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Two strategies of the US Ending the HIV Epidemic initiative are early diagnosis of infections via widespread testing and prevention of new infections using pre-exposure prophylaxis (PrEP). These strategies are particularly important for adolescents and young adults (AYAs) who are disproportionately affected by HIV, particularly if they identify as Black and/or lesbian, gay, bisexual, transgender, queer or questioning, and others (LGBTQ+). This study will develop and test an interactive life-simulation game in which players can enact real-life behaviors and receive their HIV risk profile to improve HIV testing and PrEP access among AYAs aged 13-24 years in Washington, DC.
This mixed methods study aims to determine the acceptability of an interactive, enhanced life-simulation game prototype among AYAs, conduct a pilot test of the gaming intervention among a small cohort of AYAs to ensure game usability and acceptability, and evaluate the efficacy of the game in a randomized controlled study with AYAs at risk for HIV in Washington, DC.
This research protocol will be conducted in 3 phases. A formative phase will involve surveys and focus groups (n=64) with AYAs living in the DC area. These focus groups will allow researchers to understand youth preferences for game enhancement. The second phase will consist of a pilot test (n=10) of the gaming intervention. This pilot test will allow researchers to modify the game based on formative results and test the planned recruitment and data collection strategy with intended end users. The third phase will consist of a randomized controlled study among 300 AYAs to examine the efficacy of the life-simulation game compared with app-based HIV educational materials on HIV and PrEP in changing HIV testing, knowledge, risk behaviors, and PrEP access. Participants will have unlimited access to either the life-simulation game or the educational app for 3 months from the time of enrollment. Study assessments will occur at enrollment and at 1, 3, and 6 months post enrollment via e-surveys. At 6 months, a subset of intervention participants (n=25) will participate in in-depth
Institutional review board approval was received on February 5, 2020. This project is currently recruiting participants for the formative phase.
This interactive life-simulation intervention aims to increase HIV testing and PrEP access among AYAs in the DC area. In this intervention, players can enact real-life behaviors and receive their HIV risk profile to promote HIV testing and PrEP seeking. Such an intervention has great potential to improve knowledge of HIV and PrEP among AYAs, increase motivation and self-efficacy related to HIV testing and PrEP use, and decrease individual and structural barriers that often preclude engagement in HIV prevention services.
ClinicalTrials.gov NCT04917575; https://clinicaltrials.gov/ct2/show/NCT04917575
PRR1-10.2196/29792
The goals of the US National HIV AIDS Strategy, Ending the HIV Epidemic initiative, and the HIV care continuum to reduce new HIV infections by intensifying prevention efforts where HIV is most heavily concentrated [
Barriers to HIV testing among youth include difficulty identifying and accessing HIV testing sites, low health literacy and beliefs that HIV remains a severe and fatal disease, and lack of self-perceived risk for HIV [
Despite the fact that AYAs are more receptive to HIV information when it is provided in an entertaining format [
We will use social cognitive theory (SCT) and the health belief model (HBM) to ground our intervention development. SCT provides a framework relevant to both health behaviors and interventions and has been widely used in HIV interventional studies [
This mixed methods study will enhance a life-simulation game intervention for AYAs at risk for HIV in the Washington, DC, metropolitan area. The game will be informed by findings from the focus groups with 64 AYAs. We will then conduct a pilot test with 10 AYAs and a randomized controlled trial (RCT) with 300 AYAs. To evaluate the efficacy of the life-simulation game compared with app-based HIV educational materials on HIV and PrEP in changing HIV testing, knowledge, risk behaviors, and PrEP access, RCT participants will have unlimited access to either the game or the educational app for 3 months from the time of enrollment. Electronic study assessments will occur at enrollment and at 1, 3, and 6 months post enrollment. At 6 months, a subset of intervention participants (n=25) will participate in in-depth
AYAs will be eligible for enrollment in each phase of the study based on the following criteria: (1) ages 13-24 years; (2) English speaking; (3) sexually active; (4) HIV-negative status; (5) residing in DC, Maryland, or Virginia; and (6) able to provide informed consent or assent. AYAs participating in the second and third phases will also need to have a mobile phone that they are willing to use for the study. We are limiting the study to AYAs aged 13-24 years because they account for a significant proportion of new HIV cases in Washington, DC, and doing so will allow for the development of a life-simulation gaming intervention that is targeted, acceptable, and engaging for this specific population. We plan to enroll a sample representative of diverse racial and ethnic and sexual behaviors.
