Telenovela Intervention for HIV Prevention in Latinas

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Natalia Villegas Rodriguez, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: HIV positive, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Infección de Amor, Love Infection for HIV prevention in Latinas?

The telenovela 'Infección de Amor' was developed with input from Latinas to promote HIV prevention behaviors, and similar interventions have shown promise in increasing engagement and reducing stigma, suggesting it could be effective in encouraging HIV prevention among Latinas. ^{1 2 3 4 5}

Is the Telenovela Intervention for HIV Prevention in Latinas safe for humans?

The available research does not provide specific safety data for the Telenovela Intervention for HIV Prevention in Latinas, but it focuses on promoting HIV prevention behaviors and does not involve any physical or medical procedures, suggesting it is generally safe for participants. ^{2 4 6 7 8}

How does the Telenovela Intervention for HIV Prevention in Latinas differ from other treatments for HIV prevention?

This treatment is unique because it uses a culturally tailored telenovela (soap opera) to promote HIV prevention behaviors among Latinas, making it more relatable and accessible compared to traditional methods. It incorporates the ideas and feedback of the target audience, which may enhance its effectiveness in reducing HIV-related disparities. ^{1 3 4 9 10}

Research Team

Natalia Villegas Rodriguez, PhD

Principal Investigator

University of North Carolina at Chapel Hill School of Nursing

Eligibility Criteria

This trial is for self-identified Latinas, aged 18-44, living in North Carolina who are sexually active with men and have internet access. They must be fluent in English or Spanish and assigned female at birth.

Inclusion Criteria

I am fluent in either English or Spanish.

I am between 18 and 44 years old.

Have internet access from any device

Exclusion Criteria

Do not have access to internet

HIV positive

I do not want to participate in the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability Testing

Participants test the feasibility and acceptability of the IA intervention website and provide feedback

1 month

1 online orientation

Randomized Controlled Trial

Participants view four IA intervention episodes, one per week, and complete post-episode surveys

4 weeks

Weekly online access to episodes

Follow-up

Participants are monitored for changes in HIV prevention behaviors with surveys at 1 month and 7 months post-baseline

6 months

Surveys at 1 month and 7 months

Treatment Details

Interventions

• Infección de Amor (Behavioural Intervention)

Trial Overview The study tests an online telenovela-style intervention called 'Infección de Amor' aimed at improving HIV prevention behaviors among Latinas. It will compare changes in condom use, HIV testing, and PrEP awareness between participants watching the episodes and a control group over seven months.

Participant Groups

Group I: Wait-listed Experimental Treatment 1 Intervention

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.

Group II: Infección de Amor (Infectious Love) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

A culturally appropriate meta-intervention significantly increased the intention to enroll in HIV-prevention counseling among Latino participants, with 96% of those in the experimental group expressing interest compared to only 53% in the control group.

The positive effects of the meta-intervention were consistent across different genders and ages, suggesting it could be a broadly effective strategy for improving participation in HIV-prevention programs within the Latino community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing cultural and psychological barriers to Latino enrollment in HIV-prevention counseling: initial data on an enrollment meta-intervention. Wilson, K., Durantini, MR., Albarracín, J., et al.[2021]

A study involving 274 Hispanic women in South Florida found that 57% engaged in the SEPA educational intervention, indicating a willingness to participate in group support despite risks of HIV and intimate partner violence.

Factors such as education level, experiences of intimate partner violence, and acculturation significantly influenced engagement, highlighting the need for tailored outreach to connect with women who have lower education and are at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in SEPA, a sexual and relational health intervention for Hispanic women. Mitrani, VB., McCabe, BE., Gonzalez-Guarda, RM., et al.[2021]

A study conducted in Botswana found that viewers of the television drama The Bold and the Beautiful, which featured a positive portrayal of HIV, reported significantly lower levels of HIV-related stigma compared to nonviewers.

The results suggest that media portrayals of HIV in a compassionate and accepting way can effectively reduce stigma associated with the disease, highlighting the potential of television as a tool for public health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between exposure to an HIV story line in The Bold and the Beautiful and HIV-related stigma in Botswana. O'Leary, A., Kennedy, M., Pappas-DeLuca, KA., et al.[2019]

A culturally tailored telenovela was developed to promote HIV prevention behaviors among Latinas, addressing the urgent need for effective interventions in this community.

The study involved 44 Spanish-speaking Latinas aged 18-35, and the telenovela was created based on their feedback, highlighting the importance of community involvement in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infección de Amor (Infectious Love): Development and Acceptability of a Telenovela/Soap Opera Intervention for HIV Prevention For Latinas. Villegas, N., Norris, AE., Cianelli, R., et al.[2023]

The study identified key sociocultural factors influencing HIV risk among adult Latino men, highlighting barriers to healthcare access and the impact of traditional masculinity on risk behaviors.

