Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore
Phase: NA
Conditions: HIV Infections, Syphilis
Sponsor: Johns Hopkins University

 
Date: 08/15/2024. Principal Investigator: Matthew Hamill MBChB, PhD. Application Number: IRB00274090 
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JHM IRB - eForm A – Protocol 
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ENDING THE HIV EPIDEMIC THROUGH POINT-OF-CARE 
TECHNOLOGIES (EHPOC): PERFORMANCE EVALUATION OF 
NOVEL POC HIV TESTS IN BALTIMORE 
NCT number: NCT04793750 
List of abbreviations: 
Ab: Antibody 
Ag: Antigen 
AIDS: Acquired Immunodeficiency Syndrome 
ART: Anti-Retroviral Therapy 
CDC: Centers for Disease Control and Prevention  
CLIA: Clinical Laboratory Improvement Amendments 
EHE: Ending the HIV Epidemic 
HIV: Human Immunodeficiency Virus 
MSM: Men who have Sex with Men 
NAAT: Nucleic Acid Amplification test  
POC: Point Of Care 
POCT: Point Of Care Test 
PEP: Post Exposure Prophylaxis 
PrEP: Pre Exposure Prophylaxis 
RNA: Ribonucleic Acid 
STI: Sexually Transmitted Infections 
SOC: Standard of Care 
US: United States 

 
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VL: Viral Load 
1. Abstract: 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
The strategy for Ending the HIV Epidemic (EHE) includes four key strategies that together can 
end the HIV epidemic in the United States (US): Diagnose, Treat, Prevent, and Respond. 
Diagnosis is the gateway to all other interventions; it is the cornerstone of EHE. In 2019/20 it was 
estimated that more than 160,000 Americans are unaware they are living with HIV[1]. Early 
diagnosis coupled with rapid linkage to care is critical and can lead to improved individual and 
community health outcomes. Achieving this goal will require improved, more accessible, and 
routine HIV testing; immediately connecting people with HIV to care services; and connecting 
those without HIV to appropriate HIV prevention services. Maryland was ranked 6th among states 
and territories in adult/adolescent HIV diagnosis rates (per 100,000) in 2018, tied with Mississippi. 
Among people living with HIV in Maryland in 2019, the Centers for Disease Control and 
Prevention (CDC) estimated that 89.2% had been diagnosed, and that ~3,830 people with HIV are 
undiagnosed[2].  
Evaluation of existing and new point-of-care (POC) HIV tests is needed to inform testing 
guidelines and provide updated information to HIV test providers. Characterizing the performance 
of POC tests can provide estimates for the window period for HIV detection (i.e., the time from 
HIV acquisition to the time that a diagnostic test becomes positive). The window period provides 
key information needed to interpret an initial positive test result and assess the risk of transmission 
to others. It may also help guide decisions about repeat testing and initiation of ART in those with 
HIV and prevention interventions, including pre-exposure prophylaxis [PrEP] and post-exposure 
prophylaxis [PEP]) (in those without HIV)[3].   
During the window period for an HIV Antigen/Antibody (Ag/Ab) test, infected individuals may 
have non-reactive test results, falsely reassuring patients and providers. HIV RNA (or ‘viral load’ 
[VL]) assays have window periods that are approximately 10 days shorter than most HIV Ag/Ab 
tests, providing greater sensitivity for detection of early HIV infection[4]. Use of HIV RNA 
detection platforms for HIV screening facilitates earlier diagnosis and more effective 
implementation of ART and PrEP. This may be especially useful in settings where infection is 
acquired in persons using PrEP, since PrEP agents may suppress viral replication and delay 
antibody production.  
The following hypotheses underpin the planned study: 
A. Determining the performance characteristics of HIV POC tests will inform optimal testing 
strategies in different populations and settings. 
B. Use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services.  
The implications of this CDC-sponsored research are important, since this research could improve 
early diagnosis of HIV, reduce the time to ART initiation, and facilitate timely and appropriate 

 
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referral for prevention services. Additionally, if someone is infected while using long-acting PrEP, 
or initiated PrEP while infected, the risk of resistance and side effects can be minimized; if 
infection is missed. These are critical issues for EHE success.  
2. Objectives: 
Primary: To evaluate the impact of a HIV POC viral load (molecular) test on linkage to HIV care 
or prevention in persons with, or at higher risk of, HIV infection being seen in acute care settings.  
Secondary: A. To evaluate the performance of HIV POC serologic tests using fresh whole blood 
and oral fluid specimens at baseline in all participants against a reference lab HIV testing algorithm 
B. To evaluate the seroconversion sensitivity of the HIV tests through serial follow-up and describe 
characteristics of persons in the process of seroconversion compared to those of persons with 
established infection. 
Exploratory Aim:  Evaluate the diagnostic and clinical performance of the Roche cobas® Plasma 
Separation Cards compared to point-of-care and nucleic acid tests in clinical settings. Remnant 
venous blood collected from a random subset of participants (up to N=100) may be spotted on 
Plasma Separation Cards, stored for a minimum of 4 hours and up to 56 days and then processed. 
Results will be compared against plasma HIV RNA levels to determine the sensitivity of POC 
NAATs at varying levels of viremia.    
3. Background:  
(briefly describe pre-clinical and clinical data, current experience with procedures, drug or device, 
and any other relevant information to justify the research)  
Identification of HIV infection in the acute stage serves a public health need since those with acute 
infection usually have high viral loads and thus, have an increased risk of transmitting infection[5].  
In this phase of infection, tests based on HIV antigen and/or antibody will often be non-
reactive/negative. Lack of a timely diagnosis can increase the risk of on-going HIV transmission, 
since initiation of ART will be delayed[6, 7]. Studies suggest that early initiation of ART has both 
clinical and public health benefits[6].  Although sensitivity of HIV Ag/Ab tests appears to be 
improving over time, these tests are not sufficiently sensitive for detecting many early/acute 
infections. Assays that measure HIV RNA have traditionally been complicated, available only in 
centralized reference labs, and expensive to perform; although a variety of strategies to use these 
tests for HIV screening in clinical settings have been proposed, these tests are still not widely used 
at the POC. In a 2019 review of 32 manuscripts, Agutu et al. examined the performance and clinical 
utility of HIV VL POC tests[8].  The authors concluded that HIV VL POC assay performance was 
comparable to reference assays, and have potential to improve patient outcomes. Of the studies 
examined, only two studies (with comparator testing) used the results of the POC assays for clinical 
management. Studies using the Cepheid GeneXpert HIV-1 Qual POC HIV VL to assist with early 
infant HIV diagnosis demonstrated a sensitivity of 94.1% and specificity of 99.8% compared to 
the standard of care Roche CAP/CTM HIV-1 qualitative PCR assay[9].  

