Formative Research for an HIV Videogame for Young Black Women

As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based interventions targeting risk reduction and prevention in youth and young adults, this study is designed to develop a paper prototype and intervention design manual of an online social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention in young black women. The ultimate plan is to incorporate focus group participants input and feedback into the development of a conceptual model, intervention manual, and videogame intervention prototype. This prototype will then be tested using 20 participants and will utilize a pre-post design to evaluate the effectiveness of the program.

Study Overview

• Status: Completed
• Conditions: HIV Prevention; STI Prevention
• Intervention / Treatment: Other: One Night Stan Prototype

Detailed Description

The specific aims of this study are to:

Develop an online social network game for HIV/STI risk reduction and prevention by conducting a first set of focus groups with a total of 25 participants (5 focus groups with 5 participants each) in order to better understand preferences for online social network and gaming platforms, characteristics and design.

These collected data, established theoretical constructs, and the literature will be harnessed to develop a conceptual model for HIV/STI risk reduction and prevention in this specific population of women.

From the data collected and the new conceptual model, an intervention manual will be created that will incorporate a culturally and socially-tailored online social network game intervention paper prototype and design manual. In an iterative fashion, a second series of focus groups will be conducted (5 groups with 5 participants each for a total of 25 participants) to refine the intervention.

To pilot test the prototype intervention we will determine, in a pre-post design: (a) the intervention's acceptability and feasibility based on self-report data on the game experience and (b) preliminary evidence of the efficacy of the intervention collecting data on 1) HIV/STI knowledge 2) intentions/attitudes regarding condom use and HIV/STI partner testing 3) self-efficacy to insist on condom use and HIV/STI partner testing 4) self-efficacy and beliefs related to sexual risk behaviors, 4) perceived social norms, and 5) behaviors related to condom use and partner HIV/STI testing.

The focus of this registration record will be the participants and collected outcomes used to assess the prototype of the social network game. Assessments will be conducted at baseline, 2 weeks after playing the game and at 4 weeks post follow up.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• African-American race
• Female
• Ages 18 to 24 yeats

Exclusion Criteria:

