Enhanced Provision of Male Circumcision for HIV Prevention, Rakai, Uganda

乌干达拉凯加强男性包皮环切术以预防艾滋病毒

• 批准号: 8473160
• 负责人: RONALD H GRAY
• 金额: $ 94.91万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8473160
• 关键词: AIDS prevention; Acceptor Characteristics; Adult; Adverse event; Africa; Africa South of the Sahara; African; Age-Months; Behavioral; Body Weight; Camping; Caring; Cellular Phone; Characteristics; Client; Clinic; Clinical; Cohort Studies; Communities; Cost Savings; Cost Sharing; Data; Development; Education; Effectiveness; Enrollment; Epidemic; Evaluation; Event; Exposure to; Female; Fishes; Foundations; Funding; Future; General Population; Government; Grant; HIV; HIV Infections; HIV/STD; Health Sciences; Human Resources; Incidence; Infant; Infection; Licensing; Link; Local anesthesia; Male Circumcision; Measures; Modeling; Monitor; Motivation; National Institute of Child Health and Human Development; Newborn Infant; Nurse Midwives; Operations Research; Operative Surgical Procedures; Outcome; Parents; Participant; Pattern; Penetration; Persons; Physicians; Policy Developments; Policy Maker; Population; Postpartum Period; Pregnancy; Prevalence; Prevention; Prevention Research; Procedures; Program Development; Qualitative Research; Randomized; Research; Research Infrastructure; Risk; Risk Behaviors; Rural; Rural Health Centers; Rural Population; Safety; Services; Sports; Structural Models; Text; Time; Time Series Analysis; Training; Uganda; United States National Institutes of Health; Work; Wound Healing; age group; aged; arm; authority; cost; cost effective; cost effectiveness; follow-up; high risk; high risk men; implementation science; improved; male; men; models and simulation; older men; outreach; population based; programs; randomized trial; rural area; safety study; satisfaction; scale up; sex risk; uptake; young man

DESCRIPTION (provided by applicant): 60% of the sub-Saharan African population and 85% of Ugandans reside in rural areas, where there is an urgent need to increase coverage of male circumcision (MC). The Rakai Health Sciences Program (RHSP) has conducted randomized trials of MC for HIV/STI prevention, implementation science research on PEPFAR- funded MC services, and has monitored MC uptake and effectiveness in a rural population of 14,000 persons enrolled in a 50 village Rakai Community Cohort Study (RCCS). Between 2007-mid 2011, we performed >18,000 service MCs in 5 static facilities; recently, we also piloted MC provision in a mobile MC camp. However, MC coverage among non-Muslim men in the RCCS population remains modest at ~28%, and MC acceptance occurs disproportionately among younger, lower risk men. We propose the following implementation science research. Aim 1. To increase MC uptake in a rural setting, particularly in higher risk men, using enhanced messaging, targeted outreach, task shifting, task sharing and mobile camps, and to compare MC uptake, coverage, and client sociodemographic/behavioral characteristics and cost-effectiveness in static clinics versus mobile camps. We project ~27,000 MC acceptors overall within 3 years. We hypothesize that the enhanced messaging/outreach will increase overall MC uptake by higher risk men compared to our prior services, that mobile MC camps will increase acceptance by higher risk men and be more cost-effective than static services in this rural setting, and that MC prevalence in RCCS will increase to 60%. Aim 2. Early infant MC (EIMC) is simpler, safer and cheaper than adult MC, and can have a long-term impact on the HIV epidemic. Sustainable scale-up of EIMC requires task shifting to non-physicians. We will conduct a randomized study of the acceptability and safety of EIMC provided by clinical officers (COs) who currently perform adult MC, compared with nurse-midwives (NMWs) who are not currently licensed to perform the procedure. We will first train personnel in EIMC using the Mogen clamp under local anesthesia, and then enroll 500 infants aged <2 months per arm. We hypothesize that the acceptability and safety of EIMC performed by NMWs will be comparable to COs. Outcomes will be shared with policy makers for future program development. Aim 3. To assess the population prevalence of MC and its impact on HIV incidence in the RCCS population (supported almost completely by other grants), and estimate the number of MCs required to avert one HIV infection and costs per HIV infection averted, using marginal structural models for causal inference. A stochastic simulation model will be used to project infections averted and cost savings over 10 years. The proposed studies will provide a model for rapid MC scale up (Aim 1), and EIMC services (Aim 2) to help guide programs in rural Africa. The impact of MC on HIV incidence, cost-effectiveness and enhanced modeling (Aim 3) will provide data on population prevention of HIV through MC, for policy and program development.

描述（由申请人提供）：60%的撒哈拉以南非洲人口和85%的乌干达人居住在农村地区，那里迫切需要增加男性包皮环切术的覆盖率。Rakai健康科学项目（RHSP）对MC预防艾滋病毒/性传播疾病进行了随机试验，对PEPFAR资助的MC服务进行了实施科学研究，并监测了参加50个村庄Rakai社区队列研究（RCCS）的14000名农村人口对MC的吸收和有效性。在2007年至2011年中期，我们在5个静态设施中进行了18,000次服务mc；最近，我们也在一个流动的MC营试点提供MC服务。然而，在RCCS人群中，非穆斯林男性的MC覆盖率仍然适度，约为28%，并且MC接受度在年轻，低风险男性中不成比例。我们提出以下实施科学研究。目的1。通过增强信息传递、有针对性的推广、任务转移、任务共享和移动营地，提高农村地区（特别是高风险男性）对MC的接受程度，并比较固定诊所与移动营地对MC的接受程度、覆盖范围、客户社会人口/行为特征和成本效益。我们计划在3年内总共接受约27,000名MC。我们假设，与我们之前的服务相比，增强的信息传递/外展将增加高风险男性对MC的总体接受程度，移动MC营地将增加高风险男性的接受程度，并且在农村环境中比静态服务更具成本效益，并且RCCS的MC患病率将增加到60%。目标2。早期婴儿MC （EIMC）比成人MC更简单，更安全，更便宜，并且可以对艾滋病毒流行产生长期影响。EIMC的持续扩大需要将任务转移给非医生。我们将进行一项随机研究，比较目前执行成人MC的临床官员（COs）提供的EIMC的可接受性和安全性，以及目前未获得执行该程序许可的护士助产士（NMWs）。我们将首先在局部麻醉下使用Mogen钳进行EIMC人员培训，然后每只手臂招募500名<2个月的婴儿。我们假设NMWs进行EIMC的可接受性和安全性将与COs相当。研究结果将与政策制定者分享，以促进未来项目的发展。目标3。目的：评估农村社区人口中MCs的患病率及其对HIV发病率的影响（几乎完全由其他资助支持），并使用边际结构模型进行因果推理，估计避免一次HIV感染所需的MCs数量和避免每次HIV感染的成本。随机模拟模型将用于预测10年内避免感染和节省成本。拟议的研究将为快速扩大MC规模（目标1）和EIMC服务（目标2）提供一个模型，以帮助指导非洲农村的项目。MC对艾滋病毒发病率、成本效益和增强模型的影响（目标3）将为通过MC预防艾滋病毒的人口提供数据，以制定政策和规划。