Infant Male Circumcision in Botswana: Feasibility, Safety and Acceptability

背景：博茨瓦纳和撒哈拉以南非洲的其他地方迫切需要新的艾滋病预防方法。尽管成年男性包皮环切术已被证明可减少50%以上的艾滋病毒感染，但在婴儿期进行包皮环切是最佳选择，因为它相对容易、费用低、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。博茨瓦纳政府致力于在不久的将来扩大男性包皮环切服务。了解关于男婴包皮环切的决策对于最大限度地发挥这一艾滋病毒预防战略的效力至关重要。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情况，并确定接受的障碍；2)确定博茨瓦纳男婴包皮环切术的可行性和安全性；3)估计Mogen Clamp与Plastibell在人力资源、设备需求、不良事件以及博茨瓦纳家长和提供者的可接受性方面的优势（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的可接受性和接受性的相关性，通过知情同意后的婴儿男性包皮环切来定义。男婴将在医院/诊所由训练有素的医生通过两种常用程序之一进行包皮环切术：Mogen钳或Plastibell包皮环切术，在1天至2周（最多4周）之间进行。研究小组将对婴儿进行长达4个月的术后随访，以评估结果。我们还将在6周的常规儿科就诊和4个月的常规疫苗接种就诊时对父母进行问卷调查，以评估随着时间的推移对婴儿手术结果的印象/满意度。样本量将为每支手臂150名婴儿，总共300名男婴接受割礼（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指出，艾滋病毒流行严重、普遍但男性包皮环切率较低的国家应将这一手术作为一项重要的、以证据为基础的艾滋病毒预防干预措施，包括在新生儿中。这两个机构还建议对扩大男性包皮环切干预的最可行、安全和可持续的方法进行进一步研究。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.