Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline
Phase: PHASE4
Conditions: Sexually Transmitted Diseases
Sponsor: Emory University

 
 
 
 
 
 
 
 
Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline    
NCT05853120 
 
Date: 03 July, 2024 
STUDY00005552 

Protocol Title: Doxy-PEP
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Version: 7.0 dated 03Jul2024
IRB Form BIO 01192022
PROTOCOL TITLE:  Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline
PRINCIPAL INVESTIGATOR:
 
Division of Infectious Diseases 
 
  
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
, PhD 
Centers for Disease Control and Prevention 
Division of HIV/AIDS Prevention 
 
External collaborator will submit designated protocol to The Centers for Disease Control and 
Prevention IRB for review and approval. 
VERSION: 7.0 dated  03 Jul 2024
FUNDING SOURCE: Centers for Disease Control and Prevention, Division of HIV/AIDS 
Prevention

Protocol Title: Doxy-PEP
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REVISION HISTORY
Revision 
#
Version 
Date
Summary of Changes
2.0
23Jan2023

Clarified participants who are “enrolled” vs. counting 
towards the study “n”

Removed English-speaking from inclusion criteria

Added statement regarding list linking study codes to IHI 
3.0
20Mar2023

Added Certificate of Confidentiality language per CDC 
requirement 
4.0
26Apr2023

Added Emory and Grady EeMR as a recruitment method
5.0
10Aug2023

Updated Inclusion/Exclusion Criteria to remove CrCL 
and hepatitis virus and liver disease 
6.0
21May2024

Updated in Section 1, Study Summery, Study Population 
to remove “sex” and “not using gender affirming 
hormone therapy”
7.0
03Jul2024

Updated minimum anticipated sample size to 12 AMAB 
and 12 AFAB

Updated that at least 6 participants will complete ARM A 
prior to moving to ARM B 

Protocol Title: Doxy-PEP
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IRB Form BIO 01192022
Table of Contents
1.
Study Summary ......................................................................................................4
2.
Objectives...............................................................................................................5
3.
Background.............................................................................................................5
4.
Study Endpoints......................................................................................................5
5.
Study Intervention/Investigational Agent ................................................................6
6.
Procedures Involved...............................................................................................6
7.
Statistical Analysis Plan........................................................................................16
8.
Data and/or Specimen Banking............................................................................16
9.
Sharing of Results with Participants .....................................................................16
10.
Study Timelines ....................................................................................................16
11.
Inclusion and Exclusion Criteria............................................................................17
12.
Population.............................................................................................................18
13.
Vulnerable Populations.........................................................................................18
14.
Local Number of Participants................................................................................18
15.
Recruitment Methods............................................................................................18
16.
Withdrawal of Participants ....................................................................................20
17.
Risk to Participants...............................................................................................20
18.
Potential Benefits to Participants..........................................................................22
19.
Compensation to Participants...............................................................................22
20.
Data Management and Confidentiality..................................................................22
21.
Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity ....24
22.
Provisions to Protect the Privacy Interest of Participants .....................................26
23.
Economic Burden to Participants..........................................................................27
24.
Informed Consent .................................................................................................27
25.
Setting...................................................................................................................28
26.
Resources Available.............................................................................................28
27.
References ...........................................................................................................28
28.
Protocol Checklist.................................................................................................29

Protocol Title: Doxy-PEP
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1.
Study Summary
Project Title
Dose-Ranging Study of Persons Receiving Doxycycline
Project Design
To determine tissue pharmacology of multiple doses of 
doxycycline for sexually transmitted infection (STI) post-
exposure prophylaxis (PEP), investigators at Emory University 
will collaborate with the Centers for Disease Control and 
Prevention (CDC) to conduct a clinical trial of up to 40 people 
aged 18-59 (at least 12 people assigned male sex at birth 
(AMAB) and 12 people assigned female sex at birth (AFAB)), 
with measurement of doxycycline concentrations in the rectum 
and vagina at study follow-up visits. Enrolled participants will 
take a total of 5 doses of doxycycline over a 3-week period.
Primary Objective
To determine dose-ranging tissue penetration of  doxycycline 
for STI prevention strategies. 
Secondary Objective(s)
N/A
Research 
Intervention(s)/Interactions
Doxycycline & Biological Specimen Collection
Study Population
Healthy people assigned male or female at birth and are willing 
to undergo study procedures. 
Sample Size
40 participants total

Arm A (100mg Doxycycline): at least 6 AFAB and 6 AMAB 
with a target sample size of 10 in each group

Arm B (200mg Doxycycline): at least 6 AFAB and 6 AMAB 
with a target sample size of 10 in each group
Study Duration for individual 
participants
8 weeks 
Study Specific Abbreviations/ 
Definitions 
AFAB — Assigned female sex at birth
AMAB —Assigned male sex at birth
CDC — Centers for Disease Control and Prevention 
CRAI — Condomless receptive anal intercourse 
DOX — Doxycycline  
ED-PrEP —Event-driven pre-exposure prophylaxis  
HIV — Human Immunodeficiency Virus  
IDS — Investigational Drug Services
MSM — Men who have sex with men 
PrEP — Pre-exposure prophylaxis 
PEP — Post-exposure prophylaxis 
STI — Sexually transmitted infection 
WHO —World Health Organization 
Funding Source (if any)
Centers for Disease Control and Prevention 

Protocol Title: Doxy-PEP
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2.
Objectives
The purpose of this study is to collect data regarding the ability of various oral doses of 
doxycycline to penetrate mucosal tissues in people AMAB and AFAB to inform future 
studies of combinations of doxycycline to protect against bacterial STIs. 
3.
Background
Recent studies have demonstrated the potential utility of single-dose oral doxycycline post-
exposure prophylaxis (Doxy-PEP) against bacterial sexually transmitted infections (STIs)1,2. 
New dosing strategies are being explored that would allow for a single event-driven oral 
dose of medications that protect from HIV as well as other bacterial STIs. However, the 
ability of doxycycline to penetrate mucosal tissues and provide protection from STIs remains 
underexplored. A previous pilot study conducted by the DHP Laboratory Branch at CDC 
examined the ability of a 200mg oral dose of doxycycline to penetrate the vaginal and rectal 
mucosa. However, data regarding alternative doxycycline doses and accumulation of 
doxycycline with multiple doses are lacking1,2. 
The purpose of this project is to collect data regarding the ability of various oral doses of 
doxycycline to penetrate mucosal tissues in people AMAB and AFAB to inform optimization 
of doxycycline for STI prevention strategies. Results from this study will be compared to 
results of the previous pilot study conducted by the DHP Laboratory Branch at CDC. The 
objectives of this project are to conduct a clinical study investigating the pharmacokinetics of 
two different doses of doxycycline in people AMAB and AFAB where biological specimens 
are provided to the DHP Laboratory Branch for doxycycline measurement and analysis. 
Data regarding mucosal drug exposure will help inform development of STI prevention 
strategies. 
Public Health Relevance: Incidence of bacterial STIs are increasing and studies have 
recently shown that Doxy-PEP can reduce incidence of bacterial STIs among men who have 
sex with men (MSM) and Doxy-PEP is being explored for STI prevention among women3,4. 
A better understanding of mucosal drug penetration of doxycycline will inform the design of 
future studies to prevent STIs in various populations. 
4.
Study Endpoints
Primary Study Endpoints
1.
To compare doxycycline concentrations in rectal tissues collected 24 hours after T1 dose 
of 100 mg or 200 mg of doxycycline in AMAB participants. 
2.
To compare doxycycline concentrations in vaginal tissues collected 24 hours after T1 
dose of 100 mg or 200 mg of doxycycline in AFAB participants. 
3.
To compare doxycycline concentrations in rectal tissues collected 24 hours after T5 dose 
(visit 8) of 100 mg or 200 mg of doxycycline in AMAB participants. 
4.
To compare doxycycline concentrations in vaginal tissues collected 24 hours after T5 
dose (Visit 8) of 100 mg or 200 mg of doxycycline in AFAB participants. 

