A randomized controlled pilot study to examine the impact of a filmed dramatized story intervention (telenovela/soap opera) for HIV prevention in Latinas

一项随机对照试点研究，旨在检验电影化故事干预（电视剧/肥皂剧）对拉丁裔艾滋病毒预防的影响

• 批准号: 10673607
• 负责人: Natalia Andrea Villegas Rodriguez
• 金额: $ 33.97万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10673607
• 关键词: AIDS prevention; Access to Information; Acquired Immunodeficiency Syndrome; Acute; Address; Affect; Age; Attention; Awareness; Behavior; Belief; Biological; COVID-19; Cellular Phone; Central America; Clinical Trials; Communication; Communities; Comprehension; Data Collection; Devices; Disparity; Effectiveness of Interventions; Emotional; Emotions; Ensure; Environment; Female of child bearing age; Film; Funding; Future; Goals; Grant; HIV; HIV Infections; Health; Healthcare Systems; Hispanic; Human immunodeficiency virus test; Individual; Infection; Infrastructure; Institutional Review Boards; Intervention; Knowledge; Latina Population; Location; Love; Mediating; Mental Depression; Mexico; National Institute of Drug Abuse; National Institute on Minority Health and Health Disparities; Neighborhoods; Newly Diagnosed; Outcome; Participant; Perception; Pilot Projects; Preparation; Prevention; Preventive; Procedures; Protocols documentation; Randomized; Reporting; Research; Risk; Risk Reduction; Self Efficacy; Soaps; Stigmatization; Substance abuse problem; Technology; Testing; Time; Training; United States; Woman; Women' s Group; Work; acceptability and feasibility; age group; behavior change; behavior influence; built environment; condoms; cost; data management; disparity reduction; efficacy study; efficacy trial; feasibility testing; follow-up; improved; innovation; intervention delivery; intimate partner violence; multidisciplinary; novel; online delivery; online intervention; pilot test; pre-exposure prophylaxis; prevent; programs; public health relevance; randomized, clinical trials; recruit; reduced substance abuse; response; retention rate; role model; social cognitive theory; social culture; theories; trial planning; usability; web site

PROJECT SUMMARY/ABSTRACT Latinas continue to be affected disproportionally by HIV in the United States (US). Often, Latinas are not aware of their HIV status. Also, their perception of low risk for HIV interferes with condom use, HIV testing and lack of awareness, access, and use of Pre-exposure Prophylaxis [PrEP]. About 60% of total HIV cases in NC occur among women of childbearing age, thus vulnerability to HIV is particularly acute among Latinas between ages 18 and 44 years old, an age group with the highest rate of new HIV infections in NC. These disparities indicate that HIV prevention among Latinas is urgent; therefore, we propose an innovative intervention – a filmed dramatized story (telenovela/soap opera) Infección de Amor (Love Infection) – culturally tailored for Latinas in the US and delivered online. Infección de Amor was filmed and developed but has not been tested with our target audience. The proposed study will pilot test IA and move the intervention to online using a website that will allow individual access around the clock from any location and device, such as a smartphone, ensuring wide dissemination of the intervention in the future. We propose a two-year planning grant (R34) to prepare for an R01 efficacy trial. Our aims are to: 1) Develop the intervention delivery website, conduct a website usability test, and test the feasibility and acceptability of the IA intervention (four telenovela episodes) with 10 Latinas, 2) Conduct a randomized controlled pilot study to examine change in HIV prevention behaviors (condom use; HIV testing; and PrEP awareness, access, and use) comparing 71 intervention and 71 control Latinas from baseline (Time 1 [T1], 0 months) to post-active intervention (Time 2 [T2], 1 month), and to six months follow-up, a period with no contact from the study staff (Time 3 [T3, 7 months]), and 3) Complete establishing the study infrastructure, expanding our multidisciplinary team, building our research partnerships with the community, finalize the protocol and training materials, refine recruitment and retention strategies, data collection and data management procedures, and obtain institutional review board approval in preparation for an R01 efficacy study. We address the National Institute on Drug Abuse (NIDA) goal #4: increase NIDA research and programs’ public impact. We aim to use a novel intervention to advance HIV prevention for Latinas. We will implement a culturally durable and feasible intervention for Latinas.

项目概要/摘要 在美国，拉丁裔继续受到艾滋病毒的影响，但通常情况下，拉丁裔并没有受到艾滋病毒的影响。 此外，他们认为自己感染艾滋病毒的风险较低，这会影响安全套的使用、艾滋病毒检测和治疗。 北卡罗来纳州约 60% 的艾滋病毒病例缺乏对暴露前预防 [PrEP] 的认识、获取和使用。 发生在育龄妇女中，因此拉丁裔人群感染艾滋病毒的可能性特别严重 18 岁和 44 岁是北卡罗来纳州新发艾滋病毒感染率最高的年龄组。 表明拉丁美洲人的艾滋病毒预防刻不容缓；因此，我们提出一项创新干预措施—— 拍摄戏剧故事（电视剧/肥皂剧）Infección de Amor（爱情感染）——为文化量身定制 《Infección de Amor》在美国拍摄并制作，但尚未经过测试。 拟议的研究将试点测试 IA 并将干预措施转移到网上。 允许个人从任何位置和设备（例如智能手机）全天候访问的网站， 确保未来干预措施的广泛传播 我们提议向其提供两年规划补助金 (R34)。 准备 R01 疗效试验。我们的目标是： 1) 开发干预实施网站，进行 网站可用性测试，并测试IA干预的可行性和可接受性（四集电视剧） 与 10 名拉丁裔人士合作，2) 进行一项随机对照试点研究，以检验艾滋病毒预防方面的变化 比较 71 项干预措施和 71 项行为（安全套使用；HIV 检测；以及 PrEP 意识、获取和使用） 从基线（时间 1 [T1]，0 个月）到主动干预后（时间 2 [T2]，1 个月）控制拉丁裔，并 六个月的随访，研究人员没有联系的一段时间（时间 3 [T3，7 个月]），以及 3) 完成 建立研究基础设施，扩大我们的多学科团队，建立我们的研究伙伴关系 与社区合作，最终确定协议和培训材料，完善招聘和保留策略， 数据收集和数据管理程序以及机构审查委员会的批准正在准备中 对于 R01 功效研究，我们提出了国家药物滥用研究所 (NIDA) 的目标 #4：增加 NIDA。 我们的目标是利用一种新颖的干预措施来促进艾滋病毒的预防。 我们将为拉丁裔实施文化上持久且可行的干预措施。