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.

项目摘要/摘要 在美国（美国），拉丁裔继续受到艾滋病毒的不成比例。通常，拉丁裔不是 意识到他们的艾滋病毒状况。此外，他们对艾滋病毒干扰避孕套，艾滋病毒测试和 缺乏意识，访问和使用前预防的使用[PREP]。 NC中约有60％的HIV病例 在育龄的妇女中发生，因此在拉丁裔中尤其是艾滋病毒的脆弱性 18岁和44岁的年龄，是NC新艾滋病毒感染率最高的年龄组。这些差异 表明拉丁裔的艾滋病毒预防是紧急的；因此，我们提出了一种创新的干预措施 - 拍摄的戏剧性故事（Telenovela/Soap Opera）InfeccióndeAmor（爱情感染） - 从文化上量身定制的 在美国的拉丁裔并在线交付。 InfeccióndeAmor是拍摄和开发的，但尚未进行测试 与我们的目标受众。拟议的研究将尝试测试IA，并使用 将允许从任何位置和设备（例如智能手机）全天候访问的网站 确保将来对干预的广泛传播。我们提议为期两年的计划赠款（R34） 准备R01效率试验。我们的目的是：1）开发干预交付网站，进行 网站可用性测试，并测试IA干预的可行性和可接受性（四个Telenovela情节） 使用10个拉丁裔，2）进行一项随机控制的试点研究，以检查预防HIV的变化 比较71干预措施和71 从基线（时间1 [T1]，0个月）到活动后干预（时间2 [T2]，1个月），然后 六个月的随访，没有研究人员接触的期间（时间3 [T3，7个月]）和3） 建立研究基础设施，扩大我们的多学科团队，建立我们的研究合作伙伴关系 在社区中，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，并获得机构审查委员会的批准 用于R01效率研究。我们讲话美国国家药物滥用研究所（NIDA）目标＃4：增加NIDA 研究和计划的公共影响。我们的目的是利用新颖的干预来预防艾滋病毒 拉丁裔。我们将对拉丁裔实施文化持久且可行的干预措施。