The life-simulation game prototype for smartphones (iOS and Android), tablets, and the web was developed in a phase 1 Small Business Innovation Research study [
After the implied sexual activity, the music abruptly stops, and the player sees the estimated HIV risk their character just incurred (
Draft avatar editor system showing a sample character that can transition from masculine to feminine gender expression.
Draft scene of opposite sex and same sex flirtation.
Draft HIV risk screen adapted from the Centers for Disease Control and Prevention risk estimator tool.
HIV prevention services locator based on publicly available the Centers for Disease Control and Prevention locators.
Focus groups will occur in 2 rounds (n=32 each) and will be conducted by ADC, DG, and BW, who have experience with qualitative research used to develop behavioral interventions. Focus group participants will be recruited via advertisements placed on various social media sites (eg, Facebook, Snapchat, and Instagram). Interested participants will be directed to a web-based eligibility screener in the REDCap (Research Electronic Data Capture) platform, a secure Health Insurance Portability and Accountability Act (HIPAA)–compliant web application designed exclusively to support data capture for research studies [
Focus group questions cover the following topics: HIV and PrEP knowledge, perceptions and experiences regarding HIV testing, current use of and access to gaming technology (eg, use of smartphones, game consoles), perceptions regarding game enhancements and their potential role in increasing HIV testing and access to PrEP, perceptions about the role of social media and its influence on HIV testing behaviors, and opinions regarding effective recruitment approaches through social media. The enhanced life-simulation game will be demonstrated to participants, and feedback will be elicited regarding the acceptability and relevance of characters, texts, actions, and graphics, as they relate to race, culture, and structural factors. Following the focus group, participants will be sent the link to a survey in REDCap to assess their change in knowledge of HIV and PrEP as well as their satisfaction with the game prototype.
All focus groups will be audio recorded, and a verbatim transcription is professionally produced. The resulting text file will be entered into the qualitative data analysis software Atlas.ti 7.0 (ATLAS.ti Scientific Software Development GmbH) and analyzed using an a priori and open coding process aimed at identifying relevant themes and categories to inform the development of the game modifications for round 2 focus group testing as well as the final game prototype in the pilot test. Key decisions will include potential differences by age and sexual orientation, the types of games, art styles, social features, type or frequency of in-game bonuses, and responses of different kinds of in-game virtual rewards for actions such as demonstrating knowledge of HIV risks and virally spreading the game to peers. Game modifications will be made based on the initial focus group feedback (n=32), after which the second group of participants (n=32) will be recruited and shown the revised game. Survey data will be cleaned, downloaded, and exported into Excel or SAS files, and descriptive statistics will be analyzed. Pre- and postgame knowledge levels will be calculated; however, because of the small sample size, no statistical testing will be performed.
If it is determined that AYA in the formative focus group does not like the enhanced life-simulation game, additional modifications will be made. Once the look and feel have been finalized, the game production team will implement v2.0, creating base code, audio, and 3D art or animation using the Unity
Pilot test participants will be recruited via advertisements placed on various social media sites. Interested participants will be directed to a web-based eligibility screener in REDCap. Participant eligibility will be confirmed by the project staff via phone. Eligible participants will provide electronic consent and assent and complete the baseline survey electronically via a HIPAA-compliant participant management database. Participants will then be sent the gaming app electronically to download on their phone and will have unlimited access for 1 month. User pilot testing will allow project staff to identify any unanticipated issues with game log-ins, navigation, functionality, paradata collection, or other unforeseen technical issues. During user testing, game use as well as HIV testing and PrEP locator use will be monitored and paradata will be accessed for a 1-month period.
