Infant Male Circumcision in Botswana: Feasibility, Safety and Acceptability

说明(申请人提供)：背景：博茨瓦纳和撒哈拉以南非洲其他地区迫切需要新的艾滋病毒预防方法。尽管成年男性包皮环切术被证明可以减少50%以上的艾滋病毒感染，但婴儿时期的包皮环切术是最理想的，因为它相对容易，成本高，并发症发生率低。我们进行了焦点小组和半结构化访谈，表明婴儿男性包皮环切术将是博茨瓦纳可接受的公共艾滋病毒预防策略。博茨瓦纳政府承诺在不久的将来扩大男性包皮环切术服务。了解有关婴儿男性包皮环切术的决策对于最大限度地发挥这一艾滋病毒预防战略的有效性至关重要。具体目标：我们建议：1)确定博茨瓦纳东南部婴儿男性包皮环切术的可接受性和实际接受度，并确定吸收的障碍；2)确定博茨瓦纳婴儿男性包皮环切术的可行性和安全性；3)评估在博茨瓦纳，在人力资源、设备需求、不良事件和博茨瓦纳父母和提供者的接受度方面，扩大Mogen Clip与Plattibell的优势(如果有的话)。研究设计和方案：我们将对产后早期妇女进行结构化访谈，以确定婴儿男性包皮环切术的可接受性和接受度的相关性，即婴儿男性包皮环切术在知情同意后的定义。男婴将由训练有素的医生在医院/诊所通过两种常用的手术之一进行包皮环切术：Mogen夹或Plattibell包皮环切术，在1天至2周(最长4周)之间进行。研究小组将在手术后对婴儿进行长达4个月的跟踪，以评估结果。我们还将在为期6周的定期儿科访问和定期安排的4个月疫苗接种访问中向父母发放问卷，以评估一段时间以来对婴儿手术结果的印象/满意度。样本大小为每臂150名婴儿，总共300名接受割礼的婴儿男性(估计有700份父母问卷)。相关性(见说明)：世界卫生组织(世卫组织)和联合国艾滋病规划署表示，严重、普遍的艾滋病毒流行但男性包皮环切率较低的国家应将这种手术作为一项重要的循证艾滋病毒预防措施提供，包括在新生儿中。这两个机构还建议对扩大男性包皮环切术干预的最可行、最安全和最可持续的方法进行更多的研究。这项研究将与这些建议保持一致。

DESCRIPTION (provided by applicant): Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in sub- Saharan Africa. Although adult male circumcision has been shown reduced the acquisition of HIV by more than 50%, circumcision in infancy is optimal for its relative ease, cost and low rate of complications. We have conducted focus groups and semi-structured interviews that suggest infant male circumcision would be an acceptable public HIV prevention strategy in Botswana. The government of Botswana is committed to scaling up male circumcision services in the near future. Understanding decision-making around infant male circumcision will be essential to maximize the effectiveness of this HIV prevention strategy. Specific Aims: We propose to: 1) determine the acceptability and actual uptake of infant male circumcision in southeastern Botswana and identify barriers to uptake; 2) ascertain the feasibility and safety of infant male circumcision in Botswana; 3) Estimate what, if any, advantages would exist for scale up of Mogen Clamp versus Plastibell with regard to human resources, equipment needs, adverse events and acceptability to parents and providers in Botswana. Study Design and Schema: We will conduct structured interviews with early postpartum women to determine correlates of infant male circumcision acceptability and uptake, defined by infant male circumcision following informed consent. Male infants will be circumcised by a trained doctor in a hospital / clinic setting by one of two commonly used procedures: either Mogen clamp or Plastibell circumcision to occur between 1 day and 2 weeks of age (maximum 4 weeks). Infants will be followed by the study team for up to 4 months post- procedure to evaluate outcomes. We will also administer questionnaires to the parents at the regular 6-week pediatric visit and at the regularly scheduled 4-month vaccination visit to assess impressions of / satisfaction with the infant procedure outcome over time. Sample size will be 150 infants per arm for a total of 300 infants males circumcised (and an estimated 700 parental questionnaires).. RELEVANCE (See instructions): The World Health Organization (WHO) and UNAIDS state that countries with severe, generalized HIV epidemics but low rates of male circumcision should offer this surgery as an important, evidence-based HIV prevention intervention, including among neonates. These two agencies also recommended that additional research on the most feasible, safe, and sustainable ways of scaling up male circumcision intervention should be performed. This study will be in keeping with these recommendations.