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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD098031-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to develop and evaluate an innovative behavioral HIV prevention videogame intervention to bolster motivation and provide skill-building opportunities to improve Black adolescent girls' ability to negotiate around risk including advocating for partner HIV/sexually transmitted infection (STI) testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.
This study will develop and evaluate a multiplayer videogame aimed at Black adolescent girls with the intent of teaching the ability to negotiate around risk including advocating for partner HIV/STI testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.
The intervention will be developed and delivered as a social, multiplayer videogame, a compelling context for Black adolescent girls who constantly interact and seek counsel from their peers. To this end, the Specific Aims, focusing on Black adolescent girls aged 14-18 years, are to:
(Phase 1) Translate the culturally and socially-tailored card game One Night Stan to a multiplayer videogame called InvestiDate using game design and content experts and focus group input from 30 Black adolescent girls.
(Phase 2) Conduct a pilot randomized controlled trial comparing the multiplayer videogame InvestiDate (the new adaptation of the One Night Stan intervention) vs. an attention/control non-health-related multiplayer videogame with 80 participants collecting assessment data at baseline, one, and four months to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InvestiDate Intervention | Experimental | One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group. |
|
| Non-Health Related Game | Placebo Comparator | Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InvestiDate | Behavioral | Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Assessed Using Change in Retention Rates | Feasibility of this intervention is assessed by the percent of total questionnaires returned out of all distributed at each time point to assess retention rates. Rates >80% indicate high retention. | Baseline, 1 month and 4 months |
| Acceptability Assessed Via Self-reported Survey | Acceptability of the intervention condition is assessed via self-reported survey at the post gameplay time point using the game experience and satisfaction questionnaire, which is a 10-item scale with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 10-40. Data were collected from participants in the experimental group only. Higher scores indicate stronger agreement with the statement. | 1 month |
| Acceptability Assessed by Favorite Investidate Activities | Participants were asked to indicate (from a list) their favorite activity in the game. The data presented here indicates the total number of participants in the experimental group that selected each activity as their favorite. | Month 4 |
| Total Time Playing | The mean total time spent playing the videogame | Month 4 |
| Change From Baseline at 4 Months: HIV/STI Testing- Self | HIV/STI Testing- self will be used to determine if individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. Investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. Data presented here shows the number of participants who said YES they had been tested out of the total number of participants in each group that responded to the question. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Use of Condoms | At each time point, participants responded to the item "Did you use a condom the last time you had sex?" Response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Baseline, 1 month and 4 months |
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Inclusion Criteria:
Both phases (includes focus groups- Phase 1)
Pilot Test (Phase 2)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Hieftje, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimberly Hieftje | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37853731 | Derived | Budge M, Opara I, Weser VU, Sands BE, Hieftje KD. Black Adolescent Females' Perceptions of PrEP for HIV Risk Reduction. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231206934. doi: 10.1177/23259582231206934. | |
| 36689272 | Derived | Weser V, Opara I, Budge M, Duncan L, Fernandes CF, Hussett-Richardson S, Sands B, Hieftje K. Pilot-testing a Multiplayer HIV and Sexually Transmitted Infection Prevention Video Game Intervention for Black Adolescent Girls: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 23;12:e43666. doi: 10.2196/43666. |
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| ID | Title | Description |
|---|---|---|
| FG000 | InvestiDate Intervention | One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group. InvestiDate: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
| FG001 | Non-Health Related Game | Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. Non-Health Related Video Game: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | InvestiDate Intervention | One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group. InvestiDate: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | One participant turned 19 during the week that elapsed between recruitment and baseline data collection. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility Assessed Using Change in Retention Rates | Feasibility of this intervention is assessed by the percent of total questionnaires returned out of all distributed at each time point to assess retention rates. Rates >80% indicate high retention. | Posted | Number | percentage of questionnaires returned | Baseline, 1 month and 4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InvestiDate Intervention | One Night Stan will be adapted as a multiplayer videogame called InvestiDate based on the card game prototype with a focus on a slightly younger age group. InvestiDate: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly Hieftje | Yale School of Medicine | (203) 737-3301 | kimberly.hieftje@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2021 | Sep 15, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Compound | Sep 30, 2021 | Sep 15, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adolescent | Sep 30, 2021 | Sep 15, 2023 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent | Sep 30, 2021 | Sep 15, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Non-Health Related Video Game | Other | Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
