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

Primary Purpose

HIV (Human Immunodeficiency Virus), Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reality Check
Physical Activity Attention Control
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV (Human Immunodeficiency Virus) focused on measuring Human immunodeficiency virus, Sexually transmitted disease, African Americans, Young adults, Behavioral intervention, Entertainment-Education, Serial drama, Sexual behavior, HIV testing, Homophobia, Social cognitive theory

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Annenberg School for Communication, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reality Check

Physical Activity Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of condomless sexual intercourse
The number of times the participant had sex without using a condom in the past 90 days

Secondary Outcome Measures

Frequency of condom use
Rated frequency of condom use in the past 90 days
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
Frequency of sexual intercourse
The number of times the participant had sexual intercourse in the past 90 days
HIV testing
A binary variable indicating whether the participant reported being tested for HIV in the past 3 months
Homophobia
Negative attitude toward homosexuals
Homophobia
Negative attitude toward homosexuals
AIDS-related stigma
Negative attitudes toward AIDS
AIDS-related stigma
Negative attitudes toward AIDS

Full Information

First Posted
November 17, 2017
Last Updated
November 20, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03352219
Brief Title
Reality Check: An HIV Risk Reduction Serial Drama
Acronym
RC
Official Title
Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reality Check
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity Attention Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reality Check
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Attention Control
Primary Outcome Measure Information:
Title
Frequency of condomless sexual intercourse
Description
The number of times the participant had sex without using a condom in the past 90 days
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Frequency of condom use
Description
Rated frequency of condom use in the past 90 days
Time Frame
3 months post-intervention
Title
Consistent (100%) condom use
Description
A binary variable indicating whether the participants used a condom 100% of the time during sex in the past 90 days
Time Frame
3 months post-intervention
Title
Frequency of sexual intercourse
Description
The number of times the participant had sexual intercourse in the past 90 days
Time Frame
3 months post-intervention
Title
HIV testing
Description
A binary variable indicating whether the participant reported being tested for HIV in the past 3 months
Time Frame
3 months post-intervention
Title
Homophobia
Description
Negative attitude toward homosexuals
Time Frame
Immediately post-intervention
Title
Homophobia
Description
Negative attitude toward homosexuals
Time Frame
3 months post-intervention
Title
AIDS-related stigma
Description
Negative attitudes toward AIDS
Time Frame
Immediately post-intervention
Title
AIDS-related stigma
Description
Negative attitudes toward AIDS
Time Frame
3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Jemmott III, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annenberg School for Communication, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reality Check: An HIV Risk Reduction Serial Drama

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