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}

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of North Carolina at Chapel Hill Chapel Hill, NC

El Futuro Durham, NC

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill Lead Sponsor

National Institute on Drug Abuse (NIDA) Collaborator

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] Aspects of Latino culture (e.g., machismo, marianism) can act as barriers to enrollment in HIV-prevention programs. To lift these barriers, a culturally appropriate meta-intervention was designed to increase intentions to enroll in HIV-prevention counseling by Latinos. Latino participants (N=41) were recruited from the community and randomly assigned to either an experimental or control meta-intervention condition that varied the introduction to a HIV-prevention counseling program. Following the meta-intervention, participants were issued an invitation to take part in HIV-prevention counseling. The outcome measure was the intention to enroll in a HIV-prevention counseling session. Findings indicated that enrollment intentions were higher in the experimental meta-intervention condition (96%) than in the control meta-intervention condition (53%). In addition, the effects of the meta-intervention were comparable across genders and participant ages. Findings suggest that the use of a culturally appropriate meta-intervention may be an effective strategy for increasing Latino enrollment in HIV-prevention programs. These promising findings warrant further investigation into the efficacy and effectiveness of this meta-intervention.

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

Participation in SEPA, a sexual and relational health intervention for Hispanic women. [2021] HIV and intimate partner violence (IPV) risks are linked in Hispanic women, so integrated interventions can efficiently produce meaningful change. Integrated interventions for Hispanic women are promising, but factors that put Hispanic women at risk for HIV and violence may also impede engagement with interventions. This study examined barriers and facilitators of engagement in a group educational intervention, SEPA (Salud, Educación, Prevención y Autocuidado [Health, Education, Prevention, and Self-Care]), for Hispanic women. A total of 274 Hispanic women from South Florida in the SEPA condition of a randomized controlled trial completed baseline measures of violence, depression, familism, Hispanic stress, acculturation, and demographics, and 57% of the women engaged (attended two of five sessions). Education, IPV, and acculturation predicted engagement. Understanding engagement advances intervention development/refinement. Hispanic women who experience relationship violence are open to group interventions. Further program development and outreach work are needed to connect women with low education, who are particularly vulnerable.

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] HIV stigma militates against prevention and care efforts and is a significant problem in sub-Saharan Africa. During 2001-2003, after collaboration with CDC scientists from the Centers for Disease Control and Prevention, the television drama The Bold and the Beautiful aired an HIV-related story line. The story line involved a man who tested positive for HIV, was accepted by his HIV-negative fiancée, and with her, adopted an AIDS orphan in Africa. We wished to test the hypothesis that viewers of this story line would report significantly lower AIDS-related stigma than nonviewers. We surveyed a sample of residents of Botswana shortly after the story line aired there. We assessed the association between viewership of the soap opera and HIV stigma. Compared with nonviewers of the show, viewers indicated significantly lower levels of HIV stigma, when other related factors were controlled statistically. These results are suggestive that stigma was reduced after watching a television drama in which HIV infection was treated in a nonstigmatizing, humane manner.

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] Latinas continue to be disproportionately affected by HIV in the United States. Effective interventions to address HIV-related disparities among Latinas are available; however, they have not achieved widespread dissemination due to implementation challenges for real-world settings. A culturally tailored intervention that increases access to HIV prevention is urgently needed. The objective of this study was to develop a culturally tailored telenovela (i.e., a soap opera) to promote HIV prevention behaviors (condom use; HIV testing; and pre-exposure prophylaxis awareness, access, and use) among Latinas. The study was conducted in community organizations throughout South Florida. A total of 44 Spanish-speaking Latinas, 18-35 years old, and sexually active with a man in the past 6 months participated in the study. The final product was an HIV prevention telenovela that incorporated Latinas' ideas and feedback and was produced as four 10-minute filmed episodes. This study aimed to develop innovative approaches to reduce HIV-related disparities for Latinas.

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

Exploring Latino men's HIV risk using community-based participatory research. [2022] To explore sociocultural determinants of HIV risk and identify potential intervention approaches among adult Latino men.

