- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352219
Reality Check: An HIV Risk Reduction Serial Drama (RC)
November 20, 2017 updated by: University of Pennsylvania
Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
203
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Annenberg School for Communication, University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of condom use
Time Frame: 3 months post-intervention
|
Rated frequency of condom use in the past 90 days
|
3 months post-intervention
|
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
|
3 months post-intervention
|
Frequency of sexual intercourse
Time Frame: 3 months post-intervention
|
The number of times the participant had sexual intercourse in the past 90 days
|
3 months post-intervention
|
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
|
3 months post-intervention
|
Homophobia
Time Frame: Immediately post-intervention
|
Negative attitude toward homosexuals
|
Immediately post-intervention
|
Homophobia
Time Frame: 3 months post-intervention
|
Negative attitude toward homosexuals
|
3 months post-intervention
|
AIDS-related stigma
Time Frame: Immediately post-intervention
|
Negative attitudes toward AIDS
|
Immediately post-intervention
|
AIDS-related stigma
Time Frame: 3 months post-intervention
|
Negative attitudes toward AIDS
|
3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John B Jemmott III, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
March 31, 2017
Study Completion (Actual)
March 31, 2017
Study Registration Dates
First Submitted
November 17, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Sexually Transmitted Diseases
Other Study ID Numbers
- 822007
- R34MH094207 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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