Clinical trial NCT04039217
Conditions: ART HIV
Keywords: PrEP PEP MSM Short-course regimen Pharmacokinetics
Sponsor: Emory University
Start date: 2019-09-30; Completion date: 2020-08-28
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how long it persists in different body compartments, including mucosal tissues, as it may be considered for PrEP or PEP regimens in the future.

Detailed description:
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through receptive anal intercourse without condoms. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are recommended for MSM who may be exposed to HIV to prevent infection. Current recommendations for PrEP are to take the combination anti-HIV drug, tenofovir+emtricitabine (TDF/FTC), on a daily basis for the duration of someone's HIV risk exposure period, which could be months or years. For PEP, a three-drug anti-HIV medication is recommended within 72 hours of a possible exposure for a 28-day course. While PrEP and PEP are effective, some people find it difficult to follow the recommended regimen. Therefore, additional short-course dosing regimens for PrEP and PEP are being considered for future development. The study drug provided in this study will not protect participants from HIV or treat any active infection. This proposal seeks to understand how other anti-HIV medications are absorbed and how long they persist in different body compartments, including mucosal tissues, as they may be considered for PrEP or PEP regimens in the future.

Participants will be sequentially enrolled into study arms. All participants will take two doses of Biktarvy and then will have biological samples collected at different time points. Blood will be collected at three different time points and a rectal biopsy will occur once. Participants may participate in more than one study arm or subgroup; however, at least 6 weeks must lapse after completion of one study arm or subgroup, before entry into another.

Median drug levels of TAF, FTC, and BIC in plasma, peripheral blood mononuclear cells (PBMCs) and rectal tissues will be calculated at baseline, 24 hours after the first dose and 120 hours after the first dose as the primary outcomes of this study. Samples collected at other time points will be stored for future exploratory analyses.

Arms: arm 1: Participants in this study arm (Arm A) will provide biological specimens 2, 48, and 96 hours after the in-clinic dose of Biktarvy. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre-wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at one of the study visits. arm 2: Participants in this study arm (Arm B) will provide biological specimens 4, 26, and 120 hours after the in-clinic dose of Biktarvy. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre-wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at one of the study visits. arm 3: Participants in this study arm (Arm C) will provide biological specimens 24, 28, and 72 hours after the in-clinic dose of Biktarvy. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre-wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at one of the study visits.
Interventions: intervention 1: Biktarvy
Intervention descriptions: intervention 1: Participants will be given two doses of the oral fixed dose combination anti-HIV medication Biktarvy (BIC/FTC/TAF) separated by 24 hours. The first dose is given in the clinic and participants are instructed to take the second dose at home, 24 hours after the first dose.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
ART Persistence: Antiretroviral Drug Persistence in Different Body 
Compartments in HIV Negative Men Who Have Sex With Men 
 
NCT04039217 
IRB00111410 
DATE: 6/5/2020 


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
Version 6/5/2020
1
TITLE OF PROJECT: Antiretroviral drug persistence in different body compartments in HIV 
negative men who have sex with men
Short title: ART Persistence
Principal Investigator:
Colleen F. Kelley MD, MPH
Associate Professor of Medicine
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Assistant Professor of Epidemiology
Rollins School of Public Health
Co-Investigators:
Alexis Ahonen, NP
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Katherine Al-Haroun, NP
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Srilatha Edupuganti, MD
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Nadine Rouphael, MD
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
Version 6/5/2020
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Matthew Collins, MD
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Varun Phadke, MD
Co-Investigator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Coordinators:
LaShonda Hall, MPH
Research Coordinator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine
Christopher Conway- Washington
Research Coordinator
The Hope Clinic
Division of Infectious Diseases
Department of Medicine 
Emory School of Medicine
Recruiters:
Harlan Smith
Recruiter
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine 
Rameses Frederick
Recruiter
The Hope Clinic
Division of Infectious Diseases
Department of Medicine


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
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Emory School of Medicine
Nicole Baker
Recruiter
The Hope Clinic
Division of Infectious Diseases
Department of Medicine
Emory School of Medicine 


TITLE OF PROJECT: ART Persistence 
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PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
Version 6/5/2020
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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 condomless receptive anal intercourse (CRAI). To aid in 
prevention, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are 
recommended for MSM who may be exposed to HIV. Current recommendations for 
PrEP are to take the combination anti-HIV drug, tenofovir+emtricibatine (TDF/FTC), on 
a daily basis for the duration of someone’s HIV risk exposure period, which could be 
months or years. For PEP, a three-drug anti-HIV medication is recommended within 72 
hours of a possible exposure for a 28-day course. While PrEP and PEP are efficacious, 
both the daily dosing of PrEP and the 28 day course of PEP limit their utility in practice, 
as many users find long term adherence to these regimens to be difficult. Therefore, 
additional short-course dosing regimens for PrEP and PEP are being considered for 
future development. This proposal seeks to understand how other anti-HIV medications 
are absorbed into different body compartments, including mucosal tissues, and for how 
long they persist in those body compartments. Anti-HIV medications with good mucosal 
tissue levels that persist over time may be considered for testing in future clinical trials 
of PrEP or PEP regimens. The study drug provided in this study will not protect 
participants from HIV or treat any active infection.  
Design: To address the absorption and persistence of anti-retroviral drugs by mucosal 
tissues in MSM, investigators at Emory University will collaborate with the Center for 
Disease Control and Prevention (CDC) to conduct a clinical trial of up to 56 MSM aged 
18-49 with measurement of anti-retroviral drug concentrations in various body 
compartment sites of possible HIV exposure. We plan to enroll men who are HIV 
negative that engage in receptive anal intercourse (RAI) and are not currently (or have 
no current plans) taking PEP or pre- exposure prophylaxis (PrEP). We will enroll 
participants in one of 3 study arms where they will be given 2 doses of the oral fixed 
dose combination anti-HIV medication Biktarvy (TAF/FTC/BIC) separated by 24 hours. 
Depending on study arm (A, B, C), participants will undergo body compartment 
sampling at different time points including, blood, urine, optional semen, oral swabs, 
penile swabs, and rectal biopsy collections. 
Participants will undergo rectal biopsy collection at 1 study timepoint while other biologic 
specimens will be collected at 3 study time points. We will recruit participants through 
existing research databases at the Hope Clinic and the Rollins School of Public Health, 
Research Match, and Clinical Data Warehouse. Internet and paper advertisements, and 
community venues will also be used. At the first study visit, eligibility will be determined 
and screening blood work (approximately 15 mL), including a rapid HIV test, will be 
performed. At the second study visit, participants will be provided two doses 
TAF/FTC/BIC. The first does will be observed in clinic. They will be instructed to take 
the second dose at home with documentation by digital, time-stamped photo or video. 


