A Digital Intervention for HIV Prevention in Black Adolescent Girls
Phase: NA
Conditions: HIV, Risk Reduction Behavior
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 12/19/2021
IRB# 2000026487 
                   
                                   
HRP-503B – BIOMEDICAL RESEARCH PROTOCOL 
(2017-1)
Protocol Title: A Digital Intervention for HIV Prevention in Black Adolescent Girls
Principal Investigator: Kimberly Hieftje, PhD
Version Date:  12/10/2021
(If applicable) Clinicaltrials.gov Registration #: NCT04108988
INSTRUCTIONS
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needed by the IRB to determine whether a study meets approval criteria. Read the following instructions 
before proceeding:
1.
Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system Library.
2.
If a section or question does not apply to your research study, type “Not Applicable” underneath.
3.
Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system. 
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SECTION I: RESEARCH PLAN
1.
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
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/STI testing, increasing their knowledge and 
awareness of HIV/STIs, and for reducing sexual risk-taking behaviors (1.e. non-condom use). As a multiplayer 
videogame, 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, our Specific Aims, focusing on Black adolescent girls aged 14-18 years, are to:
1.
Translate our culturally and socially-tailored card game One Night Stan to a multiplayer videogame using 
game design and content experts and focus group input from 30 Black adolescent girls.
2.
Conduct a pilot randomized controlled trial comparing the multiplayer videogame InvestiDate 
intervention vs. an attention/control non-health-related multiplayer videogame with 80 participants 
collecting assessment data at baseline, one, and four months to:
a.
Determine the intervention’s acceptability and feasibility by collecting quantitative and qualitative 
data on Black adolescent girls’ satisfaction and gameplay experience of the intervention. 
b.
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. 
2.
Probable Duration of Project: State the expected duration of the project, including all follow-up and data 
analysis activities.  
2 years
3.
Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data.
Black women are disproportionately affected by HIV. At current rates, 1 in 32 Black women will be 
diagnosed with HIV in her life span1. Given that Black women are often diagnosed late in the disease 
process, it is believed that many Black women were, in fact, infected in adolescence2. Black 
adolescent girls between the ages of 14 and 19 are more than twice as likely than White girls (44% 
vs. 19%, p = 0.001) to be diagnosed with an STI (p = 0.001)3. Alarmingly, STIs are associated with an 
increase in the risk for HIV acquisition up to two- to fivefold4-6. Research suggests that inadequate 
knowledge about HIV and the role of high-risk behaviors may contribute to the high HIV rates among 
Black women7. For this reason, an early intervention that focuses specifically on Black adolescent 
girls in high school and that is gender and culturally tailored may decrease their risk for HIV/STIs 
infection. 
Studies of social and behavioral determinants of disease have increasingly focused on the role of 
peer group structures on individual outcomes8,9. Interactions in peer groups offer opportunities for 
individuals to exchange and evaluate information, to learn social norms, to develop behavioral skills, 
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IRB# 2000026487 
and to influence each other’s attitudes and behaviors10. These interactions have important effects 
on knowledge and attitudes about risk, social support for risk and behavioral skills for prevention, 
and risk or preventive behaviors per se11. For instance, a community-based pilot study demonstrated 
a 72% increase in the number of individuals getting tested for HIV/STI when peers recruited others 
through their social network 12. Similarly, a recent study of at-risk Black and Hispanic young women 
and adolescent girls, aged 13 to 24, found that a female friendship network method of engaging 
them was successful with increasing HIV testing rates of 90%13. 
Ninety-seven percent of teens ages 12-17 play computer, web, portable, or console games14, and 
94% of girls play video games. Social videogames, or games played with others, are the most popular 
and most frequently played game genre15.  Both non-digital and digital games have a well-
established role in education16 because simulated role-playing is a highly effective approach for 
situated learning17. Active participation through simulated role-playing enables individuals to 
practice behavioral change in a safe and entertaining way18,19. Role-playing is a powerful mechanism 
for influencing people’s attitudes20,21. Game interventions have demonstrated efficacy in increasing 
knowledge and affecting behaviors and psychological variables related to health promotion and 
disease management22 in areas ranging from depression to medication adherence23-29. There is also 
compelling evidence that individuals who acquire new information, motivation, behavioral skills in a 
gaming environment are more likely to act in accordance with the new skills in real life30,31. 
Multiplayer social games are often more slowly and deliberately paced than single player games. 
This may help to create a shared experience with at least one other player, thus allowing for 
conversations between players and the opportunity to influence attitudes, beliefs, and perceptions 
around serious topics32. 
