A Digital Intervention for HIV Prevention in Black Adolescent Girls

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Digital Intervention for HIV Prevention in Black Adolescent Girls

Conditions
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HIV, Risk Reduction Behavior

Intervention / Treatment
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* Behavioral: InvestiDate
* Other: Non-Health Related Video Game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: Failure to meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InvestiDate Intervention<br>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<br>* 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).<br>|
| Placebo Comparator: Non-Health Related Game<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black adolescent girls