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，那里的艾滋病病例再次出现，但仍未得到充分研究。印度缺乏降低FSWs（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FSWs。这项建议将采用一种经过验证的、基于理论的行为干预措施，促进安全套的使用，以适应那格浦尔的性服务场所的文化和需求。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的女服务员的需求；2)通过一项在那格浦尔的FSWs中进行的试点研究，确定Aim 1中基于理论的单次行为干预是否被FSWs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、理性行为理论（如自我效能感、意图）和动机性访谈技术在理论上的重要组成部分是否能预测女服务员高危性行为的变化；4)探索可能与干预反应差异相关的个人、环境和社会心理因素。为了实现目标1，我们将修改和适应我们现有的、经过验证的针对艾滋病毒阴性墨西哥FSW的FSW干预措施。这个形成性的研究阶段将持续一年，将包括与印度fswws的各个小组进行深入、开放式、定性的访谈；与社工举行辅导课程；试行所有措施，以评估有关资料的相关性、吸引力、性别及文化敏感度、展示方式及社会福利机构推行干预资料的意愿。在完善干预措施后，为了实现目标2，我们将在100名女服务员（50名艾滋病毒阳性和50名艾滋病毒阴性）中对我们的干预方案进行试点测试，他们将被随机分配到一个以理论为基础的、60分钟的干预中，该干预侧重于改善安全性行为的动机、使用安全套和协商安全性行为，或者是一个与时间相当的说教性安全性行为计划。我们将从那格浦尔招募100名不同类型的女服务员，他们在前一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期间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，并在理论上重要的变化指标（例如，协商安全性行为的自我效能）方面有所改善。虽然这项试点研究没有足够的能力来检测性传播感染的变化，但我们将收集基线性传播感染和事件性传播感染的数据，以便在更大的干预试验中设计和评估效果。制定一项简短、实用和与文化相关的干预措施，以减少印度中部地区外来劳务人员的艾滋病毒风险，这对于遏制该国迅速蔓延的艾滋病毒流行病至关重要，也可能适用于其他资源贫乏的国家。

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.