Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Phase: NA
Conditions: HIV Infections, Sexually Transmitted Diseases
Sponsor: North Carolina State University

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HEART for Teens Protocol 
October 16, 2019 
 
 
 
 
 
 
 
 
Study Protocol 
 
 
Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens 
 
 
Principal Investigator: 
Laura Widman, PhD 
Department of Psychology 
North Carolina State University 
640 Poe Hall, Campus Box 7650 
Raleigh NC, 27695 
lmwidman@ncsu.edu 
 
 
 
 
 
 
 
 
 

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HEART for Teens Protocol 
October 16, 2019 
 
 
 
 
 
TABLE OF CONTENTS 
 
TITLE PAGE……………………………………………………………………………………………………………1 
TABLE OF CONTENTS .................................................................................................................................... 2 
2 
INTRODUCTION AND STUDY RATIONALE ...................................................................................... 3 
3 
STUDY AIMS ........................................................................................................................................ 3 
4 
STUDY DESIGN ................................................................................................................................... 3 
4.1 Randomized Controlled Trial.................................................................................................................. 3 
4.2 Study Population .................................................................................................................................... 3 
4.2.1    Inclusion Criteria ..................................................................................................................... 4 
4.2.2 
Exclusion Criteria ................................................................................................................... 4 
5  
QUALTRICS DATA COLLECTION ...................................................................................................... 4 
6  
RECRUITMENT .................................................................................................................................... 4 
7 
INFORMED CONSENT ........................................................................................................................ 4 
8  
DATA COLLECTION PROCEDURES ................................................................................................. 4 
9  
PARTICIPANT REIMBURSEMENT ..................................................................................................... 5 
10 
MEASURES .......................................................................................................................................... 5 
11 
 STATISTICAL ANALYSIS STRATEGY............................................................................................... 6 
11.2 Sample Size Considerations ................................................................................................................ 6 
12 
STUDY CONDUCT ............................................................................................................................... 6 
12.1  Ethics ................................................................................................................................................... 6 
12.2  Responsibilities within the Study ......................................................................................................... 6 
12.3  Reports and Publications .................................................................................................................... 6 
12.4  Database Retention and Archiving ..................................................................................................... 7 
13 
DATA SAFETY MONITORING BOARD (DSMB)................................................................................. 7 
14 
DATA AND STUDY MONITORING PLAN (DSMP) ............................................................................. 7 
15 
PATIENT SAFETY AND MONITORING PLAN (PSMP) ...................................................................... 7 
15.1  Risks of Study Participation ................................................................................................................ 7 
15.2  Handling of Non-Study Related Harms or Adverse Events ................................................................ 7 
15.3  Handling of Study-related harms or unanticipated adverse events ................................................... 7 
 
 

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2 
INTRODUCTION AND STUDY RATIONALE 
 
As few as half of sexually active youth used a condom the last time they had sex, and 14% did not use any form of 
contraception at last intercourse (Kann et al., 2018). This risky behavior can have lasting consequences. As many 
as one in four sexually active girls has a sexually transmitted disease (STD; Centers for Disease Control and 
Prevention [CDC], 2018c; Forhan et al., 2009), which can increase the risk of HIV and infertility (CDC, 2018b). 
Further, adolescent boys, particularly young men who have sex with men, are at heightened risk of HIV and other 
STDs, with recent data showing that 17% of new HIV infections occur among young boys and men under the age 
of 24 (CDC, 2018a). 
 
New approaches are needed to engage youth in HIV prevention to curb the spread of HIV/STDs. Online, 
technology-based sexual health programs, also known as eHealth, mHealth, and digital health programs, are one 
promising tool that can be used (Lightfoot, 2012; Rapoff, 2013). Technology use is now ubiquitous among youth: 
95% of U.S. teens have access to a smartphone and nearly half of these youth report they are online “almost 
constantly” (Smith & Anderson, 2018). Thus, online sexual health programs may be a particularly relevant way to 
offer information and teach skills to youth in a way that is readily available, familiar, non-threatening, and intuitive. 
 
