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NCT05929482Completed

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

A Randomized Controlled Pilot Study to Examine the Impact of a Filmed Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention in Latinas.

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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 intervention and 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.

Status (registry)
Completed
Study type
Interventional
Enrollment
95 (actual)
First submitted
25 May 2023
Start date
15 Jul 2023
Primary completion date
31 Jul 2025
Lead sponsor
University of North Carolina, Chapel Hill
Diseases
HIV
NCT number
NCT05929482

What you commit to

  • Study type: Interventional
  • Participants enrolled: 95
  • From 15 Jul 2023 to the primary completion date, 31 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • HIV positive

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to 44 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.