• Failure to meet all inclusion criteria will exclude individuals from participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One Night Stan Pilot Testing Group; The pilot testing of the One Nigh Stan prototype intervention will utilize 20 young black women aged 18-24 as participants.	Other: One Night Stan Prototype; The One Night Stan prototype, will be a social network game with the goal of risk reduction and HIV/STI prevention in young black women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Condom Use	The program will be assessed by determining if an increase in the incidence of condom use by participants occurred after 2 weeks exposure to the program.	2 Weeks
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission	The program will be assessed by determining if a decrease in the incidence of risk behaviors associated with HIV/STI transmission by participants occurred after 2 weeks exposure to the program.	2 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Condom Use	Measured as the incidence of condom use by participants at baseline.	Baseline
Incidence of Condom Use	Measured as the incidence of condom use by participants at baseline.	4 Weeks
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission	Measured as the incidence of risk behaviors associated with HIV/STI transmission by participants.	Baseline
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission	Measured as the incidence of risk behaviors associated with HIV/STI transmission by participants.	4 Weeks
Incidence of Vulnerability to Risky Sexual Behaviors	The program will be assessed by determining if a decrease in incidence of vulnerability to risk behaviors associated with HIV/STI transmission by participants occurred after 2 weeks exposure to the program.	Baseline
Incidence of Vulnerability to Risky Sexual Behaviors	The program will be assessed by determining if a decrease in incidence of vulnerability to risk behaviors associated with HIV/STI transmission by participants occurred after 2 weeks exposure to the program.	2 Weeks
Incidence of Vulnerability to Risky Sexual Behaviors	The program will be assessed by determining if a decrease in incidence of vulnerability to risk behaviors associated with HIV/STI transmission by participants occurred after 2 weeks exposure to the program.	4 Weeks
HIV/STI Knowledge	Items from the validated instruments the HIV-KQ and STD-KQ were compiled into 12 item questionnaire measuring knowledge of HIV and STI's. These items are true/false responses in nature and the total score is based on the number of correct responses. The highest score possible is 12, which indicates superior knowledge of HIV/STI related information. The HIV Knowledge Questionnaire (18-item version) is a brief self-administered measure of the individual's HIV-related knowledge. (http://www.midss.org/content/hiv-knowledge-questionnaire-hiv-kq-18)SRB The STD-KQ is a comprehensive 27-item index that attempts to measure knowledge about sexually transmitted diseases. It is intended for use in research and applied settings (http://www.midss.org/content/sexually-transmitted-disease-knowledge-questionnaire-std-kq).	Baseline
HIV/STI Knowledge	Items from the validated instruments the HIV-KQ and STD-KQ were compiled into 12 item questionnaire measuring knowledge of HIV and STI's. These items are true/false responses in nature and the total score is based on the number of correct responses. The highest score possible is 12, which indicates superior knowledge of HIV/STI related information. The HIV Knowledge Questionnaire (18-item version) is a brief self-administered measure of the individual's HIV-related knowledge. (http://www.midss.org/content/hiv-knowledge-questionnaire-hiv-kq-18)SRB The STD-KQ is a comprehensive 27-item index that attempts to measure knowledge about sexually transmitted diseases. It is intended for use in research and applied settings (http://www.midss.org/content/sexually-transmitted-disease-knowledge-questionnaire-std-kq).	2 Weeks
HIV/STI Knowledge	Items from the validated instruments the HIV-KQ and STD-KQ were compiled into 12 item questionnaire measuring knowledge of HIV and STI's. These items are true/false responses in nature and the total score is based on the number of correct responses. The highest score possible is 12, which indicates superior knowledge of HIV/STI related information. The HIV Knowledge Questionnaire (18-item version) is a brief self-administered measure of the individual's HIV-related knowledge. (http://www.midss.org/content/hiv-knowledge-questionnaire-hiv-kq-18)SRB The STD-KQ is a comprehensive 27-item index that attempts to measure knowledge about sexually transmitted diseases. It is intended for use in research and applied settings (http://www.midss.org/content/sexually-transmitted-disease-knowledge-questionnaire-std-kq).	4 Weeks
Subjective Sexual Norms	Subjective sexual intentions are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual norms. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's sexual norms are perceived (with respect to HIV/STI transmission).	Baseline
Subjective Sexual Norms	Subjective sexual intentions are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual norms. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's sexual norms are perceived (with respect to HIV/STI transmission).	2 Weeks
Subjective Sexual Norms	Subjective sexual intentions are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual norms. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's sexual norms are perceived (with respect to HIV/STI transmission).	4 Weeks
Sexual Intentions	Sexual intentions are measured using a 10 item scale. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual intentions. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's intentions are perceived (with respect to HIV/STI transmission)..	Baseline
Sexual Intentions	Sexual intentions are measured using a 10 item scale. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual intentions. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's intentions are perceived (with respect to HIV/STI transmission)..	2 Weeks
Sexual Intentions	Sexual intentions are measured using a 10 item scale. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual intentions. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the more positive one's intentions are perceived (with respect to HIV/STI transmission)..	4 Weeks
Multi-dimensional Condom Attitudes Scale	The multi-dimensional condom attitudes scale (MCAS) was adapted for use in the study. The MCAS contains 25 items that assess attitudes toward condoms using 7-point Likert scales; higher scores indicate more favorable attitudes toward condoms. Sample items include: "Women think men who use condoms are jerks"; and "If a couple is about to have sex and the man suggests using a condom, it is less likely that they will have sex." Prior research confirmed that the scale is multidimensional, with a five-factor structure: (a) Reliability and Effectiveness, (b) Pleasure, (c) Identity stigma, (d) Embarrassment about Negotiation and Use, and (e) Embarrassment about Purchase (Helweg-Larsen & Collins, 1994). Each item uses a 5 point scale (5 = strongly agree) to assess condom attitudes. The average of the items is used, where a 5 would indicate a superior overall attitude concerning the construct being measured.	Baseline
