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: 10403030
• 负责人: Natalia Andrea Villegas Rodriguez
• 金额: $ 33.99万
• 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/10403030
• 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; Communities; Comprehension; Data Collection; Devices; Effectiveness of Interventions; Emotional; Emotions; Ensure; Environment; Female of child bearing age; Film; Funding; Future; Goals; Grant; HIV; HIV Infections; HIV diagnosis; 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; Outcome; Participant; Perception; Pilot Projects; Preparation; Prevention; Preventive; Procedures; Protocols documentation; Randomized; Randomized Clinical Trials; Reporting; Research; Risk; Self Efficacy; Soaps; Stigmatization; Substance abuse problem; Technology; Testing; Time; Training; United States; Woman; Women' s Group; Work; acceptability and feasibility; age group; base; behavior change; behavior influence; built environment; condoms; cost; data management; disparity reduction; efficacy study; efficacy trial; feasibility testing; follow-up; human old age (65+); innovation; intervention delivery; intimate partner violence; multidisciplinary; novel; online delivery; online intervention; pilot test; pre-exposure prophylaxis; prevent; programs; public health relevance; recruit; reduced substance abuse; response; retention rate; role model; social cognitive theory; social culture; theories; 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，拉丁裔继续不成比例地受到艾滋病毒的影响。通常情况下，拉丁裔并不是 了解他们的艾滋病毒状况。此外，他们认为艾滋病毒风险低的看法干扰了避孕套的使用、艾滋病毒检测和 缺乏暴露前预防[PrEP]的意识、途径和使用。北卡罗来纳州约60%的艾滋病毒总病例 发生在育龄妇女中，因此对艾滋病毒的易感性在拉丁裔中尤为严重 年龄18岁和44岁，这是北卡罗来纳州艾滋病毒新感染率最高的年龄段。这些差距 表明在拉丁裔中预防艾滋病毒是当务之急；因此，我们提出了一种创新的干预措施--a 拍摄的戏剧化故事(电视剧/肥皂剧)爱的感染(爱的感染)-文化上的定制 在美国的拉丁裔，并在网上交付。《爱的传染病》已被拍摄和冲洗，但尚未进行测试 我们的目标观众。拟议的研究将对IA进行试点测试，并使用 允许个人从任何地点和设备(如智能手机)全天候访问的网站， 确保在未来广泛传播干预措施。我们建议提供为期两年的规划拨款(R34)，以 为R01疗效试验做准备。我们的目标是：1)开发干预交付网站，开展 网站可用性测试，并测试IA干预的可行性和可接受性(四集电视连续剧) 与10名拉丁裔，2)进行随机对照试点研究，以检查艾滋病毒预防方面的变化 行为(避孕套使用；艾滋病毒检测；PrEP意识、获取和使用)比较71次干预和71次 控制拉美人从基线(时间1[T1]，0个月)到积极干预后(时间2[T2]，1个月)，以及 6个月的随访，没有研究人员联系的时期(时间3[T3，7个月])，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 与社区一起敲定协议和培训材料，完善招聘和留用战略， 数据收集和数据管理程序，并在准备过程中获得机构审查委员会的批准 用于R01疗效研究。我们解决了国家药物滥用研究所(NIDA)的目标4：增加NIDA 研究和项目的公共影响。我们的目标是使用一种新的干预措施来促进艾滋病毒的预防 拉丁裔。我们将对拉丁裔实施文化上持久和可行的干预。