The number of online sexual health programs targeting youth has been steadily increasing for the past decade (for 
reviews, see Chavez et al., 2014; Swanton et al., 2015; Widman, Nesi, et al., 2018). Yet to our knowledge, there 
are no brief online interventions that provide evidence-based sex education and are tested and found effective for 
diverse samples of both boys and girls. Such a program, particularly one shown to be efficacious among such 
diverse samples, could be of significant interest to schools or community programs that would benefit from a 
general program that is appropriate for a wide audience of youth with diverse identities. 
 
The purpose of this study is to provide an initial evaluation of one such program, called Health Education and 
Relationship Training for Teens (HEART for Teens). This brief online program was adapted from a program we 
originally developed for adolescent girls, called HEART for Girls (Widman, Golin, Noar, Massey, & Prinstein, 
2016).  
 
3 
STUDY AIMS 
 
Aim 1: Evaluate the feasibility and acceptability of the HEART for Teens program. 
 
Aims 2: Evaluate the preliminary efficacy of the HEART for Teens program in a randomized controlled trial of youth 
from a rural school district in the southeastern U.S. 
 
4 
STUDY DESIGN 
 
4.1 Randomized Controlled Trial 
 
 A two-arm randomized controlled trial. Arm 1: HEART intervention; Arm 2: attention-matched controlled 
program, called Growing Minds (Burnette et al., 2018). Participants will be assessed at pre-test and 
immediate-post test. 
 
4.2 Study Population 
 
All 10th and 11th grade students from a school district in the southeastern U.S. will be recruited to participation in 
this study (n recruited = 754). 
 

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 4.2.1    Inclusion Criteria 
1. Must be a 10th or 11th grade student 
2. Must speak English 
3. Provide written parental consent 
4. Provide written student assent 
 
4.2.2 
Exclusion Criteria  
1. Unable to speak fluent English 
2. Unwilling or unable to provide parent consent or student assent 
 
5  QUALTRICS DATA COLLECTION 
  
All data collected will be directly entered and stored in the web-based Qualtics research electronic data system. 
This Qualtics database will be stored, maintained, and monitored by the NC State Office of Information 
Technology and the study personnel. The Qualtircs system is a secure, web-based application designed to 
support survey and data collection. NC State has a license to host the Qualtrics system. Access to the Qualtrics 
database will be carefully restricted to authorized research team members as needed to perform their job 
functions, pursuant to Federal regulations.  
 
6  RECRUITMENT 
 
Potential study participants will be recruited via in-class announcements at their high school. Students will be 
provided with an informed consent document to take home to their parent/guardian. Parents are asked to sign 
and return the form to indicate whether child is approved to participate in the study. All students in the 10th and 
11th grades will be recruited. 
 
7 
INFORMED CONSENT 
 
Written informed consent from parents will be collected via an IRB-approved informed consent document. Once 
parental consent is collected, study staff will explain the study to students and also provide them with a written 
assent form approved by the NC State IRB. Students will be allowed sufficient time to ask questions about the 
study and express understanding. Only students who have received parental consent and have signed an 
assent document will be allowed to participate in the study. Written consent/assent documentation will be stored 
in a secure physical or electronic server location according to standard operations approved by the NC State 
IRB.  
 
8  DATA COLLECTION PROCEDURES 
 
After parental consent and student assent are obtained, pre-test data will be collected using computerized 
Qualtrics surveys in a small group classroom setting. Participants will then be randomly assigned to either the 
HEART for Teens online program or to an attention-matched control program focused on cultivating academic 
growth mindsets, called Growing Minds (Burnette, Russell, Hoyt, Orvidas, & Widman, 2017). Random 
assignment to study condition will be conducted using random sampling and allocation procedures in SPSS 
version 24. Participants will be stratified based on sexual activity status (ever sexually active versus never 
sexually active). Approximately one week after pre-test, participants will complete the online intervention on a 
study-provided netbook computer as well as a computerized Qualtics post-test survey in a small group 
classroom setting. Participants will use headphones to listen to program content and to control for any outside 
noise.  
 
 
 

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9  PARTICIPANT REIMBURSEMENT 
 
Participants will be compensated with a $10 gift card for the pre-test assessment and a $10 gift card for the 
intervention and immediate post-test assessment.  
 
