Infeccion de Amor (Love Infection) for HIV Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
El Futuro, Durham, NC
HIV Infections+2 More
Infeccion de Amor (Love Infection) - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
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Study 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).

Eligible Conditions

  • HIV Infections

Treatment Effectiveness

Study Objectives

12 Primary · 5 Secondary · Reporting Duration: baseline to 4 months

40 minutes
Number and Percentage of Participants who Complete all the Intervention Content
baseline to 1 month
Changes in PrEP Access from Baseline to Month 1
Changes in PrEP Use from Baseline to Month 1
baseline to 4 months
Changes in PrEP Access from Baseline to Month 4
Month 1
Change in Condom Use from Baseline to Month 1
Change in Emotional Response
Change in HIV Test Perception from Baseline to Month 1
Change in HIV Testing from Baseline to Month 1
Change in Narrative Engagement
Change in Self-Efficacy for Condom Use from Baseline to Month 1
Change in Self-Efficacy for HIV Prevention
Changes in PrEP Awareness from Baseline to Month 1
Month 4
Change in Condom Use from Baseline to Month 4
Change in Depression
Change in HIV Test Perception from Baseline to Month 4
Change in HIV Testing from Baseline to Month 4
Change in Intimate Partner Violence (IPV)
Change in Substance Abuse from Baseline to Month 4
Changes in HIV Knowledge
Changes in PrEP Awareness from Baseline to Month 4
Changes in PrEP Use from Baseline to Month 4
Changes in STI (Sexually transmitted infections) Testing
Changes in Sexual Communication with Partner
Feasibility of the Intervention
Number and Percentage of Participants Who are Retained Through all Assessments
one-month after the baseline survey
Mean Participant Acceptability with the Intervention Content Areas based on a 5 Point Rating System

Trial Safety

Trial Design

1 Treatment Group

Infeccion de Amor (Love Infection)
1 of 1
Experimental Treatment

66 Total Participants · 1 Treatment Group

Primary Treatment: Infeccion de Amor (Love Infection) · No Placebo Group · N/A

Infeccion de Amor (Love Infection)
Behavioral
Experimental Group · 1 Intervention: Infeccion de Amor (Love Infection) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 4 months
Closest Location: El Futuro · Durham, NC
Photo of durham 1Photo of durham 2Photo of durham 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching HIV Infections
0 CompletedClinical Trials

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,347 Previous Clinical Trials
3,908,522 Total Patients Enrolled
102 Trials studying HIV Infections
81,661 Patients Enrolled for HIV Infections
North Carolina Translational and Clinical Sciences InstituteOTHER
52 Previous Clinical Trials
4,444 Total Patients Enrolled
Natalia Villegas Rodriguez, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You were assigned female gender at birth.
You must be between 18 and 44 years old.
You are a North Carolina resident.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References