An Interactive Game for HIV Prevention in Early Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Interactive Video Game for HIV Prevention in Early Adolescents

Conditions
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HIV, Risk Reduction

Intervention / Treatment
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* Behavioral: Experimental Video Game
* Behavioral: Off the Shelf Video Game


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Video Game<br>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. | Behavioral: Experimental Video Game<br>* 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.<br>|
| Other: Off the Shelf Video Game<br>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. | Behavioral: Off the Shelf Video Game<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, risk, HIV, video games