We will also pilot the use of the HIPAA-compliant participant management database for participant screening, survey collection, and data management and troubleshoot for any issues with phone connectivity, data caching, paradata collection, or other potential issues. Baseline data on HIV testing and knowledge will be collected to preliminarily describe the anticipated characteristics of our web-based sample. Measures of game satisfaction [
Survey data will be cleaned, downloaded, and exported into Excel or SAS files. Given the small sample size and objectives of this study, quantitative analysis will be primarily descriptive to measure usability, acceptability, and satisfaction as well as to confirm baseline characteristics and behaviors of our intended study population. All interviews will be audio recorded, and verbatim transcription professionally produced. The resulting text file will be entered into the qualitative data analysis software Atlas.ti 7.0 and analyzed using an a priori and open coding process aimed at identifying potential barriers and facilitators to use. Critical and essential modifications will be made to the game, paradata, and HIPAA-compliant data management platforms before the RCT.
We will evaluate the impact of the life-simulation game compared with app-based HIV educational materials in an RCT with 300 AYAs. To enroll a sample representative of diverse racial or ethnic and sexual behaviors as well as a sample of non–clinic-attending AYAs, recruitment will occur primarily through social media. We will place targeted advertisements toward YMSM and Black and Hispanic AYAs on social media sites, such as Facebook, Instagram, and Snapchat. In addition, we will provide recruitment materials with quick response codes to the DC Health and Montgomery county school-based health programs. Interested AYAs will click on an advertisement and be directed to a web-based eligibility screener to determine their age, gender, sexual behaviors and orientation, state of residence, and availability of a reliable cell phone. The eligibility of the participants will be confirmed by the project staff via phone. Eligible participants will then provide electronic consent and complete the baseline survey electronically. Participants will be randomized using the block randomization method designed to ensure groups of equal sample sizes (1:1). Participants will be randomized in blocks of 6, stratified by age (13-17 years and 18-24 years) and sexual behavior (LGBTQ+ vs heterosexual), using a random number generator for assignment. Randomization will occur through the HIPAA-compliant participant management database platform. We will compare conditions on HIV testing, knowledge, risk behaviors, and PrEP access at enrollment and at 1, 3, and 6 months post enrollment via electronic survey assessments. At 6 months, a subset of intervention participants (n=25) will participate in in-depth
Aim 3 study flow diagram. DC: District of Columbia; REDCap: Research Electronic Data Capture.
Intervention participants will have access to the full revised study game for 3 months from the time of enrollment and will be able to play the game and have up to 30 hours of content available. To sustain interest and engagement over the study period and maximize potential efficacy, new downloadable game content will be available every 4 weeks post enrollment through the 3-month follow-up.
Before rolling out the RCT, we will develop an app that will include basic information on HIV (eg, routes of transmission, data on the epidemiology of HIV among youth, prevention information, and information on HIV testing and PrEP) as well as a link to the HIV risk estimator and HIV testing and PrEP locators. Participants assigned to the control arm will receive a link to download this informational app containing this content and will have unlimited access to the app for a 3-month period.
Electronic surveys via REDCap will be used to assess the behavior at baseline and at 1, 3, and 6 months post enrollment, as it is confidential and allows for complex branching or skip patterns [
At 6 months, a purposely selected subset of intervention participants (n=25) will participate in IDIs regarding their experience being in the study. The IDIs will be conducted by trained qualitative interviewers and will follow semistructured interview guides. The IDIs will assess the extent to which app components facilitate or inhibit HIV testing. Central to the IDIs will be understanding the participants’ use of the app. To obtain a range of perspectives, we will seek feedback from participants stratified by sexual behaviors (heterosexual vs LGBTQ+), age group (13-17 years vs 18-24 years), whether they sought and received HIV testing, and levels of game play and locator use based on the paradata (none, low-moderate, and high use).
The primary outcome measure for the study is HIV testing. This will be measured as self-reported HIV testing in the past 6 months. For all participants who report testing, we will attempt to validate reported testing by eliciting a description of the HIV testing process and requesting that a secure photo of their test results be sent to study staff to minimize social desirability bias. We will compare self-reported HIV testing between the 2 groups at 6 months.
