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Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial

Summary Background Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. Methods 922 uncircumcised, HIV-... Full description

Journal Title: The Lancet (British edition) 2009, Vol.374 (9685), p.229-237
Main Author: Wawer, Maria J, Dr, Prof
Other Authors: Makumbi, Frederick, PhD , Kigozi, Godfrey, MBChB , Serwadda, David, MMed , Watya, Stephen, MMed , Nalugoda, Fred, MHS , Buwembo, Dennis, MBChB , Ssempijja, Victor, ScM , Kiwanuka, Noah, MBChB , Moulton, Lawrence H, Prof , Sewankambo, Nelson K, MMed , Reynolds, Steven J, MD , Quinn, Thomas C, MD , Opendi, Pius, MBChB , Iga, Boaz, MSc , Ridzon, Renee, MD , Laeyendecker, Oliver, MBA , Gray, Ronald H, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
format: Article
creator:
  • Wawer, Maria J, Dr, Prof
  • Makumbi, Frederick, PhD
  • Kigozi, Godfrey, MBChB
  • Serwadda, David, MMed
  • Watya, Stephen, MMed
  • Nalugoda, Fred, MHS
  • Buwembo, Dennis, MBChB
  • Ssempijja, Victor, ScM
  • Kiwanuka, Noah, MBChB
  • Moulton, Lawrence H, Prof
  • Sewankambo, Nelson K, MMed
  • Reynolds, Steven J, MD
  • Quinn, Thomas C, MD
  • Opendi, Pius, MBChB
  • Iga, Boaz, MSc
  • Ridzon, Renee, MD
  • Laeyendecker, Oliver, MBA
  • Gray, Ronald H, Prof
subjects:
  • Abridged Index Medicus
  • Adolescent
  • Adult
  • Attitude to Health - ethnology
  • Biological and medical sciences
  • CD4 antigen
  • Circumcision
  • Circumcision, Male - adverse effects
  • Circumcision, Male - ethnology
  • Clinical trials
  • Disease transmission
  • Female
  • Follow-Up Studies
  • General aspects
  • Health aspects
  • Health Knowledge, Attitudes, Practice
  • HIV
  • HIV infection
  • HIV infection in women
  • HIV Infections - ethnology
  • HIV Infections - prevention & control
  • HIV Infections - transmission
  • Human immunodeficiency virus
  • Human viral diseases
  • Humans
  • Immunodeficiencies
  • Immunodeficiencies. Immunoglobulinopathies
  • Immunopathology
  • Infections
  • Infectious diseases
  • Internal Medicine
  • Kaplan-Meier Estimate
  • Male
  • Medical sciences
  • Middle Aged
  • Patient Education as Topic
  • Proportional Hazards Models
  • Risk factors
  • Risk Reduction Behavior
  • Sex Education
  • Sexual behavior
  • Sexual Partners - psychology
  • Stereotyping
  • Survival Analysis
  • Time Factors
  • Uganda - epidemiology
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
  • Women
  • Women's Health - ethnology
  • Wound Healing
  • Young Adult
ispartof: The Lancet (British edition), 2009, Vol.374 (9685), p.229-237
description: Summary Background Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. Methods 922 uncircumcised, HIV-infected, asymptomatic men aged 15–49 years with CD4-cell counts 350 cells per μL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov , number NCT00124878. Findings The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0·36). Cumulative probabilities of female HIV infection at 24 months were 21·7% (95% CI 12·7–33·4) in the intervention group and 13·4% (6·7–25·8) in the control group (adjusted hazard ratio 1·49, 95% CI 0·62–3·57; p=0·368). Interpretation Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention. Funding Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleCircumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
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creatorWawer, Maria J, Dr, Prof ; Makumbi, Frederick, PhD ; Kigozi, Godfrey, MBChB ; Serwadda, David, MMed ; Watya, Stephen, MMed ; Nalugoda, Fred, MHS ; Buwembo, Dennis, MBChB ; Ssempijja, Victor, ScM ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Sewankambo, Nelson K, MMed ; Reynolds, Steven J, MD ; Quinn, Thomas C, MD ; Opendi, Pius, MBChB ; Iga, Boaz, MSc ; Ridzon, Renee, MD ; Laeyendecker, Oliver, MBA ; Gray, Ronald H, Prof
creatorcontribWawer, Maria J, Dr, Prof ; Makumbi, Frederick, PhD ; Kigozi, Godfrey, MBChB ; Serwadda, David, MMed ; Watya, Stephen, MMed ; Nalugoda, Fred, MHS ; Buwembo, Dennis, MBChB ; Ssempijja, Victor, ScM ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Sewankambo, Nelson K, MMed ; Reynolds, Steven J, MD ; Quinn, Thomas C, MD ; Opendi, Pius, MBChB ; Iga, Boaz, MSc ; Ridzon, Renee, MD ; Laeyendecker, Oliver, MBA ; Gray, Ronald H, Prof
descriptionSummary Background Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. Methods 922 uncircumcised, HIV-infected, asymptomatic men aged 15–49 years with CD4-cell counts 350 cells per μL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov , number NCT00124878. Findings The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0·36). Cumulative probabilities of female HIV infection at 24 months were 21·7% (95% CI 12·7–33·4) in the intervention group and 13·4% (6·7–25·8) in the control group (adjusted hazard ratio 1·49, 95% CI 0·62–3·57; p=0·368). Interpretation Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention. Funding Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.