Although effective HIV/STI prevention programs for Black adolescent girls currently exist, including 
Diffusion of Effective Behavioral Interventions (DEBIs), such as Sisters Informing Healing Living and 
Empowering (SIHLE), Choosing Life: Empowerment! Action! Results! (CLEAR), and Focus on Youth 
with Informed Parents and Children Together (FOY+ImPACT)33, challenges regarding implementation 
and fidelity have been a concern. Recent studies have cited several barriers to the implementation 
of HIV/STI prevention interventions, including access to adequately trained providers, staff turnover, 
resource constraints of agencies, fidelity of the interventions, and challenges of adapting an 
intervention from one population to another34-36. In addition to consistent fidelity and limited 
demand on program resources, the proposed multiplayer videogame offers some new features that 
could augment those found in many HIV prevention interventions that target Black adolescent girls 
as it will: 1) be packaged in a self-contained “vehicle” that is easily accessible and widely available; 2) 
be interactive with opportunities for players to build and practice skills; 3) allow for Black adolescent 
girls to engage with others or on their own, increasing their exposure (or “dose”) to the intervention; 
4) build upon elements that have been identified as being crucial for successful HIV/STI prevention in 
this population; and 5) not require personnel cost or staff training. Furthermore, given that 
videogame play is widespread, a game for HIV/STI prevention will allow for greater dissemination of 
this intervention and potential expansion of this concept to other high-risk populations. 
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IRB# 2000026487 
4.
Research Plan: Summarize the study design and research procedures using non-technical language that can 
be readily understood by someone outside the discipline. Be sure to distinguish between standard of care vs. 
research procedures when applicable, and include any flowcharts of visits specifying their individual times and 
lengths. Describe the setting in which the research will take place.
The purpose of this study is to translate the card game prototype, One Night Stan, into a multiplayer 
videogame with a focus on empowering Black adolescent girls to assess their risk, improve communication 
skills, and develop self-efficacy throughout their sexual experiences. By doing so, this digital intervention may 
provide an opportunity to reduce HIV/STI disparities in Black adolescent girls. To differentiate between the 
card game and the multiplayer videogame intervention, the videogame intervention has been named 
InvestiDate.      
The study will take place in two phases. In Phase 1, we will conduct four focus groups with five participants 
each (20 participants) with Black adolescent girls to understand their attitudes, perceptions, and knowledge 
around communication about HIV/STI testing and condom use with partners. We will conduct focus groups at 
our partner settings, which include private rooms that we can access. Alternatively, we may conduct focus 
group sessions through Yale’s videoconferencing tool, Zoom. We will then develop an alpha version of the 
multiplayer videogame InvestiDate, from the prototype card game, One Night Stan, using formative research 
and focus group data. Once developed, we will then conduct playtesting with focus groups (two focus groups 
with five participants each) to develop the beta version of the game. In Phase 2, we will pilot test the game 
intervention with 80 Black adolescent girls (aged 14-18 years) at partner sites in New Haven, Connecticut. 
Alternatively, we may conduct gameplay sessions through Yale’s videoconferencing tool, Zoom, if in person 
meetings are not possible. If conducted in person, gameplay sessions will take place in private rooms 
dedicated to the study. If conducted remotely, we will ensure participants have access to a private room and 
Zoom-capable equipment.   Participants will be randomly assigned to InvestiDate, or a non-health related 
multiplayer videogame that will serve as an attention/time control condition. All participants will play their 
assigned videogame for 1-2 hours, on two instances separated by approximately a week for between 2 and 4 
hours of gameplay total. They will be evaluated at baseline, one, and four months. 
Setting: For Phase 1 and Phase 2, recruitment and enrollment will take place either in person with partner 
schools and organizations or remotely either in partnership with schools that have agreed to collaborate with 
us, or through study advertisements placed on social media. Given our ability to play the videogame and 
collect data remotely, we are seeking additional partnerships with schools nationwide and recruiting 
participants individually through social media, including Facebook and Instagram.  For Phase 1 (focus groups), 
recruitment may also take place online through social media platforms, including Facebook and Instagram. 
Focus groups will take place online through Zoom where participants will be able to see and interact with 
each other. 
Of note, the Principal Investigator, Dr. Kimberly Hieftje will not be involved in any aspects of consenting 
participants or their parents, the randomization process, data collection or direct performance of data 
analysis procedures.
