An Interactive Game for HIV Prevention in Early Adolescents

Yale University

Status: Completed

Conditions: HIV; Risk Reduction

Treatments: Behavioral: Off the Shelf Video Game; Behavioral: Experimental Video Game

Study type: Interventional

Funder types: Other

Identifiers

NCT01666496

1208010715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 333 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 2 patient groups

Experimental Video Game

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental Video Game

Off the Shelf Video Game

Other group

Description:

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.

Treatment:

Behavioral: Off the Shelf Video Game