Overview

This trial is active, not recruiting.

Conditions hiv, risk reduction
Treatments experimental video game, off the shelf video game
Sponsor Yale University
Start date January 2013
End date September 2016
Trial size 333 participants
Trial identifier NCT01666496, 1208010715

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
experimental video game
Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
(Other)
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.
off the shelf video game
Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.

Primary Outcomes

Measure
Delay in the initiation of sexual activity
time frame: 3 weeks
Delay in the initiation of sexual activity
time frame: 6 weeks
Delay in the initiation of sexual activity
time frame: 3 months
Delay in the initiation of sexual activity
time frame: 6 months
Delay in the initiation of sexual activity
time frame: 12 months
Delay in the initiation of sexual activity
time frame: 24 months

Secondary Outcomes

Measure
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 3 weeks
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 3 weeks
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 3 weeks
Drug and alcohol use behaviors
time frame: 3 weeks
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 3 weeks
Overall risk-taking behaviors
time frame: 3 weeks
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 6 weeks
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 3 months
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 6 months
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 12 months
Knowledge about HIV/AIDS risk behaviors and transmission
time frame: 24 months
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 6 weeks
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 3 months
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 6 months
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 12 months
Level of social competency in using negotiating and refusal skills in the virtual environment
time frame: 24 months
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 6 weeks
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 3 months
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 6 months
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 12 months
Level of self-efficacy regarding negotiation around initiation of sexual activity
time frame: 24 months
Drug and alcohol use behaviors
time frame: 6 weeks
Drug and alcohol use behaviors
time frame: 3 months
Drug and alcohol use behaviors
time frame: 6 months
Drug and alcohol use behaviors
time frame: 12 months
Drug and alcohol use behaviors
time frame: 24 months
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 6 weeks
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 3 months
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 6 months
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 12 months
Level of self-efficacy in negotiating situations involving offers of drugs and alcohol
time frame: 24 months
Overall risk-taking behaviors
time frame: 6 weeks
Overall risk-taking behaviors
time frame: 3 months
Overall risk-taking behaviors
time frame: 6 months
Overall risk-taking behaviors
time frame: 12 months
Overall risk-taking behaviors
time frame: 24 months

Eligibility Criteria

Male or female participants from 11 years up to 14 years old.

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

Additional Information

Official title An Interactive Video Game for HIV Prevention in Early Adolescents
Principal investigator Lynn E Fiellin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Yale University.