Participants: For both phases, participants must be Black heterosexual adolescent girls aged 14 to 18 and 
currently enrolled in high school. For Phase 2, participants must also: 1) be able to participate in web-based 
videogame (willing to sit for 60-minutes/session to play the game); 2) not have been tested for HIV in the past 
year; and, 3) be able to provide assent/parental/guardian consent. 
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Phase 1: Conduct focus groups and playtesting with Black adolescent girls and develop InvestiDate (30 
participants): Focus group discussions with Black adolescent girls will inform the new version of the game by 
providing ideas for content and gameplay around HIV/STI testing, condom use, and sexual risk taking. We 
have used and refined this iterative process for current videogame projects15,37-45. Data collected will be used 
to inform the development of the multiplayer videogame, InvestiDate. Example question for the focus groups 
include, “What are some red flags that teens your age look for when considering dating someone?”, “What 
are some green flags that teens your age look for when considering dating someone?”, “What might make it 
difficult for teens your age to get tested for HIV/STIs?” 
The card game prototype One Night Stan will be adapted as a multiplayer videogame called InvestiDate and 
will focus on a slightly younger age group. To do this we use formative research, pilot data, and focus group 
input to create an updated Game Playbook37, or intervention manual that will be used to guide the 
development and design of the game. 
Phase 2: Pilot test InvestiDate compared with a control condition: 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 assigned to either the intervention or the control condition using a 
stratified randomization procedure46. Age for the participant and partner testing in the last 30 days will be 
included in the randomization algorithm. Participants will be randomized by group so that the same group of 
participants will always play together. 
Assessments: We will assess a range of pre-intervention participant characteristics (demographic), process 
measures, and outcomes (see below in Table 1). All assessments are standardized validated instruments that 
will be collected in person, using a web-based clinical trial management system we have used with our other 
studies. Assessments will be collected online using Yale-secured Qualtrics survey collection software. Baseline 
assessments are designed to ensure that all participants meet eligibility criteria and that important predictor 
variables are assessed. We will conduct post-intervention assessments immediately after gameplay sessions 
are completed (one month) with follow-up assessments at four months following enrollment to allow an 
adequate time for accumulation of outcome events47.
Table 1: Assessments
Assessment
Base-
line
Month 1
Month 4
Participant Demographics (i.e. gender, age, education) 
X
HIV/STI Testing Rates and Partner HIV/STI Testing Rates 
X
X
X
Sexual Risk Behaviors—Self-reported measures of sexual intercourse with/without condoms48
X
X
X
Vulnerability to Risky Sexual Behaviors49,50
X
X
X
Risk Behaviors Associated with HIV/STIs - Youth Risk Behavior Survey51 
X
X
X
HIV Knowledge (HIV-KQ)52 (45 item true/false questionnaire)
X
X
X
STI Knowledge (STD-KQ)53 (27-item true/false questionnaire)
X
X
X
Subjective Norms54,55
X
X
X
Intentions56,57
X
X
X
Attitudes—Multi-dimensional Condom Attitudes Scale (MCAS)58
X
X
X
Self-efficacy in sexual risk behaviors—Sexual Risk Behavior Beliefs and Self-efficacy (SRBBS) 
Scales59
X
X
X
Condom Self-Efficacy (CUSES)60 (28-item Likert scale)
X
X
X
Sexual Communication61
X
X
X
*Satisfaction with game play/acceptability and feasibility (12-item Likert scale)44
X
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5.
Genetic Testing   
N/A ☒
6.
Subject Population: Provide a detailed description of the types of human subjects who will be recruited into 
this study.
Adolescents ages 14-18 will be recruited into this study.
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement.
☒Children
☒ Healthy 
☐Fetal material, placenta, or dead fetus
☐Non-English Speaking
☐ Prisoners
☐Economically disadvantaged persons
☐Decisionally Impaired
☐ Employees
☐Pregnant women and/or fetuses
☐Yale Students 
☐ Females of childbearing potential
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects?
Yes ☐  No ☒ 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion?
Inclusion/exclusion criteria: For both phases, participants must be Black heterosexual adolescent girls aged 14 
to 18 and currently enrolled in high school. For Phase 2, participants must also: 1) be able to participate in 
web-based videogame (willing to sit for 60-minutes/session to play the game); 2) not have been tested for 
HIV in the past year; and, 3) be able to provide assent/parental/guardian consent. 
9. How will eligibility be determined, and by whom? 
Eligibility will be determined by the research team. If a prospective participant meets the inclusion criteria, 
they will be eligible to participate in the project.
