Clinical Trials

MainTitle

Reality Check: An HIV Risk Reduction Serial Drama (RC)

This study has been completed
Sponsor
University of Pennsylvania

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
University of Pennsylvania
ClinicalTrials.gov Identifier
NCT03352219

First received: November 17, 2017
Last updated: November 20, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV (Human Immunodeficiency Virus)
Sexually Transmitted Diseases

Behavioral : Reality Check
Behavioral : Physical Activity Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures

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

Enrollment: 203
Study Start Date: September 1, 2016
Study Completion Date: March 31, 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Reality Check
Received streamed 13-episode HIV risk reduction serial drama, Reality Check, developed based on Social Cognitive Theory integrated with findings from focus groups and community advisory boards. Each character has a behavioral trajectory related to HIV. For example, one character modeled negotiating condom use with his partner when she was against it. Messages in the serial drama showed that the characters had normative support for HIV testing and condom use. One character modeled a mastery experience when she overcame her fear and got tested for HIV. Homophobia is addressed when a mother discovers that her son is gay. Over the course of the episodes, the interweaving storylines play out, with all the characters eventually achieving their positive goals.
Behavioral: Reality Check
Placebo Comparator: Physical Activity Attention Control
Received streamed physical activity promotion videos designed to control for Hawthorne effects, including special attention, consisting of a series of 13 videos from YouTube on physical activity and exercise. The videos, selected to be appropriate for African Americans 18 to 24 years of age, were tailored to be gender specific and hence varied between men and women. The videos focused on the importance of physical activity, coping strategies for lack of motivation to engage in physical activity, and other challenges faced in becoming more physically active, provided specific knowledge and skills regarding how to engage in aerobic and muscle-strengthening exercises, and model aerobic and muscle-strengthening exercises in a variety of settings.
Behavioral: Physical Activity Attention Control

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

Eligibility

Ages Eligible for Study: 18 Years to 24 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03352219

Locations

United States, Pennsylvania
Annenberg School for Communication, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: John B Jemmott III, PhD University of Pennsylvania
More Information

More Information


Responsible Party: University of Pennsylvania  
ClinicalTrials.gov Identifier: NCT03352219   History of Changes  
Other Study ID Numbers: 822007  
  R34MH094207  
Study First Received: November 17, 2017  
Last Updated: November 20, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by University of Pennsylvania:

Human immunodeficiency virus
Sexually transmitted disease
African Americans
Young adults
Behavioral intervention
Entertainment-Education
Serial drama
Sexual behavior
HIV testing
Homophobia
Social cognitive theory

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.