Infant Male Circumcision in Botswana: Feasibility, Safety and Acceptability

博茨瓦纳的婴儿男性包皮环切术：可行性、安全性和可接受性

• 批准号: 7758557
• 负责人: Rebeca Milanesi Plank
• 金额: $ 13.7万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7758557
• 关键词: AIDS prevention; Address; Adult; Adverse event; Africa; Africa South of the Sahara; Age; Allied Health Personnel; Botswana; Childhood; Clinics and Hospitals; Commit; Complication; Country; Data; Decision Making; Development; Doctor of Medicine; Effectiveness; Epidemic; Equipment; Evaluation; Focus Groups; Future; Goals; Government; Grant; HIV; HIV Infections; Health Personnel; Hemorrhage; Human Resources; Human Rights; Infant; Infection; Informed Consent; Instruction; International; Intervention; Intervention Studies; Interview; Investigation; Learning; Location; Male Adolescents; Male Circumcision; Measures; Midwife; Neonatal; Nurses; Operative Surgical Procedures; Outcome; Parents; Policies; Postpartum Women; Prevention approach; Prevention program; Prevention strategy; Preventive Intervention; Principal Investigator; Procedures; Professional counselor; Provider; Public Health; Public Sector; Questionnaires; Randomized Controlled Clinical Trials; Recommendation; Relative (related person); Research; Research Design; Resources; Risk; Risk Reduction; Role; Safety; Sample Size; Schedule; Services; Southern Africa; Structure; Techniques; Time; Training; Upper arm; Vaccination; Visit; Woman; Work; World Health Organization; base; cost; evidence base; follow-up; impression; infancy; interest; male; neonate; novel; preference; primary outcome; profession allied to medicine; programs; satisfaction; scale up; sound; standard of care; uptake

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.

描述（由申请人提供）： 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。虽然成年男性包皮环切术已被证明可将艾滋病毒感染率降低 50% 以上，但婴儿期包皮环切术是最佳选择，因为其相对容易、成本低且并发症发生率低。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。了解有关婴儿男性包皮环切的决策对于最大限度地提高这种艾滋病毒预防策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采用率，并确定采用的障碍； 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) 估计在人力资源、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，Mogen Clamp 相对于 Plastibell 的扩大规模存在哪些优势（如果有）。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可接受性和采用率的相关性，定义为婴儿男性包皮环切术在知情同意后进行。男性婴儿将在医院/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：莫根钳或塑料贝尔包皮环切术，在 1 天到 2 周龄（最多 4 周）之间进行。研究团队将在术后对婴儿进行长达 4 个月的跟踪，以评估结果。我们还将在定期的 6 周儿科访视和定期的 4 个月疫苗接种访视中向家长进行问卷调查，以评估一段时间内对婴儿手术结果的印象/满意度。样本量为每只手臂 150 名婴儿，总共 300 名接受包皮环切术的男性婴儿（以及估计 700 份家长调查问卷）。 相关性（参见说明）：世界卫生组织 (WHO) 和联合国艾滋病规划署指出，艾滋病毒流行严重、广泛但男性包皮环切率较低的国家应将这种手术作为一种重要的、基于证据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更多研究。这项研究将与这些建议保持一致。