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An Intervention for Male STD Patients in India

针对印度男性性病患者的干预措施

基本信息

批准号：
7085430
负责人：
CHRISTINA P LINDAN
金额：
$ 40.97万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-08-15 至 2008-06-30
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): We request 3 years of funding to complete an ongoing randomized trial of a behavioral intervention compared to STI treatment/HIV testing and counseling alone, among male STI patients in Mumbai, India. Trial outcomes include HIV/STI incidence and self-reported risk behavior. The cumulative prevalence of HIV among men screened to date is 14%. We have recruited over half the total 1800 HIV negative men required for randomization, and have an excellent research infrastructure on site including data management, laboratory, and trained staff. Preliminary data indicate the primary risk factor for HIV is exposure to female sex workers (FSW) and HSV2 infection; preliminary analysis of trial results reveal a strong effect in both arms over time, and a difference in self-reported risk behavior between the two arms. We found a strong association of alcohol use during sex with FSW and increased HIV risk, HSV2, syphilis, and number of episodes of unprotected sex. In addition, many men have sex with both women and other high-risk men. To address this, we propose to expand our evaluation of MSM and the role of alcohol in risky sex among men being enrolled the study. Data from the trial will supplement information obtained from the large community based STI trials in Africa, which have shown differing results. It is possible that specific STI diagnosis and treatment including HSV2, if accompanied by HIV testing and quality counseling, is an affordable and effective prevention strategy in our setting. Overall goals of the study are to develop and evaluate a feasible, culturally appropriate intervention to reduce HIV transmission in India. To be widely effective, prevention programs in south Asia should be instituted within the public health system. For this reason, we implemented this trial within the public health structure, despite the inherent difficulties of this approach. The study has already succeeded in changing public health STI treatment guidelines. Additional time and funding are required due to a short initial 4-year funding period, time required to perform such a trial in India, and slower than anticipated recruitment of subjects due to demographic shifts in the high risk population. To address these issues, we propose to add an additional recruitment site and evening follow-up clinics to enhance enrollment and retention.

描述(由申请人提供)：我们要求3年的资金，以完成一项正在进行的随机试验，该试验在印度孟买的男性STI患者中进行行为干预，并与单纯的STI治疗/艾滋病毒检测和咨询进行比较。试验结果包括艾滋病毒/性传播感染发生率和自我报告的危险行为。到目前为止，在接受筛查的男性中，艾滋病毒的累计流行率为14%。我们已经招募了随机抽样所需的1800名艾滋病毒阴性男子中的一半以上，并在现场拥有出色的研究基础设施，包括数据管理、实验室和训练有素的工作人员。初步数据表明，艾滋病毒的主要风险因素是接触女性性工作者(FSW)和感染HSV2；对试验结果的初步分析显示，随着时间的推移，这两个方面都有很强的影响，而且两个方面在自我报告的危险行为方面存在差异。我们发现在性行为中饮酒与FSW和增加HIV风险、HSV2、梅毒和无保护措施性行为的次数有很强的关联。此外，许多男性既与女性发生性关系，也与其他高危男性发生性关系。为了解决这一问题，我们建议扩大我们对MSM的评估，并在参加这项研究的男性中扩大酒精在危险性行为中的作用。这项试验的数据将补充从非洲大型社区STI试验中获得的信息，这些试验显示了不同的结果。在我们的环境下，如果伴随艾滋病毒检测和质量咨询，包括HSV2在内的特定STI诊断和治疗可能是一种负担得起的有效预防策略。这项研究的总体目标是开发和评估一种可行的、文化上适当的干预措施，以减少印度的艾滋病毒传播。为了广泛有效，南亚的预防方案应该在公共卫生系统内建立起来。出于这个原因，我们在公共卫生结构内实施了这项试验，尽管这种方法存在固有的困难。这项研究已经成功地改变了公共卫生性传播感染治疗指南。需要额外的时间和资金，因为最初的4年资助期很短，在印度进行这样的试验需要时间，而且由于高危人群的人口结构变化，招募受试者的速度比预期的要慢。为了解决这些问题，我们建议增加一个招聘地点和晚间跟进诊所，以加强登记和保留。