Protocol Title: Doxy-PEP
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Exploratory Endpoint
To assess longitudinal doxycycline concentrations in blood, urine, throat, vaginal, penile,  
and rectal secretions over the 3-week study period in people taking 5 doses of 100mg vs. 
200mg of doxycycline.
5.
Study Intervention/Investigational Agent 
Study Product Description
Doxycycline is used to treat or prevent infections that are strongly suspected to be caused 
by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually 
transmitted infections.
It will be purchased from the manufacturer and stored at the Emory Investigational Drug 
Services (IDS).
Dosage, Preparation and Administration of Study Product
Doxycycline (DOX) will be given orally at 100 and 200 mg doses. Pharmacy packages will 
be prepared by an IDS Pharmacist and delivered to the participant by a study team member. 
Prior to drug dispensing, the clinician will assess participant’s medical history, and ensure 
the participant has no known allergies to the study drug. If a participant reports an allergy 
and a suitable alternative is not available, then the clinician may opt to not enroll the 
participant into the study.
Accountability Procedures for the Study Product
The IDS pharmacist will maintain accurate accountability logs at the Hope Clinic.
6.
Procedures Involved
Study Schema 
 

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Study Visits
All study visits described below apply to both Arms A & B. The only difference between the 
two will be the dose participants receive (100 mg v. 200 mg). Study participants will be 
assigned to dosing arms in a sequential manner. Arm A will enroll at least 6 participants 
AFAB and at least 6 participants AMAB at 100mg prior to proceeding to Arm B. Target 
enrollment will be n=10 in each group. Arm B  will enroll at least 6 participants AFAB and at 
least 6 participants AMAB at 200mg. Target enrollment will be n=10 in each group. 
Recruitment 
Potential participants will be identified from one of the recruitment methods (e.g., flyers, 
social media, advertisements, etc.) mentioned in the recruitment methods section below. 
Phone Screening  
Once a potential participant is identified via recruitment methods, study staff may administer 
a pre-screening questionnaire via phone to assess preliminary eligibility. If the results of the 
pre-screening questionnaire indicate that the potential participant may be eligible for this 
study, they will be invited to the clinic to complete the screening visit. 
Screening Visit
At this visit, the informed consent will be reviewed, and all questions answered. The 
participant will sign the consent form prior to completing any study activities. Once the 
participant signs the informed consent, a study identification number will be 
assigned.  Eligibility will then be determined for each participant based primarily on 
information gathered during the screening visit. Procedures conducted during the screening 
visit may include: 

Collection of demographic information  

Collection of medical history  

Collection of current medications  

Physical exam  

Pregnancy test for women of childbearing potential 

Self-collected vaginal and/or rectal swab test for gonorrhea and chlamydia 

Urine specimen to test for gonorrhea and chlamydia

Blood sample collection - up to 17 mL 
o
HIV testing
o
CBC  
o
Coagulation Tests  
o
Creatinine 
Timing of the first doxycycline dose will be denoted at T1 = 0hr. All subsequent visits 
should be calculated from this time point. Additional doses will be denoted as T2, T3, 
T4 and T5. 

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Visit 1a (Day 0) – Enrollment, Pre-T1 Dose & T1 Dosing
This visit should occur ≤ 42 days after the Screening Visit. Participants will count towards 
the total n of the study upon completion of this visit. 
Procedures conducted PRIOR TO DOSING may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2) 
Dosing
Doxycycline (Arm A – 100mg; Arm B – 200 mg) will be administered to the participant. This 
dose should take place while the participant is in the clinic. 
Visit 1b (Hour 2-4/Day 0) – Post-T1 Dose
This visit will take place 2-4 hours after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Visit 2 (Hour 24/Day 1) – Biopsy Visit
This visit will take place 24 hours after the first dose (T1 = 0 hr). For participants who 
menstruate, this visit should take place 7-10 days after their last menstrual cycle. 
Participants will be asked to abstain from receptive anal and/or vaginal intercourse for 3 
days prior to this visit. 
Procedures conducted at this visit may include: 

Review of medical history 

Review of current medications 

Symptom-guided physical exam

Evidence-based HIV/STI risk reduction counseling

Rapid HIV test (if risk behavior has changed since screening)

Blood Sample Collection – up to 10 mL

Urine Sample Collection 

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o
Urinalysis 
o
Urine pregnancy test – for women of childbearing potential 

Staff-Assisted Swab Collection
o
Urethral (x1)
o
Glans (x1)

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)

Rectal Biopsy – Required for participants who DO NOT have a vagina. This is an 
optional, additional biopsy for those who do have a vagina. 
o
Rigid sigmoidoscopy
o
Biopsies (2-4 tissue samples)

Vaginal/Cervical Biopsy – Required for participants who DO have a vagina.
o
Speculum insertion 
o
Vaginal Biopsies (1-2 tissue samples)
o
Cervical Biopsies (1-2 tissues samples)
All participants will be instructed to place nothing in the rectum and/or vagina and to abstain 
from intercourse for 7 days after the biopsy procedure to allow the mucosa to heal.
Visit 3 (Hour 48/Day 2) 
This visit will take place 48 hours after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Visit 4 (Hour 72/Day 3) – Pre-T2 Dose & T2 Dosing 
This visit will take place 72 hours (3 days) after the first dose (T1 = 0 hr). 
Procedures conducted PRIOR TO DOSING may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Staff-Assisted Swab Collection
o
Urethral (x1)
o
Glans (x1)

Self-Administered Swab Collection

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o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Dosing
Doxycycline (Arm A – 100mg; Arm B – 200 mg) will be administered to the participant. This 
dose should take place while the participant is in the clinic. 
Visit 5 (Hour 168/Day 7) – T3 Dosing at Home
Participant will take dose (Arm A – 100mg; Arm B – 200 mg) at home and provide proof of 
dosing as described in study-specific procedures.  
Visit 6 (Hour 240/Day 10) – T4 Dosing at Home 
Participant will take dose (Arm A – 100mg; Arm B – 200 mg) at home and provide proof of 
dosing as described in study-specific procedures.  
Study Drug Dispensation Visit (if needed)
If, due to scheduling constraints, menses, holidays, etc., Visit 8 (Biopsy) cannot be 
completed per protocol, study staff may delay Visits 7a – 12 for up to 4 weeks. In this case, 
participants would continue to take doxycycline twice a week until the visits could be 
scheduled. An additional drug dispensation visit may be needed so the participant can pick 
up study drug. 
Visit 7a (Hour 336/Day 14) – Pre-Dose & T5 Dosing
This visit will take place 336 hours (14 days) after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Dosing
Doxycycline (Arm A – 100mg; Arm B – 200 mg) will be administered to the participant. This 
dose should take place while the participant is in the clinic. 
Visit 7b (Hour 338-340/Day 14) – Post-T5 Dose 
This visit will take place 2-4 hours after the T5 dose and 338-340 hours (14 days) after the 
first dose (T1 = 0 hr). 

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Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL 

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Visit 8 (Hour 360/Day 15) – Biopsy Visit
This visit will take place 360 hours (15 days) after the first dose (T1 = 0 hr) and 24 hours 
after T5 dose. 
Participants will be asked to abstain from receptive anal and/or vaginal intercourse for 3 
days prior to this visit. 

Review of medical history 

Review of current medications 

Symptom-guided physical exam

Evidence-based HIV/STI risk reduction counseling

Rapid HIV test (if risk behavior has changed since screening)

Blood Sample Collection – up to 10 mL

Urine Sample Collection 
o
Urinalysis 
o
Urine pregnancy test – for participants who are able to bear children 

Staff-Assisted Swab Collection
o
Urethral (x1)
o
Glans (x1)

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)

Rectal Biopsy – Required for participants who DO NOT have a vagina. This is an 
optional, additional biopsy for those who do have a vagina. 
o
Rigid sigmoidoscopy
o
Biopsies (8-12 tissue samples)

Vaginal/Cervical Biopsy – Required for participants who DO have a vagina.
o
Speculum insertion 
o
Vaginal Biopsies (1-2 tissue samples)
o
Cervical Biopsies (1-2 tissues samples)
All participants will be instructed to place nothing in the rectum and/or vagina and to abstain 
from sex for 7 days after the biopsy procedure to allow the mucosa to heal.

