Love Infection: A Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention

Study Overview
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Brief Summary
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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).

Detailed Description
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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. - Baseline survey. If potential participants meet the inclusion criteria, they will be asked to attend to a one hour-meeting with a member of the research team to sign the informed consent, complete a baseline survey and receive an orientation about the use of the telenovela website https://www.infecciondeamor.com/. After participants complete the survey, they will be randomized by a member of the research team to the intervention or control group. The research team member will explain the following activities they have to complete according to the group they will be assigned. If they are randomized to the control group, the orientation to the website will be delayed until they complete the 4-month post baseline survey. The survey will be available in Qualtrics and only the members of the research team will have access to the survey. After completing the baseline survey, participants will be randomized to the intervention or control groups by a computer-generated randomization table, using blocking of participants to ensure a balance between groups. An envelope will contain the result of the randomization and the assessors will open this envelop in front of the participant after she finished the baseline survey. Each participants envelop will be assigned based on the ID number (e.g., 1, 2, 3) - Intervention group: Latinas will view four IA intervention episodes, one per week. Participants will receive an email to their preferred email address with a password to access to the episode on the IA's website: https://www.infecciondeamor.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). After each episode, participants will complete a survey (on their own) on Qualtrics. This post episode survey includes questions about the mechanisms of action of the telenovela (self-efficacy, narrative engagement, and emotional elicitation). Control group: A wait-listed control group of 33 Latinas will receive IA in the same manner as the intervention group after completing T3 data collection. During the waiting time, participants will be contacted on a monthly basis to encourage participation and refer to services if needed. Follow-up surveys. Participants will answer a (one-month after baseline) survey, and complete another survey (on their own) 4 months after baseline. Participants will complete these surveys (1-month and 4-months after baseline) on their own. Participants can request help to complete these surveys (online using zoom or face to face if needed). Infección de Amor website. The website provides: a) access to the four intervention episodes 24/7 from any location or type of device (e.g., cellphone, laptop) since is mobile optimized (all the episodes are password protected); b) questionnaires for data collection deployed via Qualtrics; c) a contact section; and d) a section with community resources, services, and referrals. Secure and private servers and communication channels such as OneDrive will be used to store and to exchange information. A new episode of IA will be available each week. Women can 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. Participants will receive reminders about completion of the surveys using an automated notification system from Qualtrics. In addition, up to three reminders (e.g., phone, email) will be sent each week to participants who have not accessed an episode in a specific window period and completed the post episode survey or if the participant has not access to the website in one week. If a woman does not complete the episode in one week or does not access the website in one week, the research team will contact the participant to her preferred email or phone. The research team will discuss with her any impediments to her participation, how to watch the missed episode, and resume with the following episodes. Women will be able to pause or stop the episodes at any time if they need it. Prior episodes will remain available after a new episode is released if women would like to review them. - Procedures for Minority Retention and Potential Challenges. The website will track if participants watched the whole episode. Each episode also contains information about HIV prevention at the end and a link to the technical support and referrals sections if needed. Other retention strategies will include: 1) updating contact information frequently; 2) requesting contact information of at least two friends or relatives; 3) contacting the woman by email or cell phone (permission to contact the participants will be requested in the informed consent); 4) providing compensation for their time, internet use, and transportation; and 5) automated notification system messages for special occasions (e.g., holidays). Attrition will be monitored in both conditions. Potential issues with Latinas and community centers, and if needed, establish a community advisory board of three Latinas of the same age as those participating in the study to ask for their advice. Follow-up procedures Participants will have access to watch the intervention online individually 24/7 from their preferred location. They will be asked to watch the intervention in a comfortable and private place since some of the content (e.g., IPV, substance use) can be sensitive for them or other people (e.g., their children) if they allow them to watch. Participants will have a contact section on the online platform in case they have questions, they need referrals, or they want to talk about issues that may arise while they are watching the telenovela. If they are watching the telenovela and they experience stress or anxiety, they will be instructed to call a person from the team who will be available to listen to them and refer them to proper services if needed. The person from the team will notify the PI about the situation and how it should be managed. A protocol will be created by the research team to manage these situations. Latinas will be instructed that they can stop their participation at that moment and that this situation will not affect their ability to continue in the study. Potential risks