As self-reported measures tend to overestimate HIV testing and given the age range of our participants and potential structural barriers to the receipt of HIV testing among AYAs (eg, parental knowledge of testing, lack of transportation, inconvenient clinic times), a secondary outcome will be intent to test for HIV. The intent to test will be assessed using a validated 6-point Likert scale [
Measures planned for each phase.
Domain | Assessment time | ||||
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Focus group | Pilot test | RCTa | ||
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Tested during intervention periodb | ✓c | ✓ | ✓ |
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Interval and frequency of test | ✓ | ✓ | ✓ |
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Reason for test [ |
✓ | ✓ | ✓ |
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Perceived benefit of HIV testing | ✓ | ✓ | ✓ |
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✓ | |
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Intent to test [ |
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✓ |
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Intent to seek PrEPd [ |
✓ |
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✓ |
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Intent to reduce risky behaviors [ |
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✓ |
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HIV knowledge [ |
✓ | ✓ | ✓ | |
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Perceived susceptibility to HIV [ |
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✓ | |
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Sexual behaviors | ✓ | ✓ | ✓ |
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Ever STDe diagnoses | ✓ | ✓ | ✓ |
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Alcohol and illicit drug use [ |
✓ | ✓ | ✓ |
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Perceived norms [ |
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✓ | |
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✓ | |
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Knowledge and screening [ |
✓ |
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✓ |
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Use or uptake |
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✓ |
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Ability to negotiate condom use [ |
✓ |
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✓ |
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Encourage partners or friends or peers to get HIV testing | ✓ |
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✓ |
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Game downloads |
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✓ | ✓ |
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Frequency and duration of game play |
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✓ | ✓ |
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Game satisfaction [ |
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✓ | ✓ |
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Usability [ |
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✓ | ✓ |
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Teaching approach [ |
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✓ | ✓ |
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CDCf Risk Estimator scores |
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✓ | ✓ |
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Number of linkages to HIV testing locator |
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✓ | ✓ |
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Number of linkages to PrEP locator |
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✓ | ✓ |
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Recommend app to friend or share on social media |
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✓ | ✓ |
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Demographics | ✓ | ✓ | ✓ | |
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Use of social media and gaming | ✓ | ✓ | ✓ | |
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Exposure to health or sex education programs | ✓ | ✓ | ✓ | |
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Perceived barriers to HIV testing | ✓ |
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✓ |
aRCT: randomized controlled trial.
bVerification of HIV testing and pre-exposure prophylaxis uptake will be conducted through photos and in-depth interviews.
cThe tick mark indicates that the measure will be assessed during that specific phase of the study.
dPrEP: pre-exposure prophylaxis.
eSTD: sexually transmitted disease.
fCDC: Centers for Disease Control and Prevention.
In our pilot study [
All primary analyses will be conducted using an intent-to-treat approach. The primary analysis will focus on differences between the treatment and control groups at the 6-month follow-up visit using a chi-square test for independence (the outcome will be taken as having had an affirmative response on the outcome measure during the 6-month study period). We will also investigate the differences between the rates of HIV testing in the treatment and control groups, stratifying by age (13-17 years vs 18-24 years) and sexual orientation (LGBTQ+ vs heterosexual identity). We will perform a longitudinal analysis on the repeated measures from each subject using logistic mixed effects models with a subject-specific random intercept. In each model, we will include time as a 4-level categorical predictor (with baseline serving as the reference level) as well as a treatment indicator and time-by-treatment interaction. We will jointly test the interaction coefficients to determine if the effect of treatment varies over time. If the effect is found to vary over time, we will test the intervention effect at each time point and characterize the difference between the treatment and control groups using risk differences and their corresponding 95% CIs. If no evidence of a time-by-treatment interaction is present, we will refit the logistic model without the interaction terms and provide the overall intervention effect and its corresponding 95% CI.
