ClinicalTrials.gg
CompletedNCT03352219RCUpdated Nov 24, 2017

Reality Check: An HIV Risk Reduction Serial Drama

An interventional study of Reality Check and Physical Activity Attention Control in HIV (Human Immunodeficiency Virus) and Sexually Transmitted Diseases, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-24.

Primary conditionSexually Transmitted DiseasesRegistry: Acquired Immunodeficiency SyndromeReclassifiedWhy we changed it
Registry
Acquired Immunodeficiency Syndrome — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sexually Transmitted Diseases
Why
  1. The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Sexually Transmitted Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2016, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Sexually Transmitted Diseases by University of Pennsylvania — none open to participants now, 1 under way, none of them phase 3. Sexually Transmitted Diseases · University of Pennsylvania.

Enrollment
12th of 13
203 · median 662
Started
2016
the only one that year
No phase
11 of 13
none open now
Registered
11th of 13
by date

Among the 13 studies in Sexually Transmitted Diseases by University of Pennsylvania, this one is the 12th largest by enrollment, is the only one that started in 2016, is one of 11 with no phase, and was the 11th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study11 · 0 open
Phase 2/31 · 0 open
Phase 31 · 0 open

By the year they started

First in 2001; this study’s year is marked. 1 started in 2016.

Size and results

Median enrollment 662 across the 13 interventional studies. Of the 12 that completed or were terminated, 6 (50%) have results posted.

Was this useful?
Download CSVWith an account: the 13 studies in Sexually Transmitted Diseases by University of Pennsylvania as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
04

In context

Sexually Transmitted Diseases Reclassified

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

This study's enrollment of 203 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Compared within Sexually Transmitted Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
203 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralReality Check
  • BehavioralPhysical Activity Attention Control
07

What researchers measure

Primary outcomes

  1. Frequency of condomless sexual intercourse

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

    Time frame: 3 months post-intervention

Secondary outcomes

  1. Frequency of condom use

    Rated frequency of condom use in the past 90 days

    Time frame: 3 months post-intervention

  2. 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

    Time frame: 3 months post-intervention

  3. Frequency of sexual intercourse

    The number of times the participant had sexual intercourse in the past 90 days

    Time frame: 3 months post-intervention

  4. HIV testing

    A binary variable indicating whether the participant reported being tested for HIV in the past 3 months

    Time frame: 3 months post-intervention

  5. Homophobia

    Negative attitude toward homosexuals

    Time frame: Immediately post-intervention

  6. Homophobia

    Negative attitude toward homosexuals

    Time frame: 3 months post-intervention

  7. AIDS-related stigma

    Negative attitudes toward AIDS

    Time frame: Immediately post-intervention

  8. AIDS-related stigma

    Negative attitudes toward AIDS

    Time frame: 3 months post-intervention

08

Study locations

1 site
  • Annenberg School for Communication, University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Mar 2017, 6 months.

Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 6 months is below that.

Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Nov 24, 2017
StartActual
Sep 1, 2016
Primary completionActual
Mar 31, 2017
CompletionActual
Mar 31, 2017
Last update
Nov 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03352219
Responsible party
Sponsor
First posted
Nov 24, 2017
Start date
Sep 1, 2016
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Nov 24, 2017

Study contacts

John B Jemmott III, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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