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临床试验/NCT02337179
NCT02337179已完成不适用

A Pilot Study to Introduce Male Circumcision (MC) Services to Prevent HIV Infection in Two High Prevalence Areas of the Dominican Republic (DR)

University of Illinois at Chicago3 个研究点 分布在 2 个国家目标入组 539 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
539
试验地点
3
主要终点
Number and percentage of participants who agreed to undergo circumcision after being offered.

研究概览

简要总结

The purpose of this study is to determine the feasibility of introducing voluntary medical male circumcision as a form of HIV prevention in high HIV prevalence areas in the Dominican Republic.

详细描述

Voluntary Medical Male circumcision (VMMC) is an effective strategy to reduce the risk of HIV acquisition in heterosexual men. Observational data and randomized controlled trails (RCTs) conducted in Africa(1,2,3) suggest that the procedure reduces the risk of HIV acquisition by 50-76% in heterosexual males. VMMC has also been shown to reduce the incidence of other sexually transmitted infections (STI), including herpes simplex virus type 2 (HSV-2) and human papilloma virus (HPV) in men(4), and Chlamydia(5), trichomonas vaginalis (TV), bacterial vaginosis (BV) and HPV in their female partners(6).

The results of the RCT's are generating increased demand for safe and affordable MC services in areas of moderate-to-high HIV prevalence where the MC rates are low. Latin America is a region where circumcision of males is uncommon(7). In the Dominican Republic (DR), which is the focus of this study, a 2007 nationwide household survey found that only 13.7% of men between the ages of 15-59 were circumcised(8).

AIDS is the leading cause of death in the Caribbean basin among adults aged 15-44 years. There are approximately 240,000 people currently living with the disease, most of them residing in the Dominican Republic (DR) and Haiti(9). The prevalence of HIV infection in the DR is approximately 0.8% nationwide(8) but it is higher in selected high-risk populations, such as among people living in the "bateyes", the small towns surrounding sugar cane plantations, where the prevalence is 3.2%(10). In pregnant women seeking prenatal care at the main hospital in the Altagracia province HIV seroprevalence is 4.5 %(11). One of the areas of highest prevalence (1.2%) in the country is Region V of health, which includes the provinces of La Altagracia, El Seibo, Hato Mayor, La Romana and San Pedro de Macorís. Prevalence is also higher in the urban slums of the capital city, Santo Domingo.

The public health impact of introducing MC as a strategy to prevent HIV/STI transmission in areas of high HIV/STI prevalence and low MC rates can be significant. In addition to decreasing the rates of HIV and other STI, the intervention could indirectly help decrease the rates of HPV associated cervical cancer. The study proposed here is to develop, implement, monitor and evaluate pilot MC services in selected sites to assess the acceptability, uptake, safety and demand for these services, and to use these data to develop, in collaboration with the Dominican Ministry of Health (MoH), a proposal to the National Institute of Mental Health (NIMH) for support of operations research concerning the safety, uptake, and efficacy of MC interventions in the DR.

  1. Specific Aims:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Uncircumcised men;
  • Aged 18-40 years

排除标准

  • Foreskin covering less than half of the glans;
  • Bleeding disorders;
  • Keloid formation;
  • Other conditions that might unduly increase the risks of elective surgery.

结局指标

主要结局

Number and percentage of participants who agreed to undergo circumcision after being offered.

时间窗: 13 months

次要结局

  • Number and percentage of individuals who had ≥ 2 sex partners over the last 30 days(23 months)
  • Number and percentage of individuals who experienced problems with penis and foreskin prior to circumcision(23 months)
  • Number and percentage of individuals who use illicit drugs(23 months)
  • Number and percentage of adverse events by severity (mild, moderate, severe)(23 months)
  • Number and percentage of men who have sex with men(23 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximo Brito

Associate Professor of Medicine & Vice Chair for Urban Global Health

University of Illinois at Chicago

研究点 (3)

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