 
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Several new HIV tests have recently been approved by the US Food and Drug Administration 
(FDA) for use on unprocessed specimens (e.g., fingerstick whole blood and/or oral fluid) at POC, 
or their approval is imminent. In a Peruvian study, the Chembio HIV-syphilis DPP test with an 
electronic reader demonstrated excellent sensitivity and specificity for HIV antibody detection 
(100.0% [97.6–100.0] and 98.7% [96.6–99.6], respectively). The detection of Treponema pallidum 
(TP) antibodies had slightly lower sensitivity (compared to HIV) with high specificity, (94.7% 
[89.8–97.7] and 99.7% [98.2–100.0], respectively)[10]. Syphilis can pre-date HIV infection in 
high risk individuals, having a dual test may be useful in identifying individuals with syphilis most 
likely to benefit from HIV PrEP[11-13]. 
Evaluation of new HIV testing technologies in high-risk populations will require evaluation of the 
sensitivity of these tests during the earliest stages of infection, including the acute stage, and 
comparing their performance against other rapid tests and the gold-standard reference lab standard 
algorithm. This information will help identify persons with previously undiagnosed infection, 
those in care who may not be taking their antiretroviral therapy, and those at high risk who may 
benefit from pre-exposure prophylaxis and using the results to link participants to appropriate 
treatment or prevention services.  
4. Prior research:  
In the past, the CDC Special Studies and Diagnostics team in the Behavioral and Clinical 
Surveillance Branch in the Division of HIV/AIDS has been involved in studies that evaluated the 
performance of HIV tests approved for use in the US, including rapid HIV tests intended for use 
at POC and laboratory-based HIV testing technologies[14]. A key finding was that OraQuick test 
using oral fluid samples detected fewer infections than the comparator tests[15].  Additionally, in 
a study of testing preferences among men who have sex with men (MSM) seeking HIV testing, 
O’Neal et al found that MSM often opted for oral fluid testing, even though they trusted and 
preferred more sensitive HIV testing methods, such as HIV Nucleic Acid Amplification Tests 
(NAAT)[16]. These evaluations led to the development of revised guidelines for HIV testing in 
the US[17].  The CDC’s HIV Laboratory Branch also participated in evaluation of newly-approved 
testing technologies for which field performance data were not yet available[18, 19]. The 
Laboratory Branch is also working closely with test manufacturers to develop and refine nucleic 
acid tests for use at POC, in both the US and resource-limited settings[20].  
Justification for the current study 
The CDC provides guidelines for HIV testing and diagnosis for the US, as well as 
programmatic technical guidance for its grantees. Detailed evaluation of the diagnostic 
performance of nucleic acid (molecular) tests in real-world settings will allow the CDC to 
determine the applicability of this technology for use in a variety of clinical and POC 
settings. The CDC will use data collected in this study to inform HIV testing guidelines 
and provide information to HIV test providers about the appropriate use of different HIV 
testing technologies in different settings and for different populations. 

 
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5. Study Design/procedures: 
a. Study design, including the sequence and timing of study procedures (distinguish research 
procedures from those that are part of routine care).  
Study Schema: 
 

 
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Patients attending clinical services will undergo their usual clinical procedures prior to joining the 
study; all SOC testing will be performed as usual. Potential study participants will be asked if they 
are interested in taking part in the study. Those who express an interest in the study will be 
introduced to a member of the research team to discuss the study, assess eligibility and provide 
written informed consent before any study procedures take place. Those who do not agree to 
participate will continue with their routine clinical care.  
 
Some potential participants might be at high risk of poor sexual health outcomes, but may not meet 
inclusion criteria for the randomized group because they are unable or unwilling to commit to the 
follow-up portion of the study or are taking daily ART or PrEP. In order to maximize equity of 
access to research opportunities for those described above, a non-randomized group will be made 
available. Those in the non-randomized group will be offered rapid and laboratory-based HIV and 
syphilis diagnostics, will be appropriately linked to care, and will have a telephone and/or an email 
follow-up interview at 4 weeks after their enrollment visit. 
 
Inclusion: 
- 
Aged 18 years or older 
- 
At high risk for HIV and STIs (e.g., patients who receive STI, HIV and/or HCV 
testing, or treatment for STI) 
- 
Willing to undergo phlebotomy and collection of oral fluid samples 
- 
Willing to complete a questionnaire   
- 
Willing to have laboratory results shared with the clinician(s) and Disease 
Intervention Specialists (DIS) associated with their care 
- 
Willing to complete follow-up visits/activities 
- 
Willing to have the research team look at the medical record to make a note of 
examination findings, diagnoses, and test results when required 
- 
Willing for samples to be stored at the Johns Hopkins STD research laboratory for 
future research use and for samples to be transferred to the CDC for analysis and 
storage 
- 
Randomized group only: 
▪ Those living with HIV who do not have a documented undetectable HIV 
viral load during the last 6 months or who do not take HIV medications 
every day; or, those at risk for HIV who are not taking daily PrEP 
 
Exclusion:  
- 
Aged <18 years 
- 
Unwilling to undergo study procedures 
- 
Any other reason deemed pertinent by the study team  
 
Study Procedures: 
At enrollment (all participants): 