10 MEASURES 
 
10.1 Participant Characteristics. Demographic data will be collected on participant gender, age, race/ethnicity, 
sexual orientation, and receipt of free or reduced-price lunch (a proxy for socioeconomic status). Sexual activity 
status will be assessed with two items: one that inquired if participants had ever engaged in any sexual activity, 
including sexual touching, oral sex, and/or intercourse; and a second, if they answered “yes” to the first question, 
that inquired if participants had ever engaged in sexual intercourse. Additionally, among those who reported 
sexual intercourse, information was gathered about condom use at last sex. 
 
10.2 Program Acceptability. Program acceptability will be assessed through a questionnaire that was adapted 
from prior acceptability surveys (Bauermeister et al., 2015; Widman et al., 2017). Specifically, six items will be 
included to assess six aspects of acceptability: 1) how much participants liked the program; 2) how much they 
learned from the program; 3) how much they felt the program kept their attention; 4) whether they would use 
information from the program in the future; 5) whether the program would be useful for girls their age; and 6) 
whether the program would be useful for boys their age. Items are rated on a four-point Likert scale ranging from 0 
(not at all) to 3 (a lot).  
 
10.2 Intentions. Intentions to discuss sexual health and to use condoms will be assessed with two items. The first 
asks how likely teens are to discuss sexual health issues, including pregnancy and STDs, with their partner(s) 
prior to sexual activity (communication intentions). The other item asks how likely teens are to use condoms the 
next time they have sex (condom intentions). Participants will be prompted to answer these questions whether or 
not they had engaged in sexual activity before. Response options range from 0 (not at all likely) to 4 (very likely). 
 
10.2 Sexual Self-Efficacy. The Self-Efficacy for HIV Prevention Scale (Brown et al., 2014) will be used to assess 
self-efficacy about communication and condom use. Six items assess confidence communicating about sexual 
topics (e.g., “How sure are you that you could talk to your partner about safer sex?”). Two items assess confidence 
obtaining and using condoms (e.g., “How sure are you that you could have condoms available when you need 
them?”). Participants responded from 1 (Couldn’t do it) to 4 (Very Sure), with higher scores indicating greater 
sexual self-efficacy.  
 
10.3 Knowledge. HIV/STD knowledge will be assessed with 9 items (e.g., “STDs usually have noticeable 
symptoms, like itching or burning”). Participants rate each item as True, False, or Don’t Know. Responses are 
recoded as 0 (Incorrect or Don’t Know) or 1 (Correct). Scores are summed to reflect the total number of correct 
HIV/STD knowledge questions (possible range=0-9).  
 
10.4 Condom Attitudes. Participants’ attitudes about condoms will be assessed with the 3-item effect on sexual 
experiences subscale of the Condom Attitudes Scale Adolescent Version (St. Lawrence et al., 1994). An example 
item includes, “Condoms take away the pleasure of sex.” Responses are on a scale from 1 (Strongly Disagree) to 
5 (Strongly Agree).  
 
10.5 Condom Norms. The 3-item condom norm subscale from the Sexual Risk Behavior Beliefs and Self-Efficacy 
Scale for adolescents (Basen-Engquist et al., 1999) will be used to assess participants’ perceptions of their peers’ 
views of condom use. Participants respond from 1 (Strongly Disagree) to 5 (Strongly Agree) to items such as, 
“Most teenagers believe condoms should always be used if a person my age has sex”.  

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10.6 Sexual Assertiveness. Self-reported sexual assertiveness will be assessed with 3-items from the 
Multidimensional Sexual Self-Concept Scale (Snell, 1998). Items such as, “I’m very assertive about the sexual 
aspects of my life,” are rated on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree).   
 
11  STATISTICAL ANALYSIS STRATEGY  
 
11.1 Analysis Plan 
 
First, descriptive statistics will be utilized to summarize sociodemographic variables and pre-test levels of each 
outcome variable. To establish pre-test equivalence, differences between groups will be assessed using t-tests for 
continuous variables and 2-tests for categorical variables. Second, to assess the efficacy of the HEART 
intervention from pre-test to immediate post-test, linear regression analyses will be utilized to compute adjusted 
means and mean differences between intervention and control groups. For each outcome, the corresponding pre-
test measure will be included as a covariate. Third, moderation analyses will be conducted to examine if 
intervention effects are moderated by gender or sexual orientation. Cohen’s d value will be calculated as an 
indication of effect size. Analyses will be completed using SPSS Version 24. 
 
