HIV RISK AMONG WOMEN IN PUERTO RICO

波多黎各女性的艾滋病毒风险

• 批准号: 7380875
• 负责人: Lisa R Norman
• 金额: $ 5.63万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380875
• 关键词: HIV; RISK; AMONG; WOMEN; PUERTO

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The principal goal of this proposal is to conduct a cross-sectional research study for the purposes of characterizing different risk factors associated with HIV infection acquisition and transmission among impoverished women in Puerto Rico. The purpose of the proposed research is to advance the understanding the HIV epidemic in Puerto Rican women. The general hypothesis behind the proposed research is that risk of HIV acquisition and transmission for women is influenced by various individual and social factors and in order to decrease HIV risk, these factors must be identified and measured. Based on previous research findings, the focus on this research proposal is to measure individual and social factors that are hypothesized to contribute to increase risk. The specific aims are designed to provide a comprehensive assessment of these factors. 1. Identify epidemiologic, socio-cultural, psychological, and behavioral factors associated with increased HIV risk for women living in public housing developments (PHDs) in Ponce, PR. 2. Determine the need and feasibility of an HIV prevention intervention targeting women living in PHDs in Ponce, PR. The proposed research will advance the understanding and knowledge of the risk factors associated with HIV infection among impoverished women in Puerto Rico. In addition, it will access the need and feasibility of an HIV prevention intervention targeting women living in public housing developments (PHDs). Specifically, this study will target women living in public housing developments Ponce using a multi-stage random design. Both focus groups and face-to-face interviewing will be used to collect data. This study is of public health importance in that it identify the factors that are contributing to the increased risk of HIV to women in Puerto Rico and inform the development of a large-scale, HIV prevention intervention project targeting this population. Studies and Activities 1. Conducting focus groups with women living in PHD, exploring issues related to HIV knowledge and risks. 2. Validation of formative baseline instrument. 3. Recruiting women to be part of the project; visiting multiple PHD and meeting with administration and residents Ethical Review This project was submitted to the PSM Institutional Review Boards (IRB) and approved on March 23, 2006 Informed Consent Participants will be required to sign an informed consent approved by the IRB. They will be explained of the nature of the research study, how many participants, the risks and benefits of participation. They will be informed that they can withdraw their participation at anytime during the study period and that their services will not be interrupted. For participants under the legal age of consent, assent will be received from the participant and informed consent from the parent/guardian. Compensation Provided IRB approval is obtained, the participants will be compensated for their time and effort in this study. As described in the protocol and the informed consent participants will receive the amount of $20.00 for completion of the interview. This is a nominal amount and is not considered coercive for our standards. Furthermore, it is the amount that has been used in other Puerto Rican HIV-related research targeting women where interview data were collected. Inclusion/Exclusion Inclusion Criteria 1. Able and willing to consent 2. 