 
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After informed consent, eligible participants will provide blood and oral fluid specimens which 
will be obtained to evaluate the performance characteristics of HIV (and syphilis) POC tests  
1. Chembio dual platform for HIV and syphilis (DPP HIV-Syphilis System) – whole blood 
2. OraSure OraQuick ADVANCE HIV, CLIA-waived rapid oral fluid test for HIV 
3. Reverse algorithm syphilis serological testing (EIA, RPR plus titer, TPPA) 
4. Collect Oral fluid (e.g. in DPP sampletainer) – process and freeze for storage in the 
biorepository and future lab evaluation of HIV and Syphilis at the CDC 
Blood and oral fluid samples will be tested in a Clinical Laboratory Improvement Amendments 
(CLIA)-waived laboratory at the study sites if appropriate, otherwise testing will happen at the 
research laboratory. The intent is that all specimens from prospectively-enrolled participants will 
be tested as soon as possible after collection (‘Prospective Fresh Specimens’) without freezing. 
Specimens obtained from prospectively-enrolled participants will also be frozen and saved for 
future HIV test evaluation purposes.  
All blood will also undergo the SOC HIV testing algorithm used at the Immunology Laboratory 
at Johns Hopkins Hospital (JHH). The current HIV testing protocol in this laboratory is: a 
laboratory-based, instrumented, Roche Elecsys HIV combi PT (an HIV-1/HIV-2 Ag/Ab 
immunoassay), with reflexive testing using the Geenius HIV1/2 Supplemental Assay, and ‘tie-
breaker’ Roche Cobas Quantitative HIV-1 RNA test.  
Participants will also complete a demographic, sexual behavior, and drug use questionnaire 
(Enrollment survey), and physical exam findings will be abstracted from the medical record if 
appropriate.  
For the randomized group, in addition to SOC testing, participants will also be randomized to 
either undergo HIV VL POC testing (Cepheid GeneXpert  HIV‐1 Viral Load (Xpert VL; Cepheid, 
Sunnyvale, CA)) using blood already collected or receive SOC testing only. . Those in the non-
randomized group will all undergo the Cepheid GeneXpert HIV-1 Qual test, if resources allow. If 
resources do not allow, the non-randomized group will undergo all standard HIV diagnostics 
without the HIV VL POC test. Those with confirmed HIV infection will be referred to their 
preferred clinician, and to the local Disease Intervention Specialist (DIS) team for linkage to care 
and partner services. Those with non-reactive/negative test results will be referred to their 
preferred clinician for consideration of HIV PrEP and prevention counselling. 
Participants will receive an HIV VL result from the Johns Hopkins Molecular virology lab within 
24 hours (same day) using either a validated FDA approved or a validated result from a research 
use only test performed in a CLIA-licensed lab. Only the results of FDA-approved testing or 
validated result from a research use only test performed in a CLIA-approved lab may be shared 
with participants. We will collect blood and transfer the sample to the Immunology Laboratory at 
JHH for testing. Participants will be contacted within 1 working day of results being released to 
clinical staff and referred to HIV prevention or treatment services. For the randomized group, in 
order to ensure that contact details are up-to-date and to proactively answer any participant 
questions we will contact participants between the 4- and 12-week visits by telephone, SMS, or 
email as previously agreed.  

 
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At Week 4 Visit (all participants – email and/or telephone call) 
Participant: Questionnaires: HIV symptom and care; behavioral survey. Linkage to care 
information. Change in medication. Results of interval laboratory tests. 
Study Team (abstraction from medical record): Participant symptoms, physical exam 
findings. Linkage to care information. Change in medication. Results of interval laboratory 
tests. 
At Week 12 Visit (participants in randomized group only) 
Participant: Questionnaires (using REDCap to be completed on site or through email as 
previously agreed): HIV symptom and care; behavioral survey. Provide oral fluid (e.g. in 
DPP sampletainer) – to be processed and frozen for storage in the biorepository and future 
lab evaluation of HIV and syphilis at the CDC. Linkage to care information. Change in 
medication. Results of interval laboratory tests.  
Study Team (abstraction from medical record): Participant symptoms, physical exam 
findings. Linkage to care information. Change in medication. Results of interval laboratory 
tests. 
Laboratory tests: HIV RNA testing – qual (batched) / quant (real time) – on everybody 
For participants with discordant Chembio DPP Syphilis results when compared with 
 
reverse algorithm syphilis serological testing results at enrollment, both tests will be 
 
repeated. 
Off-Study 
Randomized group: 
• After the completion of the 12-week visit, participants in the randomized group will be 
followed for an additional 30 days to monitor for any adverse events from the blood draw 
and any relevant outcomes (e.g. linkage-to-care). After this 30-day period, participants 
will be considered off-study and will no longer be followed. 
• For participants who do not complete the 12-week visit, after the eligibility window for 
the visit has passed, participants in the randomized group will be followed for an 
additional 30 days to monitor for any relevant outcomes (e.g. linkage-to-care). After this 
30-day period, participants will be considered off-study and will no longer be followed. 
Non-randomized group: 
• After the completion of the 4-week visit, participants in the non-randomized group will 
be followed for an additional 30 days to monitor for any relevant outcomes (e.g. linkage-
to-care). After this 30-day period, participants will be considered off-study and will no 
longer be followed. 
• For participants who do not complete the 4-week visit, after the eligibility window for the 
visit has passed, participants in the non-randomized group will be followed for an 

 
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additional 30 days to monitor for any relevant outcomes (e.g. linkage-to-care). After this 
30-day period, participants will be considered off-study and will no longer be followed. 
 
Sample storage  
During the consent process participants will be asked if they consent to sample storage at Johns 
Hopkins. For those who provide written consent, a proportion of samples will be sent to the Point 
of Care Center’s repository at Johns Hopkins University where they may be used to develop or 
test performance of STI diagnostics in the future.  
b. If your study involves data/biospecimens from participants enrolled under other research 
studies with a written consent or under a waiver of consent, please list the IRB application 
numbers for those studies.  Please note:  Certificate of Confidentiality (CoC) protections 
applied to the data in source studies funded by NIH or CDC will extend to this new study if 
the funding was active in 2016.  If this situation applies, Section 36, question 6 in the 
application will need to be answered “Yes” and “Hopkins Faculty” should be selected in 
question 7. No other documents are required. 
There are no plans to enroll participants enrolled in other research studies. 
c. Study duration and number of study visits required of research participants. 
The study will recruit participants over a 36-month period. Each participant will be enrolled for up 
to 12 weeks after the Day 0 visit.  
For all participants, the following visits are planned 
Day 0 – enrollment  
Week 4 post-enrollment (window: minus 7 days to plus 14 days) 
Week 12 post-enrollment, for the randomized group only (window: minus 14 days to plus 
21 days) 
Persons whose initial POC test results are discordant with laboratory-based HIV test results will 
be offered additional study follow-up visits to evaluate the seroconversion sensitivity of the HIV 
tests through serial follow-up.  
Discordance is defined as: 
• 
OraQuick result is different than DPP HIV result 
• 
OraQuick or DPP HIV are negative and lab algorithm indicates positive 
• 
OraQuick negative and Cobas quant/Cepheid GeneXpert HIV POC VL positive 
• 
DPP HIV negative and Cobas quant/Cepheid GeneXpert HIV POC VL positive 
• 
Any other permutation deemed relevant by the research team  

