HIV (Human Immunodeficiency Virus)RCNCT03352219
Reality Check: An HIV Risk Reduction Serial Drama
A study testing Reality Check in people with HIV (Human Immunodeficiency Virus) and Sexually Transmitted Diseases, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Sexually Transmitted Diseases
- What is being tested?
- Reality Check
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Annenberg School for Communication, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Being tested
- Reality Check, Physical Activity Attention Control
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Sexual Behavior, Homophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reality CheckBehavioural
Physical Activity Attention ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Reality Check | Experimental | 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. Receives: Behavioral: Reality Check |
| Physical Activity Attention Control | Placebo comparator | 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. Receives: Behavioral: Physical Activity Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of condomless sexual intercourse
The number of times the participant had sex without using a condom in the past 90 days
Measured: 3 months post-intervention
Secondary outcomes (8)
Frequency of condom use
Rated frequency of condom use in the past 90 days
Measured: 3 months post-intervention
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
Measured: 3 months post-intervention
Frequency of sexual intercourse
The number of times the participant had sexual intercourse in the past 90 days
Measured: 3 months post-intervention
HIV testing
A binary variable indicating whether the participant reported being tested for HIV in the past 3 months
Measured: 3 months post-intervention
Homophobia
Negative attitude toward homosexuals
Measured: Immediately post-intervention
Homophobia
Negative attitude toward homosexuals
Measured: 3 months post-intervention
AIDS-related stigma
Negative attitudes toward AIDS
Measured: Immediately post-intervention
AIDS-related stigma
Negative attitudes toward AIDS
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Sep 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John B Jemmott III, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352219
- Sponsor's protocol ID
- 822007
- Other IDs
- R34MH094207
- Acronym
- RC
- Status last verified
- Nov 2017
- First submitted
- 17 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reality Check: Evaluation of an HIV Risk Reduction Serial Drama for Black Youth
- ClinicalTrials.gov ID
- NCT03352219
- Acronym / sponsor ID
- RC / 822007
- Keywords
- Human immunodeficiency virus, Sexually transmitted disease, African Americans, Young adults, Behavioral intervention, Entertainment-Education, Serial drama, Sexual behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reality Check | Experimental | Behavioral: Reality CheckReceived 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. |
| Physical Activity Attention Control | Placebo comparator | Behavioral: Physical Activity Attention ControlReceived 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reality Check | Behavioural | Reality Check |
| Physical Activity Attention Control | Behavioural | Physical Activity Attention Control |
Primary outcome
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
8 secondary outcomes
Frequency of condom use
Time frame: 3 months post-intervention
Consistent (100%) condom use
Time frame: 3 months post-intervention
Frequency of sexual intercourse
Time frame: 3 months post-intervention
HIV testing
Time frame: 3 months post-intervention
Homophobia
Time frame: Immediately post-intervention
Homophobia
Time frame: 3 months post-intervention
AIDS-related stigma
Time frame: Immediately post-intervention
AIDS-related stigma
Time frame: 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B Jemmott III, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reality Check in people with HIV (Human Immunodeficiency Virus) and Sexually Transmitted Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of condomless sexual intercourse (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.