Att 13 Project Determination Human Subjects

Print Date: 8/25/21

Title:

Project DETECT 2.0 Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence

Project Id:

0900f3eb81d78c3c

Accession #:

NCHHSTP-BCSB-7/12/21-78c3c

Project Contact:

Kevin Delaney

Organization:

NCHHSTP/DHAP/BCSB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

07/19/2021

Estimated Completion Date:

09/30/2024

CDC/ATSDR HRPO/IRB Protocol #:
0920-1100

OMB Control #:

Determinations
Determination

HSC:
Does NOT Require HRPO
Review

PRA:
PRA Applies

Justification
Research that involves de-identified/unlinkable data or biospecimens, but not involving FDA
investigational products

Completed

Entered By & Role

7/16/21

Dodson_Janella R. (jhd7) CIO HSC

7/20/21

Bonds_Constance (akj8) CTR OMB/PRA
Coordinator

45 CFR 46.102(e)

ICRO:
PRA Applies

OMB Approval date: 1/16/19
OMB Expiration date: 1/31/22

7/20/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

07/30/2021

Determination Start Date:

07/12/21

Description:

The purpose of this request is to amend the original project determination (PD) which was approved on 08/18/2015 before STARS
and is being entered into STARS for the first time. The original PD received an HSR determination that the activity is research
involving human subjects but CDC involvement does not constitute engagement in human subject research and that has not
changed. The PRA does apply. An ICR has been submitted to extend the current OMB approval (OMB 0920-1100, Exp. January
31, 2022) and to add an additional data collection site. The ICR packet was submitted and the 60-day FRN was published on (July
12, 2021; (Docket #CDC-2021-0066). This evaluation of new HIV testing technologies in clinical settings with high HIV incidence
(DETECT 2.0) is a 3-year research project to assess the relative performance of new and developing POC HIV tests, particularly
among persons who: (a) present diagnostic challenges, including those exposed to HIV PrEP; (b) those with very recent HIV
infection (before the development of a mature antibody response); and (c) those achieving viral suppression before developing an
antibody response, among others. To achieve this, CDC awarded two recipients to evaluate the differences in sensitivity and
specificity of the newest HIV serologic tests, using unprocessed specimens collected from infected individuals who are in the acute
or early stages of disease. One recipient is the University of Washington, which participated in the original project since the initial
determination; this amendment adds Johns Hopkins University as a site.

IMS/CIO/Epi-Aid/Chemical Exposure Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goals of the project are to 1) characterize the performance (sensitivity and specificity) of HIV tests under development and/or
new HIV tests for detecting established and early HIV infection at the point of care (POC), relative to each other and to currently
used gold standard, non-POC tests which are processed in a centralized laboratory rather than at point of care and 2) identify
behavioral and clinical predictors of early HIV infection

Objective:

The overall project objectives include: 1) Developing and implementing recruitment strategies and procedures to: (a) identify
appropriate study participants to evaluate the differences in sensitivity (including acute HIV infection sensitivity) and specificity of the
newest HIV tests in real time using fresh whole blood and oral fluid specimens; and (b) compare results to the currently
recommended CDC laboratory algorithm (12). Patients with exposure to either early ART or PrEP should be oversampled to
evaluate HIV test performance in these populations as well. 2) Evaluate the seroconversion sensitivity of the newest HIV tests
through serial follow-up of study participants with discordant baseline test results. 3) Evaluate the diagnostic and clinical
performance of nucleic acid (molecular) tests to determine the applicability of this technology for use in a variety of clinical and POC
settings. 4) Collect matched demographic, behavioral and clinical data from participants to assess the impact of these factors on
HIV test performance, including the use of behavioral and clinical data to categorize the timing of exposure for those with newly
diagnosed infection. 5) Develop panels of specimens with accompanying demographic, clinical and behavioral data for evaluations
of laboratory-based HIV tests.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Secondary Data or Specimen Analysis ; Purchase, Use, or Transfer of
Information, Data, Biospecimens or Materials

Target Populations to be Included/Represented:

General US Population ; Asian ; Black or African American ; Hispanic or Latino ; Native Hawaiian or Other Pacific Islander - Men
who have sex with men; persons who inject drugs ; White ; Female ; Male ; Transgender ; Adult 18-24 years ; Other - Men who
have sex with men; persons who inject drugs

Tags/Keywords:

HIV Infections ; HIV Seropositivity ; Acute Disease

CDC's Role:

CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens ; CDC employees will participate
as co-authors in presentation(s) or publication(s) ; CDC employees will provide substantial technical assistance or oversight ; CDC
is providing funding ; CDC provides technical assistance but does not specifically request or approve study design or data collection

Method Categories:

Analytic Services (can be data/specimen TA for non-research,research,investigations); Method/Device Evaluation; Prospective
Cohort Study; Randomized Controlled Trial; Secondary Data Analysis; Secondary Specimen Analysis
For those who consent to testing at the clinics or emergency department, basic demographic information, HIV testing history, and
HIV risk in the prior 3 months will be extracted from data routinely collected from all clinic patients regardless of study participation.
These data will be used to categorize patients into high or low risk groups. Patients classified as high risk#males who have reported
any male sex partners (MSM) in the past 12 months, transgender women, minorities, and persons who inject drugs (PWIDs)# will
be immediately enrolled in Phase 1 of the study, for which specimens are collected for additional testing with novel HIV testing

Methods:

Collection of Info, Data or Biospecimen:

technologies. Those categorized as low risk (i.e., all other patients) will be offered the current standard of care for HIV testing at the
clinical site. If individuals receiving standard of care testing receive a test result indicating HIV infection, or have been referred to the
study because of a positive test result, they will also be offered the opportunity to enroll in Phase 1 of the study, with specimen
collection for testing with the novel HIV tests. Phase 1 participants who have discordant results when tested with the novel testing
technologies will be eligible for Phase 2 of the study, involving serial follow-up to resolve the discrepancies observed in Phase 1.
The respondent universe for Project DETECT 2.0 will be persons who present to Seattle- and Baltimore-area clinics and Johns
Hopkins emergency department who are at high risk for HIV infection or have been diagnosed with established or early HIV
infection. The following groups will be approached for participation through convenience sampling if they are 18 years of age or
older and able to complete the computer-assisted self-interview in English: 1) Persons who present to the PHSKC STD Clinic,
Johns Hopkins Infectious Diseases Clinic, Baltimore City STD Clinic, the Johns Hopkins Emergency Department (ED), seeking
services and are identified as being at high risk of HIV infection based on their responses to a routinely used clinic intake
questionnaire (males who reported any male sex partner in the past 12 months, transgender women, minorities, and PWIDs), 2)
Persons who test antibody-positive through routine HIV testing at the PHSKC STD clinic or other participating Seattle-area clinics,
Johns Hopkins Infectious Diseases Clinic, Baltimore City STD Clinic, the Johns Hopkins Emergency Department (ED), 3) Persons
who self-report their HIV-positive status when seeking other services from the PHSKC STD Clinic, Johns Hopkins Infectious
Diseases Clinic, Baltimore City STD Clinic, the Johns Hopkins Emergency Department (ED), 4) Persons who tested HIV-antibody
positive at another clinical site in Seattle or Baltimore and were referred to participate in the study, and 5) Persons with test results
indicative of early HIV infection (defined according to the CDC recommended HIV testing algorithm) who tested at a site in Seattle
or Baltimore outside of the PHSKC STD clinic, Johns Hopkins Infectious Diseases Clinic, Baltimore City STD Clinic, the Johns
Hopkins Emergency Department (ED), and were referred to participate in the study. CDC investigators will not participate in data
collection or have any other interactions with participants. Only de-identified data will be delivered to CDC scientists; CDC will not
receive any personally identifiable information. Any individually identifiable information collected by the recipients
The purpose of this study component is to use data routinely collected at the clinics and emergency department to ascertain
whether individuals are at low or high risk for HIV to determine eligibility for Phase 1. Study staff will extract socio-demographic,
behavioral, medical history, and testing data routinely collected from all patients for the purposes of clinical care, program
monitoring and evaluation, and sentinel surveillance. Basic demographic information, HIV testing history, history of HIV prophylaxis
and HIV risk in the prior year will be used in real-time to screen patients to identify high- and lower-risk groups. Those categorized
as being at high risk based on this information will be enrolled in Phase 1 of the study, and those categorized as being at lower risk
will be enrolled in Phase 1 only if they receive a test result indicating HIV infection. UW and JHU will report de-identified STD
program data collected during screening to CDC, and for those deemed to be at lower risk, will also report the results of HIV testing
conducted using the standard of care HIV test(s). UW and JHU will develop and maintain a system to link participant information
extracted from data collected by the Public Health King County STD clinic, Johns Hopkins Infectious Diseases Clinic, Baltimore City
STD Clinic, the Johns Hopkins Emergency Department (ED) to those data collected in Phase 1 and Phase 2 of the study, as
described below. Phase 1 Phase 1 participants will consist of two groups of clinic patients: those deemed to be at high risk for
recent HIV infection based on the screening questionnaire, and those known to be HIV-positive. The latter group is composed of
those considered to be at lower risk who test HIV-positive using the standard of care test conducted at the clinic, those who selfreport being HIV-infected during routine data collection at the clinic when they seek STD or other services there, and those who are
referred to the study because they were identified as having newly diagnosed HIV infections. The last 2 groups are being included
to increase the sample size for evaluation of the sensitivity of the tests under investigation. Those consenting to participate in Phase
1 will have anti-coagulated whole blood, oral fluid and dried-blood spot specimens collected for the evaluation of the new HIV
screening and diagnostic tests. UW and JHU will use fresh anti-coagulated whole blood and oral fluid specimens to perform up to 7
new HIV tests. Additionally, UW and JHU will follow an algorithm that includes a 4th generation immunoassay, an HIV-1/HIV-2
differentiation test and a nucleic acid test on the entire Phase 1 study population as the reference standard for the evaluation of the
new test technology. Finally, UW and JHU will perform a quantitative HIV-1 viral load test for all study participants identified as HIVinfected. All test results (for the new tests under evaluation, testing with the reference standard, and HIV-1 viral load) as well as the
short behavioral questionnaire collected from Phase 1 participants will be reported to CDC. Specimens will be collected for storage
and future testing from a subset of participants who consent to specimen storage. In the first 3 years of the study, nearly all

