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Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe.

Mavhu W, Larke N, Hatzold K, Ncube G, Weiss HA, Mangenah C, Mugurungi O, Mufuka J, Samkange CA, Sherman J, Gwinji G, Cowan FM, Ticklay I - J. Acquir. Immune Defic. Syndr. (2015)

Bottom Line: The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7).As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp.Nearly all mothers (99.5%) reported great satisfaction with the outcome.

View Article: PubMed Central - PubMed

Affiliation: *Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; †University College London, London, United Kingdom; ‡London School of Hygiene & Tropical Medicine, London, United Kingdom; §Population Services International, Harare, Zimbabwe; ‖Ministry of Health and Child Care, Harare, Zimbabwe; ¶University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; and #UNICEF, Harare, Zimbabwe.

ABSTRACT

Background: Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe.

Methods: Between January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability.

Results: One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son.

Conclusions: This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device.

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Trial participants recruitment and follow-up.
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Related In: Results  -  Collection


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Figure 1: Trial participants recruitment and follow-up.

Mentions: To enroll 150 babies in the comparative trial, we approached 1151 parents of newborn male infants, corresponding to a 13% uptake of EIMC. A total 984 (85%) parents declined for their son to participate. Parental reasons for nonadoption of EIMC included fear of harm and sociocultural considerations.29 A further 17 male infants were excluded after assessing their eligibility for inclusion (Fig. 1). One hundred fifty male infants aged 6–54 days were circumcised between January and June 2013. All were circumcised according to their allocated intervention (n = 100 AccuCirc; n = 50 Mogen clamp). All participants attended the 3 scheduled follow-up visits on days 2, 7, and 14.


Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe.

Mavhu W, Larke N, Hatzold K, Ncube G, Weiss HA, Mangenah C, Mugurungi O, Mufuka J, Samkange CA, Sherman J, Gwinji G, Cowan FM, Ticklay I - J. Acquir. Immune Defic. Syndr. (2015)

Trial participants recruitment and follow-up.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4508202&req=5

Figure 1: Trial participants recruitment and follow-up.
Mentions: To enroll 150 babies in the comparative trial, we approached 1151 parents of newborn male infants, corresponding to a 13% uptake of EIMC. A total 984 (85%) parents declined for their son to participate. Parental reasons for nonadoption of EIMC included fear of harm and sociocultural considerations.29 A further 17 male infants were excluded after assessing their eligibility for inclusion (Fig. 1). One hundred fifty male infants aged 6–54 days were circumcised between January and June 2013. All were circumcised according to their allocated intervention (n = 100 AccuCirc; n = 50 Mogen clamp). All participants attended the 3 scheduled follow-up visits on days 2, 7, and 14.

Bottom Line: The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7).As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp.Nearly all mothers (99.5%) reported great satisfaction with the outcome.

View Article: PubMed Central - PubMed

Affiliation: *Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; †University College London, London, United Kingdom; ‡London School of Hygiene & Tropical Medicine, London, United Kingdom; §Population Services International, Harare, Zimbabwe; ‖Ministry of Health and Child Care, Harare, Zimbabwe; ¶University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; and #UNICEF, Harare, Zimbabwe.

ABSTRACT

Background: Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe.

Methods: Between January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability.

Results: One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son.

Conclusions: This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device.

Show MeSH