 
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This will include people with both newly diagnosed/acute HIV infection, and persons who had at 
least one false reactive/positive test result. These individuals will also be linked to routine clinical 
services for clinical care. The participants with discordant results will be followed by the study 
team until one of the following events occurs:   
1) They test reactive/positive for HIV for all tests being evaluated, 
2) They have two consecutive study visits with non-reactive/negative results for all tests 
(indicating tests that had false-reactive/positive results), or  
3) They complete follow up out to 70 days after the initial visit (Day 0).   
The follow-up schedule will include return visits at 3, 7, 10, 14, 21, 28, 42, 56, and 70 days after 
the initial visit (i.e., the day of Study participation or Day 0). At each follow-up visit, participants 
will provide blood (via venipuncture) and oral fluid specimens for storage and testing with the 
HIV POC tests under evaluation (e.g., OraQuick, DPP HIV/syphilis); other laboratory HIV 
diagnostics where applicable and HIV RNA Quant and HIV RNA Qual as well as complete a HIV 
symptom and care questionnaire. Linkage to care information. Change in medication. Results of 
interval laboratory tests. 
Day 0 – enrollment 
Day 3 (window minus 1 day to plus 2 days) 
Day 7 (window minus 1 day to plus 2 days) 
Day 10 (window minus 1 day to plus 2 days) 
Day 14 (window minus 1 day to plus 3 days) 
Day 21 (window minus 3 day to plus 3 days) 
Day 28 (window minus 3 day to plus 7 days) 
Day 42 (window minus 7 day to plus 7 days) 
Day 56 (window minus 7 day to plus 7 days) 
Day 70 (window minus 7 day to plus 14 days) 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
For the randomized group, participants will be randomized to receive either a POC HIV VL test 
or usual clinical care. It will not be possible to blind participants or the research team to this 
intervention. The participant and their clinician will be informed of the POC HIV VL result.   
e. Justification of why participants will not receive routine care or will have current therapy 
stopped. 

 
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All participants will receive routine clinical care. The study will provide additional assessments to 
routine care and will not replace any element of routine care. There is no implication for changes 
in participant’s current therapy. 
f. Justification for inclusion of a placebo or non-treatment group. 
There is no placebo group. Treatment is not a component of this study. For the randomized group, 
participants will be randomized to receive an additional HIV POC VL test that is not currently 
used in clinical practice in Baltimore to diagnose HIV infection and to guide referral for rapid ART 
initiation or HIV PrEP. There is sufficient equipoise to justify use of HIV POC VL testing.   
g. Definition of treatment failure or participant removal criteria. 
Treatment failure is not a component of this study.  
Participants who provide consent and are enrolled, but who do not provide biological samples will 
be classified as early withdrawals. 
Voluntary Withdrawal by a Participant: Participants may withdraw voluntarily from study 
participation at any time.  Participants who withdraw will continue their care with the appropriate 
clinical service for evaluation and care. 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
NA. Treatment is not a component of this study. 
i. If biological materials are involved, please describe all the experimental procedures and 
analyses in which they will be used. 
Blood samples: 
Blood:  
- 
POC HIV and syphilis testing (DPP HIV-Syphilis System) – whole blood 
- 
Plasma: POC HIV VL testing (Cepheid GeneXpert or comparable platform)  
- 
Plasma: Reference laboratory-based HIV diagnostic (Roche Elecsys with reflex to Geenius 
and Roche cobas quantitative HIV-1 RNA tie-breaker) and HIV RNA testing (Roche cobas 
qualitative and quantitative test) as appropriate. Plasma remaining after HIV diagnostic testing 
will be retrieved by study staff and used for IRB-approved testing, and biorepository storage.  
All Roche cobas qualitative tests will be run retrospectively on frozen plasma with batched 
testing.  
- 
Remnant blood collected from a random subset of participants (up to N=100) may be spotted 
on Plasma Separation Cards, stored and then processed. Results will be compared against SOC 
plasma HIV RNA viral load tests to determine the sensitivity of POC viral loads tests at varying 
levels of viremia.    
- 
Serum: reference lab-based testing for treponemal antibody testing, and, if positive, RPR titer.  
Serum remaining after treponemal antibody testing will be retrieved by study staff and stored 
in the research laboratory for IRB-approved testing, and biorepository storage. 

 
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- 
For storage for testing with future HIV or syphilis assays 
Oral fluid:  
- 
OraQuick HIV antibody testing  
- 
For storage for testing with future HIV assays (e.g., using the Chembio DPP sampletainer) 
Randomization: 
For participants in the randomized group, all eligible consented participants will be randomized 
to receive one of two testing arms using a computerized randomization system in the ratio of 1:1. 
Participants will be randomized to receive either POC HIV VL plus SOC testing or SOC testing 
only. Randomization will be performed by research staff after informed consent and verification 
of all eligibility criteria have been performed. 
Early Withdrawals: 
Participants who have provided consent and are enrolled, but who do not complete all study 
procedures at the time of enrollment, will be removed from the study and classified as early 
withdrawals. Participants may also be removed from the study early for failing to follow 
instructions, if continuation is deemed potentially harmful, or for any other reason at the 
discretion of the study principal investigator. 
6. Study sites: 
The following study sites are planned for the conduct of this study.  
1. Johns Hopkins Medicine Emergency Department (JHMED) 
2. The John G. Bartlett Specialty Practice (JGBSP), Johns Hopkins Hospital  
3. The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual 
Health Clinics 
These sites have been selected to provide optimal settings for patient interaction, and to provide 
access to patients at high risk of HIV infection.  
Potential participants may be seen at any of the sites mentioned below or the Clinical Research 
Units (CRU) at the Institute for Clinical and Translational Research (ICTR). 
Johns Hopkins Hospital Emergency Department (JHHED) is located in East Baltimore, 
Maryland. (Drs. Rothman and Hsieh).  The mission of JHHED is to provide a patient-centered care 
experience by world-class emergency health care providers. The JHH ED serves a predominantly 
socioeconomically-disadvantaged population in the metropolitan area with 60% from Baltimore 
City, one of the localities hardest hit by the HIV epidemic and 33% from Baltimore County. JHH 
adult ED patient population is comprised of 15% previous or current injection drug users, with a 
high prevalence of sexually transmitted infections (STIs) [21-23] and 6% HIV seroprevalence[24]. 
In FY 2022, the JHH ED had approximately 60,000 adult patient visits. Of these, approximately 
65% of the patients were Black or African American and 5% had previously-diagnosed HIV 

