Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
Phase: NA
Conditions: HIV
Sponsor: Indiana University

Protocol Cover Page 
Official title of study: Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-
Center Study of the Adolescent Medicine Trials Network for HIV/AIDS 
Interventions (ATN) 
NCT number: NCT03242954 
Secondary ID: 5U24HD089880-02 [U.S. NIH Grant/Contract Award Number] 
Document Date: 18 October 2018 

ATN 150 Version 6.0 
December 5, 2018 
Innovative Approaches for Minor Consent: Consent 2.0 
A Multi-Center Study of the Adolescent Medicine Trials Network for 
HIV/AIDS Interventions (ATN) 
Sponsored by: 
The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD) 
with co-funding from: 
The National Institute on Drug Abuse (NIDA) 
The National Institute of Mental Health (NIMH) 
The National Institute on Minority Health and Health Disparities (NIMHD) 
Protocol Chair: 
Amy Knopf, Ph.D., M.P.H., R.N. 
NICHD Health Scientist Administrator: 
Sonia S. Lee, Ph.D. 
Protocol Manager: 
Becca Baker, M.P.H, C.C.R.P.

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TABLE OF CONTENTS 
ATN PROTOCOL TEAM ROSTER ........................................................................................................ 5 
REQUIREMENTS FOR SITE PARTICIPATION IN PROTOCOL ............................................................... 7 
STUDY MANAGEMENT ..................................................................................................................... 8 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ..................................................................... 9 
STUDY ABSTRACT............................................................................................................................ 11 
STUDY SCHEMAS ............................................................................................................................ 15 
1.0 
INTRODUCTION .............................................................................................................. 16 
1.1 
Background ................................................................................................................................. 16 
1.2 
Rationale ..................................................................................................................................... 17 
1.3 
Preliminary Studies ..................................................................................................................... 18 
2.0 
SPECIFIC AIMS ................................................................................................................ 18 
3.0 
STUDY DESIGN ............................................................................................................... 19 
3.1 
Study Population ........................................................................................................................ 20 
3.2 
Sample Size ................................................................................................................................. 20 
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment Procedures 20 
3.4 
Outcome Measures .................................................................................................................... 21 
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS ............................................. 22 
4.1 
Adolescent Inclusion Criteria ...................................................................................................... 22 
4.2 
Parent Inclusion Criteria ............................................................................................................. 22 
4.3 
Recruitment and Screening ........................................................................................................ 23 
4.4 
Locator/Contact Information ...................................................................................................... 24 
4.5 
Informed Consent ....................................................................................................................... 24 
4.6 
Co-enrollment Guidelines ........................................................................................................... 25 
5.0 
STUDY PROCEDURES ...................................................................................................... 25 
5.1 
Enrollment Procedures ............................................................................................................... 25 
5.2 
Randomization Procedures ........................................................................................................ 25 
5.3 
Investigation Procedures ............................................................................................................ 25 
5.4 
Research Staff Training ............................................................................................................... 26 
5.5 
Monitoring/Quality Control ........................................................................................................ 27 
6.0 
EVALUATIONS AND MEASURES ..................................................................................... 27 
6.1 
Screening .................................................................................................................................... 27 

 
 
 
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6.2 
Enrollment/Entry ........................................................................................................................ 27 
6.3 
Premature Discontinuation from Intervention .......................................................................... 29 
7.0 
DATA COLLECTION AND SITE MONITORING .................................................................. 29 
7.1 
Development of Protocol and Case Report Forms ..................................................................... 29 
7.2 
Data Records ............................................................................................................................... 29 
7.3  Data Collection ........................................................................................................................... 30 
7.4 
Data Submission ......................................................................................................................... 30 
7.5 
Data Quality Assurance .............................................................................................................. 31 
7.6 
Role of Data Management .......................................................................................................... 31 
7.7 
Study Site Monitoring and Record Availability ........................................................................... 31 
7.8    Study Monitoring ......................................................................................................................... 32 
8.0 
PARTICIPANT MANAGEMENT ........................................................................................ 32 
8.1 
Study Visit Management ............................................................................................................ 32 
8.2 
Compensation ............................................................................................................................. 32 
8.3 
Intervening on “Social Harms".................................................................................................... 33 
8.4 
Criteria for Premature Discontinuation ...................................................................................... 33 
9.0 
MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING FROM STUDY33 
9.1 
Untoward Events Reporting ....................................................................................................... 33 
9.2 
Reportable Events by Populations .............................................................................................. 35 
10.0 
STATISTICAL AND ANALYTIC CONSIDERATIONS ............................................................ 35 
10.1 Study Design ............................................................................................................................... 35 
10.2 Study Endpoints .......................................................................................................................... 36 
10.3 Sample Size and Power Estimates .............................................................................................. 37 
10.4 Statistical Analysis Plan ............................................................................................................... 37 
10.5 Missing, Unused and Spurious Data ........................................................................................... 39 
11.0 
HUMAN SUBJECTS.......................................................................................................... 39 
11.1 Participants’ Confidentiality ....................................................................................................... 39 
11.2 Certificate of Confidentiality ...................................................................................................... 40 
11.3 Risks and Benefits ....................................................................................................................... 40 
11.4 Institutional Review Board (IRB) Review and Informed Consent ............................................... 41 
11.5 Waiver of the Requirement for Parental Permission for Special Circumstances ....................... 41 
11.6 Waiver of the Requirement for Signed Consent Form ............................................................... 42 

 
 
 
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11.7 45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health Information 
("Privacy Rule" Pursuant to the Health Insurance Portability and Accountability Act - HIPAA) 43 
11.8 Study Discontinuation ................................................................................................................ 43 
12.0 
PUBLICATION OF RESEARCH FINDINGS ......................................................................... 43 
13.0 
REFERENCES ................................................................................................................... 44 
APPENDIX I ...................................................................................................................................... 47 
Schedule of Evaluations........................................................................................................................ 47 
APPENDIX II ..................................................................................................................................... 48 
 
 
 

 
 
 
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ATN PROTOCOL TEAM ROSTER 
Protocol Chair 
Amy Knopf, Ph.D., M.P.H., R.N.  
Indiana University School of Nursing  
600 Barnhill Dr, Nursing 420  
Indianapolis, IN 46202 
Phone: (317) 274-2285  
Fax: (317) 274 2411  
E-mail: asknopf@iu.edu 
 
NICHD Health Scientist Administrator 
Sonia S. Lee, Ph.D. 
Eunice Kennedy Shriver National Institute of 
Child Health and Human Development 
(NICHD) 
6710B Rockledge Drive 
Bethesda, MD 20817 
Phone: (301) 594-4783 
Fax: (301) 496-8678 
E-mail: leesonia@mail.nih.gov 
 
ATN Coordinating Center Investigator 
Matt Psioda, Ph.D. 
Collaborative Studies Coordinating Center 
University of North Carolina   
123 W. Franklin St., Suite 450 
Chapel Hill, NC 27516 
Phone: (919) 962-3264 
E-mail:matt_psioda@unc.edu 
 
Co-Investigator 
Gregory D. Zimet, Ph.D.  
Adolescent Medicine 
410 West 10th Street, Ste 1001 
Indianapolis, IN 46202 
Phone: (317) 274-8812  
Fax: (317) 274-0133 
E-mail: gzimet@iu.edu 
 
Co-Investigator 
Claire B. Draucker, Ph.D., R.N., FAAN 
600 Barnhill Drive, NU409W 
Indianapolis, IN 46202 
Phone: (317)-274-4139 
E-mail: cdraucke@iu.edu 
Co-Investigator 
Mary A. Ott, M.D., M.A.  
Adolescent Medicine 
410 West 10th Street, Ste 1001 
Indianapolis, IN 46202 
Phone: (317) 274-8812  
Fax: (317) 274-0133 
E-mail: maott@iu.edu 
 
Co-Investigator 
J. Dennis Fortenberry, M.D., M.S.  
Adolescent Medicine 
410 West 10th Street, Ste 1001 
Indianapolis, IN 46202 
Phone: (317) 274-8812  
Fax: (317) 274-0133 
E-mail: jfortenb@iu.edu 
 
Site Investigator 
Renata Sanders, M.D.  
Johns Hopkins  
200 N. Wolfe Street 
Room 2083 
Baltimore, Maryland 21287 
Phone: (410)-502-8166 
E-mail: rarring3@jhmi.edu 
 

 
 
 
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Site Investigator 
Daniel Reirden, M.D. 
University of Colorado 
Children’s Hospital Colorado 
13123 E. 16th Ave., B025 
Aurora, CO 80045 
Phone: (720)-777-4971 
E-mail: 
Daniel.Reirden@childrenscolorado.org 
 
Site Investigator 
Diane Straub, M.D.  
University of South Florida 
2 Tampa General Circle, Ste. 500 
Tampa, FL 33606 
Phone: (813) 259-8772 
E-mail: dstraub@health.usf.edu 
  
Site Investigator 
John Schneider, M.D.  
University of Chicago 
5841 South Maryland Avenue  
Chicago, IL 60637 
Phone: (773)-702-1000 
E-mail: 
jschnei1@medicine.bsd.uchicago.edu 
 
Protocol Statistician 
Susan Ofner, M.S. 
Indiana University 
410 West 10th Street, Suite 3045 
Indianapolis, IN 46202 
Phone: (317) 278-6666 
E-mail: sofner@iu.edu 
Program/Protocol Manager 
Becca Baker, MPH, CCRP 
IU School of Nursing 
600 Barnhill Drive, NU 312D 
Indianapolis, IN 46202 
Phone: (317) 278-6758 
Fax: (317) 278-2021 
E-mail: bbaker11@iu.edu  
 
Lead Statistician 
Giorgos Bakoyannis, M.S., PhD 
Indiana University 
410 West 10th Street, Suite 3000 
Indianapolis, IN 46202 
Phone: (317) 278-5457 
E-mail: gbakogia@iu.edu   
 
 
Data Manager 
Carla Kettler 
Indiana University 
410 West 10th Street, Suite 3000 
Indianapolis, IN 46202 
Phone: (317) 278-0113 
E-mail: ckettler@iu.edu  
 
 

 
 
 
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REQUIREMENTS FOR SITE PARTICIPATION IN PROTOCOL 
Each enrolling site should have the following minimum capabilities: 
• Ability to enroll in a 15 month period 36 adolescents (18 natal males, 18 natal females) and 
approximately 36 parents of adolescents (parents of 18 natal male adolescents, parents of 
18 natal female adolescents); 
• Have adequate private space to administer Computer Assisted Self-Interview (CASI); 
• Have adequate private space for the Study Coordinator to conduct a debriefing interview; 
and 
• Ability to designate Study Coordinator, or other research staff (RS), time for recruitment of 
subjects, subject management, and completion of study-related data collection forms 

 
 
 
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STUDY MANAGEMENT 
Before the recruitment and enrollment of participants, the participating ATN study sites must 
have the protocol approved by the governing Institutional Review Board (IRB).  In addition, ATN 
study sites must receive protocol registration approval from the ATN Coordinating Center (CC). 
All original approved documents must be maintained at the clinical site.   
All queries for this protocol should be sent to the IU project team using the ATN Protocol Query 
and Notification System (QNS) accessible via the ATN website 
(https://www2.cscc.unc.edu/atn/). Dr. Knopf or the Consent 2.0 Program Manager will respond 
to queries generally within 48 business hours via the ATN QNS and copy the other team 
members. The Consent 2.0 Program Manager, with the help of other study staff and/or NICHD, 
if necessary, will answer general protocol implementation, eligibility, and data collection 
queries. The Protocol Chair or her designee will respond to study and participant management, 
exemptions and/or adverse event queries. Queries and replies will automatically be archived at 
the ATN CC. The Consent 2.0 Program Manager will post those queries deemed relevant to all 
sites on the ATN website, where they will be available for future reference. 
This study will use Qualtrics to collect study data via the internet. All questions related to the 
Qualtrics survey and screening survey should be directed to the IU Data Manager (Carla Kettler, 
ckettler@iu.edu) and the Consent 2.0 Program Manager (Becca Baker, bbaker11@iu.edu) 
during regular business hours, Monday-Friday 8:00am-4:00pm ET.  After hours Qualtrics 
questions should be directed to Dr. Amy Knopf at asknopf@iu.edu.  Qualtrics questions/issues 
that do not require immediate attention should be sent via the ATN QNS.  
For protocol or site registration issues or general ATN-related questions, contact 
ATNhelp@unc.edu. This account will be monitored on a regular basis during normal business 
hours.  
 
