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

描述(申请人提供)：马哈拉施特拉邦是印度各州中艾滋病毒流行率最高的州。那格浦尔是马哈拉施特拉邦北部的一个工业中心，以其红灯区而闻名，最近经历了艾滋病毒病例的复苏，但对它的研究仍然不足。印度缺乏降低性工作者(女性性工作者)性行为风险的干预措施，这些干预措施需要简短，以节省成本并吸引性工作者。这项建议将调整一种经过验证的、基于理论的行为干预措施，促进避孕套的使用，以适应那格浦尔暗娼的文化和需求。我们的具体目标是：1)进行形成性研究，以使现有的、有效的性风险降低干预措施适应印度那格浦尔暗娼的需求；2)通过在那格浦尔暗娼中进行的试点研究，确定目标1所产生的基于理论的单次行为干预是否可以为暗娼接受，并在6个月的随访中收集数据，以估计效果大小，以便随后的疗效试验；3)确定社会认知理论、理性行为理论(例如，自我效能、意图)和动机访谈技术在理论上的重要组成部分是否可以预测FSWs高危性行为的变化；以及4)探索可能与干预的不同反应相关的个人、背景和心理社会因素。为了实现目标1，我们将修改并在文化上调整我们现有的、经过验证的针对HIV阴性墨西哥FSWs的FSW干预措施。这一形成研究阶段将持续一年，将包括对印度性服务工作者不同分组的深入、不限成员名额的定性访谈；与性服务工作者的咨询会议；评估相关性、吸引力、性别和文化敏感性、陈述风格和性服务工作者执行干预材料的意愿的所有措施的试点。在细化干预之后，为了解决目标2，我们将对100名FSWs(50名HIV阳性和50名HIV阴性)进行试点测试，他们将被随机分配到基于理论的60分钟干预，重点是改善安全性行为的动机、避孕套的使用和安全性行为的谈判，或者是时间相等的教导性安全性行为计划。我们将从那格浦尔招募100名FSWs的多样化样本，他们在上个月至少与一名客户发生了无保护措施的性行为。两组都将在基线和六个月的随访时接受面谈和艾滋病毒/性传播感染检测。我们假设，干预部门将报告不安全性行为次数的减少，并将在理论上重要的变化指标(例如，谈判安全性行为的自我效能)方面有所改善。虽然这项初步研究没有足够的能力来检测性传播感染的变化，但我们将收集有关基线和事件性传播感染的数据，以努力在更大的干预试验中设计和评估有效性。制定一项简短、实用和具有文化相关性的干预措施，以减少印度中部妇女中的艾滋病毒风险，对于遏制该国迅速蔓延的艾滋病毒流行病至关重要，并可能适用于其他资源贫乏的国家。 公共卫生相关性：由于各种社会和经济原因，从事高风险性行为的人群中艾滋病毒和其他性传播疾病的发病率不断上升，许多国家普通民众的健康安全受到威胁。该项目旨在使在美国(甲基苯丙胺使用者)和墨西哥(女性性工作者)某些高危群体中成功减少危险行为的咨询计划适应印度那格浦尔市女性性工作者的需求和情况，印度那格浦尔是一个艾滋病毒感染率很高的群体。如果这种适应被证明是成功的，它可能会对减缓或阻止艾滋病毒感染在这一群体和普通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.