Clinical trial NCT03352219: Reality Check: An HIV Risk Reduction Serial Drama
Official title: Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Sexually Transmitted Diseases
Keywords: Human immunodeficiency virus
Sexually transmitted disease
African Americans
Young adults
Behavioral intervention
Entertainment-Education
Serial drama
Sexual behavior
HIV testing
Homophobia
Social cognitive theory
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-11-24
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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:

* None

Primary outcomes:
measure: Frequency of condomless sexual intercourse
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Frequency of condom use
timeFrame: 3 months post-intervention
measure: Consistent (100%) condom use
timeFrame: 3 months post-intervention
measure: Frequency of sexual intercourse
timeFrame: 3 months post-intervention
measure: HIV testing
timeFrame: 3 months post-intervention
measure: Homophobia
timeFrame: Immediately post-intervention
measure: Homophobia
timeFrame: 3 months post-intervention
measure: AIDS-related stigma
timeFrame: Immediately post-intervention
measure: AIDS-related stigma
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Annenberg School for Communication, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: John B Jemmott III, PhD
role: PRINCIPAL_INVESTIGATOR
References: