Impact of a Telenovela/Soap Opera for HIV Prevention in Latinas

NCT05929482 | Completed DMC

• 2 other identifiers: 22-06301R34DA053887-01A1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; Latinas; Primary Disease Prevention; Internet Based Intervention

Outcome Measures

Primary Outcomes (12)

• Change in Condom Use from Baseline to Month 1

  Changes in 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 1 month

• Change in Condom Use from Baseline to Month 7

  Changes in 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 7 months

• Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 1

  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 1 month

• Changes in Pre-exposure Prophylaxis [PrEP] Awareness from Baseline to Month 7

  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 7 months

• Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 1

  Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no)

  baseline to 1 month

• Changes in Pre-exposure Prophylaxis [PrEP] Access from Baseline to Month 7

  Changes in PrEP access will be measured as the number of participants who report that they have access to PrEP (dichotomous question: yes/no)

  baseline to 7 months

• Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 1

  Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no)

  baseline to 1 month

• Changes in Pre-exposure Prophylaxis [PrEP] Use from Baseline to Month 7

  Changes in PrEP use will be measured as the number of participants who self-report whether they use PrEP medication (dichotomous question: yes/no).

  baseline up to 7 months

• Change in HIV Testing from Baseline to Month 1

  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 1 month

• Change in HIV Testing from Baseline to Month 7

  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 7 months

• Change in HIV Test Perception from Baseline to Month 1

  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 1 month

• Change in HIV Test Perception from Baseline to Month 7

  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 7 months

Secondary Outcomes (14)

• Number of Participants who Complete all the Intervention Content

  40-minute

• Number of Participants Who are Retained Through all Assessments

  baseline up to 7 months

• Change in Emotional Response

  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.

• Change in Narrative Engagement

  week 1 to week 4

• Change in Self-Efficacy for Condom Use

  week 1 to week 4

Study Arms (2)

Infección de Amor (Infectious Love)

EXPERIMENTAL

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.

Behavioral: Infección de Amor (Infectious Love)

Wait-listed

EXPERIMENTAL

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.

Behavioral: Infección de Amor (Infectious Love)

Interventions

Infección de Amor (Infectious Love) BEHAVIORAL

Infectious Love is a filmed dramatized story (telenovela/soap opera) 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.

Infección de Amor (Infectious Love); 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
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

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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

Study Officials

• Natalia A Villegas Rodriguez, PhD

  University of North Carolina at Chapel Hill School of Nursing

  PRINCIPAL INVESTIGATOR

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 6-month assessment.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 3, 2023
• Study Start: July 15, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

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)