TITLE OF PROJECT: ART Persistence 
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Depending on which study arm the participant is sequentially assigned to, the 
participant will be asked to return to the Hope Clinic at different time points to complete 
the remaining visits (visits 3, 4, 5). During visits 3-5, all participants will undergo blood 
collection (approximately 2 tablespoons of blood will be obtained), an oral cheek swab, 
urethral swab, 1 pre- wet and 1 dry penile swabs, and a urine sample will be collected. 
Each participant will also undergo a single time-point (depending on study arm 
assignment—either visit 3 or 4 or 5) rectal secretion collection with swabs and wicks, a 
swab for rectal STI testing, and a rectal biopsy via rigid sigmoidoscopy. All participants 
will have urine tested for STIs from one time point. All participants will be asked to 
abstain from receptive anal intercourse for 7 days after biopsy procedures to allow the 
mucosa to heal. 
Participants will also be asked to provide an optional single semen specimen on the day 
of rectal sampling to further evaluate drug levels.  All biologic specimens will be 
transferred to CDC within 4 hours of collection for measurement of antiretroviral drug 
levels.  
Participants may participate in more than one study arm or subgroup; however, at least 
6 weeks must lapse after completion of 1 study arm or subgroup before entry into 
another. Men who participate in more than one arm will be consented on the arm-
specific consent form prior to starting study activities, but do not have to repeat the 
screening visit (visit 1) when starting another arm; they will begin the new arm at visit 2.
Duration: The duration of this study is 2 years. Participants will be considered ‘on-
study’ for no more than 12 weeks.  
Sample size: For this protocol we will recruit 56 HIV-negative MSM (age 18- 49) who 
meet eligibility criteria outlined in the protocol.  
Population:  The population to be studied in this protocol are healthy HIV negative 
MSM who are engaging in receptive anal intercourse (RAI) and are willing to perform 
study procedures. We will recruit participants through existing research databases at 
the Hope Clinic and the Rollins School of Public Health, through internet and paper 
advertisements, and community venues as is currently the process for Dr. Kelley’s 
ongoing research protocols.
LAY SUMMARY:
 
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. 
In 2014, MSM made up approximately 2% of the U.S. population but accounted for 70% 
of the new HIV infections (CDC)(2). The majority of MSM acquire HIV after exposure to 
the rectal mucosa through receptive anal intercourse without condoms. Pre-exposure 
prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are recommended for MSM 


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
Version 6/5/2020
6
who may be exposed to HIV to prevent infection. Current recommendations for PrEP 
are to take the combination anti-HIV drug, tenofovir+emtricibatine (TDF/FTC), on a daily 
basis for the duration of someone’s HIV risk exposure period, which could be months or 
years. For PEP, a three-drug anti-HIV medication is recommended within 72 hours of a 
possible exposure for a 28-day course. While PrEP and PEP are effective, some people 
find it difficult to follow the recommended regimen. Therefore, additional short-course 
dosing regimens for PrEP and PEP are being considered for future development. The 
study drug provided in this study will not protect participants from HIV or treat any active 
infection.  This proposal seeks to understand how other anti-HIV medications are 
absorbed and how long they persist in different body compartments, including mucosal 
tissues, as they may be considered for PrEP or PEP regimens in the future.  
For this protocol, we will recruit 56 HIV-negative MSM aged 18-49 in good general 
health. Participants will be sequentially assigned to one of 3 study arms which will 
dictate the timing of subsequent study visits. All participants will provide written informed 
consent at the first study visit and undergo a screening medical history, and safety 
laboratory tests. A physical exam may also be completed. At the beginning of the study, 
all participants will take 2 doses of the anti-HIV regimen 
tenofovir+emtricitabine+bictegrativir (TAF/FTC/BIC). At subsequent study visits (visit 
times defined by the protocol), participants will return to donate blood, oral swabs, 
penile swabs, and urine. At one study visit (visit defined by the protocol), participants 
will undergo a rectal biopsy procedure and provide a semen specimen. All biologic 
specimens collected will be transferred to CDC on the day of collection for 
measurement of drug levels.   
PROJECT DESCRIPTION
Public Health Relevance: Information about new anti-HIV agents and how they are 
absorbed by different body sites will better inform scientists about the potential of new 
agents to be used around the time of HIV exposure for HIV prevention.
Goal: To assess the pharmacokinetics and tissue distribution of anti-HIV drugs after 
taking 2 doses of TAF/FTC/BIC. 
STUDY POPULATION 
A total of up to 56 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 engagement events conducted 
by Hope Clinic recruiters, from print and on-line advertisements, and from social media. 
Research recruiters at the Hope Clinic are experienced in recruiting this population for 


