An interventional study of InvestiDate and Non-Health Related Video Game in HIV and Risk Reduction Behavior, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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 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:
72 studies on the registry are indexed under Risk Reduction Behavior; 25 are open to participants now.
This study's enrollment of 117 is below the median of 200 across 66 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Yale University is the lead sponsor of 1,763 studies on the registry; 290 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 129 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Both phases (includes focus groups- Phase 1)
Pilot Test (Phase 2)
Exclusion Criteria:
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.
Behavioral: InvestiDate
Participants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate.
Other: 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).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 4
Total Time Playing
The mean total time spent playing the videogame
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month and 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: baseline, 1 month and 4 months
| Milestone | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Started | 61 | 56 |
| Consent and baseline | 40 | 39 |
| Completed post gameplay survey | 40 | 38 |
| Completed one month follow-up | 40 | 39 |
| Completed four month follow-up | 38 | 39 |
| Completed | 40 | 39 |
| Not completed | 21 | 17 |
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.
| percentage of questionnaires returned | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 97.5 | 97.4 |
| 1 month | 97.5 | 100 |
| 4 months | 92.5 | 100 |
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.
| score on a scale | InvestiDate Intervention |
|---|---|
| I would play this game again | 3.64 ± 0.54 |
| I was frustrated with this game | 1.54 ± 0.56 |
| I would make decisions in real life like I made them in the game | 3.44 ± 0.75 |
| I liked the way the game looked | 3.51 ± 0.68 |
| I felt connected to the characters in the game | 3.03 ± 0.67 |
| I felt responsible for the choices I made in the game | 3.54 ± 0.51 |
| I liked talking with other players about what was happening in the game | 3.51 ± 0.56 |
| I enjoyed playing the game agree | 3.75 ± 0.44 |
| The game was challenging | 1.97 ± 0.81 |
| I would tell my friends to play this game | 3.44 ± 0.64 |
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.
| Participants | InvestiDate Intervention |
|---|---|
| Investigate a guy | 21 |
| Trivia | 11 |
| Presentation | 3 |
| Chat with a guy | 3 |
| Chat with a doctor | 0 |
| Chat with a friend | 0 |
| Videos with advice from Chelsea and Brandon | 1 |
The mean total time spent playing the videogame
| minutes | InvestiDate Intervention |
|---|---|
| Total Time Playing | 105.56 ± 12.92 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 4 | 8 |
| 1 month | 2 | 9 |
| 4 months | 4 | 8 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 8 | 10 |
| 1 month | 8 | 11 |
| 4 months | 4 | 8 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 11 | 9 |
| 1 month | 7 | 8 |
| 4 months | 4 | 7 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 24.5 ± 6.35 | 27.52 ± 5.7 |
| 1 month | 29.3 ± 5.46 | 26.61 ± 5.56 |
| 4 months | 28.3 ± 6.07 | 28.09 ± 6.64 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 2.87 ± 0.99 | 3.02 ± 1.07 |
| 1 month | 3.71 ± 1.13 | 3.33 ± 1.09 |
| 4 months | 3.62 ± 1.06 | 3.57 ± 0.74 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 4.03 ± 0.81 | 3.98 ± 0.87 |
| 1 month | 4.4 ± 0.75 | 3.88 ± 0.94 |
| 4 months | 4.4 ± 0.83 | 4.07 ± 0.88 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 4.14 ± 0.67 | 4.13 ± 0.77 |
| 1 month | 4.45 ± 0.62 | 4.06 ± 0.87 |
| 4 months | 4.37 ± 0.74 | 4.05 ± 0.87 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 4.16 ± 0.78 | 4.13 ± 0.75 |
| 1 month | 4.51 ± 0.57 | 4.16 ± 0.71 |
| 4 months | 4.42 ± 0.82 | 4.32 ± 0.69 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 1.64 ± 0.54 | 1.57 ± 0.75 |
| 1 month | 1.72 ± 0.56 | 1.54 ± 0.71 |
| 4 months | 1.56 ± 0.67 | 1.61 ± 0.61 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | -0.05 ± 0.43 | -0.06 ± 0.57 |
| 1 month | 0.09 ± 0.50 | 0.08 ± 0.58 |
| 4 months | -0.05 ± 0.51 | 0.11 ± 0.51 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 2.58 ± 0.81 | 2.58 ± 0.89 |
| 1 month | 3.22 ± 1.15 | 3.08 ± 1.19 |
| 4 months | 3.06 ± 1.29 | 3.34 ± 1.05 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 7.76 ± 2.36 | 8.41 ± 2.05 |
| 1 month | 9.06 ± 1.59 | 8.73 ± 1.59 |
| 4 months | 9.06 ± 1.5 | 8.43 ± 1.92 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 0.93 ± 1.07 | 0.98 ± 0.88 |
| 1 month | 1.29 ± 0.99 | 1.03 ± 0.98 |
| 4 months | 1.17 ± 0.96 | 1.05 ± 0.91 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 0.05 ± 0.54 | 0.01 ± 0.47 |
| 1 month | 0.19 ± 0.54 | 0.22 ± 0.73 |
| 4 months | -0.04 ± 0.54 | 0.25 ± 0.53 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 3.21 ± 0.68 | 3.08 ± 0.82 |
| 1 month | 3.33 ± 0.71 | 3.51 ± 0.54 |
| 4 months | 3.33 ± 0.64 | 3.42 ± 0.56 |
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.
