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.
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