Clinical trial NCT01666496: An Interactive Game for HIV Prevention in Early Adolescents
Official title: An Interactive Video Game for HIV Prevention in Early Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Risk Reduction
Keywords: Adolescent
risk
HIV
video games
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 333
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.

Detailed description: The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens. The investigators are using proven components of HIV prevention interventions, social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming principles to develop and evaluate this interactive HIV prevention video game. In Phase 1 of this project, the investigators have been working with Schell Games of Pittsburgh, PA, Digitalmill of Portland, ME, and the Farnam Neighborhood House in New Haven, CT to develop our interactive video game with the input from our experts and focus groups and interviews with adolescents. Phase 1 has been a developmental iterative process in which the investigators have been building the software for the game for the purposes of targeting HIV prevention in our population of interest: young minority adolescents. Following development of the video game, the investigators will move to Phase 2 in which the investigators will enroll 330 minority adolescents who are attendees at one of several after-school programs in the greater New Haven area and assign them to play either the experimental game or a control game. In the experimental game, the player will be presented with a series of "risk challenges" thereby helping them to develop sex, drug and alcohol negotiation and refusal skills.

Eligibility criteria: Inclusion Criteria:

1. Ages 11-14 years
2. Able to provide assent/parental/guardian consent
3. Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
4. English-speaking

Exclusion Criteria:

1. Not between the ages of 11-14 years
2. Not able to provide assent/parental/guardian consent
3. Not willing to sit at a computer for 75 minutes twice weekly to play the game
4. Non-English speaking

Primary outcomes:
measure: Delay in the initiation of sexual activity
timeFrame: 3 weeks
measure: Delay in the initiation of sexual activity
timeFrame: 6 weeks
measure: Delay in the initiation of sexual activity
timeFrame: 3 months
measure: Delay in the initiation of sexual activity
timeFrame: 6 months
measure: Delay in the initiation of sexual activity
timeFrame: 12 months
measure: Delay in the initiation of sexual activity
timeFrame: 24 months
Secondary outcomes:
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 3 weeks
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 3 weeks
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 3 weeks
measure: Drug and alcohol use behaviors
timeFrame: 3 weeks
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 3 weeks
measure: Overall risk-taking behaviors
timeFrame: 3 weeks
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 6 weeks
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 3 months
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 6 months
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 12 months
measure: Knowledge about HIV/AIDS risk behaviors and transmission
timeFrame: 24 months
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 6 weeks
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 3 months
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 6 months
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 12 months
measure: Level of social competency in using negotiating and refusal skills in the virtual environment
timeFrame: 24 months
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 6 weeks
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 3 months
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 6 months
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 12 months
measure: Level of self-efficacy regarding negotiation around initiation of sexual activity
timeFrame: 24 months
measure: Drug and alcohol use behaviors
timeFrame: 6 weeks
measure: Drug and alcohol use behaviors
timeFrame: 3 months
measure: Drug and alcohol use behaviors
timeFrame: 6 months
measure: Drug and alcohol use behaviors
timeFrame: 12 months
measure: Drug and alcohol use behaviors
timeFrame: 24 months
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 6 weeks
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 3 months
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 6 months
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 12 months
measure: Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
timeFrame: 24 months
measure: Overall risk-taking behaviors
timeFrame: 6 weeks
measure: Overall risk-taking behaviors
timeFrame: 3 months
measure: Overall risk-taking behaviors
timeFrame: 6 months
measure: Overall risk-taking behaviors
timeFrame: 12 months
measure: Overall risk-taking behaviors
timeFrame: 24 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn E Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. J Med Internet Res. 2017 Sep 18;19(9):e314. doi: 10.2196/jmir.8148.
citation: Montanaro E, Fiellin LE, Fakhouri T, Kyriakides TC, Duncan LR. Using Videogame Apps to Assess Gains in Adolescents' Substance Use Knowledge: New Opportunities for Evaluating Intervention Exposure and Content Mastery. J Med Internet Res. 2015 Oct 28;17(10):e245. doi: 10.2196/jmir.4377.