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

HIV Infections Clinical Trial

— IA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358366
• Other study ID #: 21-3214
• Secondary ID: 550KR262124
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections

Intervention

Behavioral:
• Infeccion de Amor (Love Infection)
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.

Locations

Country	Name	City	State
United States	El Futuro	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Participant Acceptability with the Intervention Content Areas based on a 5 Point Rating System	Participants will be asked to rate each of the 9 content area using a 5-star rating system where 1 star is the lowest and 5 points is the highest rating. A mean of all ratings will be calculated. The closer the mean is to 5.0, the higher the satisfaction with the content areas. Scores range from 9-45. A higher score indicates a higher level of acceptability.	one-month after the baseline survey
Other	Change in Self-Efficacy for Condom Use from Baseline to Month 1	Changes in Self-Efficacy will be measured using the HIV self-efficacy for condom use survey. Scores range from 7-28. A higher score indicates a higher level of self-efficacy for condom use.	baseline up to 1 month
Other	Change in Self-Efficacy for HIV Prevention	Changes in Self-Efficacy will be measured using the HIV self-efficacy for HIV prevention behaviors survey. Scores range from 11-55. A higher score indicates a higher level of self-efficacy for HIV prevention behaviors.	baseline up to 1 month
Other	Change in Narrative Engagement	Narrative engagement will be measured with the Perception of Narrative Performance Scale, which measures three dimensions of engagement: interest, realism, and identification. Scores range from 9-36. A higher score indicates a higher level of engagement.	baseline up to 1 month
Other	Change in Emotional Response	Changes in emotional Response will be measured with the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). Scores range from 10-50. The higher scores indicate the tendency to experience a positive and negative mood.	baseline up to 1 month
Other	Feasibility of the Intervention	Measured as the total number of sessions attended by the participants as a whole.	baseline up to 4 months
Other	Changes in HIV Knowledge	Change in HIV knowledge will be measured via the HIV Knowledge Scale. The score ranges from 0-12 with a higher score indicating a higher level of HIV-related knowledge.	baseline up to 4 months
Other	Changes in STI (Sexually transmitted infections) Testing	Changes in STI testing will be measured as the number of participants who reported to have been tested for a STI in the last month.	baseline up to 4 months
Other	Changes in Sexual Communication with Partner	Change in sexual communication with partner will be measured via the Partner communication Scale (Catania et al., 1995). The score ranges from 0-10 with a higher score indicating a higher level of partner communication.	baseline up to 4 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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