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research. 
The potential risks associated with this study have to do with maintenance of the confidentiality of the 
identities of the participants enrolled in the study and information relating to them. For focus groups, we will 
address the risk to confidentiality to participants that are participating in the study and that this cannot be 
guaranteed given that others will also be participating.  However, participants will be told that they should not 
disclose information about other participants and all participants should respect the privacy of each other. 
Only participants’ ID numbers will be recorded on the electronic assessments themselves to protect 
confidentiality. Sensitive data is encrypted in transit and in storage. The web data-entry interface allows data 
entry to be performed from anywhere on the Internet and uses 128-bit secure sockets layer (SSL) security to 
protect the confidentiality of the data. Playing InvestiDate may pose a potential psychological risk in that we 
address sensitive issues around sexual activity and how HIV/STI is transmitted, and the specifics of how certain 
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IRB# 2000026487 
risk behaviors (such as alcohol use) can result in HIV/STI. Additionally, participants may also recognize that they 
have risked acquiring HIV/STI and may have already acquired these diseases without knowing by confirmatory 
testing. It also involves interactions with the participants’ peers. The assessments and instruments may also 
present a potential risk given that some of the questions are sensitive in nature and address issues around 
sexual activity and other risky behaviors. 
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
A number of precautions will be actively integrated into the research procedures to protect the 
confidentiality and anonymity of all participants. For participating in Yale’s videoconferencing tool, Zoom, 
participants will be asked to find a secure, private setting, free from others outside the study that may 
overhear the discussion. All research staff and the staff and volunteers participating in the intervention will be 
required to complete training in research ethics. Data collection forms will be designated by ID numbers only. 
A separate master file of names, addresses, contact persons, and telephone numbers, along with the study ID 
numbers will be maintained in a locked file cabinet in the research team’s offices. All data entry and analyses 
will be completed with ID numbers only. The study will be explained to others, such as the guardian/parent 
and program staff as a study of child development that will focus on promoting healthy behaviors. In 
instances in which data are requested from other sources or it is beneficial to the participant to provide 
information to another individual or agency (e.g. medical personnel) this will only be done with the written 
permission of the guardian/parent on a “Release of Information” form stipulating who the information is 
provided to, or received from. The research staff will follow standard confidentiality procedures for research 
programs. 
The research assistant will be available at all times to provide assistance to the participants, answer their 
questions, and serve as a resource if any distress or concern arises. The research assistant will be available to 
assist the participants, the community sites staff, and the research staff member administering the 
assessments if there appears to be any distress around the questions being asked. If participants need 
additional or more intensive attention, the research assistant will contact Dr. Claudia-Santi Fernandes, our 
clinical psychologist on the team, who will consult with the team in order to potentially provide consultation 
resources to the participant.
12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.)
a. 
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? Minimal risk
b.
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? Minimal risk
c.
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are  
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for
i.
Minimal risk
ii.
Greater than minimal
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews quarterly. During the review process, the research team will evaluate whether 
the study should continue unchanged, require modification/amendment, or close to enrollment. 
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The principal investigator or the Human Investigative Committee (HIC) have the authority to stop or suspend 
the study or require modifications.
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to Subjects or 
Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event that such events occur, 
Reportable Adverse Events (which are events that are serious or life-threatening and unanticipated (or 
anticipated but occurring with a greater frequency than expected) and possibly, probably, or definitely 
related) or Unanticipated Problems Involving Risks to Subjects or Others that may require a temporary or 
permanent interruption of study activities will be reported immediately (if possible), followed by a written 
report within 5 calendar days of the Principal Investigator becoming aware of the event to the IRB via the RNI 
submission process in IRES IRB and any appropriate funding and regulatory agencies. The investigator will 
apprise fellow investigators and study personnel of all adverse events that occur during the conduct of this 
research project through regular study meetings and via email as they are reviewed by the principal 
investigator. We will use procedures to detect and respond to adverse events that ensure prompt discovery 
of any adverse events and to minimize their effects. There is adequate surveillance and protections to 
discover adverse events promptly and keep their effects minimal. Data and safety monitoring procedures in 
this study include collection and monitoring of paper-based questionnaires and an organizational structure of 
clearly defined tasks assigned to all research personnel involved in the conduct of this study. We will keep a 
thorough record of research activities and completion of scheduled assessments.
We have established a Data Safety and Monitoring Board (DSMB) composed of two experts, Dr. 