Furthermore, we will provide a descriptive analysis of each secondary outcome overall and within each intervention arm at each time point. Secondary outcomes will also be compared between the treatment and control groups using one-tailed
For their participation in the formative focus groups, AYAs will receive a US $30 gift card and an additional US $10 gift card for a peer recruited who participates in the focus group. For their participation in the pilot test, AYAs will receive US $80 gift cards (US $20 for the baseline survey, US $30 for the 1-month survey, and US $30 for the IDI). For their participation in the RCT, AYAs will receive up to US $150 in gift cards (US $30 for the baseline survey, US $25 for the 1-month survey, US $25 for the 3-month survey, US$40 for the 6-month surveys, and US $30 for the IDI).
To protect participants from potential loss of confidentiality, the following measures will be taken: informed consent and assent will be required for participation in the focus groups, pilot testing, and intervention. Each study participant will be assigned a pseudonym to participate in the focus groups, and interviews and surveys will be labeled with a study ID. Participants will be informed that individual results will not be shared, and only aggregate results will be disclosed at study completion. Summary statistical data stratified by age, race, or other categories may be released. However, if the total information will allow identification of the exact person or persons the information will not be released.
All study-related materials will only be accessible to the research staff. All data collection will take place with HIPAA-compliant software (ie, WebEx and REDCap). All study personnel have completed training and received certification in Human Subjects Research Protection (Collaborative Institutional Training Initiative Program) and HIPAA regulations and will continue to renew this training in compliance with institutional review board policies. We will adapt measures successful in other studies to reduce the risk of potential breaches by using passwords, not sending any sensitive information, and eliciting AYAs’ preferred method of communication and receipt of study information (eg, surveys and incentives).
The study was funded on April 2, 2020. The protocol has been reviewed and approved by the George Washington Institutional Review Board (NCR191708) on February 5, 2020 and was registered on ClinicalTrials.gov (NCT04917575). Data collection for the formative phase is projected to begin in June 2021.
The life-simulation gaming intervention aims to increase HIV testing and PrEP access among AYAs by reducing individual and structural barriers. Through digital content aligned with SCT and the HBM, the intervention attempts to positively influence youth self-efficacy, risk perceptions, and knowledge of HIV prevention as well as influence AYAs’ social support.
There are several potential challenges to the success of our trial. First, if it is determined that AYAs in the formative focus groups do not like the proposed enhancements, we will modify the game accordingly. Second, for all 3 phases, we plan to intentionally recruit AYAs who are not regular clinic attendees and rely primarily on social media recruitment. If this proves challenging, we will consider expanding recruitment to local community-based organizations that are not HIV focused and consider recruiting from after-school programs or events geared toward AYAs. Third, although web-based recruitment is ideal to identify our population of interest, there is a risk of fraud, and we plan to have staff verify the eligibility of potential participants. Finally, AYAs’ gaming preferences change far faster than the pace of research. Avatar clothes and other in-game items may no longer be popular during the game’s release. The software architecture is designed to be modular and flexible to allow many elements to be altered both before and after release. To ensure adequate game content to keep AYAs engaged during the study period, as per industry standards, we will build in frequent releases of new game content.
As the number of new HIV infections among AYA continues to grow, innovative methods to scale up HIV prevention for this population are required. The results of this study will be useful for understanding the extent to which a digital game can increase HIV testing and PrEP access among AYAs. If effective, we will work with the local health departments, health clinics, and school-based clinics to make the game available to their students and patients. We will also look into making the game and locators relevant and available to AYAs living in areas of the United States with some of the highest rates of HIV infection, such as the Southern United States.
Peer-review report by the Center for Scientific Review Special Emphasis Panel, Small Business: Disease Prevention and Management, Risk Reduction and Health Behavior Change (National Institutes of Health).
adolescents and young adults
health belief model
Health Insurance Portability and Accountability Act
in-depth interview
lesbian, gay, bisexual, transgender, queer or questioning, and others
pre-exposure prophylaxis
randomized controlled trial
Research Electronic Data Capture
social cognitive theory
young men who have sex with men
DG, a principal investigator on the grant, has a stake in Media Rez consistent with the policy on Small Business Innovation Research.