Prevenitng HIV/STIs in Central Indian High Risk Women: A Pilot Intervention

描述（由申请人提供）：马哈拉施特拉邦是印度各邦中艾滋病毒感染率最高的。纳格布尔是北方马哈拉施特拉邦的一个工业中心，以其红灯区而闻名，最近艾滋病毒病例有所回升，但仍未得到充分研究。印度缺乏减少FSW（女性性工作者）性风险的干预措施，这些干预措施需要简短，以节省成本并吸引FSW。该提案将采用一种经过验证的、以理论为基础的行为干预措施，促进安全套的使用，以适应纳格布尔的女性性工作者的文化和需求。我们的具体目标是：1）进行形成性研究，以使现有的有效的降低性风险干预措施适应印度纳格布尔的FSW的需求; 2）通过在纳格布尔的FSW中进行试点研究，确定目标1所产生的基于理论的单次行为干预措施是否为FSW所接受，并在6个月的随访中收集数据，以估计后续疗效试验的效应量; 3）确定社会认知理论和理性行动理论的理论重要组成部分（例如，自我效能，意图）和动机访谈技术预测的变化，女性性工作者的高风险的性行为;和4）探索个人，背景，和心理社会因素，可能与不同的反应干预。为了实现目标1，我们将修改和文化适应我们现有的，证明FSW干预设计的艾滋病毒阴性的墨西哥FSW。这一形成性研究阶段将持续一年，将包括对印度性工作者各分组进行深入、开放式、定性访谈;与性工作者举行咨询会议;试行所有措施，以评估相关性、吸引力、性别和文化敏感性、陈述风格以及性工作者实施干预材料的意愿。在完善干预措施后，为了实现目标2，我们将对100名FSW（50名HIV阳性和50名HIV阴性）进行干预方案的试点测试，这些FSW将被随机分配到基于理论的60分钟干预，重点是提高安全性行为的动机，使用避孕套和协商安全性行为，或时间等效的教导性安全性行为计划。我们将从纳格布尔招募100名不同的FSW样本，这些FSW在上个月至少与一名客户发生过无保护措施的性行为。两组都将在基线和六个月随访时接受面谈和艾滋病毒/性传播感染检测。我们假设，干预组将报告减少不安全性行为的发生，并将改善理论上重要的变化指标（例如，安全性行为谈判的自我效能）。虽然这项试点研究将没有足够的力量来检测性传播感染的变化，我们将收集基线和事件性传播感染的数据，努力设计和评估在一个更大的干预试验的疗效。制定一项简短、实用和文化相关的干预措施，以减少印度中部FSW中的艾滋病毒风险，对于遏制该国艾滋病毒流行的迅速蔓延至关重要，并可能适用于其他资源贫乏的国家。 公共卫生相关性：在许多国家，由于各种社会和经济原因，从事高风险性行为的亚人群中艾滋病毒和其他性传播感染的发病率不断上升，威胁到普通民众的健康安全。该项目旨在调整一项咨询方案，使其适应印度纳格布尔女性性工作者的需要和情况，该方案已成功地减少了美国（甲基苯丙胺使用者）和墨西哥（女性性工作者）某些高危群体的危险行为，该群体已证明艾滋病毒感染率很高。如果适应证明是成功的，它可能会对减缓或阻止艾滋病毒感染在这一群体和一般人群中的传播产生重大影响。

DESCRIPTION (provided by applicant): Maharashtra has the highest HIV prevalence among the Indian states. Nagpur, an industrial hub in northern Maharashtra known for its red light district, has recently experienced a resurgence in HIV cases, yet it remains understudied. Interventions to reduce sexual risks among FSWs (female sex workers) are lacking in India, and they need to be brief to save costs and engage FSWs. This proposal will adapt a proven, theory- based behavioral intervention that promotes condom use to the culture and needs of FSWs in Nagpur. Our specific aims are: 1) to conduct formative research to adapt an existing, efficacious sexual risk reduction intervention to the needs of FSWs in Nagpur, India; 2) to determine, by means of a pilot study among FSWs in Nagpur, if the theory-based, single-session behavioral intervention resulting from Aim 1 is acceptable to FSWs, and to collect data at six-month follow-up to estimate effect sizes for a subsequent efficacy trial; 3) to determine if theoretically important components of social cognitive theory and the theory of reasoned action (e.g., self-efficacy, intentions) and motivational interviewing techniques predict changes in FSWs' high-risk sexual practices; and 4) to explore personal, contextual, and psychosocial factors that are potentially associated with differential response to the intervention. To address Aim 1, we will modify and culturally adapt our existing, proven FSW intervention designed for HIV-negative Mexican FSWs. This formative research phase will last one year and will consist of in-depth, open-ended, qualitative interviews with various subgroups of Indian FSWs; counseling sessions with FSWs; piloting of all measures to assess relevance, appeal, gender and cultural sensitivity, presentation style and FSWs' willingness to implement intervention materials. After refining the intervention, to address Aim 2 we will pilot test our intervention protocol with 100 FSWs (50 HIV- positive and 50 HIV-negative) who will be randomly assigned either to a theory-based, 60-minute intervention that focuses on improving motivations for safer sex, use of condoms, and negotiation of safer sex, or to a time- equivalent didactic safer sex program. We will recruit a diverse sample of 100 FSWs from Nagpur who have had unprotected sex with at least one client during the previous month. Both groups will undergo interviews and HIV/STI testing at baseline and six-month follow-up. We hypothesize that the intervention arm will report reduced episodes of unsafe sex and will improve with respect to theoretically-important indicators of change (e.g., self efficacy for negotiating safer sex). While this pilot study will not have adequate power to detect changes in STIs, we will gather data on baseline and incident STIs in an effort to design and evaluate efficacy in a larger intervention trial. The development of a brief, practical and culturally relevant intervention to reduce HIV risks among FSWs in central India is critical to stem the burgeoning HIV epidemic in that country, and may have applicability to other resource-poor countries. PUBLIC HEALTH RELEVANCE: The health security of the general population in many countries is threatened by the growing incidence of HIV and other sexually transmitted infections among subpopulations that, for various social and economic reasons, engage in high-risk sexual behavior. This project seeks to adapt a counseling program that has been successful in reducing the risk behavior of certain high-risk groups in the U.S. (methamphetamine users) and Mexico (female sex workers) to the needs and circumstances of female sex workers in Nagpur, India, a group that has demonstrated high prevalence of HIV infection. If the adaptation proves successful, it could have significant impact on slowing or stopping the spread of HIV infection in this group and in the general population.