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Visit 9 (Hour 384/Day 16) 
This visit will take place 384 hours (16 days) after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
 
Visit 10 (Hour 408/Day 17) 
This visit will take place 408 hours (17 days) after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Staff-Assisted Swab Collection
o
Urethral (x1)
o
Glans (x1)

Self-Administered Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)
Visit 11 (Hour 432hr/Day 18) 
This visit will take place 432 hours (18 days) after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2)

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Visit 12 (Hour 504/Day 21) 
This visit will take place 504 hours (21 days) after the first dose (T1 = 0 hr). 
Procedures conducted at this visit may include: 

Blood Sample Collection – up to 10 mL

Urine Sample Collection – Urinalysis 

Swab Collection
o
Rectal (x3) 
o
Vaginal (x3) – for participants with a vagina only
o
Throat (x2) 
Study-Specific Procedures
Visit Windows
Windows for all study visits are provided in Table 1. Study staff should make efforts to stay 
within these windows, however, study procedures done outside the provided windows will 
not be considered a protocol deviation. 
Dosing 
Participants will be asked not to eat or drink anything except water after midnight the day 
before their scheduled dose. Study personnel will dispense study drug to participant. Doses 
1, 2 and 5 will take place in the clinic. Participants will take doses 3 and 4 at home according 
to the schedule of activities.   
Proof of Home Dosing
Photos and videos taken with smartphones automatically include a timestamp. Study staff 
will instruct participants to bring the photo/video to their next clinic visit as proof of dosing. 
Participants will also have the option to send a text study staff at a specified number at the 
time of dosing if their phone does not have video/photo capabilities. 
HIV Testing 
Participants who are presumed HIV negative but test positive on study will be referred for 
confirmatory testing. Study staff will also assist any HIV positive participant in accessing 
healthcare for HIV infection as needed. 
Evidence-based HIV/STI Risk Reduction Counseling
Topics covered in this counseling should include increasing condom use, reducing number 
of partners, addressing substance abuse, PrEP, undetectable=untransmissible, etc. 
Counseling will be provided by the study coordinator or clinician with provision of condoms 
and lubricant available for free at the Hope Clinic. 
HIV negative 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, individuals 
who are interested in PrEP for HIV prevention will be linked to community services.

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Vaginal/Cervical Mucosal Sampling Procedures
A trained, delegated clinician will be performing all vaginal/cervical mucosal sampling 
procedures with the assistance of the study coordinator utilizing a disposable speculum, 
light source, and sterilized Tischler biopsy forceps. 
Once the speculum is inserted, additional swabs will be inserted into the vagina. Then, 1 to 
2 vaginal and 1 to 2 cervical biopsies will be collected. Monsel’s paste or similar product 
may be used to stop sites of active bleeding. All participants will be informed not to place 
anything into the vagina and abstain from intercourse for 7 days after the procedure to allow 
the mucosa to heal. 
Vaginal and cervical tissue samples will not be collected in women who are menstruating, 
pregnant, or have possible cervical or vaginal infection. A pregnancy test will be 
administered to women of childbearing potential to ensure they are not pregnant. The first 
vaginal/cervical biopsy will be scheduled 7 to 10 days after their last menstrual cycle. 
Twenty-four to forty-eight hours after the procedure, study personnel will call the participants 
who donated biopsy samples and inquire about symptoms, complications, or adverse events 
related to study procedures. Participants 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.
Rectal Mucosal Sampling Procedures 
A trained, delegated clinician will be performing all rectal mucosal sampling procedures with 
the assistance of the study coordinator utilizing a disposable anoscope, rigid 
sigmoidoscope, light source, and jumbo biopsy forceps. 
Then, without the administration of any previous enemas or other preparation, a rigid 
sigmoidoscope will be inserted and 2-4 (first biopsy) or  8-12 (second biopsy) adequate ~1.0 
mm thick biopsy specimens will be taken from normal-appearing rectal mucosa 
approximately 10 cm above the external anal aperture using flexible sigmoidoscopic forceps 
mounted on a semi-flexible rod.  All biopsy specimens will be coded with a unique numeric 
identifier such that the laboratories that receive the specimens will be unable to link them 
back to the study participants. Two to three biopsy specimens will be placed immediately 
into cryotubes for testing of drug levels at CDC.  The remaining biopsy specimens will be 
placed in media and transported to Dr. Kelley’s lab where the specimens will be processed 
for various laboratory protocols (e.g., bulk and spatial transcriptomics, exogenous hormone 
treatment for bulk and spatial transcriptomics and explant challenge experiments, or flash-
frozen for subsequent quantification of HIV within rectal tissue).  
Twenty-four to forty-eight hours after the procedure, study personnel will call the participants 
who donated rectal biopsy samples and inquire about symptoms, complications, or adverse 
events related to study procedures. Participants 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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Table 1. Study Schema – Arm A & B
  
Screening 
Visit
Visit 
1a
Visit 
1b
Visit 
2
Visit 
3
Visit 
4
Visit 
5
Visit 
6
Visit 
7a 
Visit 
7b
Visit 
8
Visit 
9
Visit 
10
Visit 
11
Visit 
12
Timepoint (Days)
-42 to 0
0
0
1
2
3
7
10
14
14
15
16
17
18
21
Timepoint 
(Hours)  
-
0
2-4
24
48
72
168
240
336  
338-
340
360
384
408
432
504
Window  
-
-
±2 hr
±2 hr
± 2hr
±2 hr
±2hr
±2hr
±2hr
±2hr
±2hr
±2hr
±2hr
±72hr
±72hr
Informed 
Consent  
X
Physical Exam  
X
X1
X1
Medical History   
X
X1
X1
Current 
Medications
X
X1
X1
Screening Labs2
X
Pregnancy Test  
X
X
X
Eligibility  
X
Dose 
Administration 
X
X
X3
X3
X
Biopsy  
X
X
Urine Sample  
X
X
X
X
X
X
X
X
X
X
X
Rectal & Vaginal4 
Swab
X
X
X
X
X
X
X
X
X
X
X
X
Throat Swab
X
X
X
X
X
X
X
X
X
X
X
X
Urethral & Glans 
Swab
X
X
X
X
Blood Volume 
17 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
10 mL
1Abbreviated/symptom-directed/review during non-screening visits.
2Includes CBC, coagulation, creatinine, HIV testing, urine, and self-collected swab for chlamydia & gonorrhea. 
3Dose taken at home. 
4Vaginal swabs done only on participants with vaginas.  

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7.
Statistical Analysis Plan
Primary Outcomes 
Comparisons between time points will be conducted with a non-parametric statistical test of 
differences in median doxycycline concentrations between the two dosing regimen arms, 
stratified by sex assigned at birth. P-values less than 0.05 will be considered significant.  
Exploratory Outcomes
Exploratory outcomes will be analyzed with various statistical methods to examine changes 
over time in doxycycline concentrations between the dosing arms, stratified by sex assigned 
at birth. 
8.
Data and/or Specimen Banking
Data and biological specimens collected for this study will be stored at the Hope Clinic. 
Identifiable data will be kept in a separate, locked cabinet at Hope Clinic and only accessible 
by MPIs and study staff. Electronic data will be stored in a secure database only accessible 
to study staff.  Data and biological specimens will be stored with a unique study code 
number to maintain the blinding of the identity of the participant. After the study is 
completed, the de-identified, archived data and specimens may be stored for use by other 
researchers including those outside of the study.  Only the PI and study staff will have 
access to a list that links a participants’ unique study code to their identifiable information. 
Leftover specimens from all study participants will be stored indefinitely and may be used for 
future use including laboratory assay development, unless a participant requests that 
specimens be destroyed or if required by IRB or other regulatory authority. Other use of 
specimens may apply to studies not covered by the protocol or the informed consent form 
for the main study.   
De-identified data from this study may be placed into public databases where, in addition to 
having no direct identifiers, researchers will need to sign data use agreements before 
accessing the data. Any personal information that could identify participants will be removed 
or coded before the information is shared. Despite these measures, we cannot guarantee 
anonymity of participant personal data. 
9.
Sharing of Results with Participants
Study results, including results of laboratory tests, will not be shared with participants. If 
abnormalities deemed to be clinically significant are discovered during the procedure and/or 
from the safety labs, such as positive STI tests, these results will be discussed with the 
participant and a referral will be made to a primary care physician or specialist, as needed. 
10. Study Timelines

Participants will be considered on study for no more than 7 weeks .

