Human papillomavirus
12Humans
13Incidence
14Internal Medicine
15Male
16Men
17Middle Aged
18Poisson Distribution
19Postoperative period
20Prevention
21Studies
22Uganda - epidemiology
23Wound healing
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titleMale circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
authorGray, Ronald H, Prof ; Kigozi, Godfrey, MBChB ; Serwadda, David, MBChB ; Makumbi, Frederick, PhD ; Watya, Stephen, MBChB ; Nalugoda, Fred, MHS ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Chaudhary, Mohammad A, PhD ; Chen, Michael Z, MSc ; Sewankambo, Nelson K, MBChB ; Wabwire-Mangen, Fred, PhD ; Bacon, Melanie C, MPH ; Williams, Carolyn FM, PhD ; Opendi, Pius, MBChB ; Reynolds, Steven J, MD ; Laeyendecker, Oliver, MSc ; Quinn, Thomas C, Prof ; Wawer, Maria J, Prof
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abstractSummary 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.
copEngland
pubElsevier Ltd
pmid17321311
doi10.1016/S0140-6736(07)60313-4