Engaging Latino soccer leagues as social networks presents a promising strategy for developing targeted interventions to promote health and reduce sexual risk, addressing a population often overlooked by standard HIV prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Latino men's HIV risk using community-based participatory research. Rhodes, SD., Eng, E., Hergenrather, KC., et al.[2022]

The Sólo Se Vive Una Vez campaign, aimed at improving HIV testing among Latinx immigrants in Baltimore, did not increase the overall number of Latinx individuals getting tested for HIV.

However, those who were exposed to the campaign showed higher rates of high-risk sexual behaviors and substance use, along with increased referrals for PrEP (pre-exposure prophylaxis) through the outreach team.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sólo Se Vive Una Vez: Evaluation of a Social Marketing Campaign Promoting HIV Screening and Prevention for Immigrant Latinxs. Shah, HS., Grieb, SMD., Flores-Miller, A., et al.[2022]

Latinas are significantly more vulnerable to HIV, being four times more likely to contract the virus compared to White women, highlighting a critical public health issue.

The review of 20 studies on HIV prevention interventions for U.S. Latinas revealed a lack of focus on direct measures of HIV risk reduction, such as condom use, and insufficient incorporation of culturally relevant strategies that address gender dynamics and cultural norms affecting this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral HIV Prevention Interventions Among Latinas in the US: A Systematic Review of the Evidence. Daniel-Ulloa, J., Ulibarri, M., Baquero, B., et al.[2022]

Latina women experiencing intimate partner violence (IPV) are particularly concerned about HIV infection, primarily due to partner infidelity and experiences of forced sex, highlighting the need for targeted interventions.

Focus groups revealed that monolingual Latinas had lower HIV knowledge and were more likely to discuss myths about the virus, while bilingual Latinas engaged more with prevention techniques, indicating that HIV/AIDS prevention programs must be culturally tailored to address the specific needs and knowledge gaps of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promotion of Latina Health: Intersectionality of IPV and Risk for HIV/AIDS. Rountree, MA., Granillo, T., Bagwell-Gray, M.[2021]

The Guide-Enhanced Love, Sex, and Choices (GELSC) video series was effective in influencing sexual behaviors among at-risk Black urban women, with 40 participants engaging with the content after recruitment through Facebook ads.

The study demonstrated the feasibility of using Facebook for recruiting high-risk participants, achieving a recruitment rate of 10 per week, which is an improvement over previous methods, and successfully retaining participants for follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Is Your Man Stepping Out?" An Online Pilot Study to Evaluate Acceptability of a Guide-Enhanced HIV Prevention Soap Opera Video Series and Feasibility of Recruitment by Facebook Advertising. Jones, R., Lacroix, LJ., Nolte, K.[2022]

A 27-episode video serial drama was developed to address HIV-related issues among Black youth, focusing on testing, sexual behaviors, stigma, and attitudes towards sexual minorities, using behavior-change principles and audience input.

The involvement of the target audience in the development process likely increased the intervention's acceptability and effectiveness, suggesting that narrative communication can be a powerful tool for public health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Video-Delivered Serial Drama Designed to Reduce Community Homophobia and HIV Stigma, Decrease Sexual Risk Behavior, and Increase HIV Testing Among Black Youth. O'Leary, A., Willis, LA., Henny, KD., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Reducing cultural and psychological barriers to Latino enrollment in HIV-prevention counseling: initial data on an enrollment meta-intervention. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Participation in SEPA, a sexual and relational health intervention for Hispanic women. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Association between exposure to an HIV story line in The Bold and the Beautiful and HIV-related stigma in Botswana. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Infección de Amor (Infectious Love): Development and Acceptability of a Telenovela/Soap Opera Intervention for HIV Prevention For Latinas. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Exploring Latino men's HIV risk using community-based participatory research. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sólo Se Vive Una Vez: Evaluation of a Social Marketing Campaign Promoting HIV Screening and Prevention for Immigrant Latinxs. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral HIV Prevention Interventions Among Latinas in the US: A Systematic Review of the Evidence. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Promotion of Latina Health: Intersectionality of IPV and Risk for HIV/AIDS. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

"Is Your Man Stepping Out?" An Online Pilot Study to Evaluate Acceptability of a Guide-Enhanced HIV Prevention Soap Opera Video Series and Feasibility of Recruitment by Facebook Advertising. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Development of a Video-Delivered Serial Drama Designed to Reduce Community Homophobia and HIV Stigma, Decrease Sexual Risk Behavior, and Increase HIV Testing Among Black Youth. [2023]