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
Phase: NA
Conditions: HIV Infections
Sponsor: University of North Carolina, Chapel Hill

 
 
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 
 
 
 
NCT number NCT05358366 
Document Date 04/03/2022 
 

 
 
 
 
 
 
 
 
 
 
 
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 
 
 
 
 
 
 
Study Protocol 
 
Unique Protocol ID:  21-3214 
NCtracs # NCT05358366 
 
Date: 4.3.22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Description 
 
The study includes women between 18 to 44 years old. We will enroll 66 participants with the 
aim of testing 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 will be asked to: (1) attend to a one hour-meeting with the research team to complete 
a baseline survey and receive an orientation about the use of the telenovela website, (2) access 
the telenovela website once a week for 4 weeks to watch a telenovela episode and answer some 
questions about the episode (one hour each week, 4 in total), (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 be interview by the research team using a 
structured survey in the first meeting (baseline survey) and then they will complete the 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). 
If participants request help to complete the follow-up surveys using zoom, we will ask 
participants to access from a place that is comfortable and provides privacy and encourage the 
use of headphones if needed. We will ask them to be alone during the meeting and we will 
conduct the meeting at the participant's preferred time. We will not record the zoom meetings. 
The research team will also access from a private place and will use headphones if needed. Any 
disclosure of the participants' responses outside the research will not place them at risk of 
criminal or civil liability or damaging their financial standing, employability, or reputation since 
we will not be asking personal questions such as 
immigration status, or any financial information. Questions will be about feasibility and 
acceptability of the intervention, study mechanisms’ of action and HIV prevention related 
questions. (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) 
 
 
Informed Consent Procedures 
 
Potential participants will be screen by the study team (researcher/research assistant) 
following a verbal consent script for telephone screening. After the research team explain the 
study information, they will ask the potential participant if she is interested in the study. Then, a 
member of the research team will ask the participant if she consents to provide personal 
information to determine if she qualifies for the study. If a woman meets inclusion criteria, the 
research team member will make an appointment to meet with the participant at the community 
center, in a study office that will be located near to the community center or in any other 
participant’s preferred location. The appointment can be remotely via telephone or 
teleconferencing if needed due to COVID social distancing requirement. In a private 

room and at a convenient time for the participant, the research team member will conduct the 
informed consent process. Then participants will complete the baseline survey and the 
orientation to the intervention. Women will sign a consent form before participating in their 
preferred language (English/Spanish). 
A copy of the ICF will be given to them. This study will focus on Spanish speaking Latinas, but 
since some Latinas prefer to read in English, participants will have the option to choose the 
preferred language for the ICF process and the written consent. 
 
Subjects 
 
We will enroll 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. 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. 
 
Describe the study design. List and describe study procedures, including a sequential 
description of what subjects will be asked to do, when relevant 
 
The study includes women between 18 to 44 years old. We will enroll 66 participants 
with the aim of testing 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). 
 
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. 

• Intervention group: 33 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/ 
o 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 our 
previous studies.  
o After each episode, participants will complete a survey (on their own) on the 
telenovela website. 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. Latinas will be 
informed at recruitment of this group condition and the study randomization. During the 
three-month waiting time, we will call participants 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) 3-months. 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). We will not record the zoom meeting if we 
conduct the surveys using zoom. A description of the study measures is provided below. 
 
Infección de Amor website. The PI with a website developer and Dr. Khairat developed the IA 
intervention delivery 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 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. 
We will use secure and private servers and communication channels such as OneDrive to store 
and to exchange information.  
The intervention website is accessible only 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 their participation using an automated notification 
system from Qualtrics. We will send up to three automatic reminders 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. 
 
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 watched the whole episode. We will also 
provide information about HIV prevention 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 in case we cannot contact the participant; 3) contacting the woman by email or cell 
phone (we will ask permission in the informed consent 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). We will also be flexible in scheduling 
enrollment and data collection appointments. We will monitor attrition in both conditions. We 
will discuss 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. 
We will use unencrypted messaging to send participants information about the date/time of the 
baseline survey and follow-up surveys. If participants have not completed the electronic surveys, 
we will also use text messaging and unencrypted email to request electronic survey completion. 
We will also use it to send reminders of the telenovela episodes and post episode surveys.  
 
Team Training 
 
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). We will have monthly team meetings with all personnel 
to discuss study progress. The PI will supervise staff, talk with RAs daily-to-weekly during the 
intervention period, participate in recruitment, conduct baseline questionnaires, and coordinate 
all study implementation activities. Also, two RAs recruit participants, administer baseline 
questionnaires, and track participation. The RAs will: a) monitor Latinas’ website access; b) 
track number of times they watch the episodes and support with referrals; and c) contact the PI if 
needed. A section of the platform will provide direct contact with the research team if they need 
technological assistance. 
 