The research team will treat Latinas with respect and will be sensitive if they express that they feel or voice embarrassment with the intervention content. The research team will explain to them that this will not affect their ability to continue in the study. If a potential breach of confidentiality occurs, which could be related with someone finding out that a participant is involved in the study or if a study member unintentionally disclosures confidential information about the participants. Efforts will be made to avoid these situations, by not revealing any information about participants to any people external to the research unless requested by authorities. Participants will be requested to keep their randomization to the groups (intervention or control) confidential. In addition, all the team members will have their Human subject training up to date and will receive a training to avoid situations that can lead to breach in confidentiality. . Referrals El Futuro is a community center who provides mental health services to the Latino population. El Futuro will provide the space for the study related activities and will facilitate recruitment (flyers). In need of a referral, participants will be advised to call to this community center. A list of referrals to other community centers that provide culturally sensitive services in case they need other type of services (e.g., HIV test) will also be provided. The Investigators will be responsible for ensuring that study protocols for maintaining confidentiality are followed. The PI will provide ongoing supervision and training to essential study staff at weekly meetings, which will also ensure continued compliance with data safety protocols.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Infeccion de Amor (Love Infection)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling to be part of the study Do not read, speak, or understand Spanish or English Do not have access to internet HIV positive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms, intervention and wait-listed control group. Participants in the intervention group will receive the 4 episodes of the Love infection intervention (one episode weekly) after the baseline assessment. Participants in the wait-listed control group will receive the intervention after completing the 3-month assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infeccion de Amor (Love Infection)<br>33 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: https://www.infecciondeamor.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. | Behavioral: Infeccion de Amor (Love Infection)<br>* Love Infection is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or Love Infection - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.<br>|
| Other: Wait-listed<br>A wait-listed control group of 33 Latinas will receive IA in the same manner as the intervention group. Latinas will start watching the telenovela episodes 4 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. | Behavioral: Infeccion de Amor (Love Infection)<br>* Love Infection is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or Love Infection - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Condom Use from Baseline to Month 1 | 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. | baseline up to 1 month | 
| Change in Condom Use from Baseline to Month 4 | 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. | baseline up to 4 months | 
| Changes in PrEP Awareness from Baseline to Month 1 | 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) | baseline up to 1 month | 
| Changes in PrEP Awareness from Baseline to Month 4 | 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) | baseline up to 4 months | 
| Changes in PrEP Access from Baseline to Month 1 | Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no) | baseline to 1 month | 
| Changes in PrEP Access from Baseline to Month 4 | Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no) | baseline to 4 months | 
| Changes in PrEP Use from Baseline to Month 1 | Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no) | baseline to 1 month | 
| Changes in PrEP Use from Baseline to Month 4 | Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no). | baseline up to 4 months | 
| Change in HIV Testing from Baseline to Month 1 | Changes in HIV testing will be measured as the number of participants who reported to have been tested for HIV in the last month. | baseline up to 1 month | 
| Change in HIV Testing from Baseline to Month 4 | Changes in HIV testing will be measured as the number of participants who reported to have been tested for HIV in the last month. | baseline up to 4 months | 
| Change in HIV Test Perception from Baseline to Month 1 | 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. | baseline up to 1 month | 
| Change in HIV Test Perception from Baseline to Month 4 | 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. | baseline up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Substance Abuse from Baseline to Month 4 | Changes in substance abuse will be measured with the Substance abuse behaviors scale. Scores range from 6-36. A higher score represents a higher use of substances. | baseline up to 4 months | 
| Change in Intimate Partner Violence (IPV) | Changes in IPV will be measured using the revised Conflict Tactics Scale to measure women's self-reported IPV in the previous 3 months (e.g., your partner insulted you). Scores range from 24-72 points. A higher score indicates higher levels of IPV. | baseline up to 4 months | 
| Change in Depression | Changes in depression will be measured with the Patient Health Questionnaire (PHQ-9), a 9-item scale commonly used for depression screening in primary care and other health settings. Scores range from 5-27. A higher score indicates more depressive symptoms. | baseline up to 4 months | 
| Number and Percentage of Participants who Complete all the Intervention Content | The online website will track if the 40-minutes of the intervention content is viewed and the rate of participants who complete of all content will be calculated. | 40 minutes | 
| Number and Percentage of Participants Who are Retained Through all Assessments | The number and percentage of participants who completed all assessments divided by the number of enrolled participants | baseline up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Latinas, Primary Disease Prevention, Internet Based Intervention