An Interactive Game for HIV Prevention in Early Adolescents

HIV Clinical Trial

Official title:

An Interactive Video Game for HIV Prevention in Early Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666496
• Other study ID #: 1208010715
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: June 26, 2017
• Start date: January 2013
• Est. completion date: June 18, 2016

Study information

• Verified date: February 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: June 18, 2016
• Est. primary completion date: June 18, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Risk Reduction

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay in the initiation of sexual activity	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.	3 weeks
Primary	Delay in the initiation of sexual activity	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.	6 weeks
Primary	Delay in the initiation of sexual activity	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.	3 months
Primary	Delay in the initiation of sexual activity	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.	6 months
Primary	Delay in the initiation of sexual activity	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.	12 months
Primary	Delay in the initiation of sexual activity	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.	24 months
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	3 weeks
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents. Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	3 weeks
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	3 weeks
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	3 weeks
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	3 weeks
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	3 weeks
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	6 weeks
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	3 months
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	6 months
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	12 months
Secondary	Knowledge about HIV/AIDS risk behaviors and transmission	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases HIV risk knowledge in minority early adolescents.	24 months
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents.Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	6 weeks
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents.Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	3 months
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents.Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	6 months
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents. Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	12 months
Secondary	Level of social competency in using negotiating and refusal skills in the virtual environment	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases social competency in using negotiating and refusal skills in the virtual environment in minority early adolescents.Social competency is defined as skills that allow the individual to achieve personal goals in social interaction while maintaining positive relationships with others over time and across situations. This will be captured through data collected during the game play, including the participant's ability to negotiate social situations and successfully refuse risky situations.	24 months
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	6 weeks
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	3 months
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	6 months
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	12 months
Secondary	Level of self-efficacy regarding negotiation around initiation of sexual activity	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy regarding negotiation around initiation of sexual activity in minority adolescents.We will use 7 items to assess self-efficacy to refuse sexual behaviors. Participants will be presented with the situation "imagine you are alone with someone you like very much" and then asked to indicate how confident they are that they could stop the person if he or she wanted to (a) kiss them on the lips, (b) touch their chest or breasts, (c) touch their private parts below the waist, (d) have oral sex, or (e) have vaginal sex. Participants will report how confident they are that they could refuse sex if they had been drinking or had strong sexual feelings for someone. Self-efficacy for condom use will be measured using 5 items (e.g., "If you wanted to get a condom, how sure are you that you could go to the store and buy one?").	24 months
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	6 weeks
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	3 months
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	6 months
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	12 months
Secondary	Drug and alcohol use behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, decreases drug and alcohol use behaviors in minority early adolescents.	24 months
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	6 weeks
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	3 months
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	6 months
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	12 months
Secondary	Level of self-efficacy in negotiating situations involving offers of drugs and alcohol	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game, increases self-efficacy in negotiating situations involving offers of drugs and alcohol in minority adolescents.To assess participants' self-efficacy to refuse drugs we will use 6 items adapted from the Drug Use Resistance Self-Efficacy (DURSE) Scale for Young Adolescents (Carpenter & Howard, 2009). We will administer 2 items each for cigarettes, alcohol, and marijuana assessing participants' confidence to refuse the drug if it is offered by (a) a friend or (b) an older friend of family member.	24 months
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	6 weeks
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	3 months
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	6 months
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	12 months
Secondary	Overall risk-taking behaviors	To determine if an interactive videogame focused on developing sex, drug and alcohol negotiation and refusal skills, compared to a control game,reduces overall risk-taking behaviors in minority early adolescents.	24 months

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