TITLE OF PROJECT: ART Persistence 
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PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
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research studies, including those with rectal biopsies, and do not anticipate problems. 
Dr. Kelley has conducted several similar studies before and does not anticipate any 
problems with recruiting the target population. Based on our previous studies, we 
expect a percentage of men will not complete all study visits, therefore the sample size 
of up to 56 men will ensure study completion for at least 28 men. 
INCLUSION CRITERIA FOR MSM 
1) HIV-negative person assigned male sex at birth who reports receptive anal sex 
with another person assigned male sex at birth in the last 6 months 
2) Aged 18-49 years
3) Not currently taking PrEP and no plans to initiate during study
4) Not currently taking PEP
5) Able to provide informed consent in English 
6) No plans for relocation in the next 3 months
7) Willing to undergo peripheral blood, penile swabs, urine, 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.  
10) Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
11) Creatine clearance >60 ml/min
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) Currently infected with hepatitis virus and/ or have liver disease
3) Current or chronic history of kidney disease 
4) 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
e) HBsAg reactive
5) 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: 


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
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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, fistula, or malignancy
e) History or evidence on clinical examination of ulcerative, suppurative, or 
proliferative lesions of the anorectal mucosa, or untreated sexually 
transmitted disease with mucosal involvement  
6) 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 lubricants or douching used 
for sexual intercourse
7) 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 (short course steroids less than 7 days 
duration, allowable at the discretion of the investigators)
c) Experimental medications, vaccines, or biologicals
8) Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) 
during the study, outside of the study procedures 
9) Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, 
discharge, bleeding, etc.)
10)Current use of hormonal therapy
11)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.
12) Participants taking potent inhibitors (e.g. itraconazole, diltiazem) or inducers (e.g. 
rifampin, phenytoin) of the CYP3A4 enzyme will be excluded from the study.  
PROCEDURES
Recruitment procedures
Participants will be recruited with several methods.  First, the Hope Clinic maintains 
large databases of volunteers interested in participating in future research.  Email blasts 
and phone calls will be made to potential volunteers from these databases.  
ResearchMatch, a secure online database used by researchers who are seeking 
volunteers and people who are interested in finding research/ clinical trial studies to 
participate in, will also be used as a recruitment source.  Site will recruit from the Emory 
Healthcare Clinical Data Warehouse.  The Clinical Data Warehouse is a repository that 
integrates data from clinical applications within Emory Healthcare, providing data 


TITLE OF PROJECT: ART Persistence 
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needed for clinical reporting, research and operational support.  Any contact made by 
email and or phone (refer to online engagement section for direct & SMS messaging 
script), recruiters will use one of the following scripts:
Phone call
Participants who are called will be greeted by the study staff. “Hello, my name is [        ]. 
I am calling from the Hope Clinic…” Staff will refer to Oral Consent and Pre-Screener.
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 understand how certain HIV medications are absorbed into different body 
tissues and may be considered for future HIV prevention regimens in the future. Study 
visits range from two 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 ___________ or ___________. These are the basic 
qualifications to participate in the study:
You may qualify if you are:
Age 18-49
HIV negative man who has sex with men
HIV transgender woman who has sex with men who is not 
taking hormone therapy
Not currently taking PrEP or PEP
Willing to undergo rectal biopsy sampling
Print and on-line ads will also be placed around Emory and other community settings.  
Finally, active recruitment will be conducted as outlined below with face-to-face and 
online engagements. Dr. Kelley and co-investigators have a successful track record in 
recruiting MSM for their research protocols utilizing all of these methods.     
Volunteer contact details are collected by conducting in person face-to-face and/or 
online social network engagement.
Face- to-face engagements: Participants may be actively or passively recruited at 
community venues listed below and engaged with limited information about the study 
and study qualifications. Recruiters will use 1 out of 2 generalized scripts when 
engaging with participants (please see section B below). A site contact sheet or a tablet 
using icapture/redcap application will be used to populate name, phone number, email 
address, and physical address of interested participants.
A.  Face -to- Face engagement


TITLE OF PROJECT: ART Persistence 
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a. Community annual events attended by MSM (e.g. Pride festivals, MSM 
symposium, etc.)
b. Bars and Night Clubs catering towards MSM
c. Community organizations serving MSM
d. Sporting events
e. Other community venues where MSM might visit/patronize
Online engagements: Potential participants will be engaged and supplied with limited 
information about the study and study qualifications via paid advertisements on social 
media sites and dating apps. All print and online advertisement copies will be submitted 
to the Emory IRB for approval prior to launching these activities. Interested participants 
will click a posted ad with an embedded hyperlink, which will redirect them to a short 
screener. This screener will capture information regarding eligibility, including HIV 
status, name, phone number and email. Recruiters will use information obtained from 
online screener to contact and schedule participant visits. Volunteers may also be 
engaged directly on social media to assess interest in research participation. Any 
contact made through direct messaging, recruiters will have a generalized script 
(mentioned below) to follow (script can also be used for SMS contacting, as well).  We 
will seek permission from creator/ moderator of the private website/ group, etc. before 
entering and interaction.
A. Online Social Network
f.
Dating Sites (Jack’d, Adam4Adam, Grindr, etc.)
g. Social Network (Facebook, Snapchat, Instagram, etc.)
h. Other online social media platforms and websites where MSM 
might visit/patronize
B. Script used by recruiters when engaging by direct messaging (can be 
used for SMS):
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).  


TITLE OF PROJECT: ART Persistence 
Emory IRB protocol
PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
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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___
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.  
If contact responds negatively or does not responds, no further 
contact will be attempted. 
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 
 
 
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 respond, no further contact will be attempted.
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).  
Study visits
When possible, study activities such as questionnaires will be done remotely due to the ongoing 
COVID-19 pandemic. 


TITLE OF PROJECT: ART Persistence 
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Eligible Subjects will be sequentially assigned to study arms. After the completion of 
Arm A, study staff will start enrollment for Arm B. After the completion of Arm B, study 
staff will start enrollment for Arm C.  
Participants may participate in more than one study arm or subgroup; however, at least 
6 weeks must lapse after completion of one study arm or subgroup, before entry into 
another. Participants who participate in more than one arm or subgroup, will be 
consented on the arm-specific consent form prior to completing study activities, but do 
not have to repeat the screening visit (visit 1) when starting another arm or subgroup; 
they will begin the new arm at visit 2.
The consent process will be conducted in a private exam room at the Hope Clinic. 
Copies of the consent 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.  All participants will be provided a copy of the signed informed consent form 
(ICF).
Arm A (up to n=24 maximum enrolled):
Participants will be sequentially assigned to groups A.1, A.2, A.3. Once 4 
participants complete their biopsy visits for subgroup A.1, subsequent 
participants will be enrolled into sub-group A.2 and then A.3. A total of 12 
participants must complete all study visits for this arm.  
Group A.1 (n=8; enrollment will close once 4 participants complete their biopsy 
visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. Staff will provide instructions to participant on when to take dose the 
second dose at home (i.e. 24 hours after the first dose). Participants will be instructed to 
photograph or videotape themselves taking the second dose with the timestamp 
included with their smartphone. Study staff will instruct participants to bring the 
photo/video to their next visit to provide proof of dosing. Participants will also have the 
option to send a text to a specified number with the time and date of dose if their phone 
device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 2hrs (+/- 1 hr) after the first/in-clinic dose. Approximately 24 
mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile 
swab, and a urethral swab will be collected. After previous swab collections are 


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complete, participants will be asked to provide a urine sample (some of which will be 
used for gonorrhea and chlamydia testing), then the practitioner (Principal investigator 
or Co- investigator) will collect rectal secretion samples by using two swabs and insert 
an aptima swab for rectal gonorrhea and chlamydia testing, before the participant 
undergoes a rectal biopsy via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
Visit 4: Visit 4 takes place 48hrs (+/- 1 hour) after the in-clinic first dose and 24 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample. 
Visit 5: Visit 4 takes place 96hrs (+/- 1 hour) after the in-clinic first dose and 72 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.   
  
Group A.2 (up to n=8; enrollment will close once 4 participants complete their 
biopsy visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. Staff will provide instructions to participant on when to take dose the 
second dose at home (i.e. 24 hours after the first dose). Participants will be instructed to 
photograph or videotape themselves taking the second dose with the timestamp 
included with their smartphone. Study staff will instruct participants to bring the 
photo/video to their next visit to provide proof of dosing. Participants will also have the 
option to send a text to a specified number with the time and date of dose if their phone 
device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 2hrs (+/- 1 hr) after the first/in-clinic dose. Approximately 24 
mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile 
swab, and a urethral swab will be collected. After previous swab collections are 


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complete, participants will be asked to provide a urine sample (some of which will be 
used for gonorrhea and chlamydia testing). 
Visit 4: Visit 4 takes place 48hrs (+/- 1 hour) after the in-clinic first dose and 24 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swabs and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample, then the practitioner (Principal investigator or Co- investigator) 
will collect rectal secretion samples by using two swabs and insert an aptima swab for 
rectal gonorrhea and chlamydia testing, before the participant undergoes a rectal biopsy 
via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
Visit 5: Visit 4 takes place 96hrs (+/- 1 hour) after the in-clinic first dose and 72 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.   
Group A.3 (up to n=8; enrollment will close once 4 participants complete their 
biopsy visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. Staff will provide instructions to participant on when to take dose the 
second dose at home (i.e. 24 hours after the first dose). Participants will be instructed to 
photograph or videotape themselves taking the second dose with the timestamp 
included with their smartphone. Study staff will instruct participants to bring the 
photo/video to their next visit to provide proof of dosing. Participants will also have the 
option to send a text to a specified number with the time and date of dose if their phone 
device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 2hrs (+/- 1 hr) after the first/in-clinic dose. Approximately 24 
mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile 
swab, and a urethral swab will be collected. After previous swab collections are 


