Dataset Information

A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

ABSTRACT: BACKGROUND:Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings. METHODS:We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, parental satisfaction, and staff impressions were recorded. RESULTS:Of 302 male neonates randomized, 300 (99%) underwent circumcision, 153 (51%) with Mogen clamp, and 147 (49%) with Plastibell. There were no major adverse events in the Mogen clamp arm, but there were 2 major adverse events in the Plastibell arm (both were a proximally migrated ring that had to be removed by study staff). Minor adverse events were more common with the Mogen clamp compared with the Plastibell, specifically removal of too little skin and formation of skin bridges or adhesions (12 versus 1 and 11 versus 3, respectively, all P < 0.05). Five (3%) infants in the Mogen clamp arm and none in the Plastibell arm had minor bleeding (P = 0.03). More than 94% of mothers reported being highly or completely satisfied with the procedure. CONCLUSIONS:NMC can be performed in Botswana with a low rate of adverse events and high parental satisfaction. Although the risk of migration and retention of the Plastibell is small, the Mogen clamp may be safer for NMC in regions where immediate emergent medical attention is not available.

SUBMITTER: Plank RM

PROVIDER: S-EPMC3683122 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

Plank Rebeca M RM Ndubuka Nnamdi O NO Wirth Kathleen E KE Mwambona Janet T JT Kebaabetswe Poloko P Bassil Barbara B Lesetedi Chiapo C Magetse Jane J Nkgau Maggie M Makhema Joseph J Mmalane Mompati M Creek Tracy T Powis Kathleen M KM Shapiro Roger R Lockman Shahin S

Journal of acquired immune deficiency syndromes (1999) 20130401 5

<h4>Background</h4>Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings.<h4>Methods</h4>We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, ...[more]

PMID: 23314413

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Project description:BACKGROUND:Partnerships in global health and development governance have been firmly established as a tool to achieve effective outcomes. Botswana implements Safe Male Circumcision (SMC) for HIV prevention through a North-South partnership comprising the local Ministry of Health, US Centers for Disease Control and Prevention (funded by PEPFAR) and Africa Comprehensive HIV/AIDS Partnership (funded by the Bill and Melinda Gates Foundation). The SMC partnership experienced significant antagony and the aim of this paper is to illuminate the actions and processes in the SMC program that contributed to that antagony. METHODS:Methods used to gather data include observation of the partners' planning and strategic meeting in 2012, in-depth interviews with lead officers at national level, focus group discussions with district officers and implementers, younger male officers and old community members as recipients of the service. RESULTS:The findings reveal that the partnership experienced antagony during operational processes and as the ultimate outcome. Target setting, financial power of the North, superficial ownership given to the South, ignoring local traditional realities results in antagony. Three roots of antagony have been identified: 1. therapeutic domination-medical expertise given with arrogance; 2.iatrogenic violence-good intentions that cause unintended harm; 3. the Trojan horse-Reckless acceptance of the gift as well as deceptive power positioned under the pretext of benevolence. CONCLUSION:The three roots of antagony; therapeutic domination, iatrogenic violence and the Trojan horse, constitute attitudes, hidden intentions and unintended consequences that influence program implementation and cause harm at different levels. Examples of therapeutic domination and the Trojan horse have highlighted the need for vigilance at the stage of establishing a partnership, to prevent more powerful partners from developing and applying hidden agendas and to strengthen accountability from the local partner. Iatrogenic violence has highlighted the need for partnership interventions to prevent good partner intentions accidentally producing bad outcomes.

Project description:OBJECTIVES:To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. METHODS:We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. RESULTS:Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. CONCLUSIONS:The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Dataset Information

A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

Publications

A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.

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