The duration anticipated to enroll all study participants is 1 years.

This study is expected to take 2 years to complete. 

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11. Inclusion and Exclusion Criteria
Inclusion Criteria 
1.
Aged 18-59 years  
2.
Assigned male sex or female sex at birth
3.
In good general health  
4.
Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans 
to initiate during the study  
5.
For HIV positive people, on stable antiretroviral therapy with an undetectable viral load 
and CD4 count> 300ul/ml
6.
Willing to use condoms consistently for the duration of the study  
7.
Able to provide informed consent 
8.
No plans for relocation in the next 4 months  
9.
Not pregnant and does not plan on getting pregnant for the duration of the study 
10. Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a 
rectal or vaginal and cervical biopsy procedure  
11. Willing to use study products as directed  
Exclusion Criteria 
 
1.
Current or chronic history of liver disease  
2.
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.
Chemotherapy or radiation for treatment of malignancy 
d.
Experimental medications, vaccines, or biologicals  
3.
Intent to use doxycycline or other tetracycline-derived antibiotics during the course of 
the study, outside of the study procedures 
4.
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  
5.
Known allergic reaction to study drugs.  
6.
Significant laboratory abnormalities at baseline visit for rectal biopsies, including but 
not limited to:
a.
Hgb ≤ 10 g/dL 
b.
PTT > 1.5x ULN or INR > 1.5x ULN 

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c.
Platelet count <100,000 
12. Population
This study will not include any of the vulnerable populations listed below.

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners

Cognitively impaired or 

Individuals with Impaired Decision-Making Capacity
At the time of enrollment, participants will be asked to complete a demographic form in 
which they will indicate their sex assigned at birth (male/female), gender identity, ethnicity 
(Hispanic/Latinx or non-Hispanic/Latinx) and race with which they identify (White, 
Black/African American, American Indian/Alaska Native, Asian, Native Hawaiian/Other 
Pacific Islander, and/or Other). Other than sex assigned at birth, this information will be used 
for descriptive statistics only and not as a variable to explain differences between 
participants.
13. Vulnerable Populations
This research will not involve human fetuses, neonates, prisoners, minors or cognitively 
impaired adults. 
14. Local Number of Participants
This study will accrue a total of 40 participants (20 AMAB and 20 AFAB). In order to reach 
this number, it is anticipated that 80 will sign consent and be screened. 
Our goal will be to enroll approximately 50% AMAB and 50% AFAB. We will include 
participants from all races and ethnicities in the study. Every effort will be made to include 
data from diverse individuals. Based on similar studies previously conducted at the Hope 
Clinic, we expect a nearly 1:1 ratio AMAB: AFAB and a race/ethnicity distribution of 
approximately 45% Caucasian, 50% Black/African American, and 5% Hispanic/Latinx. 
15. Recruitment Methods
Databases 
The Hope Clinic maintains an extensive database of people who have previously expressed 
interest in participating in future research.  Additionally, the study team will use existing 
Emory University databases, including Research Match and the Emory Healthcare Clinical 
Data Warehouse, which have agreed to be contacted about research opportunities.  
Email blasts and phone calls will be made to potential participants from these databases. 
Electronic Medical Records
The Emory Healthcare and Grady EeMR systems will be utilized to identify patients who are 
living with HIV. Once a potential participant is identified, the study team will communicate 
with their care provider. The care provider will then reach out to the participant and ask if the 

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study team may contact them. If the patient agrees, a member of the study team will reach 
out directly to that patient. 
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. A site contact 
sheet or a tablet will be used to populate name, phone number, and email address of 
interested participants. Examples of locations used for face-to-face engagement are listed 
below:  
a.
Community annual events attended by study population 
b.
Bars and Night Clubs  
c.
Community organizations serving study population 
d.
Sporting events 
e.
Community venues  
Online Engagements  
Potential participants will be engaged and supplied with limited information about the study 
and study qualifications via free & paid advertisements on social media sites and dating 
apps.  
a.
Dating Sites (Tinder, Bumble, Jack’d, Adam4Adam, Grindr, etc.) 
b.
Social Network (Facebook, Snapchat, Instagram, etc.) 
c.
Other online social media platforms and websites where study population might 
visit/patronize 
d.
Craigslist 
Management of the social media sites will be the responsibility of approved and trained 
clinical recruitment research staff members. Site log-in credentials are kept in a locked 
document, to which access is only granted after a full review of expectations and training. 
Upon registration for potential social media sites, the research team plans to review and 
screen content for adherence to site specific terms of use and advertising, privacy and 
prohibited content policies of the social media sites to be used for recruitment. A team 
supervisor will conduct regular reviews of posted material to ensure continued compliance to 
both social media site and IRB-communication guidelines. Team members will continuously 
monitor media for posts and comments that may need to be addressed as a result of 
involving PHI, study specific information, or any other inappropriate content. Those staff 
members engaging with the community through approved social media accounts will abide 
by the following guidelines: 

When action is supported by the site’s platform, 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.  

When posting in site user groups/discussion boards, research staff will seek 
permission from creator/ moderator of the private website/ group, etc. before entering 
an interaction if possible. 

If a potential participant reaches out to the team via social media site, the team will 
respond providing contact info for the clinic and requesting their information and 
consent to be contacted via phone. To avoid a potential violation of privacy, the team 
will not request any PHI via direct message and after responding, delete any 
unsolicited private information that the potential participant may have sent.   

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Print Ads and Listservs  
In order to reach a wider audience, print ads will be placed around Emory and other 
community settings. Study staff will also utilize listservs run by our community partners to 
disseminate recruitment materials.   
Text Messaging  
This method will only be used for participants who have indicated they are willing to receive 
messages via text. This information will be collected in sign in sheets or via questionnaires. 
For texting, an initial text message will be sent asking if the participant consents to receiving 
text messages. Consent to message via text will be stored in Clinical Conductor. 
Participants who have already consented to text messages via previous recruitment efforts, 
will receive a message asking if they’re still interested in participating and for the best time 
and date to contact them if so. 
16. Withdrawal of Participants
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. Participants are free to 
withdraw from participation in the study at any time upon request. Under certain 
circumstances, an individual participant may be terminated from participation in this study. 
Specific events that will result in early termination include:  

Participant refuses further participation  

Participant relocates prior to completion of the biopsy visit  

If any laboratory abnormality, or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the 
participant  

If the participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation  
The reason for participant discontinuation or withdrawal from the study will be recorded on 
the appropriate Case Report Form (CRF). 
17. Risk to Participants
Phlebotomy 
Risks include discomfort, pain, bruising, bleeding, dizziness, fainting and possibility of 
infection. Only qualified and trained staff using sterile technique will perform the procedure.
Collection of Rectal and Vaginal Fluid 
This swab procedure is a non-invasive sample collection method. Brief discomfort is the only 
foreseeable risk.  
Collection of Rectal Fluid
This swab procedure is a non-invasive sample collection method. Brief discomfort is the only 
foreseeable risk. 