|
| Baseline, 1 month and 4 months |
| Change From Baseline at 4 Months: HIV/STI Testing- Partner | HIV/STI Testing- partner will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. The investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. | Baseline, 1 month and 4 months |
| Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES) | The CUSES is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. 10 of the 28 items were administered and scores were summed for each item for each participant. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. The possible range of scores is 0-40, with higher scores indicating greater self-efficacy. | Baseline, 1 month, 4 months |
| Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS) | The SRBBS measure includes 3 items (e.g., "How sure ate you that you could use a condom correctly or explain to your partner how to use a condom correctly?") measured on a scale from 1 (not sure at all) to 5 (extremely sure). For each participant a mean of the 3 items was calculated. Scores range from 1-5 with higher scores indicating higher levels of self-efficacy. | Baseline, 1 month, 4 months |
| Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS | This subscale includes three items (e.g., "Imagine that you met someone at a party. He or she wants to have sex with you. Even though you are very attracted to each other, you're not ready to have sex. How sure are you that you could keep from having sex") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy for refusing sex. | Baseline, 1 month and 4 months |
| Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS | Self-efficacy for communication was assessed using the SECM subscale of the SRBBS. This subscale includes three items (e.g., "Imagine that you and your partner have been having sex but have not used condoms. You really want to start using condoms. How sure are you that you could tell that person that you want to use condoms") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of communication. | Baseline, 1 month and 4 months |
| Change in Self-efficacy for PrEP | Self-Efficacy for using PrEP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy. | Baseline, 1 month and 4 months |
| Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS | Attitudes about condom use were assessed using the ACU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about condom use. | Baseline, 1 month and 4 months |
| Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS | Attitudes about sexual intercourse were assessed using the ASI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about sexual intercourse. | Baseline, 1 month and 4 months |
| Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP | Intentions were measured with one item ("I intend to find a clinic in my community where I can speak to a doctor or health care provider about PrEP"). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating stronger intentions. | Baseline, 1 months and 4 months |
| Change in Sexually Transmitted Infections (STI)/HIV Knowledge | STI/HIV knowledge was assessed using 12 questions for which participants could answer "true", "false", or "not sure". The answers were recoded as correct or incorrect, with "not sure" being coded as incorrect, and a sum was calculated for each participant. Scores range from 0 - 12 with higher scores indicating more STI-HIV knowledge. | Baseline, 1 months and 4 months |
| Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS | Norms about condom use were assessed using the NCU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse. | Baseline, 1 months and 4 months |
| Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS | Norms about sexual intercourse were assessed using the NSI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse. | Baseline, 1 months and 4 months |
| Change in Perceived Norms About PrEP | Perceived norms about the use of PrEP were assessed using a 2 item survey. Both items were rated from 1 (not at all) to 4 (a lot). A mean of the two items was calculated for each participant with score ranging from 1-4. Higher scores indicate more positive perceived norms about the use of PrEP. | Baseline, 1 months and 4 months |
| Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS | The BCU subscale includes six items assessed on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score was calculated for each participant with score ranging from 1-5. Higher scores indicating more perceived barriers to condom use. | Baseline, 1 months and 4 months |
| Change in Behavior of Purchasing Condoms | Participants reported on whether they had purchased condoms ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Baseline, 1 month and 4 months |
| Change in Behavior of Having Looked up a Place to Get HIV or STI Testing | Participants reported on whether they had looked up a place to get HIV or STI testing ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Baseline, 1 month and 4 months |
| Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI | Participants reported on whether they had talked with a partner about getting tested for HIV or STIs ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Baseline, 1 month and 4 months |
| Change in Birth Control Use | Participants were asked to indicate if they used birth control last time they had sex. The response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Baseline, 1 month and 4 months |
| Change in Behavior Regarding Refusal to Have Sex | At 1 month and 4 months, participants were asked if they had refused to have sex with a partner because he would not use a condom in the time since they first played the videogame over zoom as part of this research study. The response options were "yes" or "no". | 1 month and 4 months |
| Number of Participants Refusal to Have Sex | At baseline participants were asked to indicate if they had refused to have sex with a partner because he would not use a condom ever. Response options were "always", "most of the time", "about half the time", "sometimes", and "never". | Baseline |
| Number of Participants That Asked Partner About Previous Condom Use | At baseline participants were asked how often they ask their sexual partners whether or not they have used a condom in previous sexual encounters? Response options were "always", "most of the time", "about half the time", "sometimes", and "never". | Baseline |
| Number of Times Participants Asked Partner About Previous Condom Use | At 1 month and 4 months, participants were asked how many times they discussed condom use with a sexual partner since first playing the videogame on zoom as part of this research study. | 1 month and 4 months |
| Number of Times Participants Talked to Family or Adults About HIV | Participants were asked how many times they had talked with their family or other adults about HIV ever (baseline) or since they played the videogame on zoom as part of this research study (1 month, 4 months). | baseline, 1 month and 4 months |
| Number of Times Participants Engaged in Sexual Intercourse | Participants were asked how many times they had engaged in sexual intercourse ever (baseline, post-intervention) or since playing the videogame on zoom as part of this research study (1 month, 4 months). | baseline, 1 month and 4 months |
| Number of Times Participants Engaged in Anal Sex | Participants were asked how many times they had engaged in anal sex ever (baseline) or since playing the videogame on zoom as part of this research study (1 month, 4 months). | baseline, 1 month and 4 months |
| BG001 |
| Non-Health Related Game |
Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. Non-Health Related Video Game: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. Non-Health Related Video Game: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). |
|
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| Primary | Acceptability Assessed Via Self-reported Survey | Acceptability of the intervention condition is assessed via self-reported survey at the post gameplay time point using the game experience and satisfaction questionnaire, which is a 10-item scale with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 10-40. Data were collected from participants in the experimental group only. Higher scores indicate stronger agreement with the statement. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
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| Primary | Acceptability Assessed by Favorite Investidate Activities | Participants were asked to indicate (from a list) their favorite activity in the game. The data presented here indicates the total number of participants in the experimental group that selected each activity as their favorite. | Posted | Count of Participants | Participants | Month 4 |
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| Primary | Total Time Playing | The mean total time spent playing the videogame | Posted | Mean | Standard Deviation | minutes | Month 4 |
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| Primary | Change From Baseline at 4 Months: HIV/STI Testing- Self | HIV/STI Testing- self will be used to determine if individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. Investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. Data presented here shows the number of participants who said YES they had been tested out of the total number of participants in each group that responded to the question. | The data represented shows the number of participants that reported testing of the total number of participants in each group that responded to the question. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Primary | Change From Baseline at 4 Months: HIV/STI Testing- Partner | HIV/STI Testing- partner will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. The investigators will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments. | The data represented shows the number of participants that reported testing of the total number of participants in each group that responded to the question. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Use of Condoms | At each time point, participants responded to the item "Did you use a condom the last time you had sex?" Response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Not all participants responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES) | The CUSES is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. 10 of the 28 items were administered and scores were summed for each item for each participant. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. The possible range of scores is 0-40, with higher scores indicating greater self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 4 months |
