A Randomized Controlled Pilot Study to Examine the Impact of a Filmed Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention in Latinas.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Condom Use from Baseline to Month 7
研究概览
简要总结
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, the investigators propose an innovative intervention - a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA) (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 the 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. This is a a two-year planning grant (R34) to prepare for an R01 efficacy trial. The 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 intervention and 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 the multidisciplinary team, building the 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. This study address the National Institute on Drug Abuse (NIDA) goal #4: increase NIDA research and programs' public impact. This is a novel intervention to advance HIV prevention for Latinas. This study implement a culturally durable and feasible intervention for Latinas.
详细描述
Aim 1. A total of 10 participants will be enrolled for aim 1 (Develop the intervention delivery website, conduct a website usability test, and test the feasibility and acceptability of the IA intervention (four telenovela episodes). This part of the study is not a randomized clinical trial. These participants will provide feedback about the usability of the intervention website. Usability testing will use approaches for recruitment, eligibility criteria, and retention protocols as planned for the Randomized Clinical Trial (RCT) pilot. As with the RCT pilot, women recruited for the usability testing will sign a consent form before participating. During usability testing, Latinas will receive: (a) username and password information, and a link to the website, (b) an online orientation to the website, (c) all the telenovela website sections including IA telenovela episodes, study measures, and access to referral information), (d) reminders about their participation using an automated notification system on the website. Latinas will receive a small incentive to compensate them for their time. After participants complete the usability test (approximately one month after the online orientation), they will complete the 10-item System Usability Scale that measures digital intervention usability. Items are scored on a 5-item Likert scale (strongly disagree to strongly agree). Based on Latinas' responses, changes to the IA website or study protocols will be made before the RCT pilot. If this is the case, an amendment to the protocols will be submitted later. Details of the Usability Testing of IA are described below.
Randomized Clinical Trial (Aim 2). A total of 142 participants will be enrolled to examine change in HIV prevention behaviors (condom use; HIV testing; and Pre-exposure Prophylaxis [PrEP] awareness, access, and use) comparing intervention and 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]) Inclusion criteria are: 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. 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. 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.
The study is targeting a minority population in the United States, and special efforts will be made to make the study attractive for them, such as offering recruitment flyers, measures and consent forms in Spanish and English; referral health centers that are accessible for, if needed; and study team personnel who are culturally sensitive to the Latinas' culture.
Infección de Amor website. The website will provide: a) access to the four intervention episodes 24/7 from any location or type of device (e.g., cellphone, laptop) since it will be mobile optimized (all the episodes are password protected); b) questionnaires for data collection deployed via Qualtrics; c) a contact section in case participants have technical problems or need to contact the research team; and d) a section with community resources, services, and referrals. Secure and private servers and communication channels will be used such as OneDrive/Microsoft teams to store and to exchange information.
The intervention website will be accessible to study participants in English and Spanish. The intervention participants will access telenovela episodes, available in Spanish or English, at their preferred time and place using a website accessible through any device since it will be mobile optimized. A new episode of IA will be available each week. Women will be instructed to watch an episode as many times as they want during the week, but they need to answer a post episode-viewing survey after viewing it the first time. Also, they will be able to pause or stop the episodes at any time if they need to take a break or stop watching for any reason. Women will be advised to watch the episodes alone. Prior episodes will remain available after a new episode is released. Each episode has an opening that introduces the characters and then the content of the telenovela.
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
研究组 & 干预措施
Wait-listed
A wait-listed control group of Latinas will receive IA in the same manner as the intervention group. Latinas will start watching the telenovela episodes 7 months after their baseline survey (after T3 survey). Latinas will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.
干预措施: Infección de Amor (Infectious Love) (Behavioral)
Infección de Amor (Infectious Love)
Latinas will view four IA intervention episodes, one per week immediately after the baseline survey and orientation. Participants will receive an email to their preferred email address with a password to access to the episode on the IA's website: www.telenoveladeamor.com Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection). The one week time frame for each episode is needed to provide time to review and reflect about IA's content and modify HIV prevention behaviors. It will also allow Latinas to obtain information and support from the team and referral if needed. This time frame was effective to improve behaviors in previous studies.
干预措施: Infección de Amor (Infectious Love) (Behavioral)
结局指标
主要结局
Change in Condom Use from Baseline to Month 7
时间窗: baseline up to 7 months
Changes in 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.
Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 1
时间窗: baseline to 1 month
Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no)
Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 7
时间窗: baseline up to 7 months
Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no).
Change in HIV Test Perception from Baseline to Month 7
时间窗: baseline up to 7 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.
Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 7
时间窗: baseline to 7 months
Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no)
Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 1
时间窗: baseline to 1 month
Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no)
Change in HIV Test Perception from Baseline to Month 1
时间窗: baseline up to 1 month
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.
Change in Condom Use from Baseline to Month 1
时间窗: baseline up to 1 month
Changes in 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.
Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 1
时间窗: baseline up to 1 month
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)
Change in HIV Testing from Baseline to Month 1
时间窗: baseline up to 1 month
Changes in HIV testing will be measured as the number of participants who reported to have been tested for HIV in the last month.
Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 7
时间窗: baseline up to 7 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)
Change in HIV Testing from Baseline to Month 7
时间窗: baseline up to 7 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.
Change in Condom Use
时间窗: baseline up to 7 months
Change in the proportion of sexual episodes (oral, vaginal, or anal intercourse) in which condoms were used in the last month. Change from Baseline was calculated to Month 1 and Month 7.
Pre-exposure Prophylaxis (PrEP) Awareness
时间窗: baseline up to 7 months
PrEP awareness will be measured as the number of participants who self-report whether they know about PrEP medication (dichotomous question: yes/no).
Changes in Pre-exposure Prophylaxis [PrEP] Access
时间窗: baseline to 7 months
Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no)
Changes in Pre-exposure Prophylaxis [PrEP] Use
时间窗: baseline to 7 months
Changes in PrEP use will be measured as the number of participants that have familarity with PrEP and self-report whether they currently use PrEP medication (dichotomous question: yes/no)
Change in HIV Testing
时间窗: baseline up to 7 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.
次要结局
- Change in Emotional Response(Changes in emotional Response (ER) will be measured with the International Positive and Negative Affect Schedule Short Form (IPANAS-SF). Scores range from 10-50. Higher scores indicate the tendency to experience a positive and negative mood.)
- Change in Self-Efficacy for Condom Use(week 1 to week 4)
- Substance abuse, intimate partner violence, and depression as predictors of PrEP awareness(baseline up to 7 months)
- Emotional response, narrative engagement, and self efficacy as predictors of HIV testing(one month to 7 months post baseline)
- Emotional response, narrative engagement, and self efficacy as predictors of PrEP awareness(one month to 7 months post baseline)
- Change in Intimate Partner Violence (IPV)(baseline up to 7 months)
- Change in Depression(baseline up to 7 months)
- Number of Participants who Complete all the Intervention Content(40-minute)
- Number of Participants Who are Retained Through all Assessments(baseline up to 7 months)
- Emotional response, narrative engagement, and self efficacy as predictors of condom use(one month to 7 months post baseline)
- Change in Narrative Engagement(week 1 to week 4)
- Change in Substance Abuse from Baseline to Month 7(baseline up to 7 months)
- Substance abuse, intimate partner violence, and depression as predictors of HIV testing(baseline up to 7 months)
- Substance abuse, intimate partner violence, and depression as predictors of condom use(baseline up to 7 months)
- Number of Episodes Watched by Participants(40-minute)
- Number of Participants Who Are Retained Through All Study Timepoints(baseline up to 7 months)