Trace Kershaw and Dr. Cindy Crusto, in clinical trials in young teens and in statistical analysis of 
clinical trials to oversee the safety and data integrity of this study. DSMB will also review the 
progress of the study.
Dr. Trace Kershaw, Department Chair and Professor of Social and Behavioral Sciences, focuses on 
the social and structural determinants of health (e.g., sexual health, substance use, mental health, 
reproductive health) among adolescents and emerging adults. His current focus is using innovative 
technologic methods to understand how social and geographic context influence their behaviors and 
health. Further, he is an expert in developing interventions aimed to improve the health and well-
being of adolescents and emerging adults.
Cindy A. Crusto, Ph.D., Associate Professor of Psychiatry, Yale University School of Medicine, is the 
Director of Program and Service System Evaluation at The Consultation Center. Dr. Crusto has more 
than 20 years of experience in developing, implementing, and evaluating preventive interventions in 
schools and community agencies. She also has extensive experience providing training and technical 
assistance to schools and to community-based organizations on the evaluation of prevention 
programs. She is interested in culturally relevant interventions for children from racial/ethnic 
minority and low-income backgrounds and in school-based behavioral health services. 
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i.
How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? Write here
ii.
What provisions are in place for management of interim results? Write here
iii.
What will the multi-site process be for protocol modifications? Write here
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13. Statistical Considerations: Describe the statistical analyses that support the study design. 
All of the statistical analyses, including ensuring the completeness and integrity of the data is being 
carried out by the Yale Center for Analytical Studies (YCAS) in conjunction with the personnel 
overseeing CTMS. YCAS is a relatively new center for collaborative science. Developed in partnership 
with the Yale Center for Clinical Investigation and the Yale School of Public Health (YSPH), YCAS 
brings together existing academic strengths in biostatistics, epidemiology, health economics and 
health services research at Yale. Their collaborative teams provide expertise in the design, conduct 
and analysis of health and healthcare studies, methodological development and education and 
training to Yale and the extended research community.  YCAS operates in a vital and expanding YSPH 
community of scholars engaged in research that enhances the quality of the analytical and 
computational tools needed to effectively use the data being generated by rapidly advancing 
technology. Hence, it serves as a nexus for clinical investigators and analytical scientists with 
common interests to nurture the development and application of new approaches to design and 
data analysis.
Focus Groups: Data will be analyzed using the principles of grounded theory, using the constant 
comparative method for systematic inductive analysis62. The transcripts from focus groups will be 
reviewed by members of the research team jointly who will perform data coding. We will develop 
the codes in a step-wise fashion63, beginning with the creation of an initial code structure from the 
first two transcripts that are independently reviewed by each team member. All focus groups will be 
analyzed before initiating subsequent focus groups and new concepts will be used as probes in the 
subsequent interviews. To enhance inter-rater reliability, focus group transcripts will be 
independently reviewed and coded by each researcher and coding will be compared for agreement. 
Manual coding will then be electronically applied to the textual data using Dedoose a software 
program designed to facilitate the analysis of qualitative data. Data collected will be used to inform 
the development of the multiplayer videogame, InvestiDate.
Data Analyses General Considerations: Statistical procedures and models for analyzing data have 
been selected according to the research hypotheses being investigated and the types of data 
available. In general, we will use two-tailed tests and p-values smaller than 0.05 will be considered to 
indicate statistical significance. When necessary, however, we will use appropriate adjustment of the 
level of significance (alpha) to account for multiple statistical tests. All statistical analyses will be 
conducted on an intention-to-treat sample using either SPSS/SAS statistical packages. Baseline 
characteristics will be analyzed using descriptive statistics. We will use baseline, one-month, and 
four-month data to estimate effect sizes for the primary outcome125. Given the limited sample size 
(n=80), we anticipate that the power of this study to identify small but significant effect sizes will be 
low. A strength of this design is that it provides a number of perspectives from which to view 
treatment effects, including a treatment condition, a control condition, and a follow-up period. The 
results will inform the sample size calculation for a subsequent full-scale randomized trial. 
We will evaluate the preliminary efficacy of InvestiDate at increasing HIV/STI testing and partner 
HIV/STI testing. We will test the hypothesis that individuals who play InvestiDate will report more 
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HIV/STI testing and partner testing in comparison to the control condition. We 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 (i.e., baseline, one month and four 
months). Hierarchical modeling will allow us to account for the fact that the data are nested as the 
participants will play the game in groups. An advantage of mixed models is that participants with 
missing data need not be excluded as all available data are used in estimating parameters. We will 
also use logistic regression models to determine if any relevant baseline variables are associated 
with improvement in reported HIV/STI testing or partner testing (constructed as a binary outcome 
(Yes/No). We plan to evaluate the prognostic significance of a small set of predictor variables (e.g., 
intentions, attitudes, self-efficacy, social norms, and knowledge) and use them as covariates in the 
primary analysis. All of these analyses will be exploratory given the study sample size.
SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES
A.  RADIOTRACERS
☒N/A
B.  DRUGS/BIOLOGICS    ☒N/A
C.  DEVICES
 ☒N/A
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 
1. Targeted Enrollment: Give the number of subjects: 250
a.
Targeted for enrollment at Yale for this protocol: 110
b.
If this is a multi-site study, give the total number of subjects targeted across all sites: n/a
2.
Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used.
☒Flyers
☐ Internet/web postings
☐ Radio
☒ Posters
☐ Mass email solicitation
☐ Telephone
☐ Letter
☐ Departmental/Center website
☐ Television
☐ Medical record review* 
☐ Departmental/Center research boards
☐ Newspaper
☐ Departmental/Center newsletters
☐ Web-based clinical trial registries
☐ Clinicaltrails.gov 
☐ YCCI Recruitment database
☒ Social Media (Twitter/Facebook): 
☐ Other: 
3.  Recruitment Procedures: 
a. Describe how potential subjects will be identified. SEE BELOW
b. Describe how potential subjects are contacted. SEE BELOW
c. Who is recruiting potential subjects? SEE BELOW
The study will be advertised via posters and flyers located and circulated at the partnering schools. The 
opportunity to participate in the study will also be announced in classrooms at our participating schools. The 
study will also be advertised through social media, including Facebook and Instagram. Participation in this 
study will be strictly voluntary, confidential and non-discriminatory. Participants interested in participating in 
our study will follow a link displayed on the flyers and social medial advertisements to a Yale Qualtrics 
webpage where they will fill out a form with basic demographic information (age, race, sexual orientation) 
and their contact information (email and phone number) and the parent/guardian contact information 
(email) for participants younger than 18. All participants who fill out the Qualtrics form will receive an email 
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from the project director/research assistant with details about the study and exclusion/inclusion criteria. If 
the participant is under 18, the research staff member will email the parental information sheet to the parent 
and contact them by email or phone to obtain written consent. If either the participant or the parent do not 
wish to be in the study or have their child participate in the study, no further contact will be made. 
Participants that meet the requirements and after consent or parent permission and assent have been 
obtained, will be enrolled in the study by the project director/research assistant. For focus groups, 
participants will also be recruited through the use of social media sites, including Facebook and Instagram. 
Participants will be asked to click on a link in the ad, which will take them to the Yale Qualtrics webpage 
where they will fill out a form with basic demographic information (age, race) and their contact information 
(email and phone number) and parental contact information (email and phone number) if the participant is 
under 18.  If participants meet eligibility criteria, a research staff member will email the potential participant 
the focus group information sheet for them to review and set up a time to contact them by phone to review 
the study and obtain verbal consent. If the participant wishes to participate in the study and is under 18, the 
research staff member will email the parental information sheet to the parent and contact them by phone to 
obtain verbal consent.  If either the participant or the parent do not wish to be in the study or have their child 
participate in the study, no further contact will be made. Focus groups will take place through Zoom where 
participants will be able to see and interact with each other. 
Participants will be provided with an age-appropriate description of the study and told about what they might 
expect. In describing the study to the participant, the purpose of the study will be described as “finding out 
how teen girls can make choices that are healthier for them”. In describing the study to the guardian/parent, 
we will indicate that the study will focus on promoting healthy behaviors in adolescence and on providing 
strategies to assist adolescents in making decisions about the many challenges they face; particularly as they 
relate to risky behaviors, including sex. If a participant or their guardian/parent indicates that they do not 
wish to participate, there will be no further involvement in the study. 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject? 
☐Yes, all subjects
☐Yes, some of the subjects
☒No
If yes, describe the nature of this relationship. Write here
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.)
Choose one: 
☒ For entire study – for Focus Group participants/parents only – waiver of written authorization
☐ For recruitment/screening purposes only
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated HIPAA 
research authorization form available on the University’s HIPAA website at hipaa.yale.edu.
i.
Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data: Write here
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ii.
If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data: A waiver will be obtained given that we 
will not obtain any identifying or personal health information from participants as part of the focus 
group. 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer.
6.
Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making. 
