Impact of a Telenovela/Soap Opera for HIV Prevention in Latinas
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
🗓️ Study Start (Actual) 15 July 2023
🗓️ Primary Completion (Estimated) 30 April 2024
✅ Study Completion (Estimated) 30 July 2024
👥 Enrollment (Estimated) 142
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * Unwilling to be part of the study
    • * Do not read, speak, or understand Spanish or English
    • * Do not have access to internet
    • * HIV positive
Ages Eligible for Study: 18 Years to 44 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 May 2023
  • First Submitted that Met QC Criteria 26 June 2023
  • First Posted 3 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 October 2023
  • Last Update Posted 18 October 2023
  • Last Verified June 2023