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HIV PreventionNCT02685410

Formative Research for an HIV Videogame for Young Black Women

A study testing One Night Stan Prototype in people with HIV Prevention and STI Prevention, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention, STI Prevention
What is being tested?
One Night Stan Prototype
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Jan 2013to 18 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

Other trials in United States

About this study

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.

Read the 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.

Being tested
One Night Stan Prototype

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One Night Stan PrototypeOther

    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.

Study groups in NCT02685410
Study groupRoleWhat they receive
One Night Stan Pilot Testing GroupExperimentalThe pilot testing of the One Nigh Stan prototype intervention will utilize 20 young black women aged 18-24 as participants.
Receives: Other: One Night Stan Prototype

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 Weeks

  2. 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.

    Measured: 2 Weeks

Secondary outcomes (31)
  1. Incidence of Condom Use

    Measured as the incidence of condom use by participants at baseline.

    Measured: Baseline

  2. Incidence of Condom Use

    Measured as the incidence of condom use by participants at baseline.

    Measured: 4 Weeks

  3. Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission

    Measured as the incidence of risk behaviors associated with HIV/STI transmission by participants.

    Measured: Baseline

  4. Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission

    Measured as the incidence of risk behaviors associated with HIV/STI transmission by participants.

    Measured: 4 Weeks

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: 2 Weeks

  7. 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.

    Measured: 4 Weeks

  8. 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).

    Measured: Baseline

  9. 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).

    Measured: 2 Weeks

  10. 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).

    Measured: 4 Weeks

  11. 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).

    Measured: Baseline

  12. 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).

    Measured: 2 Weeks

  13. 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).

    Measured: 4 Weeks

  14. 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)..

    Measured: Baseline

  15. 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)..

    Measured: 2 Weeks

  16. 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)..

    Measured: 4 Weeks

  17. 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.

    Measured: Baseline

  18. 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.

    Measured: 2 Weeks

  19. 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.

    Measured: 4 Weeks

  20. 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).

    Measured: Baseline

  21. 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).

    Measured: 2 Weeks

  22. 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).

    Measured: 4 Weeks

  23. 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.

    Measured: Baseline

  24. 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.

    Measured: 2 Weeks

  25. 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.

    Measured: 4 Weeks

  26. 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.

    Measured: Baseline

  27. 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.

    Measured: 2 Weeks

  28. 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.

    Measured: 4 Weeks

  29. 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.

    Measured: Baseline

  30. 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.

    Measured: 2 Weeks

  31. 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.

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2016 (estimated)
  2. Study startJan 2013
  3. Primary completion18 Jun 2016
  4. Study completion18 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685410
Sponsor's protocol ID
1301011336
Status last verified
Feb 2017
First submitted
12 Feb 2016
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing One Night Stan Prototype in people with HIV Prevention and STI Prevention, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Condom Use (time frame: 2 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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