 
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infection [24]. The JHH ED has been a leader in ED-based HIV screening and linkage to care 
(LTC) programs since 2005 and currently has a robust testing and LTC program for both HIV and 
hepatitis C virus (HCV), operating since 2015. Past research includes evaluation of the feasibility 
and validation of new POC technologies. 
Johns Hopkins Bayview Medical Center Emergency Department (JHBMC ED) is located in 
East Baltimore, Maryland (Drs. Rothman and Hsieh). The mission of the JHBMC ED is to provide 
a patient-centered care experience by world-class emergency health care providers. The JHBMC 
ED, located 3.5 miles southeast of the JHHED near the city–county border, serves non-inner-city 
communities with diverse, socioeconomically-disadvantaged populations in the metropolitan area. 
The JHBMC ED patient population is comprised of 8% current injection drug users, with a high 
prevalence (~14%) of sexually transmitted infections (STIs) in those aged 18-31 years. In FY 2022, 
the JHBMC ED had approximately 51,500 adult patient visits. Of these, approximately 44% of the 
patients were White or Caucasian, 33% Black or African American, and 15% Latinx. The JHBMC 
ED implemented an ED-based rapid POC HIV screening and linkage to care (LTC) program from 
2008 to 2011, and since 2015 has operated a 4th generation venipuncture whole blood testing and 
LTC program for HIV. The newly diagnosed HIV infection rate from the testing program is 0.2%. 
John G. Bartlett Specialty Practice (JGBSP) is part of the Johns Hopkins Medical Institutions 
(JHMI), a non-profit academic medical center located in East Baltimore, Maryland.  Faculty from 
the Division of Infectious Diseases (ID) (Drs. Manabe and Hamill) in the Department of Medicine 
run the program; the mission is to provide outstanding, evidence-based, clinical infectious disease 
care, accessible to all. The population served by this practice is similar to the patient population of 
the JHH ED. This practice is a trusted local provider of HIV treatment and prevention services and 
provides care to more than 3,000 people living with HIV as well as patients with viral hepatitis, 
general ID, and transplant ID.  
This site has experience with on-site recruitment of clinician-collected and self-collected swabs 
for POC STI diagnostic testing.  
The Baltimore City Health Department (BCHD) Sexual Health and Wellness Clinics currently 
serve approximately 16,000 patients per year for STI testing, treatment and care. It operates two 
clinics one in East Baltimore (Fayette Street) and one clinic in West Baltimore (Druid). These 
areas have high rates of STIs, HIV, opioid use, and social deprivation. The clinics are each open 5 
days per week and provide care for STI, HIV, HCV and PrEP. The clinical services are headed by 
Clinical Chiefs in sexually transmitted disease (STD) (Dr. Hamill). The Johns Hopkins University 
School of Medicine (JHU SOM) has a greater than 30-year collaborative relationship with the 
HIV/STD Program at the BCHD.  
Routine opt-out serologic testing for HIV is provided. In many cases, testing is offered more 
frequently for high-risk patients, including patients on or eligible for PrEP. 
BCHD’s two sexual health and wellness clinics also play an important role for community 
members who may not otherwise have access to health-care services, including those who are 
uninsured/underinsured and at high risk for HIV.  

 
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We will also recruit potential participants through the use of flyers and by direct provider referral 
from Johns Hopkins Community Physicians (JHCP).  JHCP will partner with the study team to 
allow communication between the study team, clinicians, and potential participants through the 
use of flyers and study information. JHCP providers may also directly refer their patients to the 
study team if they (the patients) express an interest in learning more about the study. JHCP serves 
patients in more than 40 locations throughout Maryland and Washington, D.C. JHCP also provides 
access to a network of Johns Hopkins specialists. Their vision is to assist patients to achieve their 
best health by bringing Johns Hopkins Medicine to their communities. Associated with the Johns 
Hopkins Medical Institutions (JHMI), JHCP serves as a trusted source for excellent patient care in 
the communities it serves.  
Non-clinic-based recruitment:  
To maximize recruitment efforts and facilitate access to research to the broadest possible 
community, we will invite members of the public to consider joining the study. We will target key 
populations, including PrEP users, MSM, and transgender people through outreach to trusted 
community-based organizations (CBOs). Information will be made available through social media 
and more traditional methods, such as posters and flyers. Individuals who contact the study team 
expressing an interest in the study will be invited to the ICTR CRUs.  
Prior to study enrollment, the study team will confirm that people who are recruited via non-clinic 
venues have a medical provider who can be contacted with the results of positive study laboratory 
results. If a participant does not have a provider, the study team will confirm that they are willing 
to be referred to an appropriate provider for care and treatment.  
Venue for follow up visits and sample collection 
Study participants who are recruited from the non-clinical sites described above will be asked to 
come to the ICTR-CRUs. Similarly, for those with discordant HIV results (recruited from any 
location) will attend the CRU, Bartlett Clinic, and BCHD for their follow up visits.  
7. Drugs/ Substances/ Devices: 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
In this study, we will be testing performance of point of care (POC) devices, Chembio DPP 
HIV-Syphilis and OraQuick Advance HIV test, for rapid detection of HIV and Syphilis 
antibodies. Participants in the intervention (POC) arm will also receive nucleic acid 
amplification test for HIV viral load quantification using Roche Cobas HIV-1 Realtime 
PCR test and/or Cepheid GeneXpert HIV-1 viral load test.    
We acknowledge in-kind contribution (non-monetary support), as Roche Diagnostics and 
Cepheid have agreed to provide test kits (cartridges) for this study. 
b. Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed. 

 
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NA 
c. Justification and safety information if non-FDA approved drugs without an IND will 
be administered.  
NA 
8. Study Statistics: 
a. Primary outcome variable. 
Proportion of participants linked either to PrEP or ART 
b. Secondary outcome variables. 
Syphilis: linkage to syphilis treatment and time to linkage 
HIV: time to linkage to either PrEP or ART; HIV case identification; proportion of 
persons with HIV started on ART; proportion of persons with HIV and on ART who 
are virally suppressed at 12 weeks.  
HIV ‘knowledge’ – behavioral change (awareness/risk behavior change) since the time 
of diagnosis. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
With a LTC rate of 30% for known positive ED patients who are not in care and a 
ballpark estimated LTC rate of 50% in STD patients, this translates into an aggregate 
LTC rate of 40% (assuming 50% patient enrollment in the ED and 50% in the STD 
clinics). For the randomized group, assuming that the aggregate LTC rate will increase 
from 40% to 55% after the intervention (POC VL testing), a total of 173 participants 
are required to enroll in each arm to have a power of 80% to detect the increase of LTC 
rate from 40% to 55% with a two-sided significant level of 0.05. Factoring in 15% non-
response rate, we will need 204 participants in each arm, respectively. 
 