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Rigid Sigmoidoscopy
Risks associated with lower gastrointestinal endoscopy performed for clinical purposes 
include colitis from chemicals for endoscope sterilization, bowel perforation, bleeding, 
diverticulitis, and infection. Colonoscopy has been shown to be associated with a still low, 
but significantly greater risk of complications than rectosigmoidoscopy5. The frequency of 
serious complications after flexible sigmoidoscopy is extremely low and complications from 
rigid sigmoidoscopy are presumably even lower, but unknown. All sigmoidoscopy 
procedures will be performed by a trained, delegated clinician who will utilize disposable 
rigid sigmoidoscopes and forceps for the procedures. 
Rectal Biopsies 
To minimize risks in this study, the number of biopsies taken will be limited to 12. In two 
studies on rectal biopsies6,7, serious complications occurred at a rate of 0.33%. More 
relevant to the present protocol, in a study of subjects undergoing endoscopic procedures 
exclusively for research purposes8, there were no major complications. Minor risks include 
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. Of note, Dr. Kelley’s team has performed >400 such 
procedures for other research protocols at the Hope Clinic with zero complications. 
There is theoretical risk of increased acquisition of HIV or other infection if an HIV negative 
study participant is exposed soon after the rectal biopsy procedure (i.e., while the mucosal 
surface is damaged). Similarly, transmission risk from an HIV positive participant to sexual 
partners may also be heightened with mucosal bleeding. Therefore, study subjects will be 
counseled not to engage in anal intercourse for 1 week after the procedure.   
Any abnormalities discovered during the procedure and/or from the safety labs conducted 
will be discussed with the participant, and a referral will made to a primary care physician, 
gastroenterologist or other specialist as needed.  
 
Vaginal and Cervical Biopsies  
To minimize the risks in this study, the number of vaginal and cervical biopsies taken will be 
limited to 2 each. Risks of vaginal and cervical biopsies include pain, discomfort, a persistent 
odor, bleeding, and infection. If bleeding occurs that cannot be stopped by applying 
pressure, medication will be used, such as Monsel’s solution and paste, to stop it. When 
applied, Monsel’s solution will produce silver nitrate. Silver nitrate has a gray color that can 
cause gray flecks in the vaginal discharge after the biopsy is completed. All female 
participants will be notified of this expected side effect. Subjects will be instructed on how to 
care for the area and to contact the PI or their medical care provider if any of the 
aforementioned risks occur and persist.  
 
Doxycycline  
Doxycycline (DOX) is a medication used to treat or prevent infections that are strongly 
suspected to be caused by bacteria9-11. DOX is an antimicrobial drug indicated for bacterial 
infections such as sexually transmitted infections. The most common adverse reaction 
reported is diarrhea. Other adverse reactions include vomiting, nausea, dysphagia, and 
inflammatory lesions. Additional adverse reactions that are rare and not expected to occur 
with the short course regimen prescribed in this protocol include hepatotoxicity, exfoliative 

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dermatitis (skin), rise in BUN levels, hypersensitivity reactions, hemolytic anemia, 
neutropenia, and eosinophilia9-11.
The medication provided in this study is not for treatment or prevention of HIV and other STI 
infections. Participants who are interested in pre-exposure prophylaxis (PrEP) or STI PEP 
after this study ends, will be referred to a medical provider who can prescribe these.  
To protect against possible side effects of the study drug, women who are pregnant or 
nursing a child may not take part in this study. If a female participant becomes pregnant, 
there may be risks to the participant, the embryo, or fetus. These risks are not yet known. 
Women of childbearing potential will be asked to provide a urine pregnancy test to ensure 
they are not pregnant, prior to administering drug. Women of childbearing ability will discuss 
contraceptive methods to use throughout the study and may be asked to abstain throughout 
the duration of the study. If the participant becomes pregnant during the study, they must 
inform the study doctor immediately. Pregnant women will be excluded or removed from the 
study. 
18. Potential Benefits to Participants
There is no anticipated direct benefit to participants.  
19. Compensation to Participants
Participants will be compensated according to the schedule below: 

Screening Visit: $50 

In Clinic Follow-Up Visits: $50 x 10 visits = $500 

Biopsy Visit: $100 x 2 visits = $200  

Total Compensation: $750

Optional Rectal Biopsy (Participants with Vaginas Only): $100 x 2 visits = $200 

Unscheduled/Drug Dispensation Visit (if needed): $20  
If they do not finish the study, they will be compensated for the visits they have completed. 
Participants may also receive an additional $25 for peer referrals to the study if the peer 
referral enrolls in the study and identifies the enrolled participant as the referral source.   
Compensation will be provided via Emory ClinCard. 
20. Data Management and Confidentiality
The principal investigator, Dr. Colleen Kelley, will be ultimately responsible for receipt and 
transmission of the data and biospecimens. Biospecimens may be transported by local 
courier or shipping. 
Participants will be assigned a unique study-specific identification number after they sign the 
consent form. All collected data and specimens will be associated with this number 
(excluding demographic intake forms). Data will be recorded on paper Case Report Forms 
(CRFs) and entered into a study-specific REDCap Database. Data entered in REDCap will 
only be linked to a participant by a unique study identification number. Paper forms will be 

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stored in a locked cabinet at Hope Clinic. Only study staff will have access to identifiable 
data. 
Biologic specimens will be labeled with a unique study identification number at stored at the 
Hope Clinic prior to processing or shipment to another lab for assays. Laboratory staff will be 
unable to link the specimen identifier number with identifiable information. 
Data and specimens will be stored indefinitely. However, once the IRB protocol is closed, 
deidentified electronic data will be exported from the REDCap database for long-term 
storage on Emory OneDrive. Paper records will be destroyed no sooner than 1 year after 
IRB close out.  
Certificate of Confidentiality
Consistent with Section 301(d) of the Public Health Service Act, a Certificate of 
Confidentiality (CoC) applies to this research because this research is funded, conducted, or 
supported by CDC and the following is true:
The activity constitutes biomedical, behavioral, clinical, or other research; AND
1.
Individually identifiable (including coded) information or biospecimens will be 
obtained or used for research purposes or as defined at 45 CFR 46.102(e); 
and/or
2.
Biospecimens are collected or used as part of the research, and is there a small 
risk that some combination of the biospecimen and other available data sources 
could be used to deduce the identity of an individual; and/or
3.
The research involves information about an individual for which there is at least a 
very small risk, that some combination of the information, a request for the 
information, and other available data sources could be used to deduce the 
identity of an individual
Therefore, CDC and any of its collaborators, contractors, grantees, investigators or 
collaborating institutions that receive “identifiable, sensitive information” as defined by 
subsection 301(d) of the Public Health Service Act shall not:

Disclose or provide, in any Federal, State, or local civil, criminal, administrative, 
legislative, or other proceeding “identifiable, sensitive information” that was created 
or compiled for purposes of the research, unless such disclosure or use is made with 
the consent of the individual to whom the information, document, or biospecimen 
pertains; or

Disclose “identifiable, sensitive information” or provide ISI to any other person not 
connected with the research.
Disclosure is permitted only when:

Required by Federal, State, or local laws (e.g., as required by the Food, Drug and 
Cosmetic Act or required by state laws requiring the reporting of communicable 
diseases to State and local health departments), excluding instances of disclosure in 
any Federal, State, or local civil, criminal, administrative, legislative, or other 
proceeding;

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
Made with the consent of the individual to whom the information, document, or 
biospecimen pertains; or