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complete, participants will be asked to provide a urine sample (some of which will be 
used for gonorrhea and chlamydia testing). 
Visit 4: Visit 4 takes place 48hrs (+/- 1 hour) after the in-clinic first dose and 24 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Visit 5: Visit 4 takes place 96hrs (+/- 1 hour) after the in-clinic first dose and 72 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample, then the practitioner (Principal investigator or Co- investigator) 
will collect rectal secretion samples by using two swabs and insert an aptima swab for 
rectal gonorrhea and chlamydia testing, before the participant undergoes a rectal biopsy 
via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
Arm B (up to n=16 maximum enrolled):
Participants will be sequentially assigned to groups B.1 and B.2. Once 4 
participants complete their biopsy visits for subgroup B.1, subsequent 
participants will be enrolled into sub-group B.2. A total of 8 participants must 
complete all study visits for this arm.  
Group B.1 (n=8; enrollment will close once 4 participants complete their biopsy 
visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. Staff will provide instructions to participant on when to take dose the 
second dose at home (i.e. 24 hours after the first dose). Participants will be instructed to 
photograph or videotape themselves taking the second dose with the timestamp 
included with their smartphone. Study staff will instruct participants to bring the 
photo/video to their next visit to provide proof of dosing. Participants will also have the 
option to send a text to a specified number with the time and date of dose if their phone 
device does not have video/photo capabilities.


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Visit 3: Visit 3 takes place 4hrs (+/- 1 hr) after the first/in-clinic dose. Approximately 24 
mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile 
swab, and a urethral swab will be collected. After previous swab collections are 
complete, participants will be asked to provide a urine sample (some of which will be 
used for gonorrhea and chlamydia testing), then the practitioner (Principal investigator 
or Co- investigator) will collect rectal secretion samples by using two swabs and insert 
an aptima swab for rectal gonorrhea and chlamydia testing, before the participant 
undergoes a rectal biopsy via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
Visit 4: Visit 4 takes place 26hrs (+/- 1 hour) after the in-clinic first dose and 2 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Visit 5: Visit 4 takes place 120hrs (+/- 1 hour) after the in-clinic first dose and 96 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample. 
Group B.2 (n=8; enrollment will close once 4 participants complete their biopsy 
visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. Staff will provide instructions to participant on when to take dose the 
second dose at home (i.e. 24 hours after the first dose). Participants will be instructed to 
photograph or videotape themselves taking the second dose with the timestamp 
included with their smartphone. Study staff will instruct participants to bring the 
photo/video to their next visit to provide proof of dosing. Participants will also have the 
option to send a text to a specified number with the time and date of dose if their phone 
device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 4hrs (+/- 1 hr) after the first/in-clinic dose. Approximately 24 
mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile 


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swab, and a urethral swab will be collected. After previous swab collections are 
complete, participants will be asked to provide a urine sample (some of which will be 
used for gonorrhea and chlamydia testing).
Visit 4: Visit 4 takes place 26hrs (+/- 1 hour) after the in-clinic first dose and 2 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Visit 5: Visit 4 takes place 120hrs (+/- 1 hour) after the in-clinic first dose and 96 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample, then the practitioner (Principal investigator or Co- investigator) 
will collect rectal secretion samples by using two swabs and insert an aptima swab for 
rectal gonorrhea and chlamydia testing, before the participant undergoes a rectal biopsy 
via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
Arm C (up to n=16 maximum enrolled):
Participants will be sequentially assigned to groups C.1 and C.2. Once 4 
participants complete their biopsy visits for subgroup C.1, subsequent 
participants will be enrolled into sub-group C.2. A total of 8 participants must 
complete all study visits for this arm.  
Group C.1 (n=8; enrollment will close once 4 participants complete their biopsy 
visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. If participant is in clinic for their visit 3 (24hrs after first dose), study 
staff will instruct participant to take dose immediately at the start of visit. If participant is 
late to visit, but still within the +/- 1hr window, study staff will provide instructions to 
participant on when to take the second dose at home (i.e. 24 hours after the first dose). 
Participants will be instructed to photograph or videotape themselves taking the second 
dose with the timestamp included with their smartphone. Study staff will instruct 


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participants to bring the photo/video to their next visit to provide proof of dosing. 
Participants will also have the option to send a text to a specified number with the time 
and date of dose if their phone device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 24hrs (+/- 1 hr) after the first/in-clinic dose. If the participant 
did not dose at home, study staff will instruct participant to take dose after in clinic study 
procedures are performed. Approximately 24 mL of blood will be drawn, an oral cheek 
swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample (some of which will be used for gonorrhea and chlamydia 
testing), then the practitioner (Principal investigator or Co- investigator) will collect rectal 
secretion samples by using two swabs and insert an aptima swab for rectal gonorrhea 
and chlamydia testing, before the participant undergoes a rectal biopsy via rigid 
sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home, no more than 2hrs before/after the biopsy visit. 
Visit 4: Visit 4 takes place 28hrs (+/- 1 hour) after the in-clinic first dose and 4 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Visit 5: Visit 4 takes place 72hrs (+/- 1 hour) after the in-clinic first dose and 48hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Group C.2 (n=8; enrollment will close once 4 participants complete their biopsy 
visit):
Visit 1(screening): Eligible MSM will provide written informed consent, be questioned 
about their medical history, undergo an HIV test, and a peripheral blood sample for a 
complete blood count, creatinine, coagulation test, and hepatitis B testing. A physical 
exam may also be completed. Participants will then be asked to return within 1- 6 weeks 
for visit 2.
Visit 2: Participants will be given 2 doses of TAF/FTC/BIC. The first dose will be 
observed in clinic. If participant is in clinic for their visit 3 (24hrs after first dose), study 
staff will instruct participant to take dose immediately at the start of visit. If participant is 
late to visit, but still within the +/- 1hr window, study staff will provide instructions to 
participant on when to take dose the second dose at home (i.e. 24 hours after the first 


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dose). Participants will be instructed to photograph or videotape themselves taking the 
second dose with the timestamp included with their smartphone. Study staff will instruct 
participants to bring the photo/video to their next visit to provide proof of dosing. 
Participants will also have the option to send a text to a specified number with the time 
and date of dose if their phone device does not have video/photo capabilities.
Visit 3: Visit 3 takes place 24hrs (+/- 1 hr) after the first/in-clinic dose. If the participant 
did not dose at home, study staff will instruct participant to take dose after performing in 
clinic study procedures. Approximately 24 mL of blood will be drawn, an oral cheek 
swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample (some of which will be used for gonorrhea and chlamydia 
testing). 
Visit 4: Visit 4 takes place 28hrs (+/- 1 hour) after the in-clinic first dose and 4 hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample.
Visit 5: Visit 4 takes place 72hrs (+/- 1 hour) after the in-clinic first dose and 48hours 
after the at-home second dose. Approximately 24 mL of blood will be drawn, an oral 
cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be 
collected. After previous swab collections are complete, participants will be asked to 
provide a urine sample, then the practitioner (Principal investigator or Co- investigator) 
will collect rectal secretion samples by using two swabs and insert an aptima swab for 
rectal gonorrhea and chlamydia testing, before the participant undergoes a rectal biopsy 
via rigid sigmoidoscopy.
Participants will also provide a single optional semen sample, which will be collected at 
home or the clinic, no more than 2hrs before/after the biopsy visit. 
All participants will be asked to abstain from receptive anal intercourse for three days 
prior to drug dosing and during the study protocol in order to limit additional exposures 
(e.g. semen, douching, additional lubricants) to the rectal mucosa.
All participants who undergo a rectal biopsy will be informed not to place anything into 
the rectum and abstain from intercourse 7 days after their rectal biopsy procedure to 
allow the mucosa to heal.  If tested positive for gonorrhea and/or chlamydia, participant 
will be notified and referred to linkage for treatment. 


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Biologic specimens:
Biologic specimens collected after the screening visit will be transferred directly to CDC 
for measurement of study drug levels.  Specimens will be labeled with a unique ID that 
only the Emory study team will be able to link to identifiable information. CDC personnel 
will not have access to identifiable information.   
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.  
Timing of procedures after dose:
The procedures conducted after dose, particularly those less than 24 hours after dose, 
should occur as close to the scheduled time points as possible. Protocol deviations will 
be filed for visits that occur outside of the target windows identified above only if the visit 
is conducted more than 3 hours beyond the target window defined above for each arm 
and visit. 
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
All biopsies will be completed by either the PI or a delegated, licensed medical 
professional whom the PI has trained in the procedure. 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 (now 
retired) experienced gastroenterologist at Emory University. 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 
in Dr. Kelley’s research protocols >300 times with no complications. Briefly, without the 
administration of any previous enemas or other preparation, up to 10 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 


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be unable to link them back to 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.
Optional semen collection:
After participants have taken study dose in clinic, they will be instructed to obtain semen 
sample 2hrs before or after the scheduled rectal biopsy visit. The semen will be 
collected by the participant at home using a provided collection cup and will be stored 
on ice until it is brought to the clinic. Participant will be provided towelettes for cleaning 
the head of the penis before masturbation is started.  The sample should be collected 
no more than 2 hours before delivery to the clinic. The participant will be instructed to 
refrain from ejaculating, putting lubricants or saliva on their penis, or having insertive 
vaginal, anal or oral sex for at least 48 hours prior to semen collection. If these 
instructions are not followed, a notation will be made and the semen sample will still be 
accepted. 
Statistical analysis plan
Median (range) drug levels (TAF and FTC and BIC) will be calculated at baseline, 
twenty four hours after the first dose, and 120 hours after first dose for plasma, PBMCs, 
and, rectal tissues.  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. 
Future use of specimens
Additional biologic specimens not used for above drug level testing may be used and/or 
stored for future research use at Emory University Hope Clinic or the CDC. 
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 


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will be referred for confirmatory testing to their local health department, community 
based organization that provides HIV testing, or provider of their choice. We will also 
assist any HIV positive participant in accessing healthcare for HIV infection as needed. 
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. 
Risk of TAF/FTC/BIC
TAF/FTC/BIC is a combination anti-HIV medication that contains the drugs tenofovir 
alafenamide, emtricitabine, and bictegravir. Based on clinical trials previously conducted 
of TAF/FTC/BIC, the drug showed to be well tolerated (see package insert). The most 
common adverse events reported in clinical trials (> 5% incidence) included diarrhea, 
nausea, and headache. Additional adverse reactions occurring in less than 2% of 
subjects administered TAF/FTC/BIC included vomiting, flatulence, dyspepsia, 
abdominal pain, rash, and depression. 
Renal toxicity and bone density loss are rarely reported with chronic use of TAF 
containing products and are not expected to occur with the two-dose regimen 
prescribed in this protocol. Similarly, lactic acidosis and severe hepatomegaly have 
rarely been associated with medications in the same class as TAF and FTC; however, 
are not expected to occur with this two-dose regimen.  
Use of TAF/FTC 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 (see package insert). For this reason, it is important that participants not 
participate in the study if they are known to have Hepatitis B. Nonetheless, the 
maximum 2-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 HIV positive people taking 
intermittent dosing of anti-HIV medication. For this protocol, we will test participants 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 