 
 

 
Potential risks 
 
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. The PI will train the research assistant 
(RA) on how to manage these situations, how to support women, and help them feel comfortable. 
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. 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 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. 
 
During enrollment in the study and the study, Latinas may run across other Latinas that are 
joining the study from their community. We will reinforce during the informed consent process 
that their participation and information provided to the study will remain confidential and will 
not be shared outside the study. 
 
A password protected linking file with the identifiers will be stored in a different physical 
location from the research data. Only the research team will have access to this file. All the paper 
records with this information will be storage in a locked office at the School of Nursing at the 
University of North Carolina at Chapel Hill and will be store separate from the research data. 
Zoom sessions will not be recorded. 
 
Confidentiality of the data 
 
Confidentiality will be protected through a coding mechanism. The names of all participants will 
be removed from the data and a code number assigned. Each participant’s identifying data will 
be separated from the study data, and the PI will keep key identifying code numbers and the 
participant identification in a locked file cabinet that only the PI and the RAs will have access. 

Qualtrics will be used for the study measures, and this online questionnaire platform is password 
protected. The study questions will be accessible online to the RAs/participants through the use 
of a link. Data will be reported in an aggregate form without identifying information by site or 
individual. 
 
All research personnel study personnel will be trained in IRB guidelines to maintain the security 
and confidentiality of the data. Latinas will be made aware of the precautions that the research 
team will take in keeping their data confidential. All identifying information will be destroyed at 
the earliest possible time following completion of the study. Publications arising from the study 
will not contain personal information. All data will be analyzed by groups, with no potential for 
individual participants to be identified. 
In addition, the telenovela website does not have any personal information from participants, all 
the data is collected through Qualtrics and is password protected. Access to the episodes on the 
website only is possible if participants receive a password with access to a specific episode. Only 
the research team members will have access to the information collected in Qualtrics. We will 
use secure and private servers and communication channels such as OneDrive to store and to 
exchange information. Zoom meetings will be used to conduct the interviews using structured 
surveys in the 2 meetings. We will not record zoom meetings. 
 
We will create a one drive folder to storage the study information and only the team members 
will have access if needed. We will also have a Qualtrics account with the survey information 
that only the research team will have access. 
 
We will ask HIV status as an inclusion criteria of the study. For aim 2 we will HIV related 
prevention outcomes including sexual behavior, condom use, HIV testing, Pre-exposure Prophylaxis 
[PrEP] awareness and use, substance abuse (SA), intimate partner violence (IPV), and depression, 
and other sensitive information. 
 
We will use an eligibility form for this study that will be enter in Qualtrics, which has protected 
access and only the research team members will have access. All the information will be kept in 
the UNC one drive if we need to download the file during the study and only the research team 
members will have access. We will keep this information until one year after the research is 
conducted. We will refer participants in case they experience any distress while answering the 
surveys. 
 
Recruitment 
The sample will consist of 66 Latinas ages 18-44 years who report sexual activity with a man in 
the last six months, have access to the internet from any device (e.g., cellphone, laptop), and who 
resides in NC. We refer to Latinas as women who self-identify as having Latino ancestry. 
Latinas positive for HIV will be excluded given our focus on primary prevention. 
 
Recruitment strategies will include talking to women in the community face-to-face, using 
posters/flyers and/or brochures, and snowball sampling. The PI has used these strategies 
successfully in previous studies with Latinas. To increase the intervention's future scalability and 
reduce contact with the project staff, we will add online recruitment using Facebook Ads, found 

effective in other studies with Latinas. One month before enrollment, the research assistants 
(RAs) will begin recruitment efforts in the two El Futuro community centers and place Spanish 
and English posters, brochures in waiting rooms and online using Facebook Ads. Also, posters 
will be hung in areas where Latinas gather in the community (e.g., churches, community centers, 
coffee shops). 
For the online recruitment, we will use Facebook ads (which are part of Facebook). The PI will 
create a password protected account. The account will post the study poster automatically with 
the study contact information during one month. If a participant is interested she will need to call 
the study phone number. No contact information from participants will be requested online. The 
post option will not be available online to talk with participants. 
Potential participants will be screened by the study team (researcher/research assistant) following 
a verbal consent script for telephone screening that includes the inclusion criteria for the study.. 
We will conduct the two meetings at a convenient time for the participant in a private room and 
their preferred language using COVID precautions on-site (e.g., temperature check, symptoms 
assessment, facial mask). After the research team explain the study information, they will ask the 
potential participant if she is interested in the study. Then, the researcher/research assistant will 
ask the participant if she consents to provide personal information to determine if she qualifies 
for the study. 
 
