Reality Check: An HIV Risk Reduction Serial Drama

Sexually Transmitted Diseases Clinical Trial

— RC  

Official title:

Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352219
• Other study ID #: 822007
• Secondary ID: R34MH094207
• Status: Completed
• Phase: N/A
• First received: November 17, 2017
• Last updated: November 20, 2017
• Start date: September 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: November 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

African Americans have considerably higher rates of HIV infections than do White, Hispanic, Asian, and Native Americans. African Americans accounted for 59% of all diagnoses of HIV infection among youth (13-24 years of age) in the United States. Young African Americans also have disproportionately high rates of other sexually transmitted infections (STIs). Therefore, the broad, long-term objective of this research is to identify interventions to reduce the risk of HIV and other STIs among young African Americans. Entertainment-education refers to narrative interventions designed to change behavior while providing entertainment. Several studies have evaluated the impact of media content on HIV risk behavior. One study found that exposure to an entertainment-education based HIV testing campaign was associated with increases in HIV testing among sexually active teens 12 months post exposure. Similarly, a radio soap opera called "Twende na Wakati" became the most popular television show in Tanzania and was highly successful in reducing the number of sexual partners and increasing condom use. A narrative video intervention study in STI clinic waiting rooms in three U.S. cities found a significant reduction in STI re-infection among patients visiting during months when the video was shown compared with patients visiting during months when it was not shown. Although these studies show that entertainment-education can be a promising medium for behavior change, none of them evaluated the efficacy of a tailored online entertainment-education intervention specifically designed for African American youth. To address this gap in the literature, this study tested the preliminary efficacy of an innovative, theory-based HIV risk-reduction serial drama intervention, Reality Check, specifically tailored to young African Americans. We used a randomized controlled trial, allocating African Americans 18 to 24 years of age to Reality Check, or an attention-control intervention promoting physical activity. Each intervention was delivered as a series of videos streamed online and accessible via any Internet-capable device. Participants completed surveys online at baseline, immediately post intervention, and 3 months post intervention. We hypothesized that, Reality Check would reduce condomless sex during the 3-month post-intervention period compared with the attention-matched control group, adjusting for baseline of the criterion.

Description:

African Americans have considerably higher rates of HIV infections than do White, Hispanic, Asian, and Native Americans. African Americans accounted for 59% of all diagnoses of HIV infection among youth (13-24 years of age) in the United States. Young African Americans also have disproportionately high rates of other sexually transmitted infections (STIs). Therefore, the broad, long-term objective of this research is to identify interventions to reduce the risk of HIV and other STIs among young African Americans. Entertainment-education refers to narrative interventions designed to change behavior while providing entertainment. Several studies have evaluated the impact of media content on HIV risk behavior. One study found that exposure to an entertainment-education based HIV testing campaign was associated with increases in HIV testing among sexually active teens 12 months post exposure. Sabido and colleagues used "telenovelas" in Mexico to increase participation in a national literacy campaign and promote birth control use. Similarly, a radio soap opera called "Twende na Wakati" became the most popular television show in Tanzania and was highly successful in reducing the number of sexual partners and increasing condom use. A narrative video intervention study in STI clinic waiting rooms in three U.S. cities found a significant reduction in STI re-infection among patients visiting during months when the video was shown compared with patients visiting during months when it was not shown. Although these studies show that entertainment-education can be a promising medium for behavior change, none of them evaluated the efficacy of a tailored online entertainment-education intervention specifically designed for African American youth. To address this gap in the literature, this study tested the preliminary efficacy of an innovative, theory-based HIV risk-reduction serial drama intervention, Reality Check, specifically tailored to young African Americans and aimed at decreasing the frequency of condomless sex and promoting HIV testing among young adult African Americans. We used a randomized controlled trial, allocating African Americans 18 to 24 years of age to Reality Check, or an attention-control intervention promoting physical activity. Each intervention was delivered as a series of videos streamed online and accessible via any Internet-capable device (e.g., smartphone, laptop or tablet). This mode of delivery was well suited to young African Americans because high percentages of young African Americans own and use Internet enabled mobile phones as their primary way to consume online content. We recruited participants through Facebook and Instagram, flyers posted on college campuses, college mailing lists, and referrals from participants. Participants completed surveys online at baseline, immediately post intervention, and 3 months post intervention. We hypothesized that, Reality Check would reduce the frequency of condomless sex during the 3-month post-intervention period compared with the attention-matched control group, adjusting for baseline of the criterion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Self-identified as black or African American, had a Facebook ID, had a smartphone with access to the Internet, and reported having sexual intercourse in the previous 90 days

Exclusion Criteria:

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV (Human Immunodeficiency Virus)
• HIV Infections
• Immunologic Deficiency Syndromes
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Reality Check

• Physical Activity Attention Control

Locations

Country	Name	City	State
United States	Annenberg School for Communication, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of condomless sexual intercourse	The number of times the participant had sex without using a condom in the past 90 days	3 months post-intervention
Secondary	Frequency of condom use	Rated frequency of condom use in the past 90 days	3 months post-intervention
Secondary	Consistent (100%) condom use	A binary variable indicating whether the participants used a condom 100% of the time during sex in the past 90 days	3 months post-intervention
Secondary	Frequency of sexual intercourse	The number of times the participant had sexual intercourse in the past 90 days	3 months post-intervention
Secondary	HIV testing	A binary variable indicating whether the participant reported being tested for HIV in the past 3 months	3 months post-intervention
Secondary	Homophobia	Negative attitude toward homosexuals	Immediately post-intervention
Secondary	Homophobia	Negative attitude toward homosexuals	3 months post-intervention
Secondary	AIDS-related stigma	Negative attitudes toward AIDS	Immediately post-intervention
Secondary	AIDS-related stigma	Negative attitudes toward AIDS	3 months post-intervention