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.

项目总结/摘要 在美国，拉丁美洲人继续受到艾滋病毒的影响。通常，拉丁人不是 了解自己的艾滋病状况。此外，他们对艾滋病毒低风险的看法干扰了安全套的使用、艾滋病毒检测和 缺乏对暴露前预防（PrEP）的认识、获取和使用。约占北卡罗来纳州艾滋病毒病例总数的60% 艾滋病毒/艾滋病在育龄妇女中发生，因此，艾滋病毒的脆弱性在拉丁美洲人中尤为严重， 年龄在18岁和44岁之间，这是北卡罗来纳州艾滋病毒新感染率最高的年龄组。这些差距 这表明拉丁美洲人艾滋病毒预防是紧迫的;因此，我们提出了一种创新的干预措施-- 电影戏剧化的故事（电视剧/肥皂剧）爱情感染-文化上为 美国的拉丁裔并在线交付。Amor的照片被拍摄和冲洗，但尚未进行测试。 我们的目标受众。拟议的研究将试点测试IA，并使用 网站，将允许个人访问全天候从任何位置和设备，如智能手机， 确保今后广泛传播干预措施。我们建议提供两年规划补助金（R34）， 为R 01疗效试验做准备。我们的目标是：1）开发干预交付网站， 网站可用性测试，并测试IA干预的可行性和可接受性（四个肥皂剧集） 2）进行随机对照试点研究，以检查艾滋病毒预防的变化 行为（安全套使用;艾滋病毒检测;和PrEP的认识，获取和使用）比较71干预和71 从基线（时间1 [T1]，0个月）至主动干预后（时间2 [T2]，1个月），以及 6个月随访，研究人员没有联系的时间段（时间3 [T3，7个月]），和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，完善招聘和保留战略， 数据收集和数据管理程序，并获得机构审查委员会的批准 R 01疗效研究。我们致力于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， 拉丁裔我们将为拉丁美洲人实施文化上持久和可行的干预措施。