An Intervention for Male STD Patients in India

针对印度男性性病患者的干预措施

• 批准号: 6841547
• 负责人: CHRISTINA P LINDAN
• 金额: $ 58.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-15 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6841547
• 关键词: AIDS /HIV test; AIDS education /prevention; HIV infections; India; alcoholic beverage consumption; behavior therapy; behavioral /social science research tag; bisexual; clinical research; clinical trials; combination therapy; condoms; counseling; culture; high risk behavior /lifestyle; human subject; human therapy evaluation; male; microorganism disease chemotherapy; patient oriented research; public health; questionnaires; sex behavior; sexually transmitted diseases; substance abuse related behavior

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，在印度孟买的男性STI患者中，将行为干预与STI治疗/HIV检测和咨询进行比较。 试验结果包括HIV/STI发病率和自我报告的风险行为。 迄今为止，接受筛查的男子中艾滋病毒的累积流行率为14%。 我们已经招募了随机化所需的1800名HIV阴性男性中的一半以上，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暴露于女性性工作者（FSW）和HSV 2感染;试验结果的初步分析显示，随着时间的推移，两组都有很强的影响，两组之间自我报告的风险行为存在差异。 我们发现酒精使用与FSW性行为和增加HIV风险，HSV 2，梅毒和无保护性行为次数有很强的关联。 此外，许多男性同时与女性和其他高危男性发生性关系。 为了解决这个问题，我们建议扩大我们的评估男男性接触者和酒精的作用，在男性之间的危险性行为正在登记的研究。 该试验的数据将补充从非洲大型社区性传播感染试验中获得的信息，这些试验显示了不同的结果。在我们的环境中，包括HSV 2在内的特定性传播感染诊断和治疗，如果伴随着艾滋病毒检测和高质量的咨询，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制定和评估一种可行的、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，南亚的预防方案应在公共卫生系统内建立。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病治疗指南。 由于最初4年的资助期较短，在印度进行此类试验所需的时间，以及由于高风险人群的人口统计学变化而导致的受试者招募速度慢于预期，因此需要额外的时间和资金。 为解决这些问题，我们建议增设一个招募网站和夜间跟进诊所，以增加招募人数和留住人才。