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临床试验/NCT02511548
NCT02511548Unknown3 期

Increasing Medical Male Circumcision Uptake in Orange Farm (South Africa): An Operational Study of Demand Creation

Progressus0 个研究点目标入组 140 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
140
主要终点
Male circumcision uptake

研究概览

简要总结

The main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa).

详细描述

The World Health Organization and the United Nations Programme on HIV/AIDS recommend voluntary adult medical male circumcision as an intervention against HIV in Africa since 2007 and has estimated that achieving 80% male circumcision coverage would have a major public health impact. Despite evidence of its effectiveness, feasibility, cost-effectiveness and acceptability, its roll-out in Eastern and Southern Africa, the region where HIV prevalence is highest in the world, remains slow. Developing and testing innovative strategies to accelerate voluntary adult medical male circumcision roll-out is thus necessary. As a target community of this prevention method, Orange Farm (Gauteng Province) is a prime setting to conduct operational research. The team presenting this project conducted the first voluntary adult medical male circumcision randomized trial (ANRS-1265), successfully led the ANRS-12126 voluntary adult medical male circumcision roll-out, and has just completed the ANRS-12285 study on voluntary adult medical male circumcision and HIV incidence. Due to the roll-out, male circumcision prevalence increased from 12% in 2008 to 53% in 2011 in the township, but to date this prevalence has remained stagnant.

The main objective of this study is to reach 80% circumcised men in randomized clusters of Orange Farm (Gauteng Province), a township where voluntary adult medical male circumcision roll-out is ongoing since 2007.

Existing communication strategies will be revised and supplemented by personalised individual discussions to increase motivation for voluntary adult medical male circumcision and translate it into actual uptake.

The project consists of: 1) A preparatory phase to establish collaborations and prepare the communication activities, 2) a survey phase during which a) a mass communication campaign will be launched and b) 300 uncircumcised men selected from randomized clusters of Orange Farm will be recruited and undergo a baseline assessment including voluntary adult medical male circumcision general counselling, and 3) a follow-up phase during which repeated motivational interviews will be conducted to address their individual reasons for not being circumcised. Financial incentive will also be tested in a randomized trial.

Willing men will be referred to the free local voluntary adult medical male circumcision clinic and asked to attend an interview on the reasons that motivated them to become circumcised. At the end of the study, male circumcision prevalence among participants will be calculated. Factors associated with voluntary adult medical male circumcision uptake will be studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Uncircumcised men
  • Willing to participate
  • Living in Orange Farm
  • Able to speak and read English, Sotho or Zulu

排除标准

  • Unable to give informed consent
  • Planning to leave the study area within the next year

结局指标

主要结局

Male circumcision uptake

时间窗: 3 weeks

The proportion of participants who will accept to become circumcised during the course of the study in each arm.

次要结局

未报告次要终点

研究者

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

bertran Auvert

Scientific Investigator

Progressus

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