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临床试验/NCT01115335
NCT01115335已完成4 期

Feasibility, Acceptability, and Safety of Neonatal Male Circumcision at the University Teaching Hospital in Lusaka, Zambia and in the Lusaka District in Zambia Using Gomco; Plastibell; and Mogen Methods

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 661 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
661
试验地点
1
主要终点
Complication Rate

研究概览

简要总结

In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.

详细描述

As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it is important to understand the acceptability, feasibility, and safety of implementing NMC services in various clinical settings.

In this study, we will examine the acceptability of neonatal male circumcision among parents in several ways. First, we will administer a structured questionnaire on NMC to 1000 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care clinics in Lusaka. All parents approached, regardless of whether or not they complete the survey, will also be offered an opportunity to have their sons circumcised. Uptake will be calculated as the percent of parents approached who consent for their sons to be circumcised. Finally, we will assess parental satisfaction with results of the procedure.

To examine the feasibility of training providers and implementing neonatal male circumcision services in various clinical settings, we will train a group of 15-20 health care providers in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3 study sites. We will recruit 600 infants to be circumcised during the training. We will use structured questionnaires and skill assessments to evaluate provider competence after completing the training curriculum, provider preferences among the three circumcision methods, and opinion about how NMC should be scaled up within the existing health care system. We will also document logistical difficulties of scaling up NMC services at the study sites.

Finally, we will examine the safety of implementing NMC by collecting and analyzing data on complications resulting from the different circumcision methods.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 28 Days(Child)
性别
Male
接受健康志愿者

入选标准

  • Male infants who are in the first day of life (including infants < 24 hours old) and up to 4 weeks of age will be considered for circumcision
  • Gestational age >37 weeks at birth

排除标准

  • Any current illness
  • Bleeding diathesis or family history of bleeding disorder
  • Abnormality of urethra or penile shaft such as hypospadias
  • Local infection defined as redness, swelling, or a purulent discharge from the infant penis
  • Greater than four weeks of age

结局指标

主要结局

Complication Rate

时间窗: 0-6 weeks after the circumcision procedure

Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems

次要结局

  • Uptake of NMC(Ongoing, over the course of the study (1.5 years))
  • Provider Preferences(Upon completion of training in NMC)
  • Parent Satisfaction(6 weeks following the circumcision procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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