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publisherKidlington: Elsevier Ltd
subjectAbridged Index Medicus ; Adolescent ; Adult ; Attitude to Health - ethnology ; Biological and medical sciences ; CD4 antigen ; Circumcision ; Circumcision, Male - adverse effects ; Circumcision, Male - ethnology ; Clinical trials ; Disease transmission ; Female ; Follow-Up Studies ; General aspects ; Health aspects ; Health Knowledge, Attitudes, Practice ; HIV ; HIV infection ; HIV infection in women ; HIV Infections - ethnology ; HIV Infections - prevention & control ; HIV Infections - transmission ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infections ; Infectious diseases ; Internal Medicine ; Kaplan-Meier Estimate ; Male ; Medical sciences ; Middle Aged ; Patient Education as Topic ; Proportional Hazards Models ; Risk factors ; Risk Reduction Behavior ; Sex Education ; Sexual behavior ; Sexual Partners - psychology ; Stereotyping ; Survival Analysis ; Time Factors ; Uganda - epidemiology ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Women ; Women's Health - ethnology ; Wound Healing ; Young Adult
ispartofThe Lancet (British edition), 2009, Vol.374 (9685), p.229-237
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2Kigozi, Godfrey, MBChB
3Serwadda, David, MMed
4Watya, Stephen, MMed
5Nalugoda, Fred, MHS
6Buwembo, Dennis, MBChB
7Ssempijja, Victor, ScM
8Kiwanuka, Noah, MBChB
9Moulton, Lawrence H, Prof
10Sewankambo, Nelson K, MMed
11Reynolds, Steven J, MD
12Quinn, Thomas C, MD
13Opendi, Pius, MBChB
14Iga, Boaz, MSc
15Ridzon, Renee, MD
16Laeyendecker, Oliver, MBA
17Gray, Ronald H, Prof
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0Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
1The Lancet (British edition)
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descriptionSummary Background Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. Methods 922 uncircumcised, HIV-infected, asymptomatic men aged 15–49 years with CD4-cell counts 350 cells per μL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov , number NCT00124878. Findings The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0·36). Cumulative probabilities of female HIV infection at 24 months were 21·7% (95% CI 12·7–33·4) in the intervention group and 13·4% (6·7–25·8) in the control group (adjusted hazard ratio 1·49, 95% CI 0·62–3·57; p=0·368). Interpretation Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention. Funding Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.
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2Adult
3Attitude to Health - ethnology
4Biological and medical sciences
5CD4 antigen
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7Circumcision, Male - adverse effects
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9Clinical trials
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12Follow-Up Studies
13General aspects
14Health aspects
15Health Knowledge, Attitudes, Practice
16HIV
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18HIV infection in women
19HIV Infections - ethnology
20HIV Infections - prevention & control
21HIV Infections - transmission
22Human immunodeficiency virus
23Human viral diseases
24Humans
25Immunodeficiencies
26Immunodeficiencies. Immunoglobulinopathies
27Immunopathology
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30Internal Medicine
31Kaplan-Meier Estimate
32Male
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34Middle Aged
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37Risk factors
38Risk Reduction Behavior
39Sex Education
40Sexual behavior
41Sexual Partners - psychology
42Stereotyping
43Survival Analysis
44Time Factors
45Uganda - epidemiology
46Viral diseases
47Viral diseases of the lymphoid tissue and the blood. Aids
48Women
49Women's Health - ethnology
50Wound Healing
51Young Adult
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titleCircumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
authorWawer, Maria J, Dr, Prof ; Makumbi, Frederick, PhD ; Kigozi, Godfrey, MBChB ; Serwadda, David, MMed ; Watya, Stephen, MMed ; Nalugoda, Fred, MHS ; Buwembo, Dennis, MBChB ; Ssempijja, Victor, ScM ; Kiwanuka, Noah, MBChB ; Moulton, Lawrence H, Prof ; Sewankambo, Nelson K, MMed ; Reynolds, Steven J, MD ; Quinn, Thomas C, MD ; Opendi, Pius, MBChB ; Iga, Boaz, MSc ; Ridzon, Renee, MD ; Laeyendecker, Oliver, MBA ; Gray, Ronald H, Prof
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13General aspects
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15Health Knowledge, Attitudes, Practice
16HIV
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19HIV Infections - ethnology
20HIV Infections - prevention & control
21HIV Infections - transmission
22Human immunodeficiency virus
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24Humans
25Immunodeficiencies
26Immunodeficiencies. Immunoglobulinopathies
27Immunopathology
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32Male
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36Proportional Hazards Models
37Risk factors
38Risk Reduction Behavior
39Sex Education
40Sexual behavior
41Sexual Partners - psychology
42Stereotyping
43Survival Analysis
44Time Factors
45Uganda - epidemiology
46Viral diseases
47Viral diseases of the lymphoid tissue and the blood. Aids
48Women
49Women's Health - ethnology
50Wound Healing
51Young Adult
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eissn1474-547X
codenLANCAO
abstractSummary Background Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners. Methods 922 uncircumcised, HIV-infected, asymptomatic men aged 15–49 years with CD4-cell counts 350 cells per μL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov , number NCT00124878. Findings The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0·36). Cumulative probabilities of female HIV infection at 24 months were 21·7% (95% CI 12·7–33·4) in the intervention group and 13·4% (6·7–25·8) in the control group (adjusted hazard ratio 1·49, 95% CI 0·62–3·57; p=0·368). Interpretation Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention. Funding Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.
copKidlington
pubElsevier Ltd
pmid19616720
doi10.1016/S0140-6736(09)60998-3
oafree_for_read