For the non-randomized group, we will recruit up to 1100 participants for the purpose 
of testing the performance characteristics of rapid tests for HIV and syphilis against 
SOC laboratory tests, and to bank biospecimens for future evaluation of new POC 
assays. 
 
We will first analyze descriptive data to determine the proportion of participants linked 
either to PrEP or ART and the time to linkage; the proportion HIV positive; the 
proportion with no prior syphilis history who needed treatment; the proportion in which 
the treponemal test had no added value; the proportion of patients who would still be 
in the ED/STD clinic at the time the test resulted (for PrEP or ART provision); the 
proportion of those testing HIV positive who were started on ART; the  proportion of 
those testing positive and started on ART who were virally suppressed at 12 weeks; 
and the proportion of those with syphilis who are linked to syphilis treatment. This will 

 
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be followed by bivariate analysis to explore the potential association between the 
independent variable (POC HIV VL test) and other covariates with the outcome 
variable of interest. Then, we will perform multivariate regression to determine the 
association between having a POC HIV VL test and linkage to PrEP or ART, with 
adjustment of covariates and confounders.  
 
We will perform survival analysis (Cox proportional hazard model) to model the time 
to linkage to PrEP or ART by study arm with adjustment of covariates and confounders. 
We will also evaluate the performance of the ChemBio DPP HIV test and OraSure oral- 
fluid assay by calculating the sensitivity, specificity, positive predictive value (PPV), 
and negative predictive value (NPV). 
 
d. Early stopping rules 
NA 
e. Secondary Analyses 
• Performance accuracy of ChemBio DPP HIV test and OraSure compared to SOC 
algorithm for HIV 
• Seroconversion sensitivity of ChemBio DPP HIV test and OraSure compared to SOC 
algorithm for HIV 
• Performance accuracy of the DPP syphilis test vs lab-based treponemal test;  
• Proportion HIV positive 
• Performance accuracy of the POC VL test vs quant and qual Roche VL 
• Agreement between HIV VL using plasma derived from remnant blood samples and HIV 
VL tested on plasma from separation cards compared  
• Proportion with no syphilis history who needed treatment;  
• Proportion in which the treponemal test had no added value  
• Turn-around time of the POC test to determine if the patients would have been in the 
ED/STI clinic at the time the test result became available for the clinician (PrEP or ART 
provision) 
f. Data Management Plan  
 
 
Collection: JHU will be responsible for collecting all data for this program. JHU project 
staff will enroll participants into the study. Participants will complete computer-assisted 
self-interviews and the data will be stored in an electronic high-security password-

 
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protected environment. Blood and oral fluid samples will be collected and submitted for 
laboratory analyses. Medical record information, including laboratory results, will be 
abstracted and linked to the individuals study record. All study data will be deidentified 
before submission to CDC. 
 
Protection: To ensure that each respondent’s information is protected, a unique study ID 
will be created for each participant and will be the only identifier included on the data 
collection instruments. Paper forms, when used, will be filed by the unique ID and date of 
interview and stored under lock and key; information collected on paper will be entered 
into the appropriate data system at the clinical study site and the paper forms will be 
destroyed within 5 years after the study has ended. In addition to the data policy, JHU 
will implement security procedures for any recipient systems, and information contained 
therein that cover all aspects of data handling for hard copy and electronic data, 
including: 
• Ensuring project data are secured against improper disclosure or unauthorized use of 
information. 
• Access to information only on a need-to-know basis, when necessary, in the 
performance of assigned duties.  
• Notify the supervisor, the Project Director, and the CDC PO, within one (1) hour, if 
information has either been disclosed to an unauthorized individual, used in an 
improper manner, or altered in an improper manner.  
• Report immediately to both the Project Director and the CDC PO all contacts and 
inquiries concerning information from unauthorized staff and non-research team 
personnel. 
 
Data sharing: CDC will receive only deidentified data and specimens. Data will be stored 
at CDC in secure servers with access limited to CDC staff who will conduct analyses for 
publications and presentations. Specimens stored in the CDC Biorepository. 
 
A Limited Data Set (LDS) will be shared with the CDC in accordance with the funding 
agreement. Before transmission to the CDC, the LDS will be approved by the JHM IRB. 
 
Once the primary outcomes papers of the project have been published, data will be 
available from the CDC Project Officer or the JHU PI (Dr. Hamill) by email. The 
requestor will provide a justification for the request and agree to include project staff 
from JHU and CDC on all publications or preventions. 
 
Long-term preservation of public health data: Prior to the end of the of the cooperative 
agreement, JHU and CDC will determine a data disposition plan. The data disposition 
plan may include several actions including purging or destroying data, moving data to 
less expensive or more secure storage like the cloud or offline, copying files to legal hold 
archives, or encrypting sensitive content to protect against breaches. 

 
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9. Risks: 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency. 
The major risks of participation in these studies are primarily related to HIV testing, but 
may also include risks specific to the research procedures. Participants may experience 
increased stress secondary to having discussions about HIV infection, risk factors for 
acquisition of HIV infection, discussion of past medical and sexual history and discussion 
of how to cope with a recent HIV diagnosis.   
Participants may learn that they are HIV-infected as part of these studies. Participants with 
acute HIV infection may have additional stress because they may be symptomatic with 
HIV seroconversion.  Blood draws can be uncomfortable and cause bruising. 
Participants may perceive a loss of confidentiality by having records accessible to study 
staff, study monitors and JHU regulatory or fiscal oversight staff.  Participants with a 
reactive point-of-care HIV test will speak with a DIS at the clinic to initiate partner 
services. Participants who test positive on laboratory tests after testing negative on all 
point-of-care tests will also receive DIS support.  
b. Steps taken to minimize the risks. 
Participant confidentiality will be paramount at all times. All conversations about sexual 
and other behaviors as well as medical history, and communicating laboratory results will 
take place in a private area. The procedures required for these research protocols are, for 
the most part, standard medical procedures that are carried out by highly qualified and 
experienced personnel.   
Stress, anxiety, and depression (for subjects diagnosed with HIV infection as part of these 
studies) as a result of study participation will be minimized by periodic reassurance, careful 
explanation of study procedures and results, maintenance of an open, supporting attitude 
by all study personnel, and referral back to participants’ primary providers for further 
evaluation and care as needed.  Routine clinical tests will be performed in CAP-certified 
laboratories to ensure accuracy of the results. Immediate care for any medical 
complications due to the study procedures will be provided by the investigators within their 
areas of competence. Participants diagnosed with HIV as part of these studies will be 
referred for primary care. These studies will not provide HIV care or HIV treatment. 
Study documents will be retained for a minimum of 2 years after study completion, and 
longer if required by the sponsor. Study records will be retained until a letter approving 
destruction of the records is received from sponsor; this letter will be kept with the 
regulatory file.  
Each participating site will maintain appropriate records for this study, in compliance with 
ICH E6, Section 4.9, regulatory and institutional requirements for the protection of 
confidentiality of subjects.  The site participating in this study will permit authorized 
representatives of the sponsor(s), and regulatory agencies to examine (and when required 