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| Secondary | Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS) | The SRBBS measure includes 3 items (e.g., "How sure ate you that you could use a condom correctly or explain to your partner how to use a condom correctly?") measured on a scale from 1 (not sure at all) to 5 (extremely sure). For each participant a mean of the 3 items was calculated. Scores range from 1-5 with higher scores indicating higher levels of self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 4 months |
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| Secondary | Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS | This subscale includes three items (e.g., "Imagine that you met someone at a party. He or she wants to have sex with you. Even though you are very attracted to each other, you're not ready to have sex. How sure are you that you could keep from having sex") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy for refusing sex. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month and 4 months |
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| Secondary | Change in Self-efficacy in Communication Using the Self-efficacy for Communication (SECM) Subscale of the SRBBS | Self-efficacy for communication was assessed using the SECM subscale of the SRBBS. This subscale includes three items (e.g., "Imagine that you and your partner have been having sex but have not used condoms. You really want to start using condoms. How sure are you that you could tell that person that you want to use condoms") rated on a scale ranging from 1 (not sure at all) to 5 (extremely sure). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of communication. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month and 4 months |
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| Secondary | Change in Self-efficacy for PrEP | Self-Efficacy for using PrEP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating higher levels of self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month and 4 months |
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| Secondary | Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS | Attitudes about condom use were assessed using the ACU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about condom use. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month and 4 months |
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| Secondary | Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS | Attitudes about sexual intercourse were assessed using the ASI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) attitudes about condom use and positive scores indicating positive (healthy) attitudes about sexual intercourse. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month and 4 months |
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| Secondary | Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP | Intentions were measured with one item ("I intend to find a clinic in my community where I can speak to a doctor or health care provider about PrEP"). A mean score for the three items was calculated for each participant with score ranging from 1-5. Higher scores indicating stronger intentions. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Sexually Transmitted Infections (STI)/HIV Knowledge | STI/HIV knowledge was assessed using 12 questions for which participants could answer "true", "false", or "not sure". The answers were recoded as correct or incorrect, with "not sure" being coded as incorrect, and a sum was calculated for each participant. Scores range from 0 - 12 with higher scores indicating more STI-HIV knowledge. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Norms About Condom Use (NCU) Assessed Using the NCU Subscale of the SRBBS | Norms about condom use were assessed using the NCU subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS | Norms about sexual intercourse were assessed using the NSI subscale of the SRBBS. This subscale includes three items scored from -2 (strongly disagree) to +2 (strongly agree). A mean score was calculated for each participant with negative mean scores indicating negative (unhealthy) perceived about condom use and positive scores indicating positive (healthy) perceived norms about sexual intercourse. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Perceived Norms About PrEP | Perceived norms about the use of PrEP were assessed using a 2 item survey. Both items were rated from 1 (not at all) to 4 (a lot). A mean of the two items was calculated for each participant with score ranging from 1-4. Higher scores indicate more positive perceived norms about the use of PrEP. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS | The BCU subscale includes six items assessed on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). A mean score was calculated for each participant with score ranging from 1-5. Higher scores indicating more perceived barriers to condom use. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 months and 4 months |
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| Secondary | Change in Behavior of Purchasing Condoms | Participants reported on whether they had purchased condoms ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Behavior of Having Looked up a Place to Get HIV or STI Testing | Participants reported on whether they had looked up a place to get HIV or STI testing ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI | Participants reported on whether they had talked with a partner about getting tested for HIV or STIs ever (baseline) or since they first played the videogame over zoom as part of this research study (1 month, 4 months). The response options were "yes" or "no". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Birth Control Use | Participants were asked to indicate if they used birth control last time they had sex. The response options were "yes", "no", and "I have never had sex". Data presented here shows the number of participants who answered YES out of the number of people in each group that responded to the question. | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline, 1 month and 4 months |
