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

NCT05358366 | Completed Results

• 2 other identifiers: 21-3214550KR262124
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV Infections

Keywords

HIV; Latinas; Primary Disease Prevention; Internet Based Intervention

Outcome Measures

Primary Outcomes (6)

• Mean Condom Use

  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

• Number of Participants Who Report Change in PrEP Awareness

  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

• Number of Participants Who Report Change in PrEP Access

  Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (Possible responses: yes/no/don't know). Those participants who answered "Yes" to the PrEP awareness question were asked if they have access to PrEP.

  baseline to 4 months

• Number of Participants Who Report Changes in PrEP Use

  Changes in PrEP use will be measured as the number of participants who report that they have used PrEP (dichotomous question: yes/no). Those participants who answered "Yes" to the PrEP awareness question were asked about PrEP use.

  baseline to 4 months

• Number of Participants Who Report Change in HIV Testing

  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

• Mean Change in HIV Test Perception Score

  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 Outcomes (5)

• Mean Change in Substance Abuse Score

  baseline up to 4 months

• Mean Change in Intimate Partner Violence (IPV) Score

  baseline up to 4 months

• Mean Change in Depression (PHQ-9) Score

  baseline up to 4 months

• Number of Episodes Watched by Participants

  immediately after watching each 10-minute weekly episode for up to 4 weeks

• Number of Participants Who Are Retained Through All Study Timepoints

  baseline up to 4 months

Other Outcomes (9)

• Mean Participant Acceptability With the Intervention Content Areas Based on a 5 Point Rating System

  one-month after the baseline survey

• Change in Self-Efficacy for Condom Use

  baseline up to 1 month

• Change in Self-Efficacy for HIV Prevention

  baseline up to 1 month

Study Arms (2)

Infeccion de Amor (Love Infection)

EXPERIMENTAL

33 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: 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). 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.

Behavioral: Infeccion de Amor (Love Infection)

Wait-listed

OTHER

A wait-listed control group of 33 Latinas will receive IA in the same manner as the intervention group. Latinas will start watching the telenovela episodes 4 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.

Behavioral: Infeccion de Amor (Love Infection)

Interventions

Infeccion de Amor (Love Infection) BEHAVIORAL

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.

Infeccion de Amor (Love Infection); Wait-listed

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: This study includes female Latinas between 18 and 44 years old. Older women (\>44 years old) and younger children/adolescents (\<18) are excluded.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unwilling to be part of the study
• Do not read, speak, or understand Spanish or English
• Do not have access to internet
• HIV positive

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

El Futuro

Durham, North Carolina, 27517, United States

Location

Related Publications (39)

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MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Natalia Villegas Rodriguez, PhD
• Organization: University of North Carolina at Chapel Hill

navilleg@email.unc.edu

919-966-4260

Study Officials

• Natalia Villegas Rodriguez, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 3-month assessment.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 3, 2022
• Study Start: May 10, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and continuing for 36 months following publication
• Access Criteria: Borrower has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)