An Interactive Game for HIV Prevention in Early Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01666496 |
Recruitment Status
:
Completed
First Posted
: August 16, 2012
Last Update Posted
: June 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Risk Reduction | Behavioral: Experimental Video Game Behavioral: Off the Shelf Video Game | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 333 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | An Interactive Video Game for HIV Prevention in Early Adolescents |
Actual Study Start Date : | January 2013 |
Actual Primary Completion Date : | June 18, 2016 |
Actual Study Completion Date : | June 18, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental Video Game
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.
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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.
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Off the Shelf Video Game
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
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.
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- Delay in the initiation of sexual activity [ Time Frame: 3 weeks ]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.
- Delay in the initiation of sexual activity [ Time Frame: 6 weeks ]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.
- Delay in the initiation of sexual activity [ Time Frame: 3 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.
- Delay in the initiation of sexual activity [ Time Frame: 6 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.
- Delay in the initiation of sexual activity [ Time Frame: 12 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.
- 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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 3 weeks ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 3 weeks ]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.
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 3 weeks ]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?").
- Drug and alcohol use behaviors [ Time Frame: 3 weeks ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 3 weeks ]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.
- Overall risk-taking behaviors [ Time Frame: 3 weeks ]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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 6 weeks ]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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 3 months ]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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 6 months ]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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 12 months ]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.
- Knowledge about HIV/AIDS risk behaviors and transmission [ Time Frame: 24 months ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 6 weeks ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 3 months ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 6 months ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 12 months ]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.
- Level of social competency in using negotiating and refusal skills in the virtual environment [ Time Frame: 24 months ]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.
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 6 weeks ]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?").
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 3 months ]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?").
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 6 months ]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?").
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 12 months ]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?").
- Level of self-efficacy regarding negotiation around initiation of sexual activity [ Time Frame: 24 months ]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?").
- Drug and alcohol use behaviors [ Time Frame: 6 weeks ]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.
- Drug and alcohol use behaviors [ Time Frame: 3 months ]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.
- Drug and alcohol use behaviors [ Time Frame: 6 months ]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.
- Drug and alcohol use behaviors [ Time Frame: 12 months ]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.
- Drug and alcohol use behaviors [ Time Frame: 24 months ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 6 weeks ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 3 months ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 6 months ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 12 months ]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.
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol [ Time Frame: 24 months ]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.
- Overall risk-taking behaviors [ Time Frame: 6 weeks ]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.
- Overall risk-taking behaviors [ Time Frame: 3 months ]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.
- Overall risk-taking behaviors [ Time Frame: 6 months ]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.
- Overall risk-taking behaviors [ Time Frame: 12 months ]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.
- Overall risk-taking behaviors [ Time Frame: 24 months ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 11 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666496
United States, Connecticut | |
Yale School of Medicine | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Lynn E Fiellin, MD | Yale School of Medicine |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lynn E. Fiellin, Associate Professor, Yale University |
ClinicalTrials.gov Identifier: | NCT01666496 History of Changes |
Other Study ID Numbers: |
1208010715 |
First Posted: | August 16, 2012 Key Record Dates |
Last Update Posted: | June 27, 2017 |
Last Verified: | February 2017 |
Keywords provided by Lynn E. Fiellin, Yale University:
Adolescent risk HIV video games |