Made for the purposes of other scientific research that is in compliance with 
applicable Federal regulations governing the protection of human subjects in 
research.
CDC and its collaborators and contractors conducting this research will establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable 
assurance that the research is managed in compliance with subsection 301(d) of the Public 
Health Service Act. CDC will ensure: 1) that any investigator or institution not funded by 
CDC who receives a copy of identifiable, sensitive information protected by this Certificate, 
understands that it is also subject to the requirements of the Certificate; and 2) that any 
subrecipient that receives CDC funds to carry out part of this research involving a copy of 
identifiable, sensitive information protected by a Certificate understands that it is subject to 
subsection 301(d) of the PHS Act. Therefore, all study staff will receive training on the 
importance of protecting the confidentiality of human research subjects and of personal 
information acquired, including the collection of biological specimens.
All research subjects will be informed of the protections and the limits to protections 
provided by this Certificate through the informed consent process. All study staff who obtain 
consent from study subjects will be trained on how the Certificate protects the information 
collected and the limitations of the Certificate’s protections.
21. Plans to Monitor the Data to Ensure Safety of Participants and Data Integrity
X More than minimal risk – Continue below.
Select one of the following:
☐ Medium Complexity
☐ High Complexity Category A
☒ High Complexity Category B
If choosing this category for a study under an IND or IDE because 
you believe the study intervention does not significantly impact 
morbidity or mortality, please provide your rationale:
DSMP Requirement
How this Requirement is Met 
Frequency
Responsible Party(ies)
Site Monitoring at pre-
determined intervals: The 
Principal Investigator has a 
responsibility to ensure that 
the study is following all 
aspects of the protocol. 
There should be a standard 
operating procedure to review data 
(whether a sample or 100%) at pre-
determined intervals to ensure that 
there is adequate documentation of 
critical elements such as eligibility 
criteria. Monitoring is required at 
At a minimum, a 
review is required 
annually when no 
one has been 
enrolled or the study 
is in long term follow 
up. Additional risk-
Delegate a responsible 
party for each 
requirement below. Self-
assessment is 
acceptable.*
Self-assessment: a 
process for self-

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DSMP Requirement
How this Requirement is Met 
Frequency
Responsible Party(ies)
the following timepoints (but may 
be done more frequently):

study initiation  

at least every six months 
while participants are 
receiving intervention and 

annually while participants 
are in follow-up
based interim 
monitoring may be 
required at least once 
every 12-24 weeks 
based on the site 
activity, to include the 
possibility of remote 
monitoring. A longer 
frequency could be 
acceptable with 
justification about risk 
to participants.
assessment of protocol 
compliance and data 
integrity which can be 
part of an overall DSMP. 
See Emory’s self-
assessment tool on this 
page. 
Real-time review of 
participant data during initial 
data collection.
After data collection for a visit is 
complete, another study 
coordinator or nurse reviews the 
visit documentation.
Following each study 
visit
Everyone on the study 
team responsible for 
primary data collection.
100% review of regulatory 
files
A review of the study regulatory 
binder will be conducted. 
At study initiation and 
IRB close out. 
Hope Clinic Quality 
Management Staff 
100% review of consent 
forms
The Hope Clinic consenting SOP 
requires real time verification of all 
consents by a staff member other 
than who obtained consent.
Real time
Hope Clinic Staff  
Review of credentials, 
training records, the 
delegation of responsibility 
logs (if applicable)
The Hope Clinic Regulatory Core 
maintains a spreadsheet of all non-
study specific trainings/documents 
and their expiration dates. This 
spreadsheet is reviewed on a 
weekly basis. 
The Regulatory Coordinator 
maintains a study-specific 
spreadsheet tracking all study staff, 
DOA start and stop dates as well as 
training dates. This spreadsheet is 
reviewed any time an update is 
needed and on a monthly basis.  
Monthly
Study Regulatory 
Coordinator 
Comparison of case report 
forms (CRF) to source 
documentation for accuracy 
and completion
After data collection for a visit is 
complete, another study 
coordinator or nurse reviews the 
visit documentation and compare to 
the EDC. 
Following each study 
visit 
Everyone on the study 
team responsible for 
primary data collection.
Review of documentation of 
all adverse events
After data collection for a visit is 
complete, another study 
coordinator or nurse reviews the 
visit documentation. 
Following each study 
visit 
Everyone on the study 
team responsible for 
primary data collection.
Monitoring of critical data 
points (eligibility, study 
endpoints, etc.)
Self-assessment tool will be 
completed by study staff twice 
annually while subjects are still 
active on study. 
Twice annually while 
subjects are still 
active on study.
Lead Study 
Coordinator/Nurse
Laboratory review of 
processing and storage of 
specimens
Self-assessment tool will be 
completed by study staff twice 
annually while subjects are still 
active on study.
At study initiation, 
twice annually while 
subjects are still on 
study and at IRB 
close out. 
Hope Clinic Laboratory 
Manager

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DSMP Requirement
How this Requirement is Met 
Frequency
Responsible Party(ies)
Assessment of laboratory 
specimens stored locally
Self-assessment tool will be 
completed by study staff twice 
annually while subjects are still 
active on study.
Twice annually while 
subjects are still 
active on study. 
Hope Clinic Laboratory 
Manager
Test article accountability 
review
Self-assessment tool will be 
completed by study staff twice 
annually while subjects are still 
active on study.
At study initiation, 
twice annually while 
subjects are still on 
study and after the 
last subject has 
completed all dosing 
visits. 
Investigational Drug 
Services (IDS) 
Pharmacist 
Accountability logs, 
dispensing records, and 
other participant records 
Self-assessment tool will be 
completed by study staff twice 
annually while subjects are still 
active on study.
Twice annually while 
subjects are still 
active on study.
Investigational Drug 
Services (IDS) 
Pharmacist
For FDA regulated 
studies, the following 
requirements apply:
How this Requirement is Met
Timing, frequency, 
and intensity of 
monitoring
Responsible Party(ies)
Monitoring methods (may 
include centralized, on-site, 
and self-assessment)
N/A
N/A
N/A
Subject Safety
Physical exam, medical history, and safety labs will be checked prior to each biopsy visit to 
ensure no increased risk for complications. Biopsy procedures will be conducted with all 
disposable materials in a private clinic room. Case report forms will be completed in a timely 
fashion so as to be reviewed by the PI, study staff, etc. The participant will be contacted 1-2 
days after biopsy procedures to collect any adverse events. Once an unanticipated event is 
recognized and reported, the event will be investigated to determine if the event represents 
an unreasonable risk to the subject so as to terminate all or part of the study. 
The investigators will review all data in real time and resolve any inconsistencies. Adverse 
events associated with rectal biopsy will be reported per local IRB/EC requirements.  
22. Provisions to Protect the Privacy Interest of Participants
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be stored in locked cabinets at the Hope Clinic or on a secure online 
database. Electronic data will not include the participant’s contact or identifying information. 
Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by the 
Hope Clinic research staff will be secured and password protected. At the end of the study, 
all study databases will be de-identified and archived.  
Authorized representatives of the sponsor, Emory Institutional Review Board (IRB), and/or 
regulatory agencies may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) and 

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pharmacy records for the participants in this study. The clinical study site will permit access 
to such records.  
23. Economic Burden to Participants
There will be no costs to subjects for participating in this study, other than basic expenses 
like transportation.  
24. Informed Consent 
The protocol informed consent form documents that a participant (1) has been informed 
about the potential risks, benefits, and alternatives to participation, and (2) is willing to 
participate in the study. Informed consent encompasses all written or verbal study 
information study staff provide to the participant, before and during the trial. Study staff will 
obtain informed consent of participants according to applicable policies and procedures.  
The informed consent process will continue throughout the study. Key study concepts will be 
reviewed periodically with the participant and the review will be documented. At each study 
visit, study staff will consider reviewing the procedures and requirements for that visit and for 
the remaining visits.  
Additionally, if any new information is learned that might affect the participants’ decisions to 
stay in the trial, this information will be shared with trial participants. If necessary, 
participants will be asked to sign revised informed consent forms. 
Process to Document Consent in Writing  
Informed consent is a process that is initiated prior to the individual’s agreeing to participate 
in the study and continues throughout the individual’s study participation. Consent forms will 
be Institutional Review Board (IRB)-approved.  
The investigator or his/her designee will explain the research study to the participant and 
answer any questions that may arise. A verbal explanation will be provided in terms suited 
to the participant’s comprehension of the purposes, procedures, and potential risks of the 
study and of their rights as research participants. Participants will have the opportunity to 
carefully review the written consent form and ask questions prior to signing. The participants 
should have the opportunity to discuss the study with their family or surrogates or think 
about it prior to agreeing to participate. The participant will sign the informed consent 
document prior to any procedures being done specifically for the study. Participants must be 
informed that participation is voluntary and that they may withdraw from the study at any 
time, without prejudice. A copy of the informed consent document will be given to the 
participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if 
they decline to participate in this study.  
Non-English-Speaking Participants: If any non-English speaking participants plan to be 
enrolled, the study team will first use the Emory IRB provided short forms. Then, have the 
consent translated into the language the participant is proficient in, per IRB policy. 
Participants who are not yet adults (infants, children, teenagers): Not applicable 
Cognitively Impaired Adults: Not applicable  