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| Secondary | Change in Behavior Regarding Refusal to Have Sex | At 1 month and 4 months, participants were asked if they had refused to have sex with a partner because he would not use a condom in the time since they first played the videogame over zoom as part of this research study. The response options were "yes" or "no". | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | 1 month and 4 months |
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| Secondary | Number of Participants Refusal to Have Sex | At baseline participants were asked to indicate if they had refused to have sex with a partner because he would not use a condom ever. Response options were "always", "most of the time", "about half the time", "sometimes", and "never". | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Number of Participants That Asked Partner About Previous Condom Use | At baseline participants were asked how often they ask their sexual partners whether or not they have used a condom in previous sexual encounters? Response options were "always", "most of the time", "about half the time", "sometimes", and "never". | Data was analyzed from all participants that responded to the question at each time point. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Number of Times Participants Asked Partner About Previous Condom Use | At 1 month and 4 months, participants were asked how many times they discussed condom use with a sexual partner since first playing the videogame on zoom as part of this research study. | Posted | Mean | Standard Deviation | number of times asked partner | 1 month and 4 months |
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| Secondary | Number of Times Participants Talked to Family or Adults About HIV | Participants were asked how many times they had talked with their family or other adults about HIV ever (baseline) or since they played the videogame on zoom as part of this research study (1 month, 4 months). | Posted | Mean | Standard Deviation | number of times talked to family/adults | baseline, 1 month and 4 months |
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| Secondary | Number of Times Participants Engaged in Sexual Intercourse | Participants were asked how many times they had engaged in sexual intercourse ever (baseline, post-intervention) or since playing the videogame on zoom as part of this research study (1 month, 4 months). | Posted | Mean | Standard Deviation | number of times had sex | baseline, 1 month and 4 months |
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| Secondary | Number of Times Participants Engaged in Anal Sex | Participants were asked how many times they had engaged in anal sex ever (baseline) or since playing the videogame on zoom as part of this research study (1 month, 4 months). | Posted | Mean | Standard Deviation | number of times had sex | baseline, 1 month and 4 months |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Non-Health Related Game | Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. Non-Health Related Video Game: Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
Not provided
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| I liked the way the game looked |
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| I felt connected to the characters in the game |
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| I felt responsible for the choices I made in the game |
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| I liked talking with other players about what was happening in the game |
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| I enjoyed playing the game agree |
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| The game was challenging |
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| I would tell my friends to play this game |
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| Title | Measurements |
|---|---|
|
| Chat with a guy |
|
| Chat with a doctor |
|
| Chat with a friend |
|
| Videos with advice from Chelsea and Brandon |
|
| 1 month |
|
|
| 4 months |
|
|
| 0.022 |
| Superiority |
| P value at baseline | Chi-squared | 0.193 | Superiority |
| 1 month |
|
|
| 4 months |
|
|
| 0.467 |
| Superiority |
| P value at baseline | Chi-squared | 0.550 | Superiority |
| 1 month |
|
|
| 4 months |
|
|
| 0.974 |
| Superiority |
| P value at baseline. | Chi-squared | 0.651 | Superiority |
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 1 month |
|
|
| 4 months |
|
|
| 0.72 |
| Superiority |
| P value at baseline | Chi-squared | 0.97 | Superiority |
| 1 month |
|
|
| 4 months |
|
|
| 0.303 |
| Superiority |
| P value at baseline. | Chi-squared | 0.042 | Superiority |
| 1 month |
|
|
| 4 months |
|
|
| 0.467 |
| Superiority |
| P value at baseline. | Chi-squared | 0.55 | Superiority |
| 1 month |
|
|
| 4 months |
|
|
| 0.898 |
| Superiority |
| P value at baseline. | Chi-squared | 0.238 | Superiority |
| no |
|
| 4 months |
|
|
| 0.557 |
| Superiority |
| Sometimes |
|
| Never |
|
| Sometimes |
|
| Never |
|
| 0.159 |
| Superiority |
| 4 months |
|
| 0.487 |
| Superiority |
| P value at baseline. | t-test, 2 sided | 0.165 | Superiority |
| 4 months |
|
| 0.316 |
| Superiority |
| P value at baseline. | t-test, 2 sided | 0.345 | Superiority |
| 4 months |
|
| 0.314 |
| Superiority |
| P value at baseline. | t-test, 2 sided | 0.444 | Superiority |