11.2 Sample Size Considerations  
 
For this preliminary assessment, the final sample size will be determined by the number of students and parents 
who granted consent. 
 
12 STUDY CONDUCT 
 
12.1  Ethics 
 
This study will be conducted in accordance with Good Clinical Practice (GCP), as defined by the International 
Conference on Harmonization (ICH) and in accordance with the ethical principles underlying European Union 
Directive 2001/20/EC and the United States Code of Federal Regulations, Title 21, Part 50 (21CFR50). 
 
The study will be conducted in compliance with this protocol. The protocol and any amendments and the subject 
informed consent will receive Institutional Review Board (IRB) approval prior to initiation of the study. 
 
Any serious breach to the study protocol or principles of GCP in connection with the study or the protocol which 
are likely to affect the physical or mental safety of study participants or the integrity of the study will be reported 
to the NC State IRB. 
 
Personnel involved in conducting this study will be qualified by education, training, and experience to perform 
their respective tasks. 
 
12.2  Responsibilities within the Study 
 
 
The study shall be conducted as described in this approved protocol and research staff will not implement any 
deviation or change to the protocol without prior approval from the NC State IRB and sponsor. 
 
12.3  Reports and Publications 
 
The confidentiality of records that could identify participants within the database will be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). The data collected 
during this study are confidential and proprietary to NC State.  

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12.4  Database Retention and Archiving 
 
The database and supporting documentation will be maintained by the PI and research staff in electronic files 
on a secure server accessed only by authorized personnel. The database and study records will be maintained 
for at least 5 years after study completion.  
 
13 DATA SAFETY MONITORING BOARD (DSMB) 
 
No DSMB was established.  
 
14 DATA AND STUDY MONITORING PLAN (DSMP) 
 
The research team will meet weekly or as often as necessary to review and monitor all aspects of the study: 
recruitment, data collection, completeness, data quality, protocol deviations, and any reported study-related 
adverse events.  Study staff will be responsible for database integrity checks, data retrieval and export.  
 
15 PATIENT SAFETY AND MONITORING PLAN (PSMP) 
 
15.1  Risks of Study Participation 
 
The psychological risks directly posed by participating in this study are judged to be minimal and rare (<1%). 
One risk of participating in this study is that participants may feel uncomfortable answering sensitive questions 
about their attitudes or private/illegal behaviors (e.g., sexual activity). To reduce this risk, we will inform students 
that they do not have to answer any questions that they do not want to answer.  They will be told that they can 
skip any items that make them uncomfortable or stop their participation at any time. Participants can also speak 
with members of the research team if they become upset, and/or the research team can provide students with 
referrals if they would like to speak with someone about any of the information they receives as part of this 
program.  
 
Another risk of participating is that the data we are collecting is sensitive and must be carefully protected to 
ensure confidentiality. Several steps will be taken to protect participant survey data and academic records. This 
includes deidentifying all data by using only a participant ID number, and not the participant's name. We will 
also store data in password-protected files on our secure server. The spreadsheet linking participant names 
with ID numbers will be stored in a separate file from participant data and secured with a separate password. 
Only the PI, Co-Investigator, and Project Manager will have access to this spreadsheet.   
 
15.2  Handling of Non-Study Related Harms or Adverse Events 
 
Non-study related issues will not be reportable to the NC State IRB. For instance, the research team may 
become aware of a patient’s medical or psychiatric issue during the survey assessment even though 
unsolicited. The research staff will explain to the student that research is a separate activity from clinical care 
and will encourage the student to notify their physician of their concern. In the event that a student expresses an 
urgent matter or a crisis (e.g., suicidality), the research team will be trained to use good clinical judgement and 
the standard operating procedure (SOP) which has been developed for staff. 
 
15.3  Handling of Study-related harms or unanticipated adverse events 
 
Adverse events (AEs) directly related to answering survey questions is expected to be extremely rare (<1%). 
Nonetheless, should an unanticipated study-related adverse even occur that is judged by the PI to be partially 
or fully related to study participation, the event will be reported to the NC State IRB within 72 hours. 

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Unanticipated study-related AE’s may be physical, psychological, social, or legal in nature. Study-related harms 
or unanticipated AE’s will be tracked by research staff and included in a final progress report to the sponsor.