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Adults Unable to Consent: Not applicable  
Waiver or Alteration of Consent Process:  
Per IRB guidance (http://www.irb.emory.edu/forms/consent_toolkit/index.html) studies that 
are not covered by HIPAA and are not conducting any procedures during pre-screening do 
not require an oral consent. Therefore, we will not be obtaining oral consent prior to the 
phone screening questionnaire.  
25. Setting
All participant procedures will be completed in a clinic setting at the Emory Hope Clinic, 
except the at home doses.  Emory Healthcare and Grady will only be utilized for identifying 
potential participants through EeMR. No study activities will take place at Emory Healthcare 
or Grady.
26. Resources Available
The Hope Clinic routinely meets enrollment goals. Over the years, we’ve developed a large 
pool of people interested in participating in our studies as well as strong partnerships that 
serve as resources for new potential participants. The Hope Clinic has been highly 
successful in recruiting subjects who are either at lower or higher risk of acquiring HIV 
infection and the LGBT community. The study team does not anticipate any issues recruiting 
for this study.  
The Hope Clinic is a research-only facility in Decatur, with approximately 50 ongoing studies 
at a time. The facility has 8 clinic rooms on the top floor in which to see participants. The 
bottom floor houses the sample processing and storage lab. At all times there is a clinician 
in the clinic available to study staff (all clinicians are on all studies). Should a medical 
emergency arise, the clinician will manage the immediate situation. The Hope Clinic is 
located across the street from Emory Decatur Hospital. If needed, Hope Clinic staff would 
call 911 and have the participant transported there.  
All Hope Clinic research staff have completed all Emory University institutional required 
research training. Prior to working on the study, each staff member is trained thoroughly on 
each protocol and it’s supporting documents. There is a dedicated regulatory coordinator 
who ensures all training and delegation is completed appropriately for each study. 
27. References
1.
Molina JM, Capitant C, Spire B, et al. On-Demand Preexposure Prophylaxis in Men at High 
Risk for HIV-1 Infection. The New England journal of medicine 2015;373:2237-46.
2.
Massud I, Ruone S, Zlotorzynska M, et al. Single oral dose for HIV pre or post-exposure 
prophylaxis: user desirability and biological efficacy in macaques. EBioMedicine 
2020;58:102894.
3.
Service UPH. Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United 
States - 2014 Update: A Clinical Practice Guideline2014. 2014.
4.
Stewart J, Bukusi E, Sesay FA, et al. Doxycycline post-exposure prophylaxis for prevention 
of sexually transmitted infections among Kenyan women using HIV pre-exposure 
prophylaxis: study protocol for an open-label randomized trial. Trials 2022;23:495.
5.
Gatto NM, Frucht H, Sundararajan V, Jacobson JS, Grann VR, Neugut AI. Risk of 
perforation after colonoscopy and sigmoidoscopy: a population-based study. Journal of the 
National Cancer Institute 2003;95:230-6.

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6.
Koobatian GJ, Choi PM. Safety of surveillance colonoscopy in long-standing ulcerative 
colitis. The American journal of gastroenterology 1994;89:1472-5.
7.
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.
8.
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;69:906-10.
9.
Grant JS, Stafylis C, Celum C, et al. Doxycycline Prophylaxis for Bacterial Sexually 
Transmitted Infections. Clinical infectious diseases : an official publication of the Infectious 
Diseases Society of America 2020;70:1247-53.
10. Molina JM, Charreau I, Chidiac C, et al. Post-exposure prophylaxis with doxycycline to 
prevent sexually transmitted infections in men who have sex with men: an open-label 
randomised substudy of the ANRS IPERGAY trial. The Lancet Infectious diseases 
2018;18:308-17.
11. Peyriere H, Makinson A, Marchandin H, Reynes J. Doxycycline in the management of 
sexually transmitted infections. The Journal of antimicrobial chemotherapy 2018;73:553-63.
 
28. Protocol Checklist
Please note that protocol sections with an asterisk (*) should always be included in the 
protocol; if the section does not have an asterisk, and you have not included the section in the 
protocol, the IRB will consider it your attestation that the section does not apply to your study.
Protocol Section
Added 
to the 
protoc
ol?
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)  
☒ Yes
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding.
☒ Yes
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested
☒ Yes
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge
☒ Yes
Study Endpoints*: Describe the primary and secondary study endpoints. Describe any 
primary or secondary safety endpoints. 
☒ Yes
Study Intervention/Investigational Agent*: Describe the study intervention and/or 
investigational agent (e.g., drug, device) that is being evaluated.  
☒ Yes
Drug/Device Handling: If the research involves drugs or devices, describe your plans to 
store, handle, and administer those drugs or devices so that they will be used only on 
participants and be used only by authorized investigators.
☒ Yes

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If using a drug, explain if the control of the drug is managed by IDS (or VA/Grady/CHOA 
research pharmacies). If not, provide IDS exemption document.
If a device, explain how the device is being stored and managed.
If the drug is under an FDA REMS, plan to complete the REMS checklist found here, on the 
IRB website.
☐ Yes
If the drug is considered a controlled substance, make sure you have filled out this form.
☐ Yes
If applicable, identify the holder of the IND/IDE/Abbreviated IDE. An Emory investigator who 
holds an IND or IDE is considered to be a Sponsor-Investigator (S-I). If the study is under an 
S-I, review this section of our website for additional requirements.
☒ Yes
Procedures involved*: Describe and explain the study design and include a study schema.  
Describe all research procedures being performed and when they are performed, including 
procedures being performed to monitor participants for safety or minimize risks
☒ Yes
Procedures-Minimizing risk*: describe the procedures performed to lessen the probability 
or magnitude of risks.
☒ Yes
Procedures- Drug/Device Use: describe all drugs and devices used in the research and 
the purpose of their use and their regulatory approval status
☒ Yes
Procedures-Source Records*: describe source records that will be used to collect data 
about participants. Attach all surveys, scripts, and data collection forms to the submission.
☒ Yes
Procedures-Data collection*: describe what data will be collected during the study and 
how that data will be obtained
☒ Yes
Procedures- Long Term Follow Up*: once all research-related procedures are complete, 
what data will be collected during this period.  If no data is collected after procedures are 
completed, please state in the submission.
☒ Yes
Data and Specimen Banking: describe where the specimens will be stored, how long they 
will be stored, how the specimens will be accessed, and who will have access to the 
specimens.  Depending on the volume and nature of the collection, this may require a 
separate repository-specific IRB submission. The VA Data Repository SOP is required if the 
study is creating a data repository at the Atlanta VA.
List the data to be stored or associated with each specimen.
Describe the procedures to release data or specimens, including the process to request a 
release, approvals required for release, who can obtain data or specimens, and the data to 
be provided with specimens.
☒ Yes

