HIVNCT04108988
A Digital Intervention for HIV Prevention in Black Adolescent Girls
A study testing InvestiDate and Non-Health Related Video Game in people with HIV and Risk Reduction Behavior, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Risk Reduction Behavior
- What is being tested?
- InvestiDate and Non-Health Related Video Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 24 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both phases (includes focus groups- Phase 1)
- Black (race)
- Heterosexual
- Currently enrolled in high school
- Pilot Test (Phase 2)
- Ability to participate in web-based videogame
Show all 9Show fewer
- Willing to sit for at least 60 minutes (to play the game)
- No HIV testing in the last 12 months
- Ability to provide assent or parental/guardian consent
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
- Determine the preliminary impact of the intervention on knowledge (information), intentions/attitudes (motivation), social norms, and behavioral skills as related to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk behavior reduction, such as alcohol and drug use.
- Conditions
- HIV, Risk Reduction Behavior
- Being tested
- InvestiDate, Non-Health Related Video Game
- Keywords
- Black adolescent girls
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvestiDateBehavioural
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).
Non-Health Related Video GameOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: InvestiDate |
| 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. Receives: Other: Non-Health Related Video Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 4
Total Time Playing
The mean total time spent playing the videogame
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month and 4 months
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline, 1 month and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Feb 2022
- Primary completion24 Sep 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kimberly Hieftje, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108988
- Sponsor's protocol ID
- 2000026487
- Other IDs
- 1R21HD098031-01
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2019
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37853731Weser 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.
PubMed 36689272
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention for HIV Prevention in Black Adolescent Girls
- ClinicalTrials.gov ID
- NCT04108988
- Acronym / sponsor ID
- 2000026487
- Conditions
- HIV, Risk Reduction Behavior
- Keywords
- Black adolescent girls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
- Determine the preliminary impact of the intervention on knowledge (information), intentions/attitudes (motivation), social norms, and behavioral skills as related to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk behavior reduction, such as alcohol and drug use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InvestiDate Intervention | Experimental | Behavioral: InvestiDateOne 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 | Other: Non-Health Related Video GameParticipants in the non-health related game group will play a multiplayer game unrelated to the content of InvestiDate. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Both phases (includes focus groups- Phase 1)
- Black (race)
- Heterosexual
- Currently enrolled in high school
- Pilot Test (Phase 2)
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
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 |
|---|---|---|
| InvestiDateParticipants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). | Behavioural | InvestiDate Intervention |
| Non-Health Related Video GameParticipants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40). | Other | Non-Health Related Game |
Primary outcome
Feasibility Assessed Using Change in Retention Rates
Time frame: Baseline, 1 month and 4 months
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.
Acceptability Assessed Via Self-reported Survey
Time frame: 1 month
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.
Acceptability Assessed by Favorite Investidate Activities
Time frame: Month 4
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.
Total Time Playing
Time frame: Month 4
The mean total time spent playing the videogame
Change From Baseline at 4 Months: HIV/STI Testing- Self
Time frame: Baseline, 1 month and 4 months
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.
Change From Baseline at 4 Months: HIV/STI Testing- Partner
Time frame: Baseline, 1 month and 4 months
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.
25 secondary outcomes
Change in Use of Condoms
Time frame: Baseline, 1 month and 4 months
Change in Self-Efficacy to Use Condoms (SECU) Using the Condom Use Self-Efficacy Scale (CUSES)
Time frame: Baseline, 1 month, 4 months
Change in SECU Using Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS)
Time frame: Baseline, 1 month, 4 months
Change in Self-efficacy in Refusing Sex (SER) Using the SER Subscale of the SRBBS
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
Time frame: Baseline, 1 month and 4 months
Change in Self-efficacy for PrEP
Time frame: Baseline, 1 month and 4 months
Change in Attitudes About Condom Use (ACU) Assessed Using the ACU Subscale of the SRBBS
Time frame: Baseline, 1 month and 4 months
Change in Attitudes About Sexual Intercourse (ASI) Were Assessed Using the ASI Subscale of the SRBBS
Time frame: Baseline, 1 month and 4 months
Change in Intentions to Find a Clinic to Speak to a Doctor About PrEP
Time frame: Baseline, 1 months and 4 months
Change in Sexually Transmitted Infections (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
Time frame: Baseline, 1 months and 4 months
Change in Norms About Intercourse (NSI) Assessed Using the NSI Subscale of the SRBBS
Time frame: Baseline, 1 months and 4 months
Change in Perceived Norms About PrEP
Time frame: Baseline, 1 months and 4 months
Change in Barriers to Condom Use (BCU) Assessed Using the BCU Subscale of the SRBBS
Time frame: Baseline, 1 months and 4 months
Change in Behavior of Purchasing Condoms
Time frame: Baseline, 1 month and 4 months
Change in Behavior of Having Looked up a Place to Get HIV or STI Testing
Time frame: Baseline, 1 month and 4 months
Change in Behavior of Having Talked With Partner About Getting Tested for HIV or STI
Time frame: Baseline, 1 month and 4 months
Change in Birth Control Use
Time frame: Baseline, 1 month and 4 months
Change in Behavior Regarding Refusal to Have Sex
Time frame: 1 month and 4 months
Number of Participants Refusal to Have Sex
Time frame: Baseline
Number of Participants That Asked Partner About Previous Condom Use
Time frame: Baseline
Number of Times Participants Asked Partner About Previous Condom Use
Time frame: 1 month and 4 months
Number of Times Participants Talked to Family or Adults About HIV
Time frame: baseline, 1 month and 4 months
Number of Times Participants Engaged in Sexual Intercourse
Time frame: baseline, 1 month and 4 months
Number of Times Participants Engaged in Anal Sex
Time frame: baseline, 1 month and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37853731Budge 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.
- Derived from this study: PubMed 36689272Weser 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.
- Individual participant dataSharing planned: Undecided
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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 Hieftje, PhD 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 InvestiDate and Non-Health Related Video Game in people with HIV and Risk Reduction Behavior, 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 9 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 8 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility Assessed Using Change in Retention Rates (time frame: Baseline, 1 month and 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108988, which also lists 2 linked publications.
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 8 Nov 2023.