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Clinical Trials/NCT01666496
NCT01666496
Completed
N/A

An Interactive Video Game for HIV Prevention in Early Adolescents

Yale University1 site in 1 country333 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV
Sponsor
Yale University
Enrollment
333
Locations
1
Primary Endpoint
Delay in the initiation of sexual activity
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 18, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lynn E. Fiellin

Associate Professor

Yale University

Eligibility Criteria

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

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.

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)

Study Sites (1)

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