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Male circumcision and Mycoplasma genitalium infection in female partners: a randomised trial in Rakai, Uganda.

ABSTRACT: Previous randomised trial data have demonstrated that male circumcision reduces Mycoplasma genitalium prevalence in men. We assessed whether male circumcision also reduces M genitalium infection in female partners of circumcised men.HIV-negative men were enrolled and randomised to either male circumcision or control. Female partners of male trial participants from the intervention (n=437) and control (n=394) arms provided interview information and self-collected vaginal swabs that were tested for M genitalium by APTIMA transcription-mediated amplification-based assay. Prevalence risk ratios (PRR) and 95% CI of M genitalium prevalence in intervention versus control group were estimated using Poisson regression. Analysis was by intention-to-treat. An as-treated analysis was conducted to account for study-group crossovers.Male and female partner enrolment sociodemographic characteristics, sexual behaviours, and symptoms of sexually transmitted infections were similar between study arms. Female M genitalium prevalence at year 2 was 3.2% (14/437) in the intervention arm and 3.6% (14/394) in the control arm (PRR=0.90, 95% CI 0.43 to 1.89, p=0.78). In an as-treated analysis, the prevalence of M genitalium was 3.4% in female partners of circumcised men and 3.3% in female partners of uncircumcised men (PRR=1.01, 95% CI 0.48 to 2.12, p=0.97).Contrary to findings in men, male circumcision did not affect M genitalium infection in female partners.

SUBMITTER: Tobian AA

PROVIDER: S-EPMC4018720 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Male circumcision and Mycoplasma genitalium infection in female partners: a randomised trial in Rakai, Uganda.

Tobian Aaron A R AA Gaydos Charlotte C Gray Ronald H RH Kigozi Godfrey G Serwadda David D Quinn Nicole N Grabowski Mary K MK Musoke Richard R Ndyanabo Anthony A Nalugoda Fred F Wawer Maria J MJ Quinn Thomas C TC

Sexually transmitted infections 20131120 2

<h4>Objective</h4>Previous randomised trial data have demonstrated that male circumcision reduces Mycoplasma genitalium prevalence in men. We assessed whether male circumcision also reduces M genitalium infection in female partners of circumcised men.<h4>Methods</h4>HIV-negative men were enrolled and randomised to either male circumcision or control. Female partners of male trial participants from the intervention (n=437) and control (n=394) arms provided interview information and self-collected ...[more]

PMID: 24259189

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Project description:BackgroundObservational 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.Methods922 uncircumcised, HIV-infected, asymptomatic men aged 15-49 years with CD4-cell counts 350 cells per microL 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.FindingsThe 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).InterpretationCircumcision 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.FundingBill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.

Project description:BackgroundMale circumcision reduces the transmission of high-risk human papillomavirus (HPV) in HIV-uninfected men and their female partners. We assessed whether circumcision of HIV-infected men would reduce the transmission of high-risk HPV to their female partners.MethodsFemale partners of HIV-infected men (aged 15-49 years) in Rakai, Uganda, with CD4 counts of greater than 350 cells per mL who were randomly assigned to undergo circumcision immediately (intervention group) and after 24 months (control group) were assessed for infection with high-risk HPV. Randomisation was done in blocks of 20, stratified by community, with computer-generated random numbers. Laboratory technicians and female fieldworkers were masked to the circumcision status of male participants. The main outcome assessed in this study was the effects of circumcision of HIV-infected men on transmission of HPV to their female partners. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00124878.Findings474 men were assigned to the intervention group, 448 to the control group. 211 women were in consensual relationships with 193 men in the intervention group, and 171 women were in consensual unions with 155 men in the control group. High-risk HPV at the 2-year follow-up was prevalent in 88 female partners (55%) of 159 men in the intervention group and 68 (52%) of 131 female partners of men in the control group (prevalence risk ratio 1·07, 95% CI 0·86-1·32, p=0·64). Incidence of high-risk HPV over 2 years was 32·0 per 100 person-years in the female partners of men in the intervention group and 30·6 per 100 person-years in the female partners of men in the control group (incidence rate ratio 1·05, 0·77-1·43, p=0·78). No difference was noted in the clearance of genotype-specific high-risk HPV between the intervention group (196 [46%] of 424) and control group (167 [48%] of 347; rate ratio 0·96, 0·83-1·12; p=0·61).InterpretationBecause circumcision of HIV-infected men did not affect transmission of high-risk HPV to their female partners, promotion of consistent safe sexual practices for HIV-infected men remains important.FundingBill & Melinda Gates Foundation and National Institutes of Health.

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Male circumcision and Mycoplasma genitalium infection in female partners: a randomised trial in Rakai, Uganda.

Publications

Male circumcision and Mycoplasma genitalium infection in female partners: a randomised trial in Rakai, Uganda.

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