Infección de Amor (Love Infection): Online Delivery and Pilot Testing of a Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention Among Latinas in North Carolina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Mean Condom Use
研究概览
简要总结
Purpose: To test the feasibility, acceptability of the IA intervention (four telenovela episodes), assessment of the mechanisms of action (self-efficacy, narrative engagement, and emotional elicitation) and conduct a randomized controlled pilot study to examine the change in primary outcomes (condom use, HIV testing, Pre-exposure Prophylaxis (PrEP) awareness and use) and secondary outcomes (Substance abuse (SA), intimate partner violence (IPV), and depression comparing 33 intervention- and 33 control Latinas at baseline (T1, pre-intervention), T2 (immediately post-intervention, 1 month) and T3 (3 months after the end of the intervention, with no intervening contact with study staff).
Participants: 66 Latinas ages 18-44 years who report sexual activity with a man in the last 6 months, have internet access from any device, and reside in NC.
Procedures (methods): Participants will be asked to: (1) receive an orientation about the use of the Infección de Amor (IA) telenovela website and access the telenovela website once a week for 4 weeks to watch a telenovela episode and answer some questions about the episode (half hour each week, 2 in total), (2) attend to a one hour-meeting with the research team to complete a baseline survey, (3) complete a survey (on their own) one-month after the baseline survey, and (4) complete another survey (on their own) 4-months after the baseline survey. Participants will complete a structured survey in the first meeting (baseline survey) with a member of the research team and then they will complete the follow-up surveys (1-month and 4-months after baseline) on their own.
Participants can request help to complete these surveys with the help of the research team (online using Zoom or face to face if needed). The moment that participants will access the IA intervention will depend on the group to be assigned by the research team (intervention or control group).
详细描述
Background Information Latinas continue to be affected disproportionally by HIV in the US.1 In 2017, Latinas accounted for 16% of new HIV diagnoses infection among women, a rate four-fold that of White women. To address this marked disparity, an innovative intervention - a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Love Infection" - culturally tailored for US Latinas and delivered online is proposed in this study. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. IA emphasizes the influence of romantic relationships in HIV infection and is available in Spanish and English. The development of IA incorporated the National Institute on Minority Health and Health Disparities (NIMHD) Framework, conceptualizing factors relevant to the understanding and promotion of minority health and understanding and reducing health disparities, to guide its content. Social cognitive theory, narrative engagement theory, and research on emotional responses are the mechanisms of action-guiding IA's delivery.
Participants A total of 66 Latinas ages 18-44 years who report sexual activity with a man in the last 6 months, have internet access from any device, and reside in NC.
Recruitment and screening will be led by a bilingual (English and Spanish) study personnel. Participants will be asked their preferred language at the time of recruitment. All study materials, including information and consent forms, questionnaires, and recruitment ads, will be translated and available in Spanish. Any direct interaction with non-English-speaking participants will be available in Spanish
Study procedures
The research team is bilingual and will be able to assist women if they have questions about the study. Study procedures will be conducted in English and/or Spanish according to participant's preference. A screening form to see if a person qualifies for the study that is available in Qualtrics will be used. If the person qualifies for the study, a first meeting to conduct the baseline survey will be arranged with the research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-identified as a Latina
- •Assigned female gender at birth
- •Fluent in English or Spanish
- •Between 18 and 44 years old
- •Report sexual activity with a man in the last 6 months
- •Have internet access from any device
- •Reside in NC
排除标准
- •Unwilling to be part of the study
- •Do not read, speak, or understand Spanish or English
- •Do not have access to internet
- •HIV positive
结局指标
主要结局
Mean Condom Use
时间窗: baseline up to 4 months
Condom use will be measured as the number of sexual episodes (oral, vaginal, or anal intercourse) in which condoms were used with a male partner in the last month.
Number of Participants Who Report Change in PrEP Awareness
时间窗: Baseline up to 4 months
Changes in PrEP awareness will be measured as the number of participants who self-report whether they know about PrEP medication (dichotomous question: yes/no)
Number of Participants Who Report Change in PrEP Access
时间窗: baseline to 4 months
Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (Possible responses: yes/no/don't know). Those participants who answered "Yes" to the PrEP awareness question were asked if they have access to PrEP.
Number of Participants Who Report Changes in PrEP Use
时间窗: baseline to 4 months
Changes in PrEP use will be measured as the number of participants who report that they have used PrEP (dichotomous question: yes/no). Those participants who answered "Yes" to the PrEP awareness question were asked about PrEP use.
Number of Participants Who Report Change in HIV Testing
时间窗: baseline up to 4 months
Changes in HIV testing will be measured as the number of participants who reported to have been tested for HIV in the last month.
Mean Change in HIV Test Perception Score
时间窗: baseline up to 4 months
Changes in HIV testing perception will be measured with the willingness to take an HIV test measure scale. Scores range from 9-45. A higher score represents a higher willingness to take an HIV test.
次要结局
- Mean Change in Substance Abuse Score(baseline up to 4 months)
- Mean Change in Intimate Partner Violence (IPV) Score(baseline up to 4 months)
- Mean Change in Depression (PHQ-9) Score(baseline up to 4 months)
- Number of Episodes Watched by Participants(immediately after watching each 10-minute weekly episode for up to 4 weeks)
- Number of Participants Who Are Retained Through All Study Timepoints(baseline up to 4 months)