Data monitoring 
 
Our data safety and monitoring plan will take steps to minimize the risk of breach of 
confidentiality, including procedures to prevent unauthorized use of study data. Names will not 
be attached to any research instruments or digital files, and all participant data will be 
identifiable only using the sequentially assigned Study ID number. All investigators have 
experience collecting data with HIV risk populations. 
 
Data Gathered During Screening. We will assess potential participants' eligibility for the study 
using a series of screening questions, which will not include any personal identifying 
information. We will destroy any and all notes taken during screening after we verify that each 
participant is eligible for the study. 
 
Informed Consents.  Pen-and-paper data collection methods will be used to conduct the 
informed consent process with participants. A copy of the signed informed consent will be given 
to them. If we use zoom for the baseline survey, we will use the electronic version of the 
informed consent and a copy will be sent to the participants’ preferred email address. This 
informed consent will be available in Qualtrics and only the research team will have access. 
Printed copies of the informed consents will be store in the Principal Investigator’s locked 
project office at the School of Nursing. Any printed information that might identify participants 
will be transported in a sealed folder when necessary and kept in a locked cabinet in the PI's 
office, which will be accessible only to essential 
 
Surveys. Quantitative survey data will be gathered via electronic (using Qualtrics). Pen-and-
paper data collection methods will be used in case that we have Qualtrics or internet related 
issues. Printed copies of the surveys will be store in the Principal Investigator’s locked project 
office at the School of Nursing.  

 
Data will be linked to participants' sequentially assigned Study IDs, but it will not be linked to 
their Unique IDs or to any personal identifiers. Any identifying information, including the 
participants' name and number used to set up appointments, will be kept separate from data at all 
times. Unique IDs and participant contact details will be written down and kept in a separate 
locked cabinet in the PI's office. 
 
Qualtrics will be used to collect information from the surveys. Only the research team will have 
access to Qualtrics. Participants will receive a unique link in their preferred email address that 
will give them access to the follow-up surveys. Data will be de-identified for the analysis and 
files will be saved in a password-protected computer in the Principal Investigator’s locked 
project office.  
 
When Zoom is used to conduct the surveys, we will not record the meeting and all the 
information will be saved in Qualtrics. To protect participants’ confidentiality, we will have the 
following guidelines to maintain security and safety of Zoom meetings: 
 
1. We will password protect any online meeting. We will set up a unique password for 
each meeting. All participants will be required to enter the password to join the meeting. 
2. Participants will only be allowed to join the meeting after the host (either the PI, co-Is or 
project coordinator) has arrived. In addition, we will use the waiting room feature of Zoom to 
keep participants in a waiting area until the host is ready for them. 
3. We will lock down the meeting once every expected participant has arrived. This lock 
down will prevent others from joining, even if meeting IDs or access details have been leaked. 
4. For each meeting, a randomly generated meeting ID will be created. Meeting IDs will 
be sent to participant’s email or through text messaging. 
 
Intervention website. The intervention website will not have any personal information from 
participants. Participants will access to the episodes using a password. 
 
Monitoring. 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. The 
Investigator will also discuss human subjects’ issues at weekly meetings. 
Participants in human subjects’ research inevitably give up some privacy to share data about 
their individual experiences; however, we believe our data safety and monitoring plan will 
minimize the risks of any further breach of privacy or confidentiality. The Investigators will be 
responsible for ensuring that study protocols for maintaining confidentiality are followed. 
 
Statistical Analysis Plan. For Aim 1 and Aim 2 data, we will conduct descriptive analyses of 
the outcome measures (e.g., the mean and standard deviation for continuous variables and 
frequency and proportion for categorical variables). To examine the intervention effect on HIV 
prevention in Aim 2 data analysis, we will adopt multiple mixed-effects models to analyze the 
data. Specifically, we will include behavioral outcomes (e.g., substance abuse) as the dependent 
variable. In contrast, the treatment assignment status (intervention or control), age, education 
level will be included as the fixed effect terms. The subject-level cluster effect following a 
normal distribution with a mean zero will serve as the random effect term. We will also consider 

different covariance structures among repeated measurements and conduct model selection to 
determine the optimal model and covariance structure for the data, as in our early published 
work. Alternatively, if the model does not converge, we will adopt an ANOVA model to 
investigate the intervention efficacy at each measurement time point. Though the intervention 
efficacy will be evaluated across several different outcomes in the Aim 2 data analysis, multiple 
comparisons will not be adjusted since our goal in this pilot study is to collect preliminary data to 
design future R01 study and proposal submission.