 
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by applicable law, copy) clinical records for the purposes of clinical site monitoring, quality 
assurance reviews, audits, and evaluation of study safety and progress.  
c. Plan for reporting unanticipated problems or study deviations. 
Study deviations occur when there is non-adherence to the Protocol and includes Informed 
Consent, enrollment, and other occurrences of non-adherence to the Protocol. Protocol 
deviations should be sent to the JHU IRB per the JHU IRB guidelines. Any protocol 
deviation that meets reporting requirements of the IRB will also be reported with the same 
timeliness to the Johns Hopkins IRB.  All deviations from the Protocol must be addressed 
in the study subject source documents. The documentation should include the reason(s) for 
the deviation and all attempts to prevent or correct the deviation.  The site must complete 
a Protocol Deviation Form documenting each protocol deviation.  A completed copy of the 
Protocol Deviation Form must be maintained in the regulatory file as well as in the 
subject’s source documents.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
There are no anticipated legal risks to participants based on breach of confidentiality. 
Utmost care will be taken to ensure that participant data are protected and secure at all 
times. In addition, a Certificate of Confidentiality (CoCs) protects the privacy of research 
participants by prohibiting disclosure of identifiable, sensitive research information to 
anyone not connected to the research except when the subject consents or in a few other 
specific situations. National Institutes of Health (NIH) funded researchers whose 
institutions determine that their research involves collecting or using identifiable, sensitive 
information are automatically deemed to be issued a CoC through their award. Several 
Department of Health and Human Services (HHS) agencies (including the CDC) issue 
CoCs for research they fund.  
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 
• 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 
• Biospecimens are collected 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 
• 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. 
 

 
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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; 
• 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. 
 
e. Financial risks to the participants. 

 
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There are no anticipated financial risks to the participants, there is no charge for any study-
related expenditure.  
10. Benefits: 
a. 
Description of the probable benefits for the participant and for society. 
The participants will probably benefit by having the opportunity for earlier diagnosis of 
HIV and syphilis infections, this will facilitate earlier treatment and avoidance of the 
sequalae of untreated STI. The participant will have the opportunity to learn more about 
their sexual health and will be referred for rapid start of treatment/prevention services as 
well as risk reduction counselling with a clinician.  
Society may benefit through a) the reduction of spread of STIs in the community; b) 
participating in a study that may change CDC guidelines and improve HIV testing that will 
be available to all.  
11. Payment and Remuneration: 
a. 
Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
There is no payment for participating in this study. However, participants will receive a 
reimbursement of $40 for each in-person study visit attended and completed. Participants 
that complete in-person research clinic visits will also receive a parking voucher or two MTA bus 
tokens if applicable. 
12. Costs: 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them. 
There is no charge for any study-related expenditure. All study procedures and test will be 
paid for by the study. 
13. Transfer of Materials: 
Transfer of biospecimens from Johns Hopkins to another organization for research 
purposes and receipt of biospecimens from an outside organization for your research must 
adhere to JHU policies for material transfer (https://ventures.jhu.edu/faculty-
inventors/forms-policies/) 
and 
biospecimen 
transfer 
(https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.622
324232879).  

 
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Please complete this section if your research involves transfer or receipt of biospecimens. 
 
a. Will you receive biospecimens from an external entity for this research?  
No.  
 
If “Yes”, please confirm you will secure an MTA/research agreement from the appropriate 
office  (JHTV/ORA) prior to transfer.  
b. Will you transfer biospecimens to an external entity as part of this research?  
Yes. We will adhere to the Johns Hopkins “Transferring Human Biospecimens to Outside 
Organization” policy.  
https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.25523869118   
(See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/ .) 
 
 
If “Yes”, please address each of the following: 
1) Describe the nature of the research collaboration with the external entity and the rationale 
for the transfer. (Include an explanation of your intellectual contribution to the design of 
the research study, resulting data and sharing, and participation in the planned 
publications.) 
The Johns Hopkins team has designed the protocol in collaboration with the CDC.    JHU will 
undertake data analysis in conjunction with the CDC.  The JHU team will also take the lead on 
any future academic publications and collaborate with the CDC in these efforts. The CDC will 
store these samples in a biorepository, to allow cross validation with other samples from different 
populations and geographical regions. 
The study team will transfer deidentified processed plasma separation cards to Roche Diagnostics 
for HIV testing as described in the exploratory aim (page 3). JHU will only share the study ID 
number assigned to each participant. Roche will share the testing results with the JHU team (HIV 
qual and quant). The JHU team will only share the aggregate level concordance of the results as 
compared to SOC testing performed at JHU. 
2) Please confirm you will secure an MTA through the appropriate office (JHTV or ORA) 
prior to transfer. 
Yes   
3) If the biospecimens you intend to transfer were obtained through clinical or research 
procedures at Johns Hopkins and “Other” is selected in Item 4, Section 23, please 
submit the following items in that Section: 

 
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a. A pdf version of a completed JHTV Online “Material Transfer Agreement Request Form for 
Outbound 
Material” 
https://ventures.jhu.edu/technology-transfer/material-transfer-
agreements/ OR a copy of the COEUS PD (Proposal Development Summary). 
Submitted 
b. A 
completed 
Biospecimen 
Transfer 
Information 
Sheet 
https://www.hopkinsmedicine.org/institutional_review_board/forms/.   
Submitted 
 
A signed and dated “De-identified Human Subject Certification” https://livejohnshopkins-
my.sharepoint.com/:w:/g/personal/sdamare1_jh_edu/ETANthXrGPVBmYs-
_UC59fUBu9b1An7tYUWh4GjiG2fH4Q?rtime=5kjTd-F410g 
Submitted 
c. Approval documents from recipient site, if applicable. 
d. Copies of the consent forms associated with the IRB protocols under which the biospecimens 
were collected, with language appropriate to this transfer highlighted.  
Submitted  
The name of the specialist you are working with in ORA to complete a contract/MTA. 
Mr. Stephen Fischer.  
Please see the following website for more information about transferring human 
biospecimens 
to 
outside 
entities: 
https://www.hopkinsmedicine.org/institutional_review_board/news/announcement_transf
er_human_biospecimens_outside_entities.html/ .   
 
 
 

 
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References:  
 
1. 
Key Strategies in the Plan [https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/key-
strategies] 
2. 
Quick Maryland HIV Statistics 
[https://phpa.health.maryland.gov/oideor/chse/pages/statistics.aspx] 
3. 
Stekler JD, Violette LR, Clark HA, McDougal SJ, Niemann LA, Katz DA, Chavez PR, Wesolowski LG, 
Ethridge SF, McMahan VM et al: Prospective Evaluation of HIV Testing Technologies in a Clinical 
Setting: Protocol for Project DETECT. JMIR Res Protoc 2020, 9(1):e16332. 
4. 
Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS, Group CAS: Rapid HIV 
screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol 2012, 54(1):42-47. 
5. 
Miller WC, Rosenberg NE, Rutstein SE, Powers KA: Role of acute and early HIV infection in the 
sexual transmission of HIV. Current opinion in HIV and AIDS 2010, 5(4):277-282. 
6. 
Cohen MS, Smith MK, Muessig KE, Hallett TB, Powers KA, Kashuba AD: Antiretroviral treatment 
of HIV-1 prevents transmission of HIV-1: where do we go from here? Lancet 2013, 
382(9903):1515-1524. 
7. 
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, 
Kumwenda J, Grinsztejn B, Pilotto JH et al: Antiretroviral Therapy for the Prevention of HIV-1 
Transmission. N Engl J Med 2016, 375(9):830-839. 
8. 
Agutu CA, Ngetsa CJ, Price MA, Rinke de Wit TF, Omosa-Manyonyi G, Sanders EJ, Graham SM: 
Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for 
diagnosis and care. PLoS One 2019, 14(6):e0218369. 
9. 
Opollo VS, Nikuze A, Ben-Farhat J, Anyango E, Humwa F, Oyaro B, Wanjala S, Omwoyo W, Majiwa 
M, Akelo V et al: Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early 
infant diagnosis. PLoS One 2018, 13(12):e0209778. 
10. 
Leon SR, Ramos LB, Vargas SK, Kojima N, Perez DG, Caceres CF, Klausner JD: Laboratory Evaluation 
of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing. J Clin Microbiol 
2016, 54(2):492-494. 
11. 
Tilchin C, Schumacher CM, Psoter KJ, Humes E, Muvva R, Chaulk P, Checkley W, Jennings JM: 
Human Immunodeficiency Virus Diagnosis After a Syphilis, Gonorrhea, or Repeat Diagnosis 
Among Males Including non-Men Who Have Sex With Men: What Is the Incidence? Sex Transm 
Dis 2019, 46(4):271-277. 
12. 
Girometti N, Gutierrez A, Nwokolo N, McOwan A, Whitlock G: High HIV incidence in men who 
have sex with men following an early syphilis diagnosis: is there room for pre-exposure 
prophylaxis as a prevention strategy? Sex Transm Infect 2017, 93(5):320-322. 
13. 
Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, 
Fernandez T, Grant RM, Team iS: Syphilis predicts HIV incidence among men and transgender 
women who have sex with men in a preexposure prophylaxis trial. Clin Infect Dis 2014, 
59(7):1020-1026. 
14. 
Delaney KP, Branson BM, Uniyal A, Phillips S, Candal D, Owen SM, Kerndt PR: Evaluation of the 
performance characteristics of 6 rapid HIV antibody tests. Clinical infectious diseases : an official 
publication of the Infectious Diseases Society of America 2011, 52(2):257-263. 
15. 
Stekler JD, O'Neal JD, Lane A, Swanson F, Maenza J, Stevens CE, Coombs RW, Dragavon JA, 
Swenson PD, Golden MR et al: Relative accuracy of serum, whole blood, and oral fluid HIV tests 
among Seattle men who have sex with men. Journal of clinical virology : the official publication 
of the Pan American Society for Clinical Virology 2013, 58 Suppl 1:e119-122. 

 
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16. 
O'Neal JD, Golden MR, Branson BM, Stekler JD: HIV nucleic acid amplification testing versus rapid 
testing: it is worth the wait. Testing preferences of men who have sex with men. J Acquir 
Immune Defic Syndr 2012, 60(4):e117-120. 
17. 
CDC: Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. In. 
Edited by Laboratories CfDCaPaAoPH: Centers for Disease Control and Prevention and Association 
of Public Health Laboratories; 2014. 
18. 
Masciotra S, Luo W, Youngpairoj AS, Kennedy MS, Wells S, Ambrose K, Sprinkle P, Owen SM: 
Performance of the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test with specimens from 
HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. Journal of 
clinical virology : the official publication of the Pan American Society for Clinical Virology 2013, 58 
Suppl 1:e54-58. 
19. 
Delaney KP ES, Wesolowski L, Owen SM, Branson BM: Performance of the Geenius HIV-1/HIV-2 
Assay in the CDC HIV testing algorithm. In: CROI 2015: 2015; Seattle, Washington; 2015. 
20. 
Stevens W, Gous N, Ford N, Scott LE: Feasibility of HIV point-of-care tests for resource-limited 
settings: challenges and solutions. BMC medicine 2014, 12(1):173. 
21. 
Mehta SD, Rothman RE, Kelen GD, Quinn TC, Zenilman JM: Clinical aspects of diagnosis of 
gonorrhea and Chlamydia infection in an acute care setting. Clin Infect Dis 2001, 32(4):655-659. 
22. 
Rogers SM, Miller WC, Turner CF, Ellen J, Zenilman J, Rothman R, Villarroel MA, Al-Tayyib A, Leone 
P, Gaydos C et al: Concordance of chlamydia trachomatis infections within sexual partnerships. 
Sex Transm Infect 2008, 84(1):23-28. 
23. 
Gaydos CA, Ako MC, Lewis M, Hsieh YH, Rothman RE, Dugas AF: Use of a Rapid Diagnostic for 
Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department 
Can Improve Clinical Management: Report of a Randomized Clinical Trial. Ann Emerg Med 2019, 
74(1):36-44. 
24. 
Kelen GD, Hsieh YH, Rothman RE, Patel EU, Laeyendecker OB, Marzinke MA, Clarke W, Parsons T, 
Manucci JL, Quinn TC: Improvements in the continuum of HIV care in an inner-city emergency 
department. AIDS 2016, 30(1):113-120.