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Telenovela Intervention for HIV Prevention in Latinas
N/A
Recruiting
Led By Natalia A Villegas Rodriguez, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 7 months
Awards & highlights
Study Summary
This trial will develop and test a novel online "telenovela" intervention targeting Latinas in the US, to reduce HIV disparities and increase HIV prevention.
Who is the study for?
This trial is for self-identified Latinas, aged 18-44, living in North Carolina who are sexually active with men and have internet access. They must be fluent in English or Spanish and assigned female at birth.Check my eligibility
What is being tested?
The study tests an online telenovela-style intervention called 'Infección de Amor' aimed at improving HIV prevention behaviors among Latinas. It will compare changes in condom use, HIV testing, and PrEP awareness between participants watching the episodes and a control group over seven months.See study design
What are the potential side effects?
Since this intervention involves educational content delivered through a soap opera format rather than a medical treatment, there are no direct physical side effects associated with participating in this clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Condom Use from Baseline to Month 1
Change in Condom Use from Baseline to Month 7
Change in HIV Test Perception from Baseline to Month 1
+9 moreSecondary outcome measures
Change in Depression
Change in Emotional Response
Change in Intimate Partner Violence (IPV)
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Wait-listedExperimental Treatment1 Intervention
A wait-listed control group of 71 Latinas will receive IA in the same manner as the intervention group. Latinas will start watching the telenovela episodes 7 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.
Group II: Infección de Amor (Infectious Love)Experimental Treatment1 Intervention
71 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: www.telenoveladeamor.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.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,683 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,589 Total Patients Enrolled
Natalia A Villegas Rodriguez, PhDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill School of Nursing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in either English or Spanish.I am between 18 and 44 years old.I was assigned female at birth.I have been sexually active with a man in the past 6 months.I do not want to participate in the study.I cannot read, speak, or understand Spanish or English.
Research Study Groups:
This trial has the following groups:- Group 1: Infección de Amor (Infectious Love)
- Group 2: Wait-listed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial restricted to those aged 50 and over?
"The guidelines set forth for this clinical trial stipulate that the minimum age of enrollees must be 18 years old while the cut-off is 44."
Answered by AI
Are there still open slots for volunteers in this research endeavor?
"The trial that was initially posted on 15th July 2023 is no longer actively recruiting, as per details supplied by clinicaltrials.gov. However, 459 other studies are currently seeking participants to enrol in their programs."
Answered by AI
Is participation in this experiment open to new applicants?
"The necessary qualifications for this study are a diagnosis of human immunodeficiency virus infection and an age between 18-44. A total of 142 individuals will be recruited in the trial."
Answered by AI
What outcome is this research seeking to uncover?
"This clinical trial aims to observe the Change in Condom Use from Baseline to Month 7 over a course of 1 month. Secondary objectives include tracking Number of Participants Who are Retained Through all Assessments, measuring Changes in Emotional Response with IPANAS-SF (10-50) and gauging changes in Self-Efficacy for Condom Use using an HIV self-efficacy survey (7 - 28)."
Answered by AI
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