15 years or older 3. Female resident of public housing in the city of Ponce 4. Sexually experienced (ever having oral, anal and/or vaginal intercourse) Exclusion Criteria 1. Unable or unwilling to consent 2. Not complying with the inclusion criteria definition for the cohort Confidentiality All study-related information will be stored securely at the study site. All participant information will be stored in locked file cabinets with limited access. All local databases will be secured. Forms, lists, logbooks, appointment books, and any other listings that link participant ID numbers to other identifying information will be stored in a separate, locked file in an area with only PI access. Participants' study information will not be released outside of the study without the written permission of the participant, except as required by communicable disease reporting regulations. Benefits There might be no benefit to participants in this study. Participants who are referred to service providers will receive those services. However, the study may provide information that could benefit participants and others in the future. Study staff will refer participants to other organizations for services, such as drug treatment and domestic violence. Importance The primary specific aims of this project will provide the first behavioral data for Puerto Rican women at risk of acquiring or transmitting HIV in Ponce. These data can be used to inform HIV prevention efforts targeting this population. Usage and Disclosure of Information ¿ Data Safety Each participant will be requested to read and sign the study informed consent form, which will have been approved by the FDA registered Ponce School of Medicine Institutional Review Board (FWA 00000345). Data will be collected only under assigned coded identification numbers and will be stored in the system server of the AIDS Research Program, which is separated from institutional computer network. No data will include a personal identifier. Data access will be granted only under the PI¿s password, which will not be shared with any other individuals except those who are specifically and explicitly authorized by the PI. In accordance with the HIPAA regulation, however, a participant may request disclosure of data related to his/her participation through a written request. In such a case, participant will be requested to provide his/her assigned coded ID. We will be in full conformity to HIPAA regulations. Inclusion of Women Women are the sole cohort of the proposed study and constitute a significant proportion of those affected by the HIV/AIDS epidemic. Inclusion of Minorities: Since 98.8% of Puerto Ricans self-identify as Hispanic or Latino, the sample can be classified as ¿Minority.