Clinical trial NCT05929482: Impact of a Telenovela/Soap Opera for HIV Prevention in Latinas
Official title: A Randomized Controlled Pilot Study to Examine the Impact of a Filmed Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention in Latinas.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Latinas
Primary Disease Prevention
Internet Based Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-03
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 6-month assessment.
Primary purpose: PREVENTION

Brief summary: 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 71 intervention and 71 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.

Detailed description: 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 71 intervention and 71 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.

Participants will receive reminders about completion of the surveys. 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 (e.g., emails, calls, or text messages) 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.

Recruitment and enrollment. The investigators will enroll 60-64 Latinas per quarter (5-6 per week). If needed, enrollment timeline can be extended and advice from health departments and Dr. Barrington will be requested if there are issues enrolling participants. A standardized eligibility form will be used to assess if Latinas meet inclusion criteria (e.g., age, internet access) that will be available in Qualtrics.

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. 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 will randomize participants to the intervention and control groups by a computer-generated randomization table, using blocking of participants to ensure a balance between groups in relation to participant's characteristics (e.g., presence of substance abuse \[SA\], intimate partner violence \[IPV\], or depression), and participants will be informed of their group assignment by phone. 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 7-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.

Intervention group: 71 Latinas will view four Infección de Amor (IA, Love Infection) 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.

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.

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 71 Latinas will receive IA in the same manner as the intervention group after completing T3 data collection. 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.

Follow-up surveys. Participants will answer a (one-month after baseline) survey, and complete another survey (on their own) 7 months after baseline. Participants will complete these surveys (1-month and 7-months after baseline) on their own. Participants can request help to complete these surveys (online using zoom or face to face if needed). Zoom meetings will not be recorded if the surveys are conducted using zoom.

Procedures for Minority Retention and Potential Challenges. For each video episode, participants will have a one-week window to view and will receive reminders using an automated notification system from Qualtrics when the end of the viewing-window is approaching. The website will track if participants watch the whole episode. Information about HIV prevention will be provided at the end of each episode 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 in the informed consent will be requested for contacting them); 4) providing compensation for their time, internet use, and transportation; and 5) automated notification system messages for special occasions (e.g., holidays). The researchers will be flexible in scheduling enrollment and data collection appointments. Attrition will be monitored in both conditions. Potential issues with Latinas and community centers will be discussed, and if needed, a community advisory board of three Latinas of the same age as those participating in the study to ask for their advice will be established. Participants will receive a compensation for their participation in the study.

Fidelity of the Intervention. The NIH five-category treatment Fidelity Framework will be used. For study design, the theoretical model was articulated; Latinas in both intervention and wait-listed control groups will receive the same telenovela intervention at different times. Also an optimal protocol will be created to ensure that the intervention is fully operationalized.

Variables and their measurement. The measures will be available in Spanish and English; in previous studies with Latinas, they demonstrated excellent reliability and validity and are written at a 4th-grade reading level. Measures available in Spanish and English that are part of the PhenX toolkit recommended by the NIDA were added, including: a) sociodemographic information (e.g., income, housing situation); b) questionnaires at each timepoint assessing HIV behavioral outcomes and moderators of HIV prevention behaviors; c) post-IA episode surveys measuring the mechanisms of action.

All study personnel will be adult, bilingual, and will receive training in human subjects and a 3-5 day training about study procedures and their specific functions in the study (e.g., website access, use of Qualtrics, and Microsoft excel).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Condom Use from Baseline to Month 1
timeFrame: baseline up to 1 month
measure: Change in Condom Use from Baseline to Month 7
timeFrame: baseline up to 7 months
measure: Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 1
timeFrame: baseline up to 1 month
measure: Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 7
timeFrame: baseline up to 7 months
measure: Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 1
timeFrame: baseline to 1 month
measure: Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 7
timeFrame: baseline to 7 months
measure: Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 1
timeFrame: baseline to 1 month
measure: Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 7
timeFrame: baseline up to 7 months
measure: Change in HIV Testing from Baseline to Month 1
timeFrame: baseline up to 1 month
measure: Change in HIV Testing from Baseline to Month 7
timeFrame: baseline up to 7 months
measure: Change in HIV Test Perception from Baseline to Month 1
timeFrame: baseline up to 1 month
measure: Change in HIV Test Perception from Baseline to Month 7
timeFrame: baseline up to 7 months
Secondary outcomes:
measure: Number of Participants who Complete all the Intervention Content
timeFrame: 40-minute
measure: Number of Participants Who are Retained Through all Assessments
timeFrame: baseline up to 7 months
measure: Change in Emotional Response
timeFrame: 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.
measure: Change in Narrative Engagement
timeFrame: week 1 to week 4
measure: Change in Self-Efficacy for Condom Use
timeFrame: week 1 to week 4
measure: Emotional response, narrative engagement, and self efficacy as predictors of condom use
timeFrame: one month to 7 months post baseline
measure: Emotional response, narrative engagement, and self efficacy as predictors of HIV testing
timeFrame: one month to 7 months post baseline
measure: Emotional response, narrative engagement, and self efficacy as predictors of PrEP awareness
timeFrame: one month to 7 months post baseline
measure: Change in Substance Abuse from Baseline to Month 7
timeFrame: baseline up to 7 months
measure: Change in Intimate Partner Violence (IPV)
timeFrame: baseline up to 7 months
measure: Change in Depression
timeFrame: baseline up to 7 months
measure: Substance abuse, intimate partner violence, and depression as predictors of condom use
timeFrame: baseline up to 7 months
measure: Substance abuse, intimate partner violence, and depression as predictors of HIV testing
timeFrame: baseline up to 7 months
measure: Substance abuse, intimate partner violence, and depression as predictors of PrEP awareness
timeFrame: baseline up to 7 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill School of Nursing
name: Natalia A Villegas Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
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