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] Latinxs in the U.S. are disproportionately affected by HIV and more likely to have delayed diagnosis than their non-Latinx peers. We developed and implemented Sólo Se Vive Una Vez (You Only Live Once), the first Spanish-language campaign aimed at improving HIV testing and prevention among Latinx immigrants in Baltimore, Maryland. Sólo Se Vive Una Vez featured a website ( www.solovive.org ) and social marketing campaign promoting free HIV testing through the Baltimore City Health Department (BCHD) clinic and Latinx outreach team. The campaign was not associated with a change in the overall number of Latinxs obtaining HIV testing. However, Latinx HIV testers who reported being exposed to the campaign had significantly higher rates of high-risk sexual behaviors, mean number of sexual partners, and substance use. The campaign was also associated with increased PrEP referrals through the BCHD Latinx outreach team.

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

Behavioral HIV Prevention Interventions Among Latinas in the US: A Systematic Review of the Evidence. [2022] Compared to White women, Latinas are 4 times more likely to contract HIV. In an effort to determine the overall state of the science meant to address this disparity, we reviewed the current HIV prevention intervention literature for U.S. Latinas. We searched 5 online electronic databases from their inception through July, 2014, for HIV prevention interventions including a majority sample of Latinas. Of 1041 articles identified, 20 studies met inclusion criteria. We documented study designs, participant characteristics, outcomes, theories used, and other intervention characteristics. Overall, HIV knowledge and attitudes were the predominant outcome; a small minority of studies included self-reported condom use or STD incidence. Strategies used to address cultural factors specific to Latinas and HIV included; lay health advisors, using ethnographic narratives, or using the Theory of Gender and Power, however few of the interventions adopted these strategies. This study identified several gaps in the intervention literature that need to be addressed. In addition to including more direct measures of decreased HIV risk (ex. condom use), more systematic use of strategies meant to address gender and cultural factors that may place Latinas at increased risk (e.g., gender inequity, traditional gender role norms such as machismo and marianismo, and relationship power dynamics).

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

Promotion of Latina Health: Intersectionality of IPV and Risk for HIV/AIDS. [2021] Latina women in the United States are vulnerable to two intersecting public health concerns: intimate partner violence (IPV) and subsequent risk for HIV/AIDS infection. Examination of the cultural and contextual life factors of this understudied population is crucial to developing culturally relevant HIV interventions. Focus groups with Latinas (15 monolingual; 10 bilingual) who have experienced IPV were conducted. Monolingual and bilingual Latinas endorsed that they were concerned about HIV infection, naming partner infidelity and experiences of forced and coerced sex as primary reasons for their concern. However, monolingual participants had lower levels of HIV knowledge, spending much time discussing myths of HIV infection, whereas bilingual participants spent more time discussing specific prevention techniques, including challenges related to the violence in their relationships. These findings suggest that HIV/AIDS prevention programs for Latinas need to pay close attention to the different historical, contextual, and cultural experiences of this at-risk group of women.

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] Love, Sex, and Choices (LSC) is a 12-episode soap opera video series developed to reduce HIV risk among at-risk Black urban women. We added a video guide commentator to offer insights at critical dramatic moments. An online pilot study evaluated acceptability of the Guide-Enhanced LSC (GELSC) and feasibility of Facebook advertising, streaming to smartphones, and retention. Facebook ads targeted high-HIV-prevalence areas. In 30 days, Facebook ads generated 230 screening interviews: 84 were high risk, 40 watched GELSC, and 39 followed up at 30 days. Recruitment of high-risk participants was 10 per week, compared to seven per week in previous field recruitment. Half the sample was Black; 12% were Latina. Findings suggest GELSC influenced sex scripts and behaviors. It was feasible to recruit young urban women from a large geographic area via Facebook and to retain the sample. We extended the reach to at-risk women by streaming to mobile devices.

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] This article describes the development of a video serial drama intervention that was designed to address factors that influence HIV in the United States among Black youth. These include HIV testing, sexual behaviors not protected by condoms, negative attitudes towards sexual minorities, and HIV stigma. Behavior-change principles (social learning theory and education-entertainment) and input from members of the priority audience formed the basis of this 27-episode (3 minutes each) drama for dissemination on multiple platforms, including in public spaces or privately online. The developmental process, specifically involving members of the population of interest and use of behavioral theory, enriched the narrative elements and likely ensured intervention acceptability, enhancing effectiveness. Public health practitioners and prevention programmers may want to consider using this intervention and/or the narrative communication approach when intervening to change behavior.