¿ With respect to race, according to the US Census 2000, 80.5% of the Puerto Rican population self-identify as ¿White¿. However, a large majority of the population represents various degrees of racial mixing. As such, they will be classified in this study as ¿More than One Race¿ without further breakdown. Inclusion of Children: The study will focus on sexually active adolescent and adult women, who are at least 15 years of age. According to UNAIDS, young people, ages 15 to 24 years, account for nearly half of all new infections worldwide. In the Caribbean, young women, ages 15 to 24 years, are almost twice as likely to be infected than are young men of the same age. Surveillance data from the Centers for Disease Control and Prevention revealed that of the estimated number of HIV/AIDS cases in 2003, 12% were among persons, ages 15 to 24 years, and another 27% were among persons, ages 25 to 34 years. Data on clinic patients in Puerto Rico indicated that from 1999 to 2002, 31% of diagnoses were made to persons, ages 25 to 34. Considering the incubation period of HIV, a number of these persons were infected during their adolescent years. Furthermore, the number of reported AIDS cases among adolescents, ages 13 to 19 years, has increased every year since 1998 and the proportion of cases among females has also increased. Also, considering 40% of young women surveyed in the PHD during the preliminary research had initiated sex before the age of 15 years, it is important to include minor women (those under the age of 21 years) in the proposed research. Results: The project is still early in the implementation phase. No data is available.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项建议的主要目标是进行一项横断面研究，以确定与波多黎各贫困妇女感染和传播艾滋病毒有关的不同风险因素。拟议研究的目的是促进对波多黎各妇女中艾滋病毒流行的了解。拟议研究背后的一般假设是，妇女感染和传播艾滋病毒的风险受到各种个人和社会因素的影响，为了降低艾滋病毒风险，必须确定和衡量这些因素。基于以往的研究成果，本研究计划的重点是测量假设有助于增加风险的个人和社会因素。具体目标旨在对这些因素进行全面评估。1. 确定流行病学、社会文化、心理和行为因素与生活在公共住房开发项目中的妇女（博士）艾滋病毒风险增加有关。确定一项针对波多黎各Ponce的妇女的艾滋病预防干预的必要性和可行性。拟议的研究将促进对波多黎各贫困妇女中与艾滋病感染相关的危险因素的理解和认识。此外，它还将了解针对居住在公共住房开发项目中的妇女（博士）的艾滋病毒预防干预的必要性和可行性。具体而言，本研究将采用多阶段随机设计，针对居住在庞塞公共住房开发项目中的女性。收集数据将采用焦点小组和面对面访谈两种方式。这项研究对公共卫生具有重要意义，因为它确定了导致波多黎各妇女感染艾滋病毒风险增加的因素，并为制定针对这一人口的大规模艾滋病毒预防干预项目提供了信息。学习与活动与在读博士的女性进行焦点小组讨论，探讨与艾滋病毒相关的知识和风险问题。2. 形成基线仪器的验证。3. 招募女性参与项目；伦理审查本项目已提交给PSM机构审查委员会（IRB），并于2006年3月23日批准知情同意参与者将被要求签署经IRB批准的知情同意书。他们将被解释研究的性质，有多少参与者，参与的风险和好处。他们将被告知，他们可以在研究期间的任何时候退出，他们的服务不会中断。对于未达到法定同意年龄的参与者，将获得参与者的同意和父母/监护人的知情同意。在获得IRB批准后，参与者在本次研究中所付出的时间和精力将得到补偿。如协议和知情同意书所述，完成访谈的参与者将获得20.00美元的报酬。这是一个名义上的数额，在我们的标准中不被认为是强制性的。此外，在波多黎各针对妇女的其他与艾滋病毒有关的研究中也使用了这一数额，这些研究收集了访谈数据。纳入/排除纳入标准能够并愿意同意。15岁及以上庞塞市公共住房的女性居民。性经验（曾经有过口交、肛交和/或阴道性交）不同意的：不能或不愿意同意的不符合队列纳入标准定义保密所有与研究相关的信息将安全存储在研究现场。所有参与者的信息将被保存在上锁的文件柜中，并限制访问。所有本地数据库都将得到保护。表单、列表、日志、约会簿以及任何其他将参与者ID号码与其他标识信息链接起来的列表将存储在一个单独的锁定文件中，该文件位于一个只有PI访问的区域。除传染病报告法规要求外，未经参与者书面许可，参与者的研究信息不得在研究之外发布。这项研究可能对参与者没有任何好处。被介绍给服务提供者的参与者将获得这些服务。然而，这项研究可能会在未来为参与者和其他人提供有益的信息。研究人员将把参与者转介到其他组织接受服务，如药物治疗和家庭暴力。该项目的主要具体目标是为在庞塞有感染或传播艾滋病毒风险的波多黎各妇女提供第一批行为数据。这些数据可用于为针对这一人群的艾滋病毒预防工作提供信息。每位参与者将被要求阅读并签署研究知情同意书，该同意书已获得FDA注册的庞塞医学院机构审查委员会（FWA 00000345）的批准。数据将根据指定的编码识别号码收集，并将存储在艾滋病研究计划的系统服务器中，该服务器与机构计算机网络分开。任何数据都不会包含个人标识符。只有在PI的密码下才能访问数据，该密码不会与任何其他个人共享，除非PI明确授权。然而，根据HIPAA规定，参与者可以通过书面请求要求披露与他/她的参与有关的数据。在这种情况下，参赛者将被要求提供他/她分配的编码ID。我们将完全遵守HIPAA的规定。妇女是拟议研究的唯一对象，在受艾滋病毒/艾滋病影响的人群中占很大比例。少数民族的纳入：由于98.8%的波多黎各人自认为是西班牙裔或拉丁裔，该样本可以被归类为少数民族。在种族方面，根据2000年美国人口普查，80.5%的波多黎各人自认为是“白人”。然而，绝大多数人口代表着不同程度的种族混合。因此，他们将在本研究中被归类为“不止一个种族”，而不会进一步细分。纳入儿童：研究将集中在性活跃的青少年和成年妇女，谁是至少15岁。根据联合国艾滋病规划署的数据，15至24岁的年轻人占全世界新感染人数的近一半。在加勒比，15至24岁的年轻妇女受感染的可能性几乎是同龄青年男子的两倍。疾病控制和预防中心的监测数据显示，在2003年估计的艾滋病毒/艾滋病病例中，12%是15至24岁的人，另外27%是25至34岁的人。波多黎各门诊病人的数据表明，从1999年到2002年，31%的诊断是对25岁至34岁的人进行的。考虑到艾滋病毒的潜伏期，其中一些人是在青少年时期感染的。此外，自1998年以来，13至19岁青少年中报告的艾滋病病例每年都在增加，女性病例的比例也有所增加。此外，考虑到在初步研究中接受博士调查的年轻女性中有40%在15岁之前就开始了性行为，在拟议的研究中包括未成年女性（21岁以下）是很重要的。结果：项目仍处于早期实施阶段。无数据。