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Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the participant’s primary care 
physicians) and if so, describe how the results will be shared If applicable (e.g. for studies 
involving scans and/or panels of exploratory testing on specimens)
Plan for managing the types of findings that might arise. This should include any secondary 
findings that are being sought actively, findings that might be anticipatable, and findings that 
might be un-anticipatable. 
Plan for recognizing, analyzing, and handling incidental findings and how incidental findings 
will be communicated to participants during the consent process. If the plan is not to disclose 
any findings, then this should be included. This plan might include the option for participants 
to opt-out of receiving incidental findings.
Description of the research team’s responsibilities following disclosure of a finding. This 
should detail educational information about the nature of the finding, how to seek care from 
a clinician or specialist, obtaining health insurance to secure treatment, and/or referral to a 
clinical specialist, if one is required. 
Reminder to include language in the consent form to let the participants know your plans for 
this – see Modular Language for Informed Consent Forms on IRB website)
☒ Yes
Study timelines*: describe the duration of an individual participant’s participation in the 
study; anticipated time to enroll all study participants and the estimated date for the 
investigators to complete this study (complete primary analyses)
☒ Yes
Inclusion and Exclusion Criteria*: describe how individuals will be screened for eligibility 
and the criteria that define who will be included or excluded in your final study sample 
☒ Yes
Population*: describe the study popualation and indicate specifically whether you will 
include or exclude each of the following special populations: 

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Note: you cannot exclude people with limited English proficiency unless you can 
demonstrate the scientific need for such exclusion.
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community in 
the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?  
If studying Race or Ethnicity, have you defined these terms, and explained their 
proposed mechanism of action if these characteristics will be used in an explanatory 
model?
☒ Yes

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Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☒ Yes
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☒ Yes
Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☒ Yes
Research involving economically or educationally disadvantaged persons: describe 
the additional safeguards that have been included in the study to protect the rights and 
welfare of these subjects
☒ Yes
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to be 
enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.) 
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.   
☒ Yes
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited.  Describe the source of participants. Describe the methods that will be used to 
identify potential participants.  Describe materials that will be used to recruit participants. 
Attach copies of these documents with the application. 
If including advertisements, attach the final copy of them. When advertisements are taped 
for broadcast, attach the final audio/videotape. You may submit the wording of the 
advertisement before taping to preclude re-taping because of inappropriate wording, 
provided the IRB reviews the final audio/videotape. Describe the amount and timing of any 
payments to participants. Reimbursement for expenses/travel?
If using contests or raffles as incentive, you must offer entry to all potential participants, not 
just those who enroll in the study/complete study-related procedures, per Georgia State 
Law.
All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities.
☒ Yes
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe any procedures for 
orderly termination. Describe procedures that will be followed when participants withdraw 
☒ Yes

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from the research, including partial withdrawal from procedures with continued data 
collection.
Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks.
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable.
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant.
If applicable, describe risks to others who are not participants.
☒ Yes
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience from taking part in the research. Include as may be useful for 
the IRB’s consideration, the probability, magnitude, and duration of the potential benefits.
Indicate if there is no direct benefit. Do not include benefits to society or others.
☒ Yes
Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit). Describe the amount and timing of any payments to participants.  
How much?  What kind?  Is tax information required? (if so, must be reflected in the 
informed consent form). Will payments be pro-rated if a participant withdraws early?
☒ Yes
Data Management and Confidentiality*: Describe the data analysis plan, including any 
statistical procedures or power analysis. Describe the steps that will be taken to secure the 
data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during storage, 
use, and transmission. Describe any procedures that will be used for the quality control of 
collected data. 
☒ Yes
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens?
•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or specimens?
•
How data or specimens will be transported?
☒ Yes
Data Monitoring and Participants Safety (if this study is more than minimal risk, this 
section is required): 
Ensure that you review our Data and Safety Monitoring plan guidance for specific details 
about this section, and examples of what the IRB will be requiring according to the level of 
risk.
☒ Yes

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If a DSMB is needed, please describe the composition of the board (if not already detailed 
in the protocol).  Review this guidance for more information.  If the sponsor protocol does 
not contain all required information, please in this section. 
Describe the plan to periodically monitor the data at the site level according to risk level. 
Include the appropriate completed monitoring table, if applicable. 
Description of the plan for notifying the IRB of reportable events, whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, a 
description of the requirements and plan for meeting them. 
Please address the specific details below. If deemed not applicable, please provide 
rationale:
Subject safety:

Specific subject safety parameters 

Frequency of subject safety observations

Individual responsible for safety monitoring

Subject stopping rules – under what conditions will a subject be removed from study 
participation and who will make the decision?

Study stopping rules - under what conditions will the study be modified or stopped 
and who will make the decision?

Reporting mechanisms (i.e. Deviations, adverse events, UPs)
Data Integrity:

Specific data elements to be reviewed

Frequency of monitoring data, points in time, or after a specific number of 
participants

Individual responsible for data monitoring
Additional considerations for FDA regulated trials 
Depending on the procedures affecting risks to participants, the site monitoring plan should 
specify:

Categorization of activities done centrally and those on-site if applicable

Monitoring methods (may include centralized/remote, on-site, and self-monitoring)

Reference to any tools used (i.e. checklists)

Identification of events that may trigger changes

Identification of deviations or failures that would be critical to study integrity
Provisions to Protect the Privacy Interests of Participants*: 

Describe the steps that will be taken to protect participants’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact with or whom 
they provide personal information.

Describe what steps you will take to make the participants feel at ease with the research 
situation in terms of the questions being asked and the procedures being performed. “At 
ease” does not refer to physical discomfort, but the sense of intrusiveness a participant 
might experience in response to questions, examinations, and procedures.

Indicate how the research team is permitted to access any sources of information about 
the participants.
☒ Yes
Economic Burden to Participants*: Describe any costs that participants may be 
responsible for because of participation in the research.
☒ Yes

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Consent Process*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent.
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to ensure 
the participants’ understanding.
Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit.
☒ Yes
Consent Process-Non-English-Speaking Participants*: 
Indicate what language(s) other than English are understood by prospective participants or 
representatives.
If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent.
If you checked N/A, please provide reasoning of why subjects with limited English 
proficiency are excluded. 
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here.
☒ Yes
Consent Process-Children: After determining if the subject is a child per GA law (or if 
enrolled outside GA, per state/country law), please describe whether parental permission will 
be obtained from:

Both parents unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of the 
child.

One parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child.
Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care.
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures
☒ Yes
Consent Process-Cognitively Impaired Adults:  describe the process to determine 
whether an individual is capable of consent. The IRB allows the person obtaining assent to 
document assent on the consent document and does not routinely require assent 
documents and does not routinely require children to sign assent documents.
☒ Yes
Consent Process-Adults Unable to Consent:  List the individuals from whom permission 
will be obtained in the order of priority. (E.g., durable power of attorney for health care, a 
court-appointed guardian for health care decisions, spouse, and adult child.)
☒ Yes

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For research conducted in the state, review “46 LEGALLY AUTHORIZED 
REPRESENTATIVES AND SURROGATE CONSENT” to be aware of which individuals in 
the state meet the definition of “legally authorized representative.”
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective subject 
to their participation in the procedure(s) involved in this research. 
Describe the process for the assent of the participants. Indicate whether:

Assent will be required of all, some, or none of the participants. If some, indicated, which 
participants will be required to assent and which will not.

If assent will not be obtained from some or all participants, an explanation of why not.
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception) 
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations.
If the research involves a waiver of the consent process for planned emergency research, 
please review the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to 
ensure you have provided sufficient information for the IRB to make these determinations.
☒ Yes
Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization.
☒ Yes
Resources Available*: Describe the resources available to conduct the research such us 
the feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing the 
research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe 
your process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions.
☒ Yes
Multi-Site Research when Emory is the Lead Site:
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites.
Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  
Describe when, where, and how potential participants will be recruited.
☒ Yes

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Describe the methods that will be used to identify potential participants.
Describe materials that will be used to recruit participants. 
Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization.
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record).
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented.
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies.
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws. 
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”):

Problems (inclusive of reportable events).

Interim results.

The closure of a study
If this is a multicenter study where you are a participating site/investigator, describe the local 
procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”)

Where and how data or specimens will be stored locally?

How long the data or specimens will be stored locally?

Who will have access to the data or specimens locally?

Who is responsible for receipt or transmission of the data or specimens locally?

How data and specimens will be transported locally?