 

 
 
 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
AIDS 
Acquired Immunodeficiency Syndrome 
AMTU 
Adolescent Medicine Trials Unit 
ANOVA 
Analysis of variance 
ATN 
Adolescent Medicine Trials Network for HIV/AIDS Interventions 
CASI 
Computer Assisted Self-Interview 
CC 
Coordinating Center 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CO 
Colorado 
DHHS 
U.S. Department of Health and Human Services 
EC 
Ethics Committee 
eCRF 
Electronic CRF 
FDA 
U.S. Food and Drug Administration 
FIMSA 
Federal Information Security Modernization Act 
FIPS 
Federal Information Processing Standards 
FL 
Florida 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
HPTN 
HIV Prevention Trials Network 
ICH 
International Conference on Harmonization 
ID 
Identification 
IL 
Illinois 
IRB 
Institutional Review Board 
IT 
Information Technology 
IU 
Indiana University 
LGBTQ 
Lesbian, gay, bisexual, transgender, questioning 
MD 
Maryland 
MTN 
Microbicide Trials Network 
NICHD 
National Institute of Child Health and Development 
NIDA 
National Institute on Drug Abuse 
NIMH 
National Institutes of Mental Health 
NIST 
National Institute of Standards and Technology 
OHRP 
Office of Human Research Protection 
PAMAB 
Pediatric, Adolescent, and Maternal AIDS Branch 
PGP 
Pretty Good Privacy 
PI 
Principal Investigator 
PrEP 
Pre-exposure prophylaxis 
QA 
Quality Assurance 

 
 
 
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QNS 
Query and Notification System 
RS 
Research Staff 
SID 
Study Identification Number 
SIS 
Study Information Sheet 
SMC 
Study Monitoring Committee 
STI 
Sexually transmitted infection 
STRC 
Study Team Review Committee 
TDF-FTC 
tenofovir-emtricitabine 
UBACC 
UCSD Brief Assessment of Capacity to Consent 
UCSD 
University of San Diego 
UE 
Untoward Event 
US 
United States 
WTP 
Willingness to Participate 
WTS 
Willingness to Support 
YMSM 
Young men who have sex with men 
YWSM 
Young women who have sex with men 

 
 
 
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STUDY ABSTRACT 
DESIGN:  
This study will use CASI completed by all participants and a 
detailed debriefing interview completed for a subset of 
participants to assess high-risk minor adolescents’ willingness 
to participate in and parents willingness to support their teen’s 
participation in two hypothetical trials using simulated consent 
processes. The two hypothetical trials are modeled after ATN 
113 and HPTN 077. 
The purpose of this study is to examine how the consent 
process affects the acceptability of participation in biomedical 
HIV prevention trials, from the perspective of behaviorally high-
risk minors and the parents of minor adolescents.  
 
 
DURATION: 
Study participation will last approximately 60 minutes on a 
single day with no follow-up. Participants who agree to 
participate in the debriefing interview will require an additional 
45 minutes immediately following the completion of the main 
study procedures. 
 
 
SAMPLE SIZE : 
Approximately 144 (36 per study site) high-risk minor 
adolescents and 144 (36 per study site) parents of adolescents 
will be recruited for participation in this study. Of note, the 
adolescents and parents will not be parent-child dyads; they 
will be unrelated. A subset of 24-32 (6-8 per study site) 
adolescents and 24-32 (6-8 per study site) parents will be 
selected to participate in the debriefing interview. 
 
 
POPULATION:  
This study will recruit adolescents between ages 14-17, 
inclusive, who are able to read and speak English, who have a 
negative or unknown HIV status; and who have engaged in 
high-risk sexual activity in the last 12 months.  
The study will also recruit adults who are able to read and 
speak English and who are parent or guardian to an adolescent 
who is between ages 14-17, inclusive. 
Adolescents and parents will be recruited from four U.S. cities:  
Baltimore, MD; Chicago, IL; Denver, CO; and, Tampa, FL. These 
cities have diverse populations, high rates of incident HIV 
infection among adolescents and young adults, and/or 
demonstrated success in recruiting minor adolescents for 
biomedical HIV research. 
 
 

 
 
 
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RANDOMIZATION:  
Adolescents will be randomized in a 1:1:1 ratio into 1 of the 3 
consent conditions using block randomization with block size 
k=3 (so that in every 3 subjects, exactly 1 is allocated to each 
condition).  The randomization will be stratified by study site 
and sex assigned at birth. Within study site, sex assigned at 
birth, and consent condition, the order in which the 
hypothetical trials will be presented to adolescents will be block 
randomized with block size k=2. A subset of 6-8 adolescents (3-
4 males and 3-4 females) at each site will be selected for 
participation in the debriefing interview. 
Enrollment of parents will be restricted to approximately 15 
parents of adolescent natal males and 15 parents of natal 
adolescent females at each study site. Parents will indicate the 
acceptability of each of the three consent conditions for each of 
the two hypothetical trials. Independently of the gender strata, 
the order of hypothetical trial presentation will be block 
randomized with block size k=2. Separately for each 
hypothetical trial, the order of evaluation of the three consent 
conditions will be randomized so that each ordering is equally 
likely. A subset of 6-8 parents at each site (for total of 24-32) 
will be selected for participation in the debriefing interview. 
 
 
SPECIFIC AIMS: 
1. Describe how consent conditions influence high-risk minor 
adolescents’ WTP in a hypothetical biomedical HIV prevention 
trial. 
2. Describe how consent conditions affect parents’ WTS a 
hypothetical biomedical HIV prevention study. 
3.  Describe the effects of the study agent (stage of 
development and method of delivery) on high-risk minor 
adolescents’ WTP and parents’ WTS a hypothetical biomedical 
HIV prevention trial. 
 
 

 
 
 
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STUDY PROCEDURES 
Potential participants will be recruited from clinical settings and 
HIV testing centers, or self-screen online. Potential participants 
will take a short CASI screening survey to determine eligibility. 
All eligible participants will provide contact information to 
establish a study visit appointment. Those eligible and 
screening in-person will either participate on the same day as 
the screening, or, if unable to stay, they will be contacted to 
establish a study visit appointment. Eligible participants who 
screen online will also provide their contact information to 
establish a study visit appointment.  
Study participants will attend an in-person session at their 
respective AMTU. During the session, they will complete a CASI 
that collects demographic, social, behavioral, and attitudinal 
measures.  
All study participants will undergo a simulated consent process 
for each of two hypothetical studies modeled after ATN 113 
and HPTN 077. Procedures are slightly different for parents 
than for adolescents, so each group is described separately 
below:  
Adolescent Participants: First, the adolescent participant will 
complete a demographic CASI. For each hypothetical trial, RS 
will lead the participant through a simulated consent process 
consistent with their randomized consent condition. Then, the 
participant will complete a CASI assessing WTP and will work 
with RS to complete the UCSD Brief Assessment of Capacity to 
Consent (UBACC). After the second UBACC, the adolescent will 
complete overall WTP, medical mistrust, and end of study 
questions.  
Parent Participants: For each hypothetical trial, RS will review 
the informed consent forms with the parent. The parent will 
complete a CASI with three vignettes that describe each of the 
three possible consent conditions. Parents will rate the 
acceptability of each vignette. Then, the participant will work 
with RS to complete the UCSD Brief Assessment of Capacity to 
Consent (UBACC). After the second UBACC, the participant will 
answer demographic questions, medical mistrust, and end of 
study questions.   
A subset of 6-8 adolescents and 6-8 parents per study site will 
complete a debriefing interview assessing adolescent and 
parent perspectives on the various consent conditions in 
greater depth, and to better understand the role of study 
features, family, and adolescent characteristics in willingness to 

 
 
 
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participate/willingness to support the hypothetical research 
studies. 
MONITORING: 
Routine team monitoring of any adverse impact of the study 
will rely on the ATN Query & Notification System (QNS), a real-
time, web-based interactive reporting system. Sites will record 
and enter in the ATN QNS, all untoward events associated with 
study participation, which will be reviewed on the Study Team 
Review Committee’s monitoring calls. Routine team monitoring 
of protocol deviations will occur through Qualtrics. RS will enter 
any deviations into the Protocol Deviations Survey, which will 
automatically notify the central IRB site PI, Dr. Amy Knopf, and 
her study team.  
 
 

 
 
 
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STUDY SCHEMAS 
 
 
Legend for both figures: 
CC – Consent Condition 
CC 1: Adolescent self-consent 
CC 2: Adult permission required  
CC 3: Parental permission required  
CAB – Cabotegravir (an HIV treatment medication) 
CASI – Computer assisted self-interview 
RS- Research Staff 
WTP – Willingness to participate in the study 
UBACC – UCSD Brief Assessment of Capacity of Consent 
 
 

 
 
 
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1.0 
INTRODUCTION 
1.1  
Background 
American youth are disproportionately affected by the HIV epidemic, accounting for an 
estimated 26% of all new HIV infections. Young men who have sex with men (YMSM), and 
young women of color are at especially high risk. Together these two groups comprise 86% of 
all incident infections among persons aged 13-24.1 New biomedical prevention approaches 
have dramatically decreased the risk of HIV infection in adults. One particularly promising 
approach is pre-exposure prophylaxis (PrEP), which involves prescribing an HIV treatment 
medication to those at high-risk of acquiring HIV. PrEP with once daily dosing of oral tenofovir-
emtricitabine [TDF-FTC] has demonstrated 95% efficacy in adherent adult users.2, 3 The U.S. 
Food and Drug Administration has approved oral PrEP with TDF-FTC for adults aged 18 and 
older. There are currently no published data on the safety and efficacy of PrEP with TDF-FTC for 
minor adolescents, so it is not yet approved for prevention in this population.  
One reason for the evidence gap is a well-described reluctance to include minors in biomedical 
HIV prevention research, because doing so presents ethical complexities.4, 5 There are three 
basic ethical principles that govern research with human subjects: respect for persons, 
beneficence, and justice.6  The first of these principles is the most difficult to operationalize in 
research with minors. Respect for persons requires treating individuals as autonomous actors, 
and protecting those with diminished autonomy. For decades, individual autonomy has been 
marked by attaining the legal age of consent to medical treatment or procedures,7 which is 
generally the age of majority, unless the treatment is for a socially stigmatized condition. Thus, 
in most research, minor adolescents fall into the category of those with diminished autonomy 
who require additional protection beyond those afforded to all human subjects. Parental 
permission is a cornerstone of these additional protections for minor research subjects.8 The 
requirement for parental permission is founded on several assumptions. The first is that 
children lack the capacity to understand and weigh the risks and benefits of research, and may 
make decisions that are not in their own best interest. The second assumption is that parents 
have a fundamental right to make decisions about their children’s health and welfare, and to 
have those decisions reflect their own values. The third assumption is that parents will act in 
the best interest of their children.8  
Connection to parents is often protective against a variety of risk behaviors,9 and disclosure to 
parents has been shown to be associated with a lower risk of HIV acquisition among YMSM.10 
However, requiring parental permission forces the disclosure of sexual behavior, and in many 
cases, sexual orientation. Research demonstrates that requiring parental permission can delay 
treatment of stigmatized conditions, such as addiction, pregnancy, and sexually transmitted 
infections (STI) when adolescents fear social harms due to their disclosure to parents.11 Delays 
in seeking treatment pose risk to the minor and, in some cases, to the public.8 Thus, for decades 
states have allowed minors to consent to the diagnosis and treatment of STI,12 and, because of 
the way “children” are defined, these exemptions extend to research. Federal regulations allow 
minors to consent, without parental permission, to research that involves the same treatments 
or procedures to which they are allowed to self-consent in the jurisdiction in which the 
proposed research will take place.8 The allowance for minor self-consent is aligned with a body 

 
 
 
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of evidence that suggests adolescents are capable of making medical decisions that are 
comparable to the decisions of adults.13 It is also reflective of the findings of two studies14,15 in 
which the institutional review boards (IRBs) changed consent processes midway through, 
creating a natural experiment of the recruitment effect of requiring parental consent. In both of 
the studies it was found that self-selection bias toward lower-risk adolescents once parental 
consent was required for participation.  
Investigators and IRBs must balance protective duties to minors with multiple vulnerabilities.16 
Two PrEP studies17,18 have faced these ethical complexities directly, and each generated new 
questions that must be answered to make progress toward providing minors’ appropriate 
access to HIV prevention research. The first study, ATN 113, examined the safety and 
tolerability of oral TDF-FTC for minor YMSM. Concerns about disclosure-related vulnerabilities 
prompted study organizers to design the protocol to allow for adolescent self-consent so that 
parental permission was neither sought nor required for enrollment. ATN 113 was the first 
biomedical HIV prevention study in the U.S. that allowed minor adolescents to self-consent for 
enrollment however roughly half the study sites failed to secure IRB approval for protocol 
implementation.19 The second study (MTN 023) is an active Phase IIa trial to assess the safety of 
a silicone vaginal ring impregnated with the antiviral dapivirine in adolescent women aged 15-
17. Unlike ATN 113, MTN 023 study participants are required to have parental permission for 
enrollment. The study is underway, but investigators have encountered difficulty accruing 
participants within the planned timeframe for enrollment, raising concerns about the 
recruitment effects of requiring parental consent. Thus, neither of the two models of consent 
(adolescent self-consent or required parental permission with adolescent assent) facilitates 
adolescent inclusion in biomedical prevention trials. The first raises concern about exposure of 
the adolescent to harm; the second fails to attract adequate numbers because of the high risk 
for disclosure. Both raise important questions about the role of potential disclosure-related 
harms, participant gender, and study agent (delivery mechanism and stage of development) in 
shaping the consent process.  
1.2  
Rationale 
This study will test a new model of consent for biomedical HIV prevention studies - optional 
parental permission. Consent has typically focused on a single actor--parent giving permission, 
or adolescent consenting for self. However, we will test a third model that includes the 
possibility of multiple actors. This support for a model of optional parental consent comes from 
a Phase III vaginal microbicide trial in South Africa.20 Schenk et al. recruited 16-17 year-old girls 
and allowed them to self-consent for enrollment with the option to involve their parents if 
desired. The researchers were able to enroll and retain minors at very high risk of HIV, and 
found no differences in their attrition, adherence, or risk behaviors compared to 18-19-year-old 
study participants. These findings suggest that not only can minors participate in biomedical 
prevention studies but they can also be enrolled in a developmentally sensitive way. We want 
to determine whether a similar consent model would acceptable to high-risk adolescents and 
parents of high-risk adolescents in the US.  

 
 
 
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1.3 
Preliminary Studies 
Adolescents’ capacity to consent to biomedical HIV research is roughly similar to that of adults. 
Ott has examined adolescent capacity to consent to research, and demonstrated that 
adolescents’ capacity to understand consent information, to appreciate their own situation, the 
ability to balance risks and benefits, and to make a voluntary choice was similar to studies of 
adults.21 These data are similar to that of Hein, et. al.22 Through the Adolescent Medicine Trials 
Network ATN) for HIV/AIDS Interventions, Ott and Zimet examined preventive misconception 
with a simulated HIV vaccine trial. In that study (ATN 076), adolescents demonstrated the 
capacity to understand that the vaccine was an experiment (and thus may not work) and that a 
placebo would be used. Similar to adult studies and consistent with poor numeracy in U.S. 
populations, a higher number had difficulty understanding the statistical concept of 
randomization.23  
Lewis-Gilbert, Knopf, Zimet, et al. evaluated the process of initiating ATN 113 across the 13 sites 
that intended to participate in the study. The study raised numerous ethical challenges that 
primarily revolved around the principle of respect for persons. Investigators and IRB members 
expressed concerns about adolescent vulnerability that were not resolved even when there was 
a legal basis for adolescent self-consent.19 We also found that investigators and IRB members 
wished for an optional parental consent model, noting that some adolescents would want 
parental involvement in the consent process and some would not.24 These studies point toward 
the acceptability of an optional parental consent model from the perspective of investigators 
and IRBs.  The current study will elicit adolescent and parent perspectives.  
2.0 
SPECIFIC AIMS 
The purpose of this study is to examine how the consent process affects the acceptability of 
participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk 
minors and the parents of minor adolescents. Acceptability will be measured by adolescents’ 
willingness to participate (WTP) in and parents’ willingness to support (WTS) their adolescent’s 
participation in two hypothetical biomedical HIV prevention trials that are modeled after PrEP 
studies that included minors. 
Aim 1: Describe how consent conditions influence high-risk minor adolescents’ WTP in a 
hypothetical biomedical HIV prevention trial. 
Primary Hypothesis: Adolescents assigned to the self-consent model will have the highest WTP 
scores, followed by those assigned to the adult permission model, and finally those assigned to 
the required parent permission consent model. 
Additional sub-aims: 
• Determine whether concern about HIV, capacity to consent, family context and 
sociodemographic characteristics moderate the relationship between consent condition 
and WTP scores.  
• Describe high-risk minors' perceptions of the risks and benefits of parental consent, how 
they anticipate the different models of consent would influence their WTP in prevention 
trials, and whether shared-decision making between minors and parents is feasible.  

 
 
 
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Aim 2: Describe the acceptability of different consent conditions, from the parent 
perspective. 
Primary Hypothesis: The parental permission required scenario will be the most acceptable to 
parents, followed by the adult permission model, and finally the adolescent self-consent model.  
Additional sub-aims: 
• Determine whether concern about HIV, capacity to consent, and sociodemographic 
characteristics moderate the relationship between consent condition and acceptability.  
• Describe parents’ attitudes toward the various consent models, their perceptions of the 
risks and benefits of each model, and their conceptualization of a shared decision 
making process for consent.  
Aim 3: Describe the effects of the study agent (stage of development and method of delivery) 
on high-risk minor adolescents’ WTP scores and parents’ acceptability scores  
Primary Hypothesis: WTP and acceptability scores will be higher for the study of an oral 
medication that is already FDA-approved for adults compared to study of a topical agent that is 
still under investigation. 
Additional sub-aims: 
• Describe perceived risks and benefits of each study design, and how adolescents and 
parents anticipate the study design would influence their WTP/WTS the hypothetical 
trial. 
3.0 
STUDY DESIGN 
This study will use a quasi-experimental design to explore how the informed consent process 
affects the acceptability of biomedical HIV prevention trials, from the perspective of 
behaviorally high-risk minor adolescents and the parents of minor adolescents. All study 
participants will complete a computer assisted self-interview (CASI) that collects demographic, 
social, behavioral, and attitudinal measures. Adolescent participants will undergo a simulated 
consent process for each of two hypothetical studies based on their randomized consent 
condition (Appendix II). Parent Participants will will undergo a simulated consent process that 
mimics what their own adolescent would hear while consenting for each of the two 
hypothetical studies. After each hypothetical study, parent participants will complete a CASI 
with three vignettes that describe each of the three possible consent conditions. Parents will 
rate the acceptability of each vignette. The order of vignettes, and the order of the two 
hypothetical studies, is varied to reduce the possibility of ordering bias. Hypothetical Study 1, 
modeled after ATN 113, is an open-label study of oral TDF-FTC and hypothetical Study 2, 
modeled after HPTN 077, is a Phase IIa trial of an injectable HIV integrase inhibitor. 
Eligible adolescent participants will complete a demographic questionnaire, then be lead by RS 
through a simulated study consent process for one of two hypothetical studies. The consent 
process will be consistent with their randomly assigned consent condition. After completing the 
simulated consent process, the adolescent will complete a CASI assessing adolescents’ WTP and 
will work with RS to complete the UCSD Brief Assessment of Capacity to Consent (UBACC)25. The 

 
 
 
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simulated consent process and follow-up assessments will then be completed for the second 
hypothetical study. After the second UBACC, the adolescent will complete overall WTP, medical 
mistrust, and end of study questions. 
Eligible parent participants will first complete a demographic questionnaire. They will then 
review the informed consent form for the first study with the RS and complete a CASI assessing 
the acceptability of three approaches to consent, presented in three different vignettes (please 
see section 3.4.2 for further information). Parents will work with RS to complete the UCSD Brief 
Assessment of Capacity to Consent (UBACC)25.  The simulated consent process and follow-up 
assessments will then be completed for the second hypothetical study. After the second UBACC, 
the participant will answer a series of questions via CASI.  
A subset of adolescent and parent participants will be selected to participate in a debriefing 
interview.  
3.1  
Study Population 
This study will recruit adolescents between ages 14-17, inclusive, who are able to read and 
speak English, who have a negative or unknown HIV status; and who have engaged in high-risk 
sexual activity (see Table 1) in the last 12 months. The study will also recruit adults who are 
able to read and speak English, who are a parent or guardian to an adolescent who is between 
ages 14-17, inclusive, and who have a negative or unknown HIV status.  Adolescent and parent 
participants will be recruited from four U.S. cities:  Baltimore, MD; Chicago, IL; Denver, CO; and, 
Tampa, FL. These cities have diverse populations, high rates of incident HIV infection among 
adolescents and young adults, and/or demonstrated success in recruiting minor adolescents for 
biomedical HIV research. Recruitment will be primarily clinic-based, but if that method proves 
insufficient for recruiting participants, we will employ a variety of strategies for recruitment 
including: social media advertising, fliers, and word of mouth. 
3.2 
Sample Size  
This study will enroll approximately 144 (36 per study site) high-risk minor adolescents and 144 
(36 per study site) parents of adolescents. A subset of 24-32 (6-8 per study site) adolescents 
and 24-32 (6-8 per study site) parents will be selected to participate in the debriefing interview. 
Of note, the adolescents and parents will not be parent-child dyads; they will be unrelated. We 
project total enrollment of 288 participants, however, since this is a multi-site project with 
simultaneous recruitment with a hard to reach population, we may schedule and enroll more 
subjects than anticipated.  
3.3 
Study Randomization, Stratification, or Description of Non-Random Assignment 
Procedures  
Adolescents will be randomized in a 1:1:1 ratio into 1 of the 3 consent conditions using block 
randomization with block size k=3 (so that in every 3 subjects, exactly 1 is allocated to each 
condition).  The randomization will be stratified by study site and sex assigned at birth. Within 
study site, sex assigned at birth, and consent condition, the order in which the hypothetical 
trials will be presented to adolescents will be block randomized with block size k=2.   

 
 
 
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Enrollment of parents will be restricted to approximately 15 parents of adolescent natal males 
and 15 parents of natal adolescent females at each study site. Parents will indicate the 
acceptability of each of the three consent conditions for each of the two hypothetical trials. 
Independently of the gender strata, the order of hypothetical trial presentation will be block 
randomized with blocks size k=2. Separately for each hypothetical trial, the order of evaluation 
for the three consent conditions will be randomized so that each ordering is equally likely.  
A subset of 6-8 adolescents (3-4 natal males and 3-4 natal females) and 6-8 parents of 
adolescents (3-4 parents of natal males and 3-4 parents of natal females) at each site will be 
selected for participation in the debriefing interview. All study participants will be asked if they 
are willing to participate in the debriefing interview until quotas have been reached. 
3.4 
Outcome Measures 
3.4.1 Adolescents’ Willingness to Participate (WTP) Scores 
Adolescents’ WTP will be used to measure the acceptability of biomedical HIV prevention trials 
from the perspective of high-risk minor adolescents. Adolescent WTP is measured using the 
question “If offered the chance, how likely would you be to participate in the study?” with 
response options ranging from “definitely not participate” to “definitely participate”. The 
adolescent WTP will be measured after each of the two simulated study consent is completed, 
resulting in two WTP scores per adolescent. 
3.4.2 Parents’ Willingness to Support (WTS) 
We use a number of measures to assess WTS a minor adolescent’s participation in the study. 
The most obvious way to assess WTS is to ask the parent whether s/he would grant permission 
for his/her teenager to enroll in the study. However, this question can only be asked after the 
scenario in which parental permission is required because in the other two scenarios parental 
permission is either optional or not solicited, rendering the parent’s preferences about 
participation moot. Thus, WTS includes not only projected likelihood of granting permission to 
join the study, but also: (1) a measure of the extent to which the parent finds the vignette’s 
consent scenario an acceptable process for enrolling his/her adolescent; (2) measures of the 
parent’s perception of his/her adolescent’s capacity to consent to the two studies in question; 
(3) a measure of the parent’s expectation that his/her adolescent would discuss the study prior 
to enrollment, even if such a discussion were not required; (4) a measure of the likelihood a 
parent would allow his/her adolescent to join the study. In summary, after each vignette the 
parent will answer two or three Likert-type questions that together will be used to assess WTS.  
3.4.3 University of San Diego Brief Assessment of Capacity to Consent (UBACC) Scores 
The UBACC will be administered to all participants. The UBACC includes ten open-ended 
questions to measure participant’s understanding of research design, risks and benefits, and 
voluntariness. Each of the ten items are given a score of 0 indicating “a clearly incapable 
response”, 1 indicating uncertainty or a partially appropriate, or 2 indicating “a clearly capable 
response”. The UBACC will be completed for each of the two simulated studies, resulting in two 
UBACC scores per participant.  
3.4.4 Qualitative Debriefing Interviews 

 
 
 
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The debriefing interview is a 30-45 minute interview designed to explore adolescent and parent 
perspectives on the various consent conditions in greater depth, and to better understand the 
role of study features, family, and adolescent characteristics in willingness to 
participate/willingness to support the hypothetical research studies. At the start of the 
interview, the participants will be informed that the interview will be recorded and transcribed 
and the participant will be asked to select a pseudonym for the researchers to use. The 
adolescent debriefing interview will consist of five sections including (1) general opinions about 
participating in HIV prevention studies, (2) opinions on the two specific studies, (3) relationship 
to parents, (4) opinions about parental involvement in the consent process, and (5) 
options/opinions for consenting in future studies. The parent debriefing interview will consist of 
four section including (1) general opinions about HIV prevention studies, (2) relationship to 
their teenager, (3) opinions about parental involvement in the consent process, and (4) 
options/opinions for consenting in future studies. 
4.0 
SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS 
4.1 
Adolescent Inclusion Criteria 
To be considered eligible for enrollment, an adolescent must meet all the criteria listed below. 
4.1.1  Age 14-17 inclusive; and 
4.1.2 Able to read and speak English; and 
4.1.3 HIV status is negative or unknown; and 
4.1.4 Engaged in high-risk sexual activity (Table 1) in the last 12 months; and 
4.1.5    Not the child of a parent already enrolled in the study. 
4.2 
Parent Inclusion Criteria 
To be considered eligible for enrollment, a parent must meet all the criteria listed below. 
4.2.1  Able to read and speak English; and 
4.2.2  Parent or guardian of an adolescent who is between ages 14-17; and 
4.2.3     not the parent of a child already enrolled in the study. 
Table 1. Criteria for high-risk sexual behavior 
High-risk sexual behavior criteria for natal males 
High-risk sexual behavior criteria for natal females 
During the last 12 months, which of the following is 
true for you? (check all that apply):  
 
• 
I had unprotected anal sex with a male  
• 
I had protected anal sex with 3 or more males  
• 
I had sex with a male for money, gifts, 
shelter, or drugs  
During the last 12 months, which of the following is 
true for you? (check all that apply):  
 
• 
I had unprotected anal or vaginal sex with a 
male  
• 
I had sex with someone who is HIV+ 
• 
I had protected vaginal or anal sex with 3 or 
more males  

 
 
 
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• 
I had sex with a male, and I have had a 
sexually transmitted infection (gonorrhea, 
chlamydia, syphilis, herpes)  
• 
I had sex with someone who is HIV+ 
• 
I had anal sex with a male and the condom 
slipped off or broke 
• 
None of the above 
 
• 
I had sex with a male for money, gifts, 
shelter, or drugs  
• 
I have had sex with one or more males, and I 
have had a sexually transmitted infection 
(gonorrhea, chlamydia, syphilis, herpes) 
• 
I had vaginal or anal sex with a male and the 
condom slipped off or broke 
• 
None of the above 
4.3 
Recruitment and Screening 
This study will recruit adolescents between ages 14-17, inclusive, and parents of adolescents in 
the same age range. Participants will be recruited from four partnering research sites in the 
following U.S. cities:  Baltimore, MD (partnering organization: Johns Hopkins University, 
partnering researcher: R. Sanders), Chicago, IL, (partnering organization: University of Chicago,  
partnering researcher: J. Schneider), Denver, CO (partnering organization University of 
Colorado, partnering researcher: D. Reirden), and Tampa, FL (partnering organization University 
of South Florida, partnering researcher: D. Straub).  
Specific recruitment procedures for each group are described in detail below. 
4.3.1 Adolescents aged 14-17:  
This study will recruit 36 adolescents at each site primarily through contact in the clinical 
setting. If recruitment is slow, we will begin using advertising on social media (Facebook, 
Twitter, chat services); support centers for lesbian, gay, bisexual, transgender, and questioning 
(LGBTQ) youth; churches and other social settings (e.g. Gay Straight Alliance at local high 
schools) and at clinics affiliated with the partnering organization. All interested adolescents will 
complete a screening questionnaire that should take about 10 minutes to complete. 
Adolescents recruited in person will complete the questionnaire on a tablet on the same day 
they are recruited. Adolescents who self-refer or hear about the study from friends will need to 
complete the screening questionnaire online. All eligible adolescents will provide contact 
information regardless of recruitment and screening method. 
To avoid the accidental inclusion of parent-child dyads, we will ask each participant to give the 
first 5 digits of their street address and first 4 characters of apartment/unit, where applicable. 
For example, if someone lived at 1234 Main Street Apt. 408, the value for that address would 
be 01234408. The value will be labeled “Family ID” and stored only until the end of the 
enrollment period. Once the site has filled all quotas, the Family ID will be permanently deleted.  
The RS will receive an email from Qualtrics indicating the participant’s eligibility. If the 
participant is eligible based on the screening questionnaire, the RS will use the Family ID Report 
in Qualtrics to idenfity any matching Family IDs. If there is no match, the participant qualifies 
and can begin the study. All eligibility requirements are assessed  without the PI’s input.  If 
interested, the adolescent will either: 1) provide contact information to arrange the study visit 
or 2) complete the study procedures the same day as s/he was screened. Eligible participants 
will be invited to participate in an on-site debriefing interview (until quota is filled), 
immediately following the final CASI.   
4.3.2 Parents or guardians:  

 
 
 
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This study will recruit 36 parents/guardians at each site. Parents will be recruited primarily 
through contact in the clinical setting. If recruitment is slow, we will begin using advertising on 
social media (Facebook, Twitter), the LGBTQ youth centers referenced above, and through the 
local chapters of Parents, Families, and Friends of Lesbians and Gays, as well as churches, and 
other social settings familiar to our target audience. Parents recruited in person will complete 
the questionnaire on a tablet on the same day they are recruited. Parents who self-refer or 
hear about the study from friends will need to complete the screening questionnaire online.  
To avoid the accidental inclusion of parent-child dyads, we will ask each participant to give the 
first 5 digits of their street address and first 4 characters of apartment/unit, where applicable. 
For example, if someone lived at 1234 Main Street Apt. 408, the value for that address would 
be 01234408. The value will be labeled “Family ID” and stored only until the end of the 
enrollment period. Once the site has filled all quotas, the Family ID will be permanently deleted. 
The RS will receive an email from Qualtrics indicating the participant’s eligibility. If the 
participant is eligible based on the screening questionnaire, the RS will use the Family ID report 
in Qualtrics to identify any matching Family IDs. If there is no match, the participant qualifies 
and can begin the study. All eligibility requirements are assessed  without the PI’s input. If 
interested, the parent participant will either: 1) provide contact information to arrange the 
study visit or 2) complete the study procedures the same day as s/he was screened. Eligible 
participants will be invited to participate in an on-site debriefing interview (until quota is filled), 
immediately following the final CASI.   
4.4 
Locator/Contact Information  
At the end of the screening questionnaire, interested and eligible individuals will be asked to 
provide their preferred method of contact and an alternative method of contact. A method of 
contact may be an email address, phone number, or Facebook profile name. Participants will 
review a sample voice/text message, and then asked if such messages can be sent (via SMS) 
and/or left (voicemail) via their preferred contact information. RS will only send/leave 
messages if expressly permitted to do so. Contact information will be accessible by designated 
research staff at the relevant research site, as well as the data manager, Program Manager, and 
the PI. All contact information will be stored in the “Scheduling Log”, which is separated from 
the study visit data. IU researchers will have access to the scheduling log for monitoring 
purposes.  
4.5 
Informed Consent  
After a screened participant is determined to be eligible, s/he will receive a study information 
sheet and provide verbal consent for the study. The study details will be discussed and all 
questions answered during the informed consent process. Written consent is not required, 
since this would include the only identifying information for participants in the study. Minors 
will not require parental consent to participate. Verbal informed consent from the individuals 
as determined by local Institutional Review Boards (IRB) will be obtained before any study 
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Those individuals who refuse to provide verbal consent to participate in the study will be asked 
if they are willing to provide their reason for declining participation and if answered; the 
responses will be recorded in an anonymous manner on the screening questionnaire.  
4.6 
Co-enrollment Guidelines  
Co-enrollment in other clinical studies is allowed and approval from the Protocol Team for co-
enrollment is not required.  
5.0 
STUDY PROCEDURES 
A Schedule of Evaluations, located in Appendix 1, provides a timeline for each study activity.  
5.1 
Enrollment Procedures 
Enrollment and study completion will occur on the same visit. Participants who are confirmed 
eligible and complete the consent process will immediately begin the study procedures. The 
participant will be considered enrolled after they provide verbal consent.  
5.2 
Randomization Procedures  
5.2.1. Adolescent Participants 
Adolescents will be randomized in a 1:1:1 ratio into 1 of the 3 consent conditions using block 
randomization with block size k=3 (so that in every 3 subjects, exactly 1 is allocated to each 
condition). The randomization will be stratified by study site and sex assigned at birth. Within 
study site, sex assigned at birth, and consent condition, the order in which the hypothetical 
trials will be presented to adolescents will be block randomized with block size k=2.   
A subset of 6-8 adolescents (3-4 of both sexes) at each site will be selected using quota 
sampling for participation in the debriefing interview. Participants will be asked if they are 
willing to participate in the debriefing interview unless the quota for their demographic group 
has been reached. 
5.2.2. Parent Participants 
Enrollment of parents will be restricted to approximately 18 parents of adolescent natal males 
and 18 parents of natal adolescent females at each study site. Parents will indicate the 
acceptability of each of the three consent conditions for each of the two hypothetical trials. 
Independently of the gender strata, the order of hypothetical trial presentation will be block 
randomized with blocks size k=2. Separately for each hypothetical trial, the order of evaluation 
for the three consent conditions will be randomized so that each ordering is equally likely.  
A subset of 6-8 parents at each site will be selected using quota sampling for participation in 
the debriefing interview. Participants will be asked if they are willing to participate in the 
debriefing interview unless the quota for their demographic group has been reached. 
5.3 
Investigation Procedures 
RS will prepare the participant’s iPad for the beginning of the study visit. Adolescents will 
complete demographic, social, and attitudinal measures by CASI. Once completed, RS will begin 

 
 
 
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the simulated consent process for study 1 or study 2 (depending on randomization) by 
reviewing the hypothetical consent form (which reflects the randomly assigned consent 
condition; Appendix II). RS will allow time for questions about the hypothetical study from the 
participant, provide answers as needed. The RS will then ask the adolescent to complete the 
WTP questions on their iPad. Finally, the RS will administer the UCSD Brief Assessment of 
Capacity to Consent (UBACC)25 for study 1 or study 2 (depending on randomization). The RS will 
then repeat the simulated consent process, WTP, and UBACC for the additional hypothetical 
study (study 1 or study 2 depending on randomization).  
For parent participants, RS will prepare the participant’s iPad for the beginning of the study 
visit. RS will begin the simulated consent process for study 1 or study 2 (depending on 
randomization) by reviewing the hypothetical consent form (which reflects the randomly 
assigned consent condition; Appendix II). RS will allow time for questions about the 
hypothetical study from the participant, provide answers as needed. The RS will then ask the 
parent to read the vignettes and answer WTS questions on their iPad. Finally, the RS will 
administer the UCSD Brief Assessment of Capacity to Consent (UBACC)25 for study 1 or study 2 
(depending on randomization). The RS will then repeat the simulated consent process, 
vignettes and answer WTS questions, and UBACC for the last hypothetical study (study 1 or 
study 2 depending on randomization). Parents will then complete demographic, social, and 
attitudinal measures by CASI.  
For both adolescent and parent participants, after all data are collected and saved, the RS will 
determine whether the participant is eligible to participate in the debriefing interview. 
Eligibility is determined by quota (3-4 natal male adolescents and 3-4 natal female adolescents 
at each site; 3-4 parents of adolescent natal males and 3-4 parents of adolescent natal females 
at each site). If the quota is not filled, the participant will answer a question at the end of the 
Qualtrics survey asking if they would like to participate in a debriefing intertivew. If quota is 
filled, the RS for that site will be notified and IU will remove the question from Qualtrics.  
The participants will complete all CASIs using Qualtrics database via a provided iPad.  
The RS will verbally administer the UBACCs. UBACCs and debriefing interviews will be audio 
recorded with participants permission.  
5.4 
RS Training  
Interview RS training, intervention monitoring, and quality control (section 5.5) will be done by 
Dr. Knopf and the Consent 2.0 Program Manager. RS conducting the interviews will ideally have 
some experience with open-ended questioning and interviewing (e.g., HIV counseling, 
anthropology, psychology, nursing, social work); however, experience is not absolutely 
necessary, and an individual with good listening and interpersonal skills can be trained in the 
technique.  
Dr. Knopf will visit each research site to conduct initial RS training over the course of two days. 
The two day training will cover:  
• Background and rationale for project 
• Project goals 

 
 
 
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• Work with human subjects, with special attention to issues of adolescent consent to 
biomedical HIV prevention research 
• Overview of the two hypothetical research studies 
• Overview of all study instruments 
• Practice interviewing, using actual study instruments 
• Debriefing of practice interviews to identify areas of improvement  
• Writing field notes 
• Dealing with participant disclosures  
• Directed reading on qualitative techniques 
Practice interviews will focus on self-presentation, and specific interview techniques, such as 
active listening, use of silence, avoiding leading questions, outlining, summarizing, and tabling 
(when the adolescent participant brings up two interesting concepts, tabling one and pursuing 
the other).  
5.5  
Monitoring/Quality Control 
Monitoring and quality control for the debriefing interviews will be done by a qualitative 
research team consisting of Dr. Knopf and the Consent 2.0 Program Manager. 
Quality of CASI and debriefing interviews will be intensely monitored at the start, and then 
periodically by the qualitative research team. After each of the first three interviews at each 
site, and before the fourth interview takes place, the qualitative research team will listen to the 
interview. Together, they will discuss the interview, covering (1) interview technique (good and 
bad), (2) interview content, (3) techniques to practice in the next interview, and (4) areas for 
further inquiry.  
After listening to the first several together, a subset of subsequent interviews will be listened to 
by the qualitative research team. These will be identified by either the RS or the qualitative 
research team, and include interviews that went particularly well or particularly poorly, or 
interviews with interesting content. 
6.0 
EVALUATIONS AND MEASURES  
6.1 
Screening 
All interested adolescents and parents/guardians will complete a screening questionnaire either 
in person on a study tablet, or online on the interested person’s personal computing device 
(desktop, tablet, smartphone).The survey software will automatically determine whether the 
individual meets the eligibility requirements without the PI’s input.  
6.2 
Enrollment/Entry 
RS will prepare the participant to complete demographic, social, and attitudinal measures by 
CASI. Adolescent participants will complete these measures in two parts. The beginning CASI 
will include demographic information, SES, parental monitoring, and concern about HIV and the 
final CASI will include overall WTP, medical mistrust, and closing questions. Parent participants 

 
 
 
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will complete demographics, SES, WTS, concern about HIV, medical mistrust, and closing 
questions during the final CASI. The measures are summarized in Table 2, below. 
6.2.1    Quantitative Evaluations 
Table 2: Quantitative Measures 
Demographics 
Scale 
Description of Items included  
Demographics 
 
Age, race/ethnicity, sexual orientation, gender identity, 
education, employment, health insurance status, city, living 
situation  
Socioeconomic 
Status 
FAS-III 26 27 
(Adolescents)  
7- questions adapted from the Family Affluence Scale-III, 
measuring a family’s financial status based off of number of 
vehicles, computers, bathrooms, adolescent having their own 
bedroom, if the family has a dishwasher, number of times 
traveled outside US, and overall perception of family’s 
financial status.  
Social Support  
MSPSS- modified28  
4 –Likert questions on a 7-point scale ranging from very 
strongly disagree to very strongly agree, measuring parental 
support and relationships with adolescents.  
Parental 
Monitoring 
 Parental knowledge - modified29 
(Adolescents & Parents)  
 
5- point Likert scale measuring parental knowledge, 
disclosure, solicitation, and parental control. The scale has 25 
statements for the (adolescent/parent) Strongly Disagree to 
Strongly Agree for each statement.  
Adolescent statements such as “My parent(s) know what I do 
during my free time.  
Parent statements such as “I know what my teen does during 
his/her free time.”  
Medical Mistrust30 
(Adolescents & Parents)  
6, 5-point Likert items that measure the degree to which the 
participant trusts medical researchers.  
Communication 
Communication with Parents31  
(Adolescents & Parents)  
5 Questions asking the number of times parents and 
adolescents have communicated about relationships, sex, 
sexually transmitted infections (HPV, HIV), same sex 
relationships, and using a condom. Answers range from 
Never, Once/twice, Many times, and Don’t know 
Concern about 
HIV 
HIV Risk perception32 
Adolescents & Parents   
2, 5-point Likert questions about adolescent worry of being 
infected with HIV/AIDS and parents worry of their 
adolescent being infected with HIV/AIDS.  
Sexual Behavior 
Sexual Behavior33 
(Adolescents)  
5 questions for adolescents regarding sexual intercourse 
partners. 
Capacity to 
Consent 
UBACC25 
8 open-ended questions (answers scored 0-2) to measure 
participant’s understanding of research design, risks & 
benefits, voluntariness 
Acceptability  
Willingness to Participate33 
(Adolescents) 
3 Likert-type items that begin with question stems such as “If 
offered a chance to participate in this study, how likely are you 
to participate…” 

 
 
 
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Acceptability of consent approach 
Assessment of adolescent capacity to consent 
Confidence in adolescent disclosure (Parents)  
 
Likert-type items (scored 1-5) that measure each of the three 
constructs.  
 
 
6.2.2    Qualitative Evaluations 
The debriefing interview is designed to explore adolescent and parent perspectives on the 
various consent conditions in greater depth, and to better understand the role of study 
features, family, and adolescent characteristics in willingness to participate/willingness to 
support the hypothetical research studies. At the start of the interview, the participants will be 
informed that the interview will be recorded and transcribed and the participant will be asked 
to select a pseudonym for the researchers to use. The adolescent debriefing interview will 
consist of five sections including (1) general opinions about participating in HIV prevention 
studies, (2) opinions on the two specific studies, (3) relationship to parents, (4) opinions about 
parental involvement in the consent process, and (5) options/opinions for consenting in future 
studies. The parent debriefing interview will consist of four sections including (1) general 
opinions about HIV prevention studies, (2) relationship to their teenager, (3) opinions about 
parental involvement in the consent process, and (4) options/opinions for consenting in future 
studies.  
6.3 
Premature Discontinuation from Intervention  
The RS will complete the ATN 150 Off Study Form (located at the end of the Qualtrics RA 
survey) when the decision is made to permanently discontinue the subject from the study and 
no further data collection will occur. (See Section 8.4) 
7.0 
DATA COLLECTION AND SITE MONITORING 
7.1 
Development of Protocol and Case Report Forms 
The ATN CC, in collaboration with the Protocol Team, is responsible for the development of this 
protocol and ATN regulatory forms (e.g. off Study form, untoward event form). Indiana 
University (IU) is responsible for constructing, testing, and implementing the CRFs and CASIs in 
Qualtrics. IU is also responsible for all qualitative data (from UBACC and debriefing interviews) 
for this study.  
7.2 
Data Records  
Participant-related study information will be identified through the Study Identification Number 
(SID) on all participant CRFs, audiotapes, and CASI data.  Participant names or other personally-
identifying information will not be used on study documents with the exception of preferred 
name or nick name to be used during the interview, and contact information, such as email 
address, phone/text number, and/or Facebook profile, which is collected from eligible and 
interested participants. Contact information is used to schedule a time to complete the study 
visit.   

 
 
 
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Electronic CRFs and CASIs are completed and keyed directly into Qualtrics.  Any printed study-
related information will be kept in double-locked, limited access areas at the study sites.   
7.3  
Data Collection 
7.3.1 Screening 
Adolescents and parents of adolescents will be screened either online or in-person using CASIs 
developed in Qualtrics. Information regarding their eligibility for the study will be collected, 
along with the first 5 digits of their street address and first 4 characters of apartment/unit, 
where applicable, in order to rule out dyads.  Eligible individuals will also be asked for basic 
contact information (see section 7.2).  
7.3.2  Computer Assisted Self-Interview  
Demographic, social, behavioral, and attitudinal measures will be collected using CASI 
developed within Qualtrics. The CASI responses will remain confidential; no personal identifying 
information will be collected.  Detailed instructions regarding completion of the CASIs will be 
provided in site MOPs. 
7.3.2.1 CASI Data Security 
The CASI data will be collected on iPad devices using Qualtrics. Qualtrics is a web-based system 
appropriate for use with sensitive data, including those data protected by the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA).  Data are stored on secure servers and 
protected by fire walls.  No data is written to the iPad hard drive.  
7.3.3 Audio Data for UBACC and Debriefing Interviews 
The entire study visit, including UBACCs and debriefing interviews, will be digitally audio-
recorded with participant consent. Immediately upon completion, the digital audio files will be 
uploaded to the Indiana University (IU) secure server. The audio recordings will be uploaded to 
a secure website belonging to a transcription company, who will listen to the recordings, 
transcribe them into a Microsoft Word file, and upload the transcript files to their secure 
website for download by IU study staff. Transcripts will be checked against audio recordings for 
accuracy. Once that process is complete, the audio files will be destroyed. Dr. Knopf will ensure 
that the audio files are destroyed by the transcription company, and permanently deleted from 
the IU server. 
7.3.4 Electronic Case Report Forms  
Data regarding study completion/early termination and protocol deviations will be collected 
using eCRFs developed within Qualtrics. The eCRFs will remain confidential; no personal 
identifying information will be collected. eCRFs will have the participants ATN Study ID number 
associated with the answers.  Detailed completion guidelines for the eCRFs will be provided in 
the MOP. 
7.4 
Data Submission 
All CASI and CRF data will be collected in electronic format using Qualtrics. For both the UBACC 
administration and debriefing interview data, the digital audio files will be uploaded to the IU 

 
 
 
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secure server. Then IU study staff will upload the digital audio files to a secure website 
belonging to a transcription company, who will listen to the recordings, transcribe them into a 
Microsoft Word file, and upload the transcript files to their secure website for download by IU 
study staff. 
All data will be submitted to the NICHD’s Data and Specimen Hub (DASH) after completion of 
the study in accordance with the NICHD DASH Data Archive Policy 
(https://dash.nichd.nih.gov/Resource/Policies) and the NIH Grants Policy Statement 
(https://grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm). 
7.5 
Data Quality Assurance 
Investigators receiving federal funding must adhere to the Code of Federal Regulations (CFR) to 
protect research participants and produce reliable study information.  Sites participating in 
research sponsored by the NICHD need to have an internal quality assurance (QA) plan that will 
identify problems and correct errors in research study records.   
For debriefing interviews, data quality will be checked at two time points. Two team members 
will listen to segments of each debriefing interview digital recording for recording quality and 
completeness and each transcription will be checked against the debriefing interview digital 
recording for accuracy and completeness. 
7.6 
Role of Data Management 
Indiana University is responsible for all eCRFs and CASI administration as well as data collection 
and cleaning. The IU Data Managerwill assist in protocol development and data analysis. The IU 
Data Manager will regularly receive data transfers from the Qualtrics database system for the 
purposes of producing study monitoring reports and/or to perform data analyses described in 
the statistical analysis plan or approved publication requests. Any data issues discovered by the 
DM will be reported to the PI and corrected  in the Qualtrics database. 
7.7  
Study Site Monitoring and Record Availability 
Site monitors from the CC will visit participating study sites to review compliance with the 
protocol, as well as accuracy and completeness of relevant study documentation and records, 
such as training logs.  Regulatory files, as required, will also be inspected to ensure that 
regulatory requirements are being followed.  Each site will work with the monitors to arrange a 
monitoring visit to ensure appropriate RS are available and that all documentation is accessible.  
Internet access will be required as well as appropriate space for the monitor to work. 
Activities that may be performed and documents that may be reviewed by the monitor include 
review of study procedure and documentation regarding compliance with protocol, GCP, and 
regulatory requirements.   
At the end of the monitoring visit, the monitor will meet with the PI, the study coordinator, and 
any other relevant RS to go over the findings. 

 
 
 
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7.8    Study Monitoring  
Implementation of the study will be monitored by the Study Team Review Committee (STRC), 
which includes the Protocol Chair, NICHD Health Science Administrator, one co-Investigator, 
Consent 2.0 Program Manager, and the IU Data Manager. 
7.8.1  Monitoring by Study Team Review Committee (STRC)  
The STRC will meet at least monthly. During these meetings, the STRC will review enrollment 
reports, reports on early discontinuation of the one-day study visit, and reports on Untoward 
Events (UEs) that have occurred since the last STRC meeting or previously reported UEs for which 
new information is available. All UEs will be reviewed within one week of occurrence; if the next 
scheduled STRC meeting is more than 7 days after a UE occurred, the team will convene a special 
meeting to address it.  
In the event that an UE occurs at a research site, the STRC will invite the relevant Site PI to attend 
either the regular STRC meeting or a specially convened meeting (see next section). During the 
STRC meeting the UE will be reviewed and the team will determine what actions are necessary. 
The Site PIs for Consent 2.0 will not be standing members of the STRC. 
8.0 
PARTICIPANT MANAGEMENT 
8.1 
Study Visit Management  
This project requires one study visit. There are no follow up visits.   
If an eligible participant does not show for a scheduled study visit, the RS will follow up and 
make at least three attempts to reschedule. Similarly, RS will make at least three attempts to 
contact all participants who are eligible and interested but unable to complete the study visit 
on the same day as screening questionnaire. Participants will be considered off study due to 
loss to follow up if they fail to respond or attend the study visit after the three attempts at 
contact/rescheduling.  
8.2 
Compensation 
All participants will receive $50, in cash or  gift card to compensate for their time. An additional 
$25 will be provided to participants who complete the debriefing interview. Each site will 
determine the most appropriate form of compensation. Gift cards may be: a Visa card, gas card, 
card for specific local store [e.g. Target, Wal-Mart]. In addition, sites may offer reimbursement 
for transportation. Each site will determine the most appropriate form of transportation 
reimbursement (e.g. bus fare, subway tokens, taxi vouchers, or cash). Participants who make a 
separate or unnecessary trip to the study site for screening but are deemed ineligible for any 
reason—including lack of interest—will receive $10 (cash or gift cards) as well as $5 
transportation reimbursement (e.g. bus pass). These incentives will be available to any 
participant who screen fails until online screening has been established. After online screening 
has been established, RS  may provide these incentives on a case by case basis at their 
discretion (e.g. in case someone cannot screen online and needs to come to the study site to 

 
 
 
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screen) Participants will receive $50 if they only stayed for part of the study visit. Participants 
will not receive any compensation for completing the online screening questionnaire.  
8.3 
Intervening on “Social Harms"  
All sites have specific policies governing the treatment of human subjects.  These policies 
specify that medical and psychological assistance will be available in the immediate 
environment in the event a participant should experience any adverse reactions resulting from 
study procedures.  
While participants will be informed that they may refuse to answer any question at any time, 
responses or reactions to certain questions may indicate distress on the part of the participants. 
If at any time during the study, a participant divulges that he or she is at risk for harm, including 
but not limited to being abused or experiencing violence, if harm is suspected or likely, or if the 
participant states he or she is suicidal/homicidal, measures will be taken to ensure his or her 
safety.  Reporting will be done as appropriate to the situation and the legal statutes, including 
reporting to child protection agencies or other appropriate agencies and referrals will be 
provided to appropriate support, counseling or treatment resources. 
8.4 
Criteria for Premature Discontinuation 
Study participants will only complete one study visit.  No participant follow up will be 
conducted; therefore premature study discontinuation will be limited to the following reasons:   
8.4.1 Consent or assent withdrawn during CASI or interview;  
8.4.2 Development of an untoward effect that warrants discontinuation from study; or 
8.4.3 Failure to adhere to or complete study evaluations;  
If it becomes apparent that a participant is becoming increasingly distressed while participating 
in any part of the study, the individual will be assessed by the RS (or designee) to determine 
whether they will be able to complete the session without experiencing undue distress. If the 
participant appears unable or refuses to continue participation, they will be offered a list of 
referral sources.    
9.0 
MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING FROM STUDY 
RS must follow the sIRB’s procedure for reporting and managing untoward events (UEs). ATN 
protocols follow the ATN Manual of Policies and Procedures (MOPP) for UE reporting.  The ATN 
Query Notification System (QNS) will be used to document the occurrence of an UE, as well as 
to provide the details, grading and rating of related or unrelatedness to the study. Protocol 
team members are notified through the ATN QNS. 
9.1 
Untoward Events Reporting  
RS will enter any UE of grade 3 or above in the ATN QNS 
(https://www2.cscc.unc.edu/atn/node/add/untoward-event-150) within 48 hours of site 
awareness. Other events (Grades 1 and 2) will be expected to be entered in the ATN QNS within 
7 days of site awareness of the untoward event.  

 
 
 
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All reported events will receive a grade by the RS. The grades are defined as noted below. The 
functional table below should be used to grade the severity of an UE. In addition, all deaths 
related to the study are to be classified as grade 5. 
 
Table 3: Untoward events grading 
PARAMETER 
GRADE 1 
MILD 
GRADE 2 
MODERATE 
GRADE 3 
SEVERE 
GRADE 4 
POTENTIALLY 
LIFE-
THREATENING 
GRADE 5 
DEATH 
Event NOT 
identified 
elsewhere in the 
grading table 
Mild symptoms 
causing no or 
minimal 
interference 
with usual social 
& functional 
activities with 
intervention not 
indicated 
Moderate 
symptoms 
causing greater 
than minimal 
interference 
with usual social 
& functional 
activities with 
intervention 
indicated  
Severe 
symptoms 
causing inability 
to perform usual 
social & 
functional 
activities with 
intervention or 
hospitalization 
indicated 
Potentially life-
threatening 
symptoms 
causing inability 
to perform basic 
self-care 
functions with 
intervention 
indicated to 
prevent 
permanent 
impairment, 
persistent 
disability, or 
death 
 
Death 
 
Examples 
Discomfort over 
survey questions 
that were self-
resolved or 
resolved without 
team 
intervention 
Mild to 
moderate 
distress 
observed by 
study team 
resolved with 
team 
intervention. 
Severe 
emotional 
distress 
observed by 
study team 
requiring 
evaluation or 
intervention. 
Suicidal ideation 
or suicide 
attempt while 
on study.  
Death 
Adapted from https://rsc.tech-res.com/docs/default-source/safety/daids-ae-grading-table-
mar2017.pdf?sfvrsn=6 
The Study Team Review Committee (STRC), listed above in Section 7.8, are responsible for 
systematically reviewing all new UEs on regularly scheduled conference calls. 
The Coordinating Center (CC) is responsible for presenting a cumulative report of all UEs 
reported in the ATN QNS for ATN 150.  All UEs will be reviewed within one week of occurence; 

 
 
 
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if the next scheduled STRC meeting is more than 7 days after a UE occurred, the team will 
convene a special meeting to address it.  
When an UE occurs at a research site, the STRC will invite the relevant Site PI to attend either 
the regular STRC meeting or a specially convened meeting.  During the STRC meeting the UE will 
be reviewed and the team will determine what actions are necessary. The Site PIs for Consent 
2.0 will not be standing members of the STRC. 
The CC will follow required reporting procedures and related timelines. RS must also follow the 
sIRB’s procedure for reporting these untoward events. For any events where it is learned that 
community members or RS members experience negative events associated with the study, the 
event will be reported to the STRC for review and determination of outcomes.   
9.2 
Reportable Events by Populations  
There are three types of untoward events to be identified: (1) those related to the participating 
adolescent or parent, (2) those related to the RS, (3) those related to the community.   
First, the study will catalogue any untoward event experienced by the participant that may be 
attributable to participation in or the conduct of the study. Reporting is required for 
occurrences including social harms and psychological distress, and serious life-threatening 
events such as suicide attempts. These may be immediately apparent to the RS, such as the 
participant’s emotional upset requiring referral for counseling; or they may be delayed and 
reported later to R, such as physical harm to a participant for having participated in the study.  
Second, RS may encounter untoward events during the conduct of this study that personally 
affect them. Training and guidance will seek to minimize this risk. Nonetheless, an assessment 
of the cost of conducting this study must include cataloguing these events as well. The Protocol 
Team should be notified of these events using the ATN QNS so that they may be immediately 
addressed, evaluated, and guidance modified or expanded to minimize similar risk to other 
staff.  
Third, the community may also be affected by an UE.  Examples of community level UEs include 
any adverse community feedback received by the research institution or team concerning the 
study and the study being portrayed adversely in any community forum or in the media. RS will 
also report any UEs that affect the community in the ATN QNS.  Both staff and community level 
untoward events do not receive a grade. 
10.0 
STATISTICAL AND ANALYTIC CONSIDERATIONS  
10.1 
Study Design 
This study will use a quasi-experimental design to explore how the informed consent process 
affects the acceptability of biomedical HIV prevention trials, from the perspective of 
behaviorally high-risk minor adolescents and the parents of minor adolescents.  
Adolescent participants will undergo a simulated consent process for each of two hypothetical 
studies based on their randomized consent condition. Hypothetical Study 1, modeled after ATN 
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is a Phase IIa trial of an injectable HIV integrase inhibitor. After completing the simulated 
consent process for the first hypothetical study, the adolescent will complete a CASI assessing 
the adolescents’ WTP and will work with RS to complete the UCSD Brief Assessment of Capacity 
to Consent (UBACC).28 The simulated consent process and follow-up assessments will then be 
completed for the second hypothetical study. The presentation order for the two hypothetical 
studies will be randomly determined (see Section 3.3 for more details on the randomization 
procedure). 
Parent participants will review all three consent conditions for each of the two hypothetical 
studies and complete a CASI assessing the acceptability of the three approaches to consent. The 
presentation order of the hypothetical studies and the review order for the consent conditions 
for each hypothetical study will be randomly determined (see Section 3.3. for more details on 
the randomization procedure).  
10.2 
Study Endpoints 
There are primary key endpoints for this study: 
1. Adolescent WTP scores (values 1 through 5) converted from a Likert scale (definitely not 
participate, probably not participate, might or might not participate, probably 
participate, definitely participate). Adolescent WTP scores are the measured adolescent 
response to the question: “If offered the chance, how likely would you be to participate 
in the first/second study?” 
2. Parental WTS scores are the measured parent response to three vignettes. Parents are 
asked the same vignettes after listening to Study 1 and Study 2. The vignettes and study 
orders are varied.  
a. Vignette 1 states: “Imagine your teen wants to join the study we just described. 
Your teen asks you to come to the research clinic with them. You are given 
information about the study, and have the opportunity to ask any questions you 
want to ask. After your questions are answered, you are asked to give your 
permission for your teen to join the study.  In this approach to consent, you have 
the final say about whether your teen can join the study. How acceptable is this 
approach to research consent?”  
b. Vignette 2 states: “Imagine your teen wants to join the study we just described. 
Your teen comes to the research clinic on their own. They read the consent form, 
and have an opportunity to ask questions. Your teen is required to have an 
adult’s permission to sign up for the study. They can choose to ask either you or 
a neutral adult, called an “ombudsman.” The ombudsman is not in charge of the 
study; the ombudsman’s job is to ensure your teen understands the research 
study, and to help your teen think about the risks and benefits of joining the 
study. Your teen would need either your permission OR the ombudsman's 
permission to join the study. In this approach to consent, your teen must have an 
adult's permission to join the study; your teen would be able to choose whether 
to seek permission from you or the ombudsman. How acceptable is this 
approach to research consent?” 

 
 
 
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c. Vignette 3 states: “Imagine your teen wants to join the study we just described. 
Your teen comes to the research clinic on their own. They read the consent form, 
and have an opportunity to ask questions. Once their questions are answered, 
your teen is ready to consent to the study. They are allowed to sign the consent 
form without speaking to anyone else about the decision. In this approach to 
consent, your teen is allowed to make the decision about joining the research 
study on their own. How acceptable is this approach to research consent?  
The vignette responses are based on a 5-point Likert scale with values ranging from ‘completely 
unacceptable’ to ‘completely acceptable.’ 
Of note, more comprehensive data are collected regarding parental WTS for the three consent 
conditions, including: (1) measures of the parent’s perception of his/her adolescent’s capacity 
to consent to the two studies in question and (2) a measure of the parent’s expectation that 
his/her teen would discuss the study prior to enrollment, even if such a discussion were not 
required. Since these measures are not applicable to all consent conditions, they were not used 
in the definition of the primary endpoint. 
10.3 
Sample Size and Power Estimates 
This study is powered to detect a meaningful difference in adolescent WTP scores and to detect 
a meaningful difference in parental WTS scores between the three consent conditions being 
studied. The WTP scores will be estimated as the mean score of three 5-point Likert scales. 
Based on the assumption that adolescent WTP scores are normally distributed and analyses 
using a linear regression model based on 120 participants (40 per consent condition) and with 7 
independent variables in the model will provide 80% power to detect a 0.09 f2 effect size, which 
is between a small (f2=0.02) and a medium effect size (f2=0.15), for consent conditions. This 
power calculation, which assumed a single observation per participant, is conservative and the 
actual study which will have two observations per participant (one for each simulated consent 
process) will have a larger statistical power to detect an f2=0.09 effect size for consent 
condition. Since the test of consent condition effects based on parental WTS scores is a within-
participant comparison rather than an across-participant comparison, a test of parental consent 
condition effects will have 80% power to detect an even smaller effect size (f2) compared to 
tests for consent condition effects using adolescent WTP scores. 
A subset of 24–32 (6–8 per study site) adolescents and 24–32 (6–8 per study site) parent 
participants will be selected to participate in the debriefing interview. Prior research with 
similar populations suggest that this sample size is sufficient for eliciting a variety of 
perspectives and establishing key themes in the data.  
10.4 
Statistical Analysis Plan 
10.4.1 Quantitative Data Analysis 
The primary analyses will estimate the effect of the three conditions and two hypothetical trial 
types on adolescent WTP scores and parent WTS scores. All analyses will be performed 
separately for adolescents and parents. The type I error rate will be set to α = 0.05 separately 
for adolescent-specific and parent-specific hypothesis tests. 

 
 
 
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Linear mixed models will be used to estimate the effect of the three consent conditions and 
two trial types on WTP and WTS scores, with a random participant effect (i.e. random intercept) 
to account for the potential correlation between the multiple responses per participant. Aside 
from consent condition and trial type effects, the LMMs will also include adolescent’s sex 
assigned at birth and study site as fixed effects.  
Heterogeneity of consent condition and trial type effects across study sites will be evaluated. If 
statistically significant interactions occur (p<0.05), site-specific estimates of effects will be 
presented to supplement the pre-planned analyses. P-values from pairwise comparisons of 
consent condition effects will be adjusted for multiple comparisons to control the type I error 
rate at the level α=0.05 separately for parents and adolescents. Tests of trial type effects will be 
performed at the level α=0.05 separately for adolescents and parents and separately from tests 
of consent condition effects. 
As a secondary sensitivity analysis, we will evaluate whether concern about HIV, family context 
(frequency of communication, connectedness), and other demographic and socioeconomic 
factors affect WTP/WTS participation in biomedical research. We will examine these effects by 
adding variables into the models to determine if they moderate the relationship between 
consent condition and WTP/WTS scores. 
Although WTS and WTP scores are discrete, it is common to analyze these data using linear 
models. Research suggests that this approach is robust to the discrete nature of the data if the 
normality assumption is not severely violated. However, usage of the LMM may be problematic 
if a large number of responses occur on the boundary (e.g. a high proportion of 1’s or 5’s). In 
this case we will fit a linear quantile mixed model for the median WTP and WTS scores, which 
does not require normality.34  
The primary endpoint analyses will be based on the observed data. By study design 
requirement, it will not be possible for sex assigned a birth to be missing and so no methods for 
missing covariates are needed for the primary analyses. If a key demographic or socioeconomic 
measures are missing in more than 5% of participants, the secondary sensitivity analyses 
described above will utilize multiple imputation by chained equations for those analyses.35 
The effect of the three conditions on the mean adolescent UBACC scores will be estimated 
using linear mixed-effect models (LMMs) that include a random participant effect (i.e. random 
intercept) to account for correlation between the multiple UBACC assessments per participant. 
Aside from consent condition and trial type effects, the LMMs will also include adolescent’s sex 
assigned at birth and study site as fixed effects.  
The effect of the trial type on the mean parent UBACC scores will be estimated using LMMs 
that includes a random participant effect (i.e. random intercept) to account for correlation 
between the multiple UBACC assessments per participant. Aside from trial type effects, the 
LMMs will also include adolescent’s sex assigned at birth and study site as fixed effects.  
Using the same strategy described in Section 6.1 (e.g., to evaluate how demographic factors 
affect WTP/WTS participation), we will perform analyses that evaluate the extent to which 
capacity to consent, as measured by the UBACC, influences WTP/WTS scores. 

 
 
 
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10.4.2 Qualitative Data Analysis  
Our analytic approach to the qualitative data collected during de-briefing interviews is 
qualitative description, as described by Sandelowski.36 Qualitative descriptive methods 
provide an in-depth description of experiences shared by a group facing a common 
challenge and are particularly useful for generating summaries of information to guide 
future interventions. The PI will analyze the transcripts using conventional content analysis 
techniques as described by Hsieh & Shannon.37 Each text unit (meaningful phrase, sentence, 
or story relevant to the study aims) will be extracted and coded with a short phrase that 
reflects its essence. A case-ordered meta-matrix38 will be constructed, with each row 
representing an individual and each column representing variables (from quantitative 
measures) and constructs (from the interviews) of interest. Separate matrices will be made 
for adolescents and parents, for ease of comparison. The research team will categorize all 
the codes in each column and provide a description of each category to describe the 
variable fully from the parents’ and YMSM perspective. For example, all the codes under 
barriers to parental involvement will be categorized to provide a list of barriers, and the 
barriers identified by each group will be compared to consider differences in the two groups’ 
perspectives. An example data matrix is shown in Table 4. 
Table 4: Sample qualitative data analysis matrix for adolescent participants 
Participant ID 
Demographic Data 
UBACC 
Qual Interview Constructs 
 
Age 
Gender Identity 
Education 
Living Situation 
Willingness to 
participate 
Relationship to 
parent 
Relationship to 
parent 
Willingness to 
involve a parent 
Barriers to parent 
involvement 
Facilitators of 
parent involvement 
Concerns about 
protocol 
NNNNNN 
 
 
 
 
 
 
 
 
 
 
 
NNNNNN 
 
 
 
 
 
 
 
 
 
 
 
NNNNNN 
 
 
 
 
 
 
 
 
 
 
 
10.5 
Missing, Unused and Spurious Data 
Every effort will be made to ensure that the amount of missing data is kept to a minimum as 
missing data complicates the statistical analyses or results in biased parameter estimates. The 
primary analyses will be based on the observed data. As a sensitivity analysis, to be performed 
if more than 5% of adolescent WTP scores and/or 5% of parental WTS scores are missing, we 
will perform a multiple imputation analyses using the method of chained equations39 to 
evaluate the impact of non-response on the primary analyses. By study design requirement, it 
will not be possible for sex assigned a birth to be missing in this study and so no methods for 
missing covariates are needed for the primary analyses. If a key demographic or socioeconomic 

 
 
 
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measure is missing in more than 5% of participants, the sensitivity analyses described in Section 
10.4.1 will utilize multiple imputation by chained equations.  
11.0 
HUMAN SUBJECTS 
This study will be conducted in compliance with the protocol, ICH Good Clinical Practice 
guidelines, and 45 CFR Part 46. 
11.1 
Participants’ Confidentiality 
Potentially identifying information is given in the screening form, and used for determining 
eligibility and scheduling the study visit. To be eligible, a screened participant cannot share a 
home with an enrolled participant. Thus, as stated in sections 4.3.1 and 4.3.2, participants will 
input the first 5 digits of their street address and first 4 characters of their apartment/unit, 
when applicable. For example, if someone lived at 1234 Main Street Apt. 408, the value for that 
address would be 01234408. The value will be labeled “Family ID” and stored only until the end 
of the enrollment period. Once the site has filled all quotas, the Family ID will be permanently 
deleted. 
For the purposes of scheduling, eligible participants will give their preferred name, nickname, 
or initials, which will allow RS to contact those who are unable to remain in clinic for a same day 
study visit.  
Participants who cannot attend the study visit on the day of screening will also need to provide 
contact information. The contact information will be linked to their ATN SID. Contact 
information and preferred name/nickname/initials will be entered and stored in the 
“Scheduling Log” until the the end of the enrollment period  
Data collected in all other questionnaires will be identified by a coded number only, to maintain 
participant confidentiality. All computer entry and networking programs will be done with 
coded numbers only.  Clinical information will not be released without written permission of 
the participant (and parent or legal guardian, when applicable), except as necessary for 
monitoring by the ATN CC or NICHD. 
11.2 
Certificate of Confidentiality 
To further protect the privacy of the study participants, the ATN has obtained a Certificate of 
Confidentiality from the U.S. Department of Health and Human Services (DHHS).  With this 
certificate in place, the ATN researchers cannot be forced to turn over identifying information 
about a study participant in any federal, state, or local criminal, administrative, legislative, or 
other proceedings.  This certificate does not prevent a study participant from volunteering to 
turn over their research information nor does it prevent researchers from providing research-
related information to others when requested by the study participant. 
11.3 
Risks and Benefits 
11.3.1 Risks 
Risks to participants in this research study may include: 

 
 
 
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Risk Category: Research not involving greater than minimal risk (45 CRF §46.404 and 21 CFR 
§50.51) 
Participation in this study poses no more harms or discomforts to research participants than 
they may experience in normal daily life, standard clinical practice, during routine physical or 
psychological examinations or tests. 
However, there are some risks of emotional discomfort or distress due to the personal nature 
of some questions asked in the CASI and debriefing interviews. Participants will be informed 
they are free to decline to answer any questions, or withdraw from participation at any time 
without penalty. Participants will be instructed to contact study personnel or to consult the list 
of referrals provided if feelings persist or worsen after several days. If the response indicates 
the participant is in urgent need of mental health assistance, RS should follow their individual 
site procedures for acute mental health referrals. RS should contact a supervisor immediately 
and stay with the study participant until the supervisor, mental health professional or 
emergency services, if needed, arrives. 
11.3.2 Benefits   
There are no individual benefits of participation; however, information from this study may 
benefit other youth, now or in the future, by understanding how to balance the risks of social 
harm due to participation against the risk of research-related harm.  
11.4 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, the informed consent documents and any subsequent modifications will be 
reviewed and approved by the IRB or ethics committee responsible for the oversight of the 
study. We will consent all participants verbally, as a signed consent form would be the only 
identifying information to link them to the study. We will use study information sheets in lieu of 
consent forms. The study information sheets describe the purpose of the study, the procedures 
to be followed, and the risks and benefits of participation. 
The study team is requesting the waiver of parental permission for minor participation based 
on 45 CFR 46.408, which provides that the IRB may waive parental permission under the same 
circumstances that it may waive individual consent, as described in 45 CFR 46.116 (d): (1) the 
research involves no more than minimal risk to participants; (2) the waiver or alteration will not 
adversely affect the rights and welfare of the participants; (3) the research could not practicably 
be carried out without the waiver or alteration; and (4) whenever appropriate, the participants 
will be provided with additional pertinent information after participation. This research clearly 
meets requirements 1 & 2. 
Assent of the children involved in this study will be sought in accordance with the regulations at 
45 CFR §46.408(a) or 21 CFR §50.55 and local IRB/EC-approved policies and procedures. 
11.5 
Waiver of the Requirement for Parental Permission for Special Circumstances  
The IRB of record will be requested to grant waiver of parental permission to participate in this 
research study for youth participants under the age of 18.   

 
 
 
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Under 45 CFR 46.408 (c), an IRB has the authority to waive parental permission if it determines 
that “a research protocol is designed for conditions or a subject population for which parental 
or guardian permission is not a reasonable requirement to protect the subjects” and “an 
appropriate mechanism for protecting the children who will participate as research subjects is 
substituted” and “that the waiver is not inconsistent with Federal, State, or local law.” 
The protocol team would submit that this study is not considered greater than minimal risk. 
None of the content of this study is beyond what would be covered during routine medical or 
psychological visits.  The probability of harm from participating in this study is no greater than 
that occurring in routine care. 
The ATN sites involved in the study and most other community agencies offering HIV-related 
services are confidential and do not require parental/legal guardian notification or permission 
to treat under state regulations. 
Contacting a parent/legal guardian could constitute a breach of confidentiality for these 
adolescents, as the study eligibility criteria indicate the adolescent is engaged in high-risk sexual 
activity of which his/her parent may not be aware. We do not wish to expose adolescent 
participants to the risk of social harm due to breach of confidentiality regarding their behavior 
and/or gender identity and/or sexual orientation.  
11.6 
Waiver of the Requirement for Signed Consent Form  
We propose using a verbal consent process for study participation.  The study information 
sheets describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. 
The study presents minimal risk to participants and involves no procedures that would require 
written consent outside of a research context.  Under these conditions the IRB is authorized to 
modify the requirements for documented consent, or waive consent altogether (45 CFR 46.117 
[c]).  
11.6.1  For Study Participation 
Street address, name, and contact information will be removed at the end of study enrollment, 
thus, a signed consent form would be the only permanent link between participants’ identities 
and the study.  In order to maintain the anonymity of the survey and fully protect the privacy of 
the volunteer study participants, the IRB will be requested to waive the requirement for a 
record of a signed consent form. A study information sheet (contains all elements of informed 
consent) will be reviewed with each potential study participant and provided to each 
participant who enrolls in the study. This form describes the purpose of the study, the 
procedures to be followed, and the risks and benefits of participation.  
Under 45 CFR §46.117 (c) (1) and (2), an IRB may waive the requirement for the investigator to 
obtain a singed informed consent for some or all of the subjects if it finds either:  (1) That the 
only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each 
participant will be asked whether he/she wants documentation linking him/her with the 
research, and the participant’s wishes will govern; or (2) that the research presents no more 

 
 
 
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than minimal risk of harm to the participants and involve no procedures for which written 
consent is normally required outside the research context.” 
The protocol team believes that both #1 and #2 applies to this study and, both combined, 
justify waiver of written consent.   
11.7 
45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health 
Information ("Privacy Rule" Pursuant to the Health Insurance Portability and 
Accountability Act - HIPAA) 
The IRB will serve as the privacy board and will be asked to grant a waiver of HIPAA 
authorization for the study.  
11.8 
Study Discontinuation 
This study may be discontinued at any time by the NICHD.  
12.0 
PUBLICATION OF RESEARCH FINDINGS 
NICHD and ATN policies will govern publication of the results of this study. Publication of the 
results of this trial will be governed by ATN Publications Policy, which will be established the 
Publications Committee. Any presentation, abstract or manuscript will be made available for 
review by the Publications Committee prior to submission. 
 

 
 
 
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13.0 
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APPENDIX I 
Schedule of Evaluations 
 
Evaluation (Procedure) 
Screening 
Day 0 
Pre-Entry 
Day 1-3 
Entry 
Day XX 
Determine eligibility and collect contact information using 
the web-based screening tool 
X 
 
 
Contact eligible adolescents/parents to schedule their visit 
 
X 
 
Participant consents to participate in the study 
 
 
X 
The participant will complete the demographic, social, and 
attitudinal measures by audio computer-assisted self-
interview (CASI). 
 
 
X 
Participant will undergo a simulated consent process for 
hypothetical Study 1, modeled after ATN 113, is an open-
label study of oral TDF-FTC. 
 
 
X 
Participant will complete the WTP/WTS scale(s) via CASI 
 
 
X 
The RS will administer the UCSD Brief Assessment of 
Capacity to Consent (UBACC) for hypothetical Study 1. 
 
 
X 
Participant will undergo a simulated consent process for 
hypothetical Study 2, modeled after HPTN 077, a Phase IIa 
trial of oral + injectable cabotegravir. 
 
 
X 
Participant will complete the WTP/WTS scale(s) via CASI 
 
 
X 
The RS will administer the UCSD Brief Assessment of 
Capacity to Consent (UBACC) for hypothetical Study 2. 
 
 
X 
Willing participants will participate in a debriefing interview, 
which will begin immediately after their 2nd UBACC. 
 
 
X