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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/arthralgia(3).  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. For this protocol, we will test participants 
for HIV at study entry and monitor clinically for high-risk behavior or any signs of acute 
HIV infection at study visits. 
Participants will be asked to abstain from receptive anal intercourse for three days prior 
to drug dosing and during the study protocol in order to limit additional exposures (e.g. 
semen, douching, additional lubricants) to the rectal mucosa. Participants taking 
TAF/FTC/BIC 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 participants 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 a nurse practitioner trained by Dr. Kelley. 
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.(4, 5) 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 sigmoidoscope 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’s team has performed >300 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 10.  Colonoscopy has been shown to be associated with a still low, but 
significantly greater risk of complications than rectosigmoidoscopy.(6)  The frequency of 
serious complications after flexible sigmoidoscopy is extremely low and complications 


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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.(6, 7) 
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%.(8, 9) 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.(10) 
Most relevant to the current study, a summary of procedures across several Microbicide 
Trial Network (an NIH-funded, international network designed to develop topical agents 
for HIV prevention) was published in 2017.(11) This manuscript reported on the safety 
of 1,004 sigmoidscopy procedures with >15,000 biopsy collection from 278 research 
participants. Many participants underwent multiple procedures (median 3 procedures). 
There were no serious adverse events, and an AE related to sigmoidoscopy was 
reported in 1.6% of procedures. Eight of the 16 related AEs reported were abdominal 
pain, flatulence, bleeding, diarrhea, and bloating. Fourteen of the 16 related AEs were 
grade 1 and 2/16 were grade 2; median time to resolution was 1 day. The authors 
concluded that repeated intestinal mucosal biopsies for research purposes are safe. 
Thus, based on the available data, the risk of serious complications from the proposed 
study procedures, even with up to 10 biopsy specimens, is expected to be very low 
(<1:5000). 
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 rectal biopsy 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.  
BREACH 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 


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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.  
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 their time and inconvenience of study 
participation. Compensation will be provided on a web-based, reloadable, debit card 
(ClinCard) that automates reimbursements. The ClinCard will be provided by study staff 
at the participants’ initial visit (visit 1), and funds will be loaded after the completion of 
each visit.
Participants who enter into Arm A, Arm B, and Arm C will be compensated $25 for visit 
1, $25 for visit 2, $50 for visits that include swab collections in addition to blood and 
urine, and $125 for visits in which a rectal biopsy procedure is performed (Total=$275 
per subgroup completion). 
If a contingency visit is necessary, participants will be compensated $20 for completion 
of a contingency study visit.
There is no charge for parking at the Hope Clinic. However, participants may be 
provided with a MARTA card if available. 
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. 
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, those assigned female at birth 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 HIPAA 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.
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. In the event 
that study staff needs additional information, after enrollment is complete, or has 


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additional questions pertaining to study analysis, staff will obtain consent from 
participant for future contact. 
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 Event Reporting
An Adverse Event (AE) as any untoward medical occurrence in a clinical investigation 
subject administered a pharmaceutical product regardless of its causal relationship to 
the study treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom or disease temporally associated 
with the use of a medicinal (investigational) product.
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 the participant’s chart.  The reporting period for 
participant AEs begins at enrollment and continues until the subject either completes or 
withdraws from the study.
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 2.1, July 2017, which can be found on the DAIDS RCC Web 
site: http://rcc.tech-res.com/tox_tables.htm.  
Each AE will be assessed for relatedness to study product. Study investigators will 
determine AEs to be either definitely related, probably related, possibly related or not 
related to study product. If the adverse event is, in the investigator’s opinion, possibly, 
probably, or not related to study drug or procedures, then an alternate etiology will be 
provided by the investigator.


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Related AEs ≥ Grade 3 will be included in the summary reports provided to the Medical 
Monitor of the study. Exceptions to expedited reporting are detailed below. 
This study uses FDA approved drugs with known common side effects (please refer to 
the risk section of the protocol for common side effects).  The following side effects will 
not be reported as an EAE unless it increases in severity or becomes prolonged beyond 
the two-day study follow-up period after final biopsy/ procedure visit.
Nausea: Report if severity is a Grade 3 or higher
Vomiting: Report if severity is a grade 3 or higher
Diarrhea: Report if severity is a Grade 3 or higher
Headache: Report if severity is a Grade 3 or higher
Rash: Report if severity is a Grade 3 or higher
Serious Adverse Event Reporting
Additionally, clinical investigators will monitor subjects for Serious Adverse Events 
(SAE) during each study visit. 
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 
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 


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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.
In this protocol, spontaneous and elective abortions will be also be considered SAEs. 
All SAEs will be reported to the Medical Monitor within 24 hours of site awareness. 
Any SAE that is considered 1) unanticipated 2) related to study product AND 3) places 
participants at greater risk of harm than previous known is an Unanticipated Problem 
(UP) and will be reported to the IRB within 10 business days of study team awareness. 
All other SAEs will be reported to the IRB at the time of annual review. 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.  
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.
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. 
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 grade 3 and 4 AEs and SAEs by study group.   The Medical Safety Monitor 
will 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 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 CDC.
In addition to the medical monitor, we will also conduct site monitoring for data quality 
and protocol compliance. The PI and the research coordinators will monitor for protocol 
compliance and data quality with periodic quality monitoring checks. In addition, we will 
perform self-monitoring twice yearly using the EU-Self-monitoring Tool available at 
http://www.ctac.emory.edu/clinical_trial_resources/Audit%20Tools.html. The 
PI 
will 


TITLE OF PROJECT: ART Persistence 
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inform the sub-investigators and the IRB if she is provided with new safety 
information about the study. 
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 laboratory assays 
will fall under the existing biosafety protocols of the Hope Clinic and CDC.  
REFERENCES
1.         Centers for Disease Control and Prevention. Updated Guidelines for Antiretroviral 
Postexposure Prophylaxis After Sexual, Injection Drug Use, or other Nonoccupational Exposure 
to HIV---United States, 2016.
2.
Centers for Disease Control and Prevention. HIV Surveillance Report, 2014.2015 
; 26. Available from: http://www.cdc.gov/hiv/library/reports/surveillance/.
3.
US Public Health Service. Pre-exposure Prophylaxis for the Prevention of HIV Infection 
in the United States-2014: A Clincal Practice Guideline 2014.
4.
American Society for Gastrointestinal E, Ikenberry SO, Anderson MA, Banerjee S, Baron 
TH, Dominitz JA, Gan SI, Harrison ME, Jagannath S, Levy M, Lichtenstein D, Shen B, Fanelli 
RD, Stewart L, Khan K. Endoscopy by nonphysicians. Gastrointestinal endoscopy. 
2009;69(4):767-70. doi: 10.1016/j.gie.2008.11.006. PubMed PMID: 19327469.
5.
Society of Gastroenterology Nurses and Associates I. Guideline for the performance of 
flexibile sigmoidscopy by registered nurses for colon cancer screening2009.
6.
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(3):230-6. PubMed PMID: 12569145.
7.
Levin TR, Conell C, Shapiro JA, Chazan SG, Nadel MR, Selby JV. Complications of 
screening flexible sigmoidoscopy. Gastroenterology. 2002;123(6):1786-92. doi: 
10.1053/gast.2002.37064. PubMed PMID: 12454834.
8.
Koobatian GJ, Choi PM. Safety of surveillance colonoscopy in long-standing ulcerative 
colitis. The American journal of gastroenterology. 1994;89(9):1472-5. PubMed PMID: 8079922.
9.
Rutter MD, Saunders BP, Wilkinson KH, Rumbles S, Schofield G, Kamm MA, Williams 
CB, Price AB, Talbot IC, Forbes A. Thirty-year analysis of a colonoscopic surveillance program 


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PRINCIPAL INVESTIGATOR: Colleen F. Kelley, MD, MPH
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for neoplasia in ulcerative colitis. Gastroenterology. 2006;130(4):1030-8. doi: 
10.1053/j.gastro.2005.12.035. PubMed PMID: 16618396.
10.
Yao MD, von Rosenvinge EC, Groden C, Mannon PJ. Multiple endoscopic biopsies in 
research subjects: safety results from a National Institutes of Health series. Gastrointestinal 
endoscopy. 2009;69(4):906-10. doi: 10.1016/j.gie.2008.05.015. PubMed PMID: 19136110; 
PubMed Central PMCID: PMC5050003.
11.
Chiu WK, Brand RM, Camp D, Edick S, Mitchell C, Karas S, Zehmisch A, Ho K, Brand 
RE, Harrison J, Abo S, Cranston RD, McGowan I. The Safety of Multiple Flexible 
Sigmoidoscopies with Mucosal Biopsies in Healthy Clinical Trial Participants. AIDS research 
and human retroviruses. 2017;33(8):820-6. doi: 10.1089/aid.2016.0293. PubMed PMID: 
28296471; PubMed Central PMCID: PMC5564058.


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All Specimen Visits
Biopsy Visits
Specimen Collection
Blood (2 CPT, 1 EDTA), 5 aliquots Plasma, 2 aliquots PBMCs
Urine, 4 aliquots
Urethral Swab
Cheek Swab, Penile Swab x2
Rectal Swabs (x2)
Rectal Biopsies (x2)
Aptima Swab-Rectal STI Testing
Urine STI Testing
Semen
Figure 1. PEP Dosing (n=56)
Design: 2 doses of TAF/FTC/BIC given 24 hours apart 
1
st dose observed in clinic, 2
nd dose recorded at home
Timing of specimen collection begins following 1st dose
2 Hr
A.1 (n=8): Specimen + Bx
A.2 (n=8): Specimen only
A.3 (n=8): Specimen only
Arm A 
(n=24)
Arm B 
(n=16)
Arm C 
(n=16)
24 Hr
Receive 
2
nd dose
4 Hr
B.1 (n=8): Specimen + Bx
B.2 (n=8): Specimen only
48 Hr
A.1 (n=8): Specimen only
A.2 (n=8): Specimen + Bx
A.3 (n=8): Specimen only
26 Hr
B.1 (n=8): Specimen only
B.2 (n=8): Specimen only
24 Hr
C.1 (n=8): Specimen + Bx
C.2 (n=8): Specimen only
28 Hr
C.1 (n=8): Specimen only
C.2 (n=8): Specimen only
96 Hr
A.1 (n=8): Specimen only
A.2 (n=8): Specimen only
A.3 (n=8): Specimen + Bx
120 Hr
B.1 (n=8): Specimen only
B.2 (n=8): Specimen + Bx
72 Hr
C.1 (n=8): Specimen only
C.2 (n=8): Specimen + Bx
0 Hr
Receive 
1st dose 
in clinic