Participation in this study will be strictly voluntary, confidential and non-discriminatory. The study will be 
advertised via posters and flyers located at partner schools and through emails sent directly to students and 
announcements made during class. The study will also be advertised through social media, including 
Facebook and Instagram. Potential participants will fill out an eligibility survey through the Yale Qualtrics 
webpage where they will provide basic demographic information (age, race, sexual orientation) and their 
contact information (email and phone number) and parental contact information (email and phone number) 
if the participant is under 18.  If participants meet eligibility criteria, a research staff member will email the 
potential participant the study information sheet for them to review and set up a time to contact them by 
phone or zoom to review the study and obtain verbal consent. If the participant wishes to participate in the 
study and is under 18, the research staff member will email the parental information sheet to the parent and 
contact them by email to obtain written consent. We will provide, via email, the adolescents and their parents 
with an age-appropriate description of the study and told about what they might expect.  In describing the 
study to the participant, the purpose of the study will be described as “finding out how teens can make 
choices that are healthier for them”. In describing the study to the guardian/parent, we will indicate that the 
study will focus on promoting healthy behaviors in adolescence and on providing strategies to assist 
adolescents in making decisions about the many challenges they face; particularly as they relate to risky 
behaviors, including sex. For the focus groups we will employ waived signature of consent. Parents who do 
not wish for their children to participate will contact the project director. For the evaluation, we will obtain 
informed written assent from the participant and written informed consent from their guardian/parent. For 
both phases, if a participant or their guardian/parent indicates that they do not wish to participate, there will 
be no further involvement in the study. We will also obtain agreement from the appropriate administrator at 
the participating program.
For both phases, participants will also be recruited through the use of social media sites, including Facebook 
and Instagram. Participants will be asked to click on a link in the ad, which will take them to the Yale Qualtrics 
webpage where they will fill out a form with basic demographic information (age, race) and their contact 
information (email and phone number) and parental contact information (email and phone number) if the 
participant is under 18.  If participants meet eligibility criteria, a research staff member will email the 
potential participant the focus group information sheet for them to review and set up a time to contact them 
by phone to review the study and obtain verbal consent. If the participant wishes to participate in the study 
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and is under 18, the research staff member will email the parental information sheet to the parent and 
contact them by phone to obtain verbal consent.  If either the participant or the parent do not wish to be in 
the study or have their child participate in the study, no further contact will be made. Focus groups will take 
place through Zoom where participants will be able to see and interact with each other.
In some cases, we may conduct focus groups through Yale’s video conferencing service, Zoom.  To obtain 
verbal consent, the Research Assistant will discuss the study with their guardian/parent and obtain verbal 
assent from the participant and verbal consent from their guardian/parent. At the beginning of the Zoom 
meeting, participants will be provided with an age-appropriate description of the study and told about what 
they might expect. In describing the study to the participant, the purpose of the study will be described as 
“finding out how kids can make choices that are healthier for them”. In describing the study to the 
guardian/parent, we will indicate that the study will focus on promoting healthy behaviors in adolescence and 
on providing strategies to assist adolescents in making decisions about the many challenges they face; 
particularly as they relate to health relationships and dating. If a participant or their guardian/parent indicates 
that they do not wish to participate, there will be no further involvement in the study. We will work with our 
study partners to identify potential participants; study partners will email our approved flyer to those that 
may fit within our study inclusion criteria (black teen girls aged 14-18). Participants that are interested in 
participating in the focus groups may reach us through the phone number or email listed on the approved 
flyer.  
7.
Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed. 
This research does not involve subjects with limited decision-making capacity. Parents and adolescents will be 
provided with an age-appropriate description of the study and told about what they might expect.  In 
describing the study to the participant, the purpose of the study will be described as “finding out how kids 
can make choices that are healthier for them”. In describing the study to the guardian/parent, we will indicate 
that the study will focus on promoting healthy behaviors in adolescence and on providing strategies to assist 
adolescents in making decisions about the many challenges they face; particularly as they relate to risky 
behaviors, including sex. For focus groups, we will employ waived signature of consent. Parents who do not 
wish for their children to participate will contact the project director. For the pilot randomized controlled 
trial, we will obtain informed written assent from the participant and written informed consent from their 
guardian/parent.
8.
Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use. 
Non-English Speaking Subjects will not be able to participate in this project.
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒
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IRB# 2000026487 
Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled.
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website.
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above. 
9.
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.  
☐Not Requesting any consent waivers 
☒Requesting a waiver of signed consent:
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only)
☒ Entire Study (Note that an information sheet may be required.) – For focus group participation 
only. 
