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.
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
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.
- Conditions
- HIV Prevention, STI Prevention
- 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 group | Role | What they receive |
|---|---|---|
| One Night Stan Pilot Testing Group | Experimental | The 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.
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
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)
Incidence of Condom Use
Measured as the incidence of condom use by participants at baseline.
Measured: Baseline
Incidence of Condom Use
Measured as the incidence of condom use by participants at baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)..
Measured: 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)..
Measured: 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)..
Measured: 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.
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.
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.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJan 2013
- Primary completion18 Jun 2016
- Study completion18 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly D Hieftje, PhD, Principal investigator, Yale UniversityLynn Fiellin, M.D., Principal investigator, Yale University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Research for an HIV Videogame for Young Black Women
- ClinicalTrials.gov ID
- NCT02685410
- Acronym / sponsor ID
- 1301011336
- Conditions
- HIV Prevention, STI Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 18 Jun 2016 (actual)
- Study completion
- 18 Jun 2016 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Night Stan Pilot Testing Group | Experimental | Other: One Night Stan PrototypeThe pilot testing of the One Nigh Stan prototype intervention will utilize 20 young black women aged 18-24 as participants. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- African-American race
- Female
- Ages 18 to 24 yeats
Key exclusion criteria (1 listed)
- Failure to meet all inclusion criteria will exclude individuals from participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Night Stan PrototypeThe One Night Stan prototype, will be a social network game with the goal of risk reduction and HIV/STI prevention in young black women. | Other | One Night Stan Pilot Testing Group |
Primary outcome
Incidence of Condom Use
Time frame: 2 Weeks
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.
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
Time frame: 2 Weeks
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.
31 secondary outcomes
Incidence of Condom Use
Time frame: Baseline
Incidence of Condom Use
Time frame: 4 Weeks
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
Time frame: Baseline
Overall Incidence of Risk Behaviors Associated with HIV/STI Transmission
Time frame: 4 Weeks
Incidence of Vulnerability to Risky Sexual Behaviors
Time frame: Baseline
Incidence of Vulnerability to Risky Sexual Behaviors
Time frame: 2 Weeks
Incidence of Vulnerability to Risky Sexual Behaviors
Time frame: 4 Weeks
HIV/STI Knowledge
Time frame: Baseline
HIV/STI Knowledge
Time frame: 2 Weeks
HIV/STI Knowledge
Time frame: 4 Weeks
Subjective Sexual Norms
Time frame: Baseline
Subjective Sexual Norms
Time frame: 2 Weeks
Subjective Sexual Norms
Time frame: 4 Weeks
Sexual Intentions
Time frame: Baseline
Sexual Intentions
Time frame: 2 Weeks
Sexual Intentions
Time frame: 4 Weeks
Multi-dimensional Condom Attitudes Scale
Time frame: Baseline
Multi-dimensional Condom Attitudes Scale
Time frame: 2 Weeks
Multi-dimensional Condom Attitudes Scale
Time frame: 4 Weeks
Sexual Risk Behavior Beliefs
Time frame: Baseline
Sexual Risk Behavior Beliefs
Time frame: 2 Weeks
Sexual Risk Behavior Beliefs
Time frame: 4 Weeks
Self-Efficacy in Sexual Risk Behaviors
Time frame: Baseline
Self-Efficacy in Sexual Risk Behaviors
Time frame: 2 Weeks
Self-Efficacy in Sexual Risk Behaviors
Time frame: 4 Weeks
Condom Self-Efficacy
Time frame: Baseline
Condom Self-Efficacy
Time frame: 2 Weeks
Condom Self-Efficacy
Time frame: 4 Weeks
Sexual Communication
Time frame: Baseline
Sexual Communication
Time frame: 2 Weeks
Sexual Communication
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly D Hieftje, PhD principal investigator
Yale University
Lynn Fiellin, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
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.