Love Infection: A Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Infeccion de Amor (Love Infection)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: HIV; Latinas; Primary Disease Prevention; Internet Based Intervention