 For a waiver of signed consent, address the following:
Would the signed consent form be the only record linking the subject and the research?  YES ☒  NO ☐ 
Does a breach of confidentiality constitute the principal risk to subjects? YES ☒  NO ☐
 
OR
Does the research pose greater than minimal risk? YES ☐    NO☐ 
Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☐ 
 ☐ Requesting a waiver of consent:
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only)
☐ Entire Study 
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For a full waiver of consent, please address all of the following:

Does the research pose greater than minimal risk to subjects?  
☐ Yes If you answered yes, stop. A waiver cannot be granted.  
☐ No

Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐

Why would the research be impracticable to conduct without the waiver? Write here

Where appropriate, how will pertinent information be returned to, or shared with subjects at a later date? 
Write here
SECTION IV: PROTECTION OF RESEARCH SUBJECTS
    Confidentiality & Security of Data:
1.
What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?   Name, Address, Telephone Number, Email Address, reported HIV/STI 
testing status and test results, sexual activity status
2.
How will the research data be collected, recorded and stored? All data collected from the assessments will 
be entered directly into the secure web-based system, Yale Qualtrics, which is Yale’s enterprise-wide 
data management system. Research staff will enter the data into the Yale Qualtrics system. To assess 
acceptability and feasibility, directly following completion of the intervention, we will collect 
quantitative and qualitative data on the intervention participants’ experiences of the game 
intervention.
3.
How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard Drive   ☒Secured Server  
☐Laptop Computer  ☐Desktop Computer  ☐Other
4.
What methods and procedures will be used to safeguard the confidentiality and security of the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study? 
Data will be stored in Yale’s secured online data collection system, Yale Qualtrics. Paper assessments will be 
kept in a locked filing cabinet in the PI’s office.
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu
5.
What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured. 
Data collected in the study will reside in our computerized database and electronic storage mechanisms. All 
data analyses will be performed under approved HIC protocols. Digital files of the focus groups will be destroyed 
at the end of the study. 
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IRB# 2000026487 
6.
If appropriate, has a Certificate of Confidentiality been obtained? A CoC automatically covers this study due to 
its NIH funding.
SECTION V: POTENTIAL BENEFITS
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.) 
It is anticipated that the Black adolescent girls enrolled in this study should benefit directly from the study as the 
purpose of the study is to reduce their risk for HIV/STI by improving their negotiation and communication skills 
around condom use and partner HIV/STI testing. It is hypothesized that the participants assigned to the 
multiplayer videogame, InvestiDate, will have higher rates of condom use and reported partner HIV/STI testing at 
4 months following study enrollment as compared to the control group. This research has the potential to benefit 
a large number of Black adolescent girls around the country and worldwide, because if the intervention is shown 
to be effective, then this program can be replicated elsewhere in the U.S. and in countries where resources are 
lacking and interventions for HIV/STI risk reduction are limited. The potential benefits to all participants are great 
while strict precautions are being taken to protect the confidentiality and well-being of participants, as has been 
described above. Thus, the potential benefits to the participants outweigh the potential risks.
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.
Alternatives: What other alternatives are available to the study subjects outside of the research? 
Not participating in the study
2.
Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation.
We will compensate focus group participants and participants who participate in pilot testing with gift cards 
with monetary value of $30. Participants in the pilot randomized controlled trial will be given a gift card 
incentive of $30 for completion of each assessment for a total of $120 (4 assessments total) for study 
participation.
3.
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects. 
No costs to subjects will be incurred.
4.
In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws). N/A
a.
Will medical treatment be available if research-related injury occurs? Write here
b.
Where and from whom may treatment be obtained? Write here
c.
Are there any limits to the treatment being provided? Write here
d.
Who will pay for this treatment? Write here
e.
How will the medical treatment be accessed by subjects? Write here  
IMPORTANT REMINDERS
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IRB# 2000026487 
Will this study have a billable service?  Yes ☐ 
 No☒
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects. 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☐ 
If Yes, please answer questions a through c and note instructions below.  
a. Does your YNHH privilege delineation currently include the specific procedure that you will perform? Yes ☐  No 
☐
b. Will you be using any new equipment or equipment that you have not used in the past for this procedure? Yes 
☐  No ☐
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐
 
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department of 
Physician Services (688-2615) for prior approval before commencing with your research protocol.
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH 
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH.
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IRB# 2000026487 
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IRB# 2000026487 
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