Multi-dimensional Condom Attitudes Scale	The multi-dimensional condom attitudes scale (MCAS) was adapted for use in the study. The MCAS contains 25 items that assess attitudes toward condoms using 7-point Likert scales; higher scores indicate more favorable attitudes toward condoms. Sample items include: "Women think men who use condoms are jerks"; and "If a couple is about to have sex and the man suggests using a condom, it is less likely that they will have sex." Prior research confirmed that the scale is multidimensional, with a five-factor structure: (a) Reliability and Effectiveness, (b) Pleasure, (c) Identity stigma, (d) Embarrassment about Negotiation and Use, and (e) Embarrassment about Purchase (Helweg-Larsen & Collins, 1994). Each item uses a 5 point scale (5 = strongly agree) to assess condom attitudes. The average of the items is used, where a 5 would indicate a superior overall attitude concerning the construct being measured.	2 Weeks
Multi-dimensional Condom Attitudes Scale	The multi-dimensional condom attitudes scale (MCAS) was adapted for use in the study. The MCAS contains 25 items that assess attitudes toward condoms using 7-point Likert scales; higher scores indicate more favorable attitudes toward condoms. Sample items include: "Women think men who use condoms are jerks"; and "If a couple is about to have sex and the man suggests using a condom, it is less likely that they will have sex." Prior research confirmed that the scale is multidimensional, with a five-factor structure: (a) Reliability and Effectiveness, (b) Pleasure, (c) Identity stigma, (d) Embarrassment about Negotiation and Use, and (e) Embarrassment about Purchase (Helweg-Larsen & Collins, 1994). Each item uses a 5 point scale (5 = strongly agree) to assess condom attitudes. The average of the items is used, where a 5 would indicate a superior overall attitude concerning the construct being measured.	4 Weeks
Sexual Risk Behavior Beliefs	The validated instrument the SRBBS was used to create items as part of a questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes (e.g., I believe condoms should always be used if a person my age has sex), self-efficacy in using and obtaining condoms (e.g., How sure are you that you could use a condom correctly or explain to your partner how to use a condom correctly?), and barriers to condom use (e.g., I would feel uncomfortable carrying condoms with me).	Baseline
Sexual Risk Behavior Beliefs	The validated instrument the SRBBS was used to create items as part of a questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes (e.g., I believe condoms should always be used if a person my age has sex), self-efficacy in using and obtaining condoms (e.g., How sure are you that you could use a condom correctly or explain to your partner how to use a condom correctly?), and barriers to condom use (e.g., I would feel uncomfortable carrying condoms with me).	2 Weeks
Sexual Risk Behavior Beliefs	The validated instrument the SRBBS was used to create items as part of a questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes (e.g., I believe condoms should always be used if a person my age has sex), self-efficacy in using and obtaining condoms (e.g., How sure are you that you could use a condom correctly or explain to your partner how to use a condom correctly?), and barriers to condom use (e.g., I would feel uncomfortable carrying condoms with me).	4 Weeks
Self-Efficacy in Sexual Risk Behaviors	The validated instrument the SRBBS was used to create an 11 item questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes.	Baseline
Self-Efficacy in Sexual Risk Behaviors	The validated instrument the SRBBS was used to create an 11 item questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes.	2 Weeks
Self-Efficacy in Sexual Risk Behaviors	The validated instrument the SRBBS was used to create an 11 item questionnaire. The Sexual Risk Behavior Beliefs and Self-Efficacy Scales (SRBBS; Basen-Engquist et al., 1996) taps into major constructs addressed within condom use theory (health belief model, theory of reasoned action, and social learning theory), and thus the current study results would easily extend to multiple theoretical approaches. The SRBBS contains 22 self-report, Likert-type items that assess five subscales of interest: condom use attitudes.	4 Weeks
Condom Self-Efficacy	The Condom Use Self-Efficacy Scale (CUSES) assesses efficacy to purchase condoms, apply and remove them, and negotiate their use with partners; ample evidence exists for the reliability of the CUSES (Brafford & Beck, 1991). The 15-item CUSES (Brien et al., 1994; Brafford & Beck, 1991) measures condom use self-efficacy using 5-point Likert scales; higher scores indicate stronger percepts of condom use efficacy.	Baseline
Condom Self-Efficacy	The Condom Use Self-Efficacy Scale (CUSES) assesses efficacy to purchase condoms, apply and remove them, and negotiate their use with partners; ample evidence exists for the reliability of the CUSES (Brafford & Beck, 1991). The 15-item CUSES (Brien et al., 1994; Brafford & Beck, 1991) measures condom use self-efficacy using 5-point Likert scales; higher scores indicate stronger percepts of condom use efficacy.	2 Weeks
Condom Self-Efficacy	The Condom Use Self-Efficacy Scale (CUSES) assesses efficacy to purchase condoms, apply and remove them, and negotiate their use with partners; ample evidence exists for the reliability of the CUSES (Brafford & Beck, 1991). The 15-item CUSES (Brien et al., 1994; Brafford & Beck, 1991) measures condom use self-efficacy using 5-point Likert scales; higher scores indicate stronger percepts of condom use efficacy.	4 Weeks
Sexual Communication	Sexual communication behaviors are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual communication. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the better one's sexual communication.	Baseline
Sexual Communication	Sexual communication behaviors are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual communication. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the better one's sexual communication.	2 Weeks
Sexual Communication	Sexual communication behaviors are measured using items from a questionnaire. Each item uses a 5 point scale (5 = strongly agree) to assess various facets of sexual communication. The average of the items is used, where an average of 5 would be the highest possible score. The higher a respondent's score is, the better one's sexual communication.	4 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Game Play/Acceptability and Feasibility	A questionnaire assessing satisfaction with the game will be included in the assessment of the program. It will use a Likert scale to capture agreement with questions measuring users' satisfaction with game play. A higher user's total score, the more favorable their overall attitude towards using the game.	2 Weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Kimberly D Hieftje, PhD, Yale University; Principal Investigator: Lynn Fiellin, M.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 18, 2016
• Study Completion (Actual): June 18, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1301011336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO