Clinical trial NCT02985996
Conditions: HIV Infections
Keywords: Preventative Medicine Infectious Diseases Sexually Transmitted Diseases
Sponsor: Emory University
Start date: 2017-02-06; Completion date: 2017-11-29
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.

Detailed description:
Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to prevent HIV infection. However, current tenofovir- based regimens have shown to have side effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study is designed to examine the ability of these new agents to penetrate mucosal tissues and potentially prevent HIV infection during RAI exposure for MSM and TGW.

Arms: arm 1: Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. arm 2: Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. arm 3: Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. arm 4: Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. arm 5: Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
Interventions: intervention 1: Truvada intervention 2: Genvoya
Intervention descriptions: intervention 1: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet. intervention 2: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.

Protocol documents:
Prot_000.pdf: 
Unique Protocol ID: IRB00092488 
NCT02985996 
 
Truvada® vs. Genvoya® 
 
Principal Investigator Colleen F. Kelley MD, MPH 
 
04/21/2017 
 
 
 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
Emory IRB00077593 
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH 
 
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TITLE OF PROJECT: Truvada® vs. Genvoya® 
Investigators: 
 
Colleen F. Kelley MD, MPH 
Assistant Professor of Medicine 
Division of Infectious Diseases 
Department of Medicine 
Emory School of Medicine 
Assistant Professor of Epidemiology 
Rollins School of Public Health 
 
Sheila Heeke, FNP 
Co-Investigator 
The Hope Clinic 
Division of Infectious Diseases 
Department of Medicine 
Emory School of Medicine  
LaShonda Hall, MPH 
Project Coordinator 
The Hope Clinic 
Division of Infectious Diseases 
Department of Medicine 
Emory School of Medicine 
 
Nicole Pescatore 
Project Coordinator 
The Hope Clinic 
Division of Infectious Diseases 
Department of Medicine 
Emory School of Medicine 
 
Recruiters: 
 
Rameses Frederick 
Project Coordinator 
The Hope Clinic 
Division of Infectious Diseases 
Department of Medicine 
Emory School of Medicine 
 
 
 
 


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ABSTRACT 
 
Rationale:  Men who have sex with men (MSM) continue to be disproportionately 
affected by HIV. The majority of HIV infections among MSM occur through exposure to 
the rectal mucosa during receptive anal intercourse (RAI). To aid in prevention, a new 
HIV prevention intervention, called pre-exposure prophylaxis (PrEP), recommends that 
MSM at risk of HIV infection take a daily anti-HIV medication called Truvada® 
(tenofovir/emtricitabine) which is shown to be highly effective. However, current 
tenofovir- based regimens have shown to cause different side effects while taken.  To 
reduce these side effects, new formulations of anti-HIV agents are being developed, but 
the ability of these new agents to penetrate mucosal tissues and prevent HIV infection 
at sites of virus exposure is unclear.    
 
Design: To address the efficacy of the new formulated anti-HIV agents and their ability 
to penetrate the mucosal tissues in MSM, investigators at Emory University will 
collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a 
randomized clinical trial of 90 MSM. Men will be randomized into a 2-arm study (forty- 
five men assigned to each arm) as follows: (Arm 1) daily oral Truvanda® or (Arm 2) daily 
oral Genvoya®. Each study arm includes 3 phases: (1) pre-drug, (2) short-course, and 
(3) steady state. For phase I, there will be 5 men assigned to both arm 1 and arm 2. 
Phases II and III will each have 20 men assigned to both arms. The study will entail 2 
study visits for phase I, 3 study visits for phase II, and 4 study visits for phase III at the 
Emory University Hope Clinic. During phase I: visit 1, all men will be screened for 
eligibility and undergo written informed consent, physical examination, rapid HIV testing, 
phlebotomy for screening laboratories, and randomization. During study visit 2 (time 1-6 
weeks after study visit 1), participant returns and a urethral swab, 2 pre- wet penile 
swabs, and a urine sample will be collected. Participant will then undergo a rectal 
biopsy via rigid sigmoidoscopy for establishment of baseline values. During phase II: 
study visit 1, men will be screened for eligibility and undergo written informed consent, 
physical examination, rapid HIV testing, phlebotomy (will collect 4 tablespoons) for 
screening laboratories, and randomization. During study visit 2 (time 1-6 weeks after 
study visit 1), men will be dispensed and instructed to take either one dose of Truvada® 
or Genvoya®. After 4 to 6 hours after dosing, a urethral swab, 2 pre- wet penile swabs, 4 
tablespoons of blood, and a urine sample will be collected. During study visit 3 (time 24 
hours after drug dosing), men will return after 24 hours of study product use for repeat 
phlebotomy, urethral and penile swabs, collection of urine and rectal secretions, and 
rectal biopsy via rigid sigmoidoscopy. For phase III: visit 1,  
 
 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
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men will be screened for eligibility and will undergo the informed consent process.  
Once informed consent is signed, a physical examination will be performed, rapid HIV 
testing, phlebotomy for screening labs, and randomization will occur. During study visit 
2 (time 1-6 weeks after study visit 1), men will be dispensed and instructed to take 
either Truvada® or Genvoya® for 10 days. After 3 to 5 consecutive days of dosing, 
participants will return for visit 3 where a urethral and penile swabs specimen, blood 
work, and a urine specimens will be obtained. During study visit 4 (time 10 days of 
consecutive drug dosing), men will return for repeat phlebotomy, urethral and penile 
swabs, collection of urine and rectal secretions, and rectal biopsy.  After collection, 
biologic specimens will be immediately transported by courier to CDC (laboratory of 
Clyde Hart) for processing. Specimens will be processed immediately for ex vivo 
laboratory assays that will include Truvada® and/or Genvoya® drug concentrations, 
inflammatory cytokine levels, HIV target cell measurement and characterization by flow 
cytometry, and in vitro HIV infection assays. Comparison of assay results between the 2 
study arms will help in determining the ability of the new formulated anti-HIV drug to 
penetrate different body compartments at the site of possible HIV exposure.   
 Participants may participate in more than one phase; however, at least 8 weeks must 
lapse after completion of 1 study phase before entry into another. Men who participate 
in more than one phase will not be consented again and do not have to repeat the 
screening visit (visit 1) when starting another phase; they will begin the new phase at 
visit 2. 
Duration: The duration of this study is 3 years. Participants will be considered ‘on-study’ 
for no more than 12 weeks.   
 
Sample size: For this protocol we will recruit 90 HIV-negative MSM or transgender 
women who are not taking hormone therapy who meet eligibility criteria outlined in the 
protocol.   
 
Population:  The population to be studied in this protocol is HIV negative MSM and 
transgender women who are not taking hormone therapy, who meet eligibility criteria, 
and are willing to perform study procedures. Participants will be recruited from existing 
databases at Hope Clinic and the Rollins School of Public Health who have agreed to 
be contacted for future studies, from community recruitment events conducted by the 
Hope Clinic, and from internet and paper advertisements currently used routinely by the 
Hope Clinic for study recruitment. 
 
LAY SUMMARY 
 
Men who have sex with men (MSM) and Transgender women (TGW) who have sex 
with men continue to be disproportionately affected by HIV. Over 60% of new HIV 
infections in the US occur among MSM. The majority of HIV infections among MSM and 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
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TGW occur through exposure to the rectal mucosa during receptive anal intercourse 
(RAI).  Pre-exposure prophylaxis (PrEP) is a new HIV prevention method that is 
recommended by CDC and WHO for MSM at risk of HIV infection.  PrEP entails taking 
an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to prevent 
HIV infection. However, current tenofovir- based regimens have shown to have side 
effects that researchers are hoping to reduce in newly developed anti-HIV agents. This 
study is designed to examine the ability of these new agents to penetrate mucosal 
tissues and potentially prevent HIV infection during RAI exposure for MSM and TGW.   
 
For this protocol, we will recruit HIV-negative MSM and TGW who are not on hormone 
therapy aged 18-49 and who are willing to adhere to study procedures. There will be 3 
phases, with 2 study visits for phase I, 3 study visits for phase II, and 4 study visits for 
phase III that will be conducted over a maximum period of 12 weeks. Participants are 
allowed to participate in more than one phase if a recovery or washout period occurs 8 
weeks in between each phase. The first visit for all phases (phase I, phase II, and 
phase III) will be a screening visit where eligibility is determined, written informed 
consent is obtained, screening tests are performed, and men will be randomized to one 
of two study groups: 1. Use of oral Truvada®; or 2. Use of oral Genvoya®. During the 
second study visit (visit 2), men in phase I will not receive product, but will come in for 
blood work, urine sample, 2 pre-wet penile swabs, urethral swab, rectal swab, and 
rectal biopsy sampling. Participants who are in phase II will receive a single dose of the 
study product during visit 2, 1-6 weeks after the screening visit. MSM will return 4 to 6 
hours after taking the drug for a urine sample. We will then collect 4 tablespoons of 
blood from the participants arm, in addition to, 2 pre-wet penile swabs, and a urethral 
swab. The third study visit will occur 24 hours from dosing time for MSM in phase II. 
Men will undergo a blood draw, urine sample, penile, urethral, and rectal swab, and rigid 
sigmoidoscopy for collection of rectal secretions and biopsies. Participants in phase III 
at study visit 2 will receive a 10-day supply of the study drug and will be instructed to 
take it for 10 consecutive days. For visit 3 in phase III, participants will return for a blood 
draw, urine collection, 2 pre-wet penile swabs, and a urethral swab to examine drug 
levels after 3-5 days of taking study drug.  They will then return 10 days from dosage for 
visit 4, where blood, urine, penile, urethral, and rectal swabs will be collected, and rectal 
biopsy sampling will occur.  All specimens will be transported directly to the laboratory 
of Clyde Hart, PhD at CDC where multiple immune assays are planned to determine the 
ability of these agents to penetrate mucosal tissues and potentially prevent HIV infection 
during RAI exposure. 
 
PROJECT DESCRIPTION 
 
Public Health Relevance: Information about new anti-HIV agents and how they 
penetrate through mucosal tissues will better inform scientists about the potential of new 
agents to be used for pre-exposure prophylaxis (PrEP).  
 
Goal: To compare the body compartment pharmacokinetics and mucosal inflammatory 
effects of Truvada® vs. Genvoya®.   


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STUDY POPULATION  
 A total of 90 HIV-negative MSM aged 18-49 will be recruited from existing Emory 
University study databases of MSM who have agreed to future contact about research 
opportunities. We will also recruit men from community engagements events conducted 
by Hope Clinic recruiters, from print and on-line advertisements, and from social media 
advertisements. Research recruiters at the Hope Clinic and the Rollins School of Public 
Health are experienced in recruiting this population for research studies, including those 
with rectal biopsies, and do not anticipate problems. Dr. Kelley is has conducted 2 
similar studies before and does not anticipate any problems with recruiting the target 
population. Based on our previous studies, we expect approximately 20% of men will 
not complete all study visits, therefore the sample size of 90 men will likely result in 
study completion for 72 men.   
 
 
INCLUSION CRITERIA FOR MSM 
 
1) HIV-negative man who reports receptive anal sex with another man in the last 6 
months  
2) Male to female transgender women who have sex with men who report receptive 
anal intercourse with another man in the last 6 months and are not currently 
taking hormonal therapy or plan to take hormonal therapy for the duration of the 
study 
3) Aged 18-49 years 
4) Not currently taking PrEP and no plans to initiate during study 
5) Able to provide informed consent in English  
6) No plans for relocation in the next 3 months 
7) Willing to undergo peripheral blood and rectal biopsy sampling 
8) Willing to use study products as directed 
9) Willing to abstain from receptive anal intercourse 3 days prior to starting study 
product and for the duration of the study and for 7 days after any rectal biopsy 
procedure.   
 
 
EXCLUSION CRITERIA 
 
1) History of inflammatory bowel disease or other inflammatory, infiltrative, 
infectious or vascular condition involving the lower gastrointestinal tract that, in 
the judgment of the investigators, may be worsened by study procedures or may 
significantly distort the anatomy of the distal large bowel 
2) Significant laboratory abnormalities at baseline visit, including but not limited to:  
a) Hgb ≤ 10 g/dL 
b) PTT > 1.5x ULN or INR > 1.5x ULN 
c) Platelet count <100,000 
d) Creatinine clearance <60 


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3) Any known medical condition that, in the judgment of the investigators, increases 
the risk of local or systemic complications of endoscopic procedures or pelvic 
examination, including but not limited to:  
a) Uncontrolled or severe cardiac arrhythmia 
b) Recent major abdominal, cardiothoracic, or neurological surgery 
c) History of uncontrolled bleeding diathesis 
d) History of colonic, rectal, or vaginal perforation, fistula, or malignancy 
e) History or evidence on clinical examination of ulcerative, suppurative, or 
proliferative lesions of the anorectal or vaginal mucosa, or untreated 
sexually transmitted disease with mucosal involvement   
4) Continued need for, or use during the 14 days prior to enrollment, of the following 
medications:  
a) Aspirin or more than 4 doses of NSAIDs 
b) Warfarin, heparin (low-molecular weight or unfractionated), platelet 
aggregation inhibitors, or fibrinolytic agents 
c) Any form of rectally administered agent besides products lubricants or 
douching used for sexual intercourse 
5) Continued need for, or use during the 90 days prior to enrollment, of the following 
medications:  
a) Systemic immunomodulatory agents 
b) Supraphysiologic doses of steroids 
c) Experimental medications, vaccines, or biologicals 
 
6) Intent to use HIV antiretroviral pre-exposure prophylaxis (PrEP) during the study, 
outside of the study procedures  
7) Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, 
discharge, bleeding, etc.) 
8) Current use of hormonal therapy 
9) Any other clinical condition or prior therapy that, in the opinion of the investigator, 
would make the patient unsuitable for the study or unable to comply with the 
study requirements. 
 
 
 
PROCEDURES 
 
Recruitment procedures 
We will recruit subjects for this protocol from existing Emory University databases of 
MSM who have consented to be re-contacted for future research opportunities (see 
below).  We will also recruit men with print, on-line, and social media advertisements 
(e.g. Facebook, Instagram, Craigslist, Grindr, etc.)  as have been utilized for other 
studies conducted by the Emory investigative team. Volunteers may be engaged 
directly on social media or dating sites to assess interest in research participation.  We 
will seek permission from creator/ moderator of the private website/ group, etc. before 
entering and interaction. Participants will also be recruited at community engagement 
events held by Hope Clinic recruiters (e.g. Pride celebrations, bars or businesses 


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catering to MSM). We will submit all print and online advertisement copies to the Emory 
IRB for approval prior to launching these activities. Also, all recruiters will use 1 of 2 
generalized scripts to introduce the study when approaching potential participants (see 
below). 
 
Scripts used for in person contact: 
 
Script A. 
“Hello, 
My name is ________, I am a recruiter for the Hope Clinic at Emory 
University.  We are currently seeking volunteers to participate in one of 
our HIV prevention research studies.  If you have a moment, would you be 
interested in hearing more?  If not, maybe you would like to leave us your 
contact information to speak at another time or take one of our flyers for 
future reference, thank you for your time.  Enjoy your day” 
If contact responds affirmatively, then their contact information will be 
collected for a screening phone call (see phone screen script).   
If contact responds negatively or does not responds, no further contact will 
be attempted.   
Or  
B. 
“We are here from the Emory University Hope Clinic. We would like to talk 
to you about volunteering in HIV prevention studies. There are several 
studies that you may be eligible for [give brief description of current 
studies]. If you would like further information, either myself or a recruiter 
can give you a call at a time that’s convenient for you. Can I take your 
name and number?  Thanks for your time” 
If contact responds affirmatively, then their contact information will be 
collected for a screening phone call (see phone screen script).   
If contact responds negatively or does not responds, no further contact will 
be attempted.   
 
  
 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
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1) The Hope Clinic at Emory University maintains a large study database of 
research participants that have agreed to be re-contacted for future research 
studies.  Due to the nature of ongoing studies at the Hope Clinic, a large 
proportion of these participants are MSM. Men will be contacted by phone or 
email and screened by phone with the eligibility criteria for this protocol. (Please 
see below for scripts used by recruiters when engaging by phone and/or email).    
Men who are eligible will be scheduled for a screening visit.   
 
Script used by recruiters when engaging by phone (phone calls and SMS): 
  
Phone 
Participants who are called will be greeted by the study staff. “Hello, my 
name is [        ]. I am calling from Hope Clinic…” Staff will refer to Oral 
Consent and Pre-Screener. 
SMS 
Script A. 
Hello, I am a recruiter for research studies at the Emory University Hope 
Clinic. We are currently looking for volunteers to participate in one or more 
of our HIV prevention research studies. Would you be interested in 
learning more? 
Thank you, 
__Insert Name and contact details here___ 
If contact responds affirmatively, then their contact information will be 
collected for a screening phone call (see phone screen script).   
If contact responds negatively or does not responds, no further contact will 
be attempted.   
Script B. 
Hello, I am a recruiter for research studies at the Emory University Hope 
Clinic. We are currently looking for volunteers to participate our HIV 
prevention research studies. All enrolled volunteers will be compensated 
for their time, travel, and inconvenience. Would you be interested in 
learning more? 
Thank you, 
__Insert Name and contact details here___ 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
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If contact responds affirmatively, then their contact information will be 
collected for a screening phone call (see phone screen script).   
If contact responds negatively or does not responds, no further contact will 
be attempted.   
or Script C. 
Hello, I am a recruiter for research studies at the Emory University Hope 
Clinic. We are currently looking for volunteers to participate in one of our 
HIV prevention research studies. All enrolled volunteers will be 
compensated for their time, travel, and inconvenience.  To learn more, 
please visit www.hopeclinic.emory.edu/studies/enrolling-studies.html or 
call 877-288-0048.  
Thank you, 
__Insert Name here___ 
If contact responds affirmatively, then their contact information will be 
collected for a screening phone call (see phone screen script).   
If contact responds negatively or does not responds, no further contact will 
be attempted.   
 
Script used by recruiters when engaging by email: 
 
Hello my name is [         ] and I am from Emory University Hope Clinic. We 
are currently looking to enroll participants into a new study at the Emory 
University Hope Clinic.  This study aims to determine the efficiency of new 
anti-HIV agents to prevent HIV infection in men who have sex with 
men and transgender women who have sex with men. Study visits range 
from three to four visits, and you will be compensated for your time of 
travel and inconvenience. If you or anyone you know may be interested or 
have any questions about this study, please contact Nicole Pescatore 
(npescat@emory.edu) or LaShonda Hall (lashonda.l.hall@emory.edu). 
These are the basic qualifications to participate in the study: 
1) HIV-negative men ages 18-49 years.  


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2) Engaged in receptive anal intercourse (bottomed) in the last 6 months.  
3) Not currently taking PrEP and no current plans to initiate.  
4) Willing to undergo peripheral blood draws, urethral swabs, and a rectal 
biopsy procedure over 
  a 1 week to 3 month period. 
 
 
 
   
2) PRISM Health (research group in the Rollins School of Public health, Dr. Kelley 
is a member of this group) maintains large study databases of MSM who have 
participated in previous research studies and have consented for future contact. 
Men will be contacted by phone or email and screened by phone with the 
eligibility criteria for this protocol (refer to number 1 under recruitment for phone 
and email script used by recruiters).  Men who are eligible will be scheduled for a 
screening visit.   
 
 
Study visits 
 
There are 3 phases for each study arm (Phase I Pre- drug, Phase II Short- course, and 
Phase III Steady state). 
 
Visit 1  
 
Phase I, II, and III 
 
During the screening visit, eligible MSM will provide written informed consent after all 
their questions are answered in a private exam room at the Hope Clinic. Subjects will 
also receive an approved HIPAA statement and will be informed about the way their 
protected health information will be used and stored. Copies of the consent/HIPAA form 
for this project will not be placed in individuals’ medical records since this study collects 
sensitive information such as HIV status and sexual orientation.   
 
After provision of informed consent, a medical history and physical examination will be 
conducted by the PI to evaluate for exclusion criteria. A rapid HIV test with finger stick 
whole blood (Determine or other CLIA waved product) will be performed by the PI or 
study coordinator who will be certified in HIV counseling and testing to confirm eligibility.  
Peripheral blood will be drawn for a complete blood count, creatinine, and coagulation 
tests.  
 
Visit 2 


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Participants will be randomized to one of two study arms: 
 
Arm 1. Use of Truvada® 
 
Arm 2. Use of Genvoya® 
 
 
Phase I 
 
10 participants (5 in each study arm) will be enrolled in study phase 1. 
 
Study visit 2 will occur 1-6 weeks after the screening visit. During visit 2, we will draw 4 
tablespoons of blood from the participants arm. A urine sample as well as penile and 
urethral swabs will be collected from participants. These samples will be used at CDC to 
develop an assay to detect Truvada® and Genvoya® in the body compartments. All 
specimens will be coded with a unique numeric identifier such that the CDC laboratories 
that receive the specimens will be unable to link them back to the study participants.  
Finally, rigid sigmoidoscopy (described further below) will be performed and, rectal 
secretions will be collected with Dacron swabs, and 8-12 rectal biopsies will be 
collected. A rectal swab will be collected for testing for gonorrhea and chlamydia to be 
performed by CDC.  If positive for gonorrhea or chlamydia, men will be referred for care 
at their private physician’s office, the health department, or AID Atlanta for treatment. All 
men will be instructed to place nothing in the rectum and to abstain from sex for 7 days 
after the procedure to allow the mucosa to heal.   
 
 
Phase II 
 
40 participants (20 in each study arm) will be enrolled in study phase 2.   
 
Study visit 2 will occur 1-6 weeks after the screening visit. During visit 2, the study group 
assignment will be reviewed and participants will be provided with a single dose of 
Truvada® or Genvoya®. Drug will be dispensed through the Emory Investigational Drug 
Service. Depending on the study arm they were assigned to, MSM will be dispensed 1 
day of Truvada® or Genvoya® and instructed on dosing for that day. Four to six hours 
after the drug is taken, a urine sample, 4 tablespoons of blood will be drawn from the 
participants arm, as well as, penile and urethral swabs will be collected from 
participants. These sample will be used at CDC to develop an assay to detect Truvada® 
and Genvoya® in the body. All specimens will be coded with a unique numeric identifier 
such that the CDC laboratories that receive the specimens will be unable to link them 
back to the study participants. Participants will be requested to abstain from receptive 
anal intercourse 3 days prior to study visit 2 and while taking study product. 
 
 


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Phase III 
 
40 participants (20 in each study arm) will be enrolled in study phase 2.   
 
Study visit 2 will occur 1-6 weeks after the screening visit. During visit 2, the study group 
assignment will be reviewed and participants will be provided with a 10 day supply of 
Truvada® or Genvoya®. Drug will be dispensed through the Emory Investigational Drug 
Service. Depending on the study arm they were assigned to, MSM will be dispensed 10 
days of Truvada® or Genvoya® and instructed on dosing for 10 consecutive days prior to 
their scheduled study visit 4. MSM will be requested to abstain from receptive anal 
intercourse while on study product. Participants will be scheduled to return for their third 
study visit after taking the study product for 3-5 consecutive days.  
 
Visit 3 
 
Phase II 
Study visit 3 will occur 24 hours after they received their study product during visit 2. 
During visit 3, we will draw 4 tablespoons of blood from the participants arm. A urine 
sample as well as penile and urethral swabs will be collected from participants. These 
samples will be used at CDC to develop an assay to detect Truvada® and Genvoya® in 
the body compartments. All specimens will be coded with a unique numeric identifier 
such that the CDC laboratories that receive the specimens will be unable to link them 
back to the study participants.  Finally, rigid sigmoidoscopy will be performed and, rectal 
secretions will be collected with Dacron swabs, and 8-12 rectal biopsies will be 
collected. A rectal swab will be collected for testing for gonorrhea and chlamydia to be 
performed by CDC.  If positive for gonorrhea or chlamydia, men will be referred for care 
at their private physician’s office, the health department, or AID Atlanta for treatment. All 
men will be instructed to place nothing in the rectum and to abstain from sex for 7 days 
after the procedure to allow the mucosa to heal.   
 
Phase III 
Study visit 3 will occur 3-5 days after they received their study product during visit 2. 
During this visit, we will collect a urine sample, 4 tablespoons of blood will be drawn 
from the participants arm, as well as, penile and urethral swabs will be collected from 
participants. These samples will be used at CDC to develop an assay to detect 
Truvada® and Genvoya® in the body. All specimens will be coded with a unique numeric 
identifier such that the CDC laboratories that receive the specimens will be unable to 
link them back to the study participants. MSM will be requested to abstain from 
receptive anal intercourse while on study product. Men will be scheduled to return for 
their fourth study visit after taking the product for 10 consecutive days. 
 
Visit 4 
 
Phase III 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
Emory IRB00077593 
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH 
 
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Study visit 4 will occur 10 days after daily dosing of the study product. During visit 4, we 
will draw 4 tablespoons of blood from the participants arm. A urine sample as well as 
penile and urethral swabs will be collected from participants. These sample will be used 
at CDC to develop an assay to detect Truvada® and Genvoya® in the body. All 
specimens will be coded with a unique numeric identifier such that the CDC laboratories 
that receive the specimens will be unable to link them back to the study participants.  
Finally, rigid sigmoidoscopy will be performed and, rectal secretions will be collected 
with Dacron swabs, and 8-12 rectal biopsies will be collected. A rectal swab will be 
collected for testing for gonorrhea and chlamydia.  If positive for gonorrhea or 
chlamydia, men will be referred for care at their private physician’s office, the health 
department, or AID Atlanta for treatment. All men will be instructed to place nothing in 
the rectum and to abstain from sex for 7 days after the procedure to allow the mucosa 
to heal.   
 
 
Contingency visit: 
 
Attempts to ensure adherence to the study visits will be made with telephone and/or 
email reminders to the participant.  However, if for example, screening laboratory results 
are lost or are inconclusive or if a participant has been unable to adhere to study 
protocol, he may be rescheduled for a future date where the above visit procedures will 
be performed.  These additional visits will be scheduled within the above visit windows.   
 
Phone calls/retention contacts: 
 
While on study, periodic phone calls, texts, or email reminders will occur between study 
staff and participants to ensure proper retention and adherence to study protocol.   
 
 
Rectal biopsy procedures 
 
Dr. Kelley or Sheila Heeke FNP will be performing all rectal biopsies utilizing a 
disposable rigid sigmoidoscope, light source, and jumbo biopsy forceps.  Dr. Kelley was 
trained in office based rectal biopsy procedures by Dr. Robin Rutherford, an 
experienced gastroenterologist at Emory University, and Dr. Kelley trained Ms. Heeke. 
All biopsy procedures will be performed in an examination room at the Hope Clinic with 
assistance from the project coordinator or clinical research nurse. Similar procedures 
have been performed by Dr. Kelley or Ms. Heeke >200 times for other research 
protocols with no complications. Briefly, without the administration of any previous 
enemas or other preparation, 8-12 adequate ~1.0 mm thick biopsy specimens will be 
taken from normal-appearing rectal mucosa 10 cm above the external anal aperture 
using a rigid sigmoidoscope and flexible sigmoidoscopic forceps mounted on a semi-
flexible rod.  All biopsy specimens will be coded with a unique numeric identifier such 
that the CDC laboratories that receive the specimens will be unable to link them back to 


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the study participants. Specimens will be transported directly to CDC after the study 
visit.   
Twenty-four to forty-eight hours after the procedure, study personnel will contact the 
subjects who donated rectal biopsy samples and inquire about symptoms, 
complications, or adverse events related to study procedures. Subjects who report 
symptoms suggestive of any significant complications will receive advice on seeking 
care, and will be given referrals to appropriate healthcare professionals as needed. This 
follow-up may be completed over the phone or through electronic communication. 


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Figure 1. Summary of study visits.  
Truvada
Arm 1
Pre-drug (n=5)
Phase I
Visit 1
Screening
Visit 2
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
Short-course (n=20)
Phase II
Visit 1
Screening
Visit 2
Recieve 1 dose of Truvada
4-6 hours post-drug
Urine, blood, penile swab, urethral 
swab
Visit 3
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
24 hours post-drug
Steady state (n=20)
Phase III
Visit 1
Screening
Visit 2
Receive 10 day supply of Truvada
Visit 3
Blood, urine, penile swab, urethral 
swab
3-5 days post-drug
Visit 4
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
10 days post-drug
Genvoya
Arm 2
Pre-drug (n=5)
Phase I
Visit 1
Screening
Visit 2
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
Short-course (n=20)
Phase II
Visit 1
Screening
Visit 2
Recieve 1 dose of Genvoya
4-6 hours post-drug
Urine, blood, penile swab, urethral 
swab
Visit 3
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
24 hours post-drug
Steady state (n=20)
Phase III
Visit 1
Screening
Visit 2
Receive 10 day supply of Genvoya
Visit 3
Blood, urine, penile swab, urethral 
swab
3-5 days post-drug
Visit 4
Blood, urine, penile swab, urethral 
swab, rectal swab, rectal biopsy
10 days post-drug


TITLE OF PROJECT: Truvada® vs. Genvoya® 
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RISKS AND HOW MINIMIZED 
 
HIV risk counseling 
 Participants that are tested for HIV to ensure eligibility will undergo HIV risk reduction 
counseling (e.g. increasing condom use, reducing number of partners, addressing substance 
abuse, etc.) by the study PI or study staff with provision of condoms and lubricant 
available freely at the Hope Clinic. HIV rapid testing will then be conducted with a CLIA 
waived product with finger-stick or whole blood from phlebotomy, depending on the test. Any 
participant who is found to be HIV positive on rapid testing will be referred for confirmatory 
testing to their local health department, AID Atlanta, or provider of their choice. We will also 
assist any HIV positive participant in accessing healthcare for HIV infection as needed. If a 
participant tests HIV positive prior to visit 2 or 3, they will be discontinued from the study and 
given the incentive for the contingency visit. 
 
Participants will also be educated about HIV pre-exposure prophylaxis during the study by the 
coordinator and/or study clinician. After completion of the study, all men who are interested in 
PrEP for HIV prevention will be linked to community services. A detailed listing of PrEP services 
available for insured and uninsured clients in Atlanta can be found at www.preplocator.org. Dr. 
Kelley is active in PrEP implementation in the Atlanta community and can facilitate these 
linkages.    
 
Blood sample collection 
The most common risks of blood sample collection are pain at the puncture site, 
bruising, and a feeling of lightheadedness. To minimize these risks, blood draws will be 
performed by trained personnel, and will be performed in a secure environment with 
access to first aid equipment, bandages, and trained healthcare professionals.  
 
 
Risks of Truvada® for PrEP 
 
Truvada® is a combination pill that contains the medications tenofovir and emtricitabine. 
In clinical trials of PrEP for MSM, the drug was well tolerated6.  Nausea was more 
common among participants taking the medication than among those taking placebo 
(9% vs. 5%).  There were no differences in severe or life-threatening adverse laboratory 
events between the active and placebo group.  Adverse events associated with 
tenofovir can include a transient decrease in renal function and slight decreases in bone 
mineral density.  Both of these effects occur with prolonged use of the medication and 
are not expected to occur with the limited 7-day dosing in this protocol.1  6 Nausea was 
more common among participants taking the medication than among those taking 
placebo (9% vs. 5%).  There were no differences in severe or life-threatening adverse 
laboratory events between the active and placebo group.  Adverse events associated 
with tenofovir can include a transient decrease in renal function and slight decreases in 
bone mineral density.  Both of these effects occur with prolonged use of the medication 
and are not expected to occur with the limited 7-day dosing in this protocol.   
 


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Risk of Genvoya® 
 
Genvoya® is a combination anti-HIV medication that contains the drugs tenofovir 
alafenamide, emtricitabine, elvitegravir, and cobicistat. Based on clinical trials previously 
conducted of Genvoya®, the drug showed to be well tolerated. According to participants, 
the most common side effect shown was nausea with diarrhea being the second most 
common side effect. Of those who reported this adverse event, 0.9% and 1.5 % 
discontinued treatment regardless of the severity. Adverse events associated with 
Genvoya® can include a transient decrease in renal function and slight decreases in 
bone mineral density. There is also a possibility of lactic acidosis, which can be hard to 
identify during early stages. These effects occur with prolonged use of the medication 
and are not expected to occur with the limited 10-day dosing in this protocol.7   In 
contrast to Truvada®, there have been no clinical trials of Genvoya® for HIV pre-
exposure prophylaxis.  However, similar concerns with acquisition of HIV infection and 
development of HIV drug resistance as discussed above also apply to Genvoya®. 
 
Genvoya® can also cause flare-ups in those who have hepatitis B virus.  It can cause 
the Hepatitis B virus to suddenly return in a worse form than before if treatment was 
provided. For this reason, it is important that participants not participate in the study if 
they are known to have Hepatitis B. Nonetheless, the maximum 10 day dosing regimen 
for this study is unlikely to cause flare-ups in Hepatitis B even if not diagnosed.    
 
 
Acquisition of HIV drug resistance is a theoretic concern for those taking Truvada® or 
Genvoya® for PrEP.   However, clinical trials of Truvada® for PrEP have shown this to 
be a very rare event except in those who were ‘acutely’ infected with HIV at the time of 
study enrollment.  In the iPrex study, there was no drug resistant virus detected in 100 
MSM who became infected after enrollment.  Of the ten men who were identified 
retrospectively to be acutely infected with HIV at enrollment, drug resistance was 
detected in 2/2 of men in the active drug arm and 1/8 of men in the placebo arm6.  For 
this protocol, we will test men for HIV at study entry and monitor clinically for high-risk 
behavior or any signs of acute HIV infection at study visits.  If high risk behavior (e.g. 
unprotected anal intercourse with a man of unknown HIV status) or symptoms of acute 
HIV infection are reported, and HIV antibody test will be repeated and the participant will 
be counseled about the need for any follow-up testing.  Clinical signs and symptoms of 
acute HIV infection that will be queried include: fever, fatigue, malaise, skin rash, 
swollen glands, oral/genital ulcers, myalgia/arthralgia1.  Dr. Kelley will review all reports 
of clinical signs/symptoms to determine appropriate follow-up and linkage to care as 
necessary.  If a diagnosis of acute HIV infection is thought to be possible or determined 
by repeat HIV testing, the participant will be discontinued from the study.6.  For this 
protocol, we will test men for HIV at study entry and monitor clinically for high-risk 
behavior or any signs of acute HIV infection at study visits.  
 
Men will be asked to abstain from receptive anal intercourse while using drug during the 
study protocol in order to limit additional exposures (e.g. semen, douching, additional 


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lubricants) to the rectal mucosa. Men taking Truvada® or Genvoya® will be counseled 
that they should not expect to achieve protection from HIV infection by taking drug 
during this study, as they will be provided a limited supply. All men included in the study 
that have an interest in taking PrEP for HIV prevention, will be referred to an area PrEP 
provider at the termination of the study. The Hope Clinic has compiled a resource sheet 
of area providers that will be distributed to interested participants.   
 
 
Rigid sigmoidoscopy and biopsies 
Risks associated with lower gastrointestinal endoscopy include colitis from chemicals 
for endoscope sterilization, bowel perforation, bleeding, diverticulitis, and infection. All 
procedures will be performed by Dr. Kelley or Ms. Heeke (FNP). Non-physician medical 
providers have performed endoscopic procedures for diagnostic and therapeutic 
procedures for years. Many of these require mastery of flexible sigmoidoscopes, 
detailed anatomy of the full colon, and familiarity with sedation procedures.889 
Procedures utilizing flexible instruments that access a deeper area of the colon and may 
or may not require sedation are more complicated and risky than the procedure detailed 
in this protocol which utilizes a rigid 8 and only accesses the sigmoid colon a maximum 
of 15 cm from the anal verge.  Therefore, it is appropriate for a trained, licensed mid-
level provider to perform the procedure. Dr. Kelley and Ms. Heeke have performed >200 
similar procedures for other IRB approved protocols with zero complications.   
 
All procedures will utilize disposable rigid sigmoidoscopes, forceps, and guides to 
reduce risk of infection and obviate the need for instrument sterilization between 
participants.  To minimize risks, rigid proctoscopy, rather than flexible sigmoidoscopy or 
full colonoscopy, will be used in this study and the number of biopsies taken will be 
limited to 12.  Colonoscopy has been shown to be associated with a still low, but 
significantly greater risk of complications than rectosigmoidoscopy10.  The frequency of 
serious complications after flexible sigmoidoscopy is extremely low and complications 
from rigid sigmoidoscopy are presumably even lower, but unknown.  In two large 
studies10,11 including a combined 144,832 clinically indicated procedures, the incidence 
of serious complications ranged from 0.06 to 0.8% utilizing flexible sigmoidoscopy. 
Obtaining biopsies may be associated with an increased risk of complications. The best 
available data on the risk of multiple biopsies comes from studies of dysplasia 
surveillance among patients with long-standing inflammatory bowel disease, in whom 
large numbers of “blind” biopsies are obtained throughout the colon for early detection 
of malignant transformation. In two such studies12,13 including a combined 3,011 
procedures and a median of eight13 and 17 biopsies12, respectively, there was only one 
serious complication, for an incidence of approximately 0.33%. More relevant to the 
present protocol, in a study of subjects undergoing endoscopic procedures exclusively 
for research purposes14, including 64 flexible sigmoidoscopies with a mean of 25 
biopsies obtained from the rectosigmoid, there were no major complications. Thirteen 
subjects experienced minor symptoms (self-limited bleeding and pain), which were not 
related to the number of biopsies. Thus, the risk of serious complications from the 
proposed study procedures, even with up to 12 biopsy specimens, is expected to be 
very low. 10 The frequency of serious complications after flexible sigmoidoscopy is 


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extremely low and complications from rigid sigmoidoscopy are presumably even lower, 
but unknown.  In two large studies including a combined 144,832 clinically indicated 
procedures, the incidence of serious complications ranged from 0.06 to 0.8% utilizing 
flexible sigmoidoscopy. Obtaining biopsies may be associated with an increased risk of 
complications. The best available data on the risk of multiple biopsies comes from 
studies of dysplasia surveillance among patients with long-standing inflammatory bowel 
disease, in whom large numbers of “blind” biopsies are obtained throughout the colon 
for early detection of malignant transformation. In two such studies including a 
combined 3,011 procedures and a median of eight and 17 biopsies, respectively, there 
was only one serious complication, for an incidence of approximately 0.33%. More 
relevant to the present protocol, in a study of subjects undergoing endoscopic 
procedures exclusively for research purposes, including 64 flexible sigmoidoscopies 
with a mean of 25 biopsies obtained from the rectosigmoid, there were no major 
complications. Thirteen subjects experienced minor symptoms (self-limited bleeding and 
pain), which were not related to the number of biopsies. Thus, the risk of serious 
complications from the proposed study procedures, even with up to 12 biopsy 
specimens, is expected to be very low.  
 
There is theoretical risk of increased acquisition of HIV or other infection if a study 
participant is exposed soon after the rectal biopsy procedure (i.e. while the mucosal 
surface is damaged).  Therefore, study subjects will be counseled not to engage in anal 
intercourse for 1 week after the procedure.  
 
Biologic samples will be coded with a unique identifier prior to processing and storage 
for immunologic assays.  Therefore, lab personnel will be unable to link specimens with 
participants.  Only the PI and designated co-investigators/study personnel will be able to 
access information to identify specimens of individual participants.   
 
 
 
BREECH OF CONFIDENTIALITY 
All measures will be taken to ensure information provided by participants is kept 
confidential.  Identifying paper information will be kept in a separate locked office and 
only accessible by the PI and study coordinator.  Electronic data will be stored on the 
Redcap server or the Emory School of Medicine HIPPAA compliant servers, which will 
be accessible to the PI and study coordinator only.  All study specimens will be labeled 
with a unique identifier prior to transport to CDC.  Identifying information will not be 
shared with laboratory collaborators at the CDC and they will be unable to link the study 
ID to any identifying information.  Any demographic data shared with CDC will also be 
stripped of HIPPAA identifiers prior to sharing.  In the event that confidentiality is 
accidentally breached, the event will be reported to Emory IRB officials who are then 
required to report to the IRB director and/or the IRB Chair any instances of which they 
are aware that involve a use or disclosure of information in violation of the confidentiality 
obligations set forth in the Confidentiality and Non-Disclosure Agreement, HIPAA 
Regulations or HIPAA Privacy and/or Security Policies.  The IRB Director and IRB Chair 


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shall, in turn, report the breach to the Emory University HIPAA Privacy Officer within the 
Office of Research Compliance.  The Emory IRB shall take such steps as are 
appropriate to mitigate any damage that may have been caused by the breach and to 
take corrective action as necessary in order to ensure that a similar breach does not 
occur in the future. 
 
BENEFITS 
Subjects will not derive direct benefit from this study.  
 
COST 
There is no cost to subjects to participate in this study. 
 
ALTERNATIVE 
The alternative to participating in this study is to decide not to participate. Subjects can 
withdraw their consent at any time. 
 
COMPENSATION 
All participants will be compensated for the time and inconvenience of study 
participation.   
 
For Phase I, study participants will be compensated $25 for visit 1 and $125 for visit 2. 
Participants who enter into Phase II will be compensated $25 for visit 1, $50 for visit 2, 
and $125 for visit 3. Participants in Phase III will receive $25 for visit 1 and $25 for visit 
2, $50 for visit 3, and $125 for visit 4.   
 
If a contingency visit is necessary, participants will be compensated $20 for the 
incomplete study visit and the above amount when the missed visit is completed.   
 
There is no charge for parking at the Hope Clinic. However, participants may be 
provided with a MARTA card if available.  
 
INCENTIVES 
In Phase II, there will be a 6 hr. time span (+/- 2 hrs.) between participant receiving drug 
and participant providing specimens (urine, penile, and urethral). As a retention method, 
study staff will provide participant with a $15 gift card to Walmart or Starbucks while 
they wait. 
 
 
PLAN FOR OBTAINING INFORMED CONSENT 
After being screened for eligibility by the PI or study coordinator, subjects will be 
informed about the study and asked to sign an Emory IRB approved informed consent. 
The consent form will describe the purpose of the study, the procedures to be followed, 
and the risks and benefits of participation. Subjects will be consented in a private exam 
room.  Subjects will be given time to read the consent, ask questions and consider the 
risks and/or benefits to participation in this research study prior to obtaining their 
signature. All subjects enrolled in the study will be given a copy of their signed and 


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dated informed consent document. This consenting process will be done by trained 
research staff at the Hope Clinic. All subjects will undergo HIV risk reduction counseling 
with provision of free condoms. Subjects who completed a previous phase will not be 
consented again at the start of the new phase. 
 
PROVISIONS FOR SUBJECTS FROM VULNERABLE POPULATIONS 
Non-English speaking subjects or illiterate subjects will not be eligible to participate in 
this study.   
 
PARTICIPATION OF WOMEN AND CHILDREN 
Because this is a study of MSM and TGW, cisgender women are not eligible.  Children 
18-21 will be eligible for this study.  It is especially important to include MSM aged 18-21 
as young MSM are at highest risk of HIV infection and research that may lead to better 
prevention interventions, including an HIV vaccine, are desperately needed for this 
group.  Children younger than 18 will not be eligible.    
 
SUBJECT PRIVACY AND DATA CONFIDENTIALITY 
 
All subjects will provide informed consent in a private room at the Hope Clinic. 
 
Case report forms (CRFs) will be provided for each subject to collect demographic, 
behavioral, clinical, and laboratory data at study entry, and additional clinical data at the 
study visit. These data will be collected from the screening clinical assessment, the 
study entry physical examination and screening laboratory tests, and rectal biopsy 
visits. Subjects will be identified by the participant identification number (PID), which will 
be provided by the study investigator upon registration.  All laboratory specimens, 
evaluation forms, reports, and other records that leave the site will be identified by 
coded number only to maintain subject confidentiality. All study samples will be kept in a 
secure area in a limited-access laboratory facility and only the research team will have 
access to the samples. The samples and data will be identified only by code numbers. 
 
Any identifiable records will be kept locked accessible only by authorized study 
personnel. Electronic data will be password protected and stored on the Redcap server 
or the Emory School of Medicine HIPPAA compliant server. Biologic samples will be 
coded with a unique identifier and no identifiable behavioral data will be shared with 
laboratory investigators at CDC.  Information about the subject’s participation will not be 
shared with individuals who are not directly involved with the research subjects.  Clinical 
information will not be released without written permission of the subject, except as 
necessary for monitoring by IRB, the FDA, the NIH, or the OHRP. Information about the 
subject’s participation will not be shared with individuals who are not directly involved 
with the research subjects or as identified in the HIPAA consent. 
 
PLANS FOR SUBJECTS AT THE END OF THE PROTOCOL 
Subjects will return to the standard of care at the end of the protocol.  Subjects who are 
interested in starting PrEP will be linked to care with a community provider.   
 


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CLINICAL SITE MONITORING AND RECORD AVAILABITLITY 
The Emory University IRB, the OHRP, FDA, or other government regulatory authorities 
may perform clinical site monitoring.  Clinical research sites monitoring may include the 
review of the individual participant records, including consent forms, CRFs, supporting 
data, laboratory specimen records, and medical records (physicians’ progress notes, 
nurses’ notes, individuals’ hospital charts) to ensure protection of study participants, 
compliance with the protocol, and accuracy and completeness of records.  The monitors 
may also inspect sites’ regulatory files to ensure that regulatory requirements are being 
followed. 
 
The investigators will make study documents (e.g., consent forms, CRFs) and pertinent 
hospital or clinic records readily available for inspection by the local IRB or the OHRP 
for confirmation of the study data. 
 
ADVERSE EVENT MONITORING AND REPORTING 
 
Adverse events (AEs) will be reported on an expedited basis at the standard level 
during the protocol-defined expedited adverse event (EAE) Reporting Period, which is 
the entire study duration for an individual subject (from study enrollment until study 
completion or discontinuation of the subject from study participation for any reason). 
AE Reporting 
 
Any AE that is reported to either the investigators or their designated research 
associates by a study subject or by medical staff caring for the subject and which meets 
the criteria will be documented.   
 
In addition, clinical investigators will monitor subjects for Serious adverse events (SAE) 
Unanticipated problems (UP) during each study visit. Any SAE that is judge related to 
study product or UP will be reported to the IRB within 5 days of the event.  The standard 
Emory IRB reporting guidelines for AE and SAE reporting, as documented at 
http://www.emory.edu/IRB/guidelines_adverse_event.php, will be followed.   
 
 
A SAE is an adverse drug experience that results in any of the following outcomes: 
1. Death. 
2. Life-threatening situation - The subject was at risk of death at the time of the 
adverse event/experience.  It does not refer to the hypothetical risk of death if the 
AE were more severe or were to progress. 
3. Inpatient hospitalization or prolongation of existing hospitalization. 
4. Persistent or significant disability/incapacity - Any AE having an outcome that is 
associated with a substantial disruption of the ability to carry out normal life 


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functions, including the ability to work.  This is not intended to include transient 
interruption of daily activities. 
5. Congenital anomaly/birth defects - Any structural abnormality in subject’s 
offspring that occurs after intrauterine exposure to treatment. 
6. Important medical events/experiences that may not result in death, be life-
threatening, or require hospitalization may be considered a serious adverse 
event/experience when, based upon appropriate medical judgment, they may 
jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed above, i.e., death, a life-threatening adverse 
event/experience, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect.  Examples of such medical events/experiences include 
allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
7. Spontaneous and elective abortions will be reported to the Emory IRB as serious 
adverse events.  
 
8.  Severity of AEs will be rated according to the following definitions: 
 
Mild: 
The adverse event is transient and easily tolerated 
by the subject. 
Moderate: 
The adverse event causes the subject discomfort 
and interrupts the subject’s normal activities. 
Severe: 
The adverse event causes considerable 
interference with the subject’s normal activities and 
may be incapacitating or life-threatening. 
 
The following definitions will be used to assess the relationship of the AE to study drugs 
or procedures: 
 
 
 
Probably Related: 
An adverse event has a strong temporal relationship to study drug or 
recurs on re-challenge, and another etiology is unlikely or significantly 
less likely. 


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Possibly Related: 
An adverse event has a strong temporal relationship to the study 
drug, and an alternative etiology is equally or less likely compared to 
the potential relationship to study drug. 
Probably Not 
Related: 
An adverse event has little or no temporal relationship to the study 
drug and/or a more likely alternative etiology exists. 
Not Related: 
An adverse event is due to an underlying or concurrent illness or 
effect of another drug and is not related to the study drug (e.g., has no 
temporal relationship to study drug or has much more likely alternative 
etiology). 
 
If the adverse event is in, the investigator’s opinion, possibly or probably related, or not 
related to study drug or procedures, then an alternate etiology will be provided by the 
investigator. 
It should however be noted that a severe adverse event /experience is not necessarily 
serious, as the term severe is a measure of intensity while a serious adverse event 
(SAE) is determined based on the aforementioned regulatory criteria. 
All AEs and laboratory abnormalities will be graded according to the Division of AIDS 
Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE 
Grading Table), Version 1.0, December 2004, which can be found on the DAIDS RCC 
Web site: http://rcc.tech-res.com/tox_tables.htm.   
DATA SAFETY MONITORING 
Summaries of adverse events (Grades 3 or 4), and targeted AEs across study groups 
as well as study conduct will be reviewed regularly (in real time and summarized 
quarterly) by study investigators. Any SAE that is judge related to study product or UP 
will be reported to the IRB within 5 days of the event.  The standard Emory IRB 
reporting guidelines for AE and SAE reporting, as documented at 
http://www.emory.edu/IRB/guidelines_adverse_event.php, will be followed.   
http://www.emory.edu/IRB/guidelines_adverse_event.php, will be followed.    
Additional safety monitoring will be performed annually by an independent Medical 
Safety Monitor.  Based on the 1 year accrual expectation for the study, it is anticipated 
that the study will undergo 2 reviews by the Medical Safety Monitor.  The first will occur 
approximately 6 months after the accrual of the first subject. The safety report will 
summarize AEs and SAEs by study group.  The DCC will work with the Medical Safety 
Monitor to complete a ‘final assessment’ following the review of each safety report.  As 
part of the final assessment the Medical Safety Monitor will conclude ‘the study can 
continue as no safety concerns have been identified at the time of the review’ or ‘the 


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study cannot continue as currently designed’.  The final assessment by the Medical 
Safety Monitor will be provided to the study PI who will make the findings available as 
appropriate to the Emory IRB and the NIH. 
STUDY DISCONTINUATION 
A study participant may elect to discontinue participation in the study at any time.  The 
study may be discontinued at any time by the IRB, the OHRP, or other government 
agencies as part of their duties to ensure that research subjects are protected. 
BIOHAZARD CONTAINMENT 
Blood-borne pathogens can occur through contact with contaminated needles, blood, 
and blood products. Appropriate blood and secretion precautions will be employed by all 
personnel in the drawing of blood and handling of all specimens for this study, as 
currently recommended by the Centers for Disease Control and Prevention and the 
National Institutes of Health. All infectious specimens will be transported using 
packaging mandated in the Code of Federal Regulations, 42 CFR Part 72. 
BIOSAFETY PLAN 
No specific biosafety plan is necessary for this protocol as all planned immunologic and 
genetic assays will fall under the existing biosafety protocols of the Hope Clinic and 
CDC.   
 
 
 
 
 
 
 
 
 
 
 
 
 


TITLE OF PROJECT: Truvada® vs. Genvoya® 
Emory IRB00077593 
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH 
 
Version 6 04/21/17 
27 
 
REFERENCES 
 
1. 
Service UPH. Pre-exposure Porphylaxis for the Prevention of HIV Infection in the 
United States-2014: A Clincal Practice Guideline. 2014. 
2. 
Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-
the-counter personal lubricants for safety and anti-HIV-1 activity. PloS one 
2012;7:e48328. 
3. 
Fuchs EJ, Lee LA, Torbenson MS, et al. Hyperosmolar sexual lubricant causes 
epithelial damage in the distal colon: potential implication for HIV transmission. The 
Journal of infectious diseases 2007;195:703-10. 
4. 
Wolf L. Studies Raise Questions About Safety of Personal Lubircants. Chemical 
and Engineering News 2012;90:46-7. 
5. 
Gorbach PM, Weiss RE, Fuchs E, et al. The slippery slope: lubricant use and 
rectal sexually transmitted infections: a newly identified risk. Sexually transmitted 
diseases 2012;39:59-64. 
6. 
Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV 
prevention in men who have sex with men. The New England journal of medicine 
2010;363:2587-99. 
7.   
Gilead Sciences. Genvoya Package Insert. 2016 
8. 
Society of Gastroenterology Nurses and Associates I. Guideline for the 
performance of flexibile sigmoidscopy by registered nurses for colon cancer screening. 
2009. 
9. 
American Society for Gastrointestinal E, Ikenberry SO, Anderson MA, et al. 
Endoscopy by nonphysicians. Gastrointestinal endoscopy 2009;69:767-70. 
10. 
Gatto NM, Frucht H, Sundararajan V, Jacobson JS, Grann VR, Neugut AI. Risk 
of perforation after colonoscopy and sigmoidoscopy: a population-based study. J Natl 
Cancer Inst 2003;95:230-6. 
11. 
Levin TR, Conell C, Shapiro JA, Chazan SG, Nadel MR, Selby JV. Complications 
of screening flexible sigmoidoscopy. Gastroenterology 2002;123:1786-92. 
12. 
Koobatian GJ, Choi PM. Safety of surveillance colonoscopy in long-standing 
ulcerative colitis. Am J Gastroenterol 1994;89:1472-5. 
13. 
Rutter MD, Saunders BP, Wilkinson KH, et al. Thirty-year analysis of a 
colonoscopic surveillance program for neoplasia in ulcerative colitis. Gastroenterology 
2006;130:1030-8. 
14. 
Yao MD, von Rosenvinge EC, Groden C, Mannon PJ. Multiple endoscopic 
biopsies in research subjects: safety results from a National Institutes of Health series. 
Gastrointest Endosc 2009;69:906-10. 
 
 
 
 

SAP_001.pdf: 
Unique Protocol ID: IRB00092488 
 
NCT02985996 
 
Statistical Analysis Plan 
 
Truvada® vs. Genvoya® 
 
Principal Investigator 
Colleen F. Kelley MD, MPH 
 
 
01/15/2019 
 
 


Demographic, behavioral, clinical, and laboratory data will be collected from the screening clinical 
assessment, the study entry physical examination and screening laboratory tests, and rectal biopsy 
visits.  
Median (range) drug levels will be calculated at baseline and each of the protocol specified follow-up 
time points.  Differences in median drug levels between baseline and study visit follow-up visits will be 
analyzed with non-parametric Wilcoxon-signed rank tests.  A p-value of <0.05 will be considered 
significant.