An Interactive Video Game for HIV Prevention in Early Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 333
- Locations
- 1
- Primary Endpoint
- Delay in the initiation of sexual activity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 11-14 years
- •Able to provide assent/parental/guardian consent
- •Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
- •English-speaking
Exclusion Criteria
- •Not between the ages of 11-14 years
- •Not able to provide assent/parental/guardian consent
- •Not willing to sit at a computer for 75 minutes twice weekly to play the game
- •Non-English speaking
Arms & Interventions
Experimental Video Game
Participants will play the experimental videogame for 6 weeks. The intervention will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
Intervention: Experimental Video Game (Behavioral)
Off the Shelf Video Game
Participants will play the off the shelf videogame for 6 weeks. The intervention be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
Intervention: Off the Shelf Video Game (Behavioral)
Outcomes
Primary Outcomes
Delay in the initiation of sexual activity
Time Frame: 24 months
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Delay in the initiation of sexual activity
Time Frame: 3 weeks
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Delay in the initiation of sexual activity
Time Frame: 6 weeks
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Delay in the initiation of sexual activity
Time Frame: 3 months
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Delay in the initiation of sexual activity
Time Frame: 6 months
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Delay in the initiation of sexual activity
Time Frame: 12 months
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
Secondary Outcomes
- Knowledge about HIV/AIDS risk behaviors and transmission(24 months)
- Level of social competency in using negotiating and refusal skills in the virtual environment(24 months)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(24 months)
- Drug and alcohol use behaviors(24 months)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(24 months)
- Overall risk-taking behaviors(24 months)
- Knowledge about HIV/AIDS risk behaviors and transmission(3 weeks)
- Level of social competency in using negotiating and refusal skills in the virtual environment(3 weeks)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(3 weeks)
- Drug and alcohol use behaviors(3 weeks)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(3 weeks)
- Overall risk-taking behaviors(3 weeks)
- Knowledge about HIV/AIDS risk behaviors and transmission(6 weeks)
- Knowledge about HIV/AIDS risk behaviors and transmission(3 months)
- Knowledge about HIV/AIDS risk behaviors and transmission(6 months)
- Knowledge about HIV/AIDS risk behaviors and transmission(12 months)
- Level of social competency in using negotiating and refusal skills in the virtual environment(6 weeks)
- Level of social competency in using negotiating and refusal skills in the virtual environment(3 months)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(6 months)
- Level of social competency in using negotiating and refusal skills in the virtual environment(6 months)
- Level of social competency in using negotiating and refusal skills in the virtual environment(12 months)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(6 weeks)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(3 months)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(12 months)
- Drug and alcohol use behaviors(6 weeks)
- Drug and alcohol use behaviors(3 months)
- Drug and alcohol use behaviors(6 months)
- Drug and alcohol use behaviors(12 months)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(6 weeks)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(3 months)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(6 months)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(12 months)
- Overall risk-taking behaviors(6 weeks)
- Overall risk-taking behaviors(3 months)
- Overall risk-taking behaviors(6 months)
- Overall risk-taking behaviors(12 months)
Investigators
Lynn E. Fiellin
Associate Professor
Yale University