| score on a scale | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 2.53 ± 0.77 | 2.59 ± 0.86 |
| 1 month | 2.32 ± 0.87 | 2.49 ± 0.84 |
| 4 months | 2.33 ± 0.74 | 2.37 ± 0.77 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 5 | 5 |
| 1 month | 7 | 6 |
| 4 months | 2 | 7 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 8 | 16 |
| 1 month | 16 | 21 |
| 4 months | 9 | 12 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 8 | 10 |
| 1 month | 8 | 11 |
| 4 months | 4 | 8 |
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.
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Baseline | 9 | 5 |
| 1 month | 4 | 3 |
| 4 months | 5 | 5 |
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".
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| 1 month — yes | 11 | 9 |
| 1 month — no | 27 | 30 |
| 4 months — yes | 7 | 3 |
| 4 months — no | 30 | 36 |
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".
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Always | 6 | 9 |
| Most of the time | 1 | 3 |
| Sometimes | 5 | 5 |
| Never | 26 | 21 |
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".
| Participants | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| Always | 9 | 7 |
| Most of the time | 3 | 3 |
| Sometimes | 4 | 3 |
| Never | 22 | 24 |
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.
| number of times asked partner | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| 1 month | 1.29 ± 2.75 | 0.59 ± 1.25 |
| 4 months | 0.92 ± 2.43 | 1.13 ± 2.90 |
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).
| number of times talked to family/adults | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| baseline | 1.60 ± 2.62 | 6.64 ± 22.08 |
| 1 month | 3.68 ± 16.12 | 1.82 ± 3.00 |
| 4 months | 1.3 ± 6.60 | 259.95 ± 1600.78 |
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).
| number of times had sex | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| baseline | 14.78 ± 79.26 | 6.64 ± 8.77 |
| 1 month | 1.58 ± 6.48 | 0.50 ± 0.98 |
| 4 months | 3.24 ± 16.41 | 1.26 ± 3.01 |
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).
| number of times had sex | InvestiDate Intervention | Non-Health Related Game |
|---|---|---|
| baseline | 0.28 ± 1.59 | 0.08 ± 0.27 |
| 1 month | 0.55 ± 3.24 | 0.03 ± 0.16 |
| 4 months | 0.03 ± 0.16 | 0.18 ± 0.60 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| InvestiDate Intervention | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Non-Health Related Game | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Customized(Participants) | InvestiDate Intervention | Non-Health Related Game | Total |
|---|---|---|---|
| 14 | 3 | 4 | 7 |
| 15 | 7 | 3 | 10 |
| 16 | 11 | 14 | 25 |
| 17 | 14 | 6 | 20 |
| 18 | 4 | 12 | 16 |
| 19 | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | InvestiDate Intervention | Non-Health Related Game | Total |
|---|---|---|---|
| Female | 40 | 39 | 79 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | InvestiDate Intervention | Non-Health Related Game | Total |
|---|---|---|---|
| Black or African American | 37 | 35 | 72 |
| Multi-Racial | 3 | 4 | 7 |
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 37 | 36 | 73 |
| Region of Enrollment(participants) | InvestiDate Intervention | Non-Health Related Game | Total |
|---|---|---|---|
| United States | 40 | 39 | 79 |
| Sexual Orientation(Participants) | InvestiDate Intervention | Non-Health Related Game | Total |
|---|---|---|---|
| Straight or heterosexual | 19 | 25 | 44 |
| Bisexual | 14 | 11 | 25 |
| Questioning or unsure | 5 | 3 | 8 |
| Queer | 1 | 0 | 1 |
| Asexual | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Feb 2022 to primary completion in Sep 2022, 7 months.
Results were first posted in Nov 2023, 1 year 1 month after primary completion.
Of 56 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 7 months is below that.
Counting every sponsor, half of 57 studies reached it within 28 months; a quarter within 19 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.