participants consented to specimen storage and future testing. Specimens will be collected from all consenting participants with at
least one reactive HIV test for future evaluations of test sensitivity. To evaluate te

Expected Use of Findings/Results:

The purpose of this research is to evaluate the performance of HIV tests under development, and/or newly available HIV tests
(compared to a gold standard), for use in point-of-care settings in the United States. Test performance and questionnaire data will
be used to inform HIV testing guidelines; provide information to HIV test providers about the appropriate use of different HIV testing
technologies in different settings, and for different populations (e.g., for highest risk persons as well as the general population); and
inform the choice of test technology and allow these technologies to be tailored to the strategies needed to end the HIV epidemic.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers?

No

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

Yes

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Funding
#

Original
Budget Yr

# Years
Award

Budget
Amount

CDC Cooperative
Agreement

Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence
(Project DETECT 2.0)

PS20001

2020

3

3322234.00

HSC Review

HSC Attributes
Other - CDC involvement does not constitute
engagement in human subject research.

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research
Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

Johns Hopkins Bloomberg Sch Public Hlth

FWA00000287

01/07/25

Johns Hopkins Medicine IRB #3

02/01/24

PS20-001

U of Washington

FWA00006878

01/29/25

U of Washington IRB #7 - J

01/04/24

PS20-001

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

Brian
Emerson

07/02
/2022

David Katz

12/27
/2021

12/27/2021

Kevin
Delaney

12/27
/2021

Pollyanna
Chavez

Yuka
Manabe

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Project
Officer

[email protected]

4047183492

SPECIAL STUDIES &
DIAGNOSTICES TEAM

12/28/2021

CoInvestigator

[email protected]

12/27/2021

12/28/2021

CoInvestigator

[email protected]

4046398630

BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH

12/28
/2021

12/28/2021

12/28/2021

Project
Coordinator

[email protected]

4046391742

SPECIAL STUDIES &
DIAGNOSTICES TEAM

12/27
/2021

12/27/2021

12/28/2021

CoInvestigator

ymanabe@jhmi.
edu

Data
DMP
Proposed Data Collection Start Date:

9/30/21

Proposed Data Collection End Date:

9/30/24

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:

Not yet available

Data Use Contact:

Kevin Delaney

U of Washington

Johns Hopkins Bloomberg Sch
Public Hlth

Public Access Justification:

These data are being collected through a Cooperative agreement with our academic partners. The data reported to CDC includes
sensitive but deidentified information about HIV risk as well as HIV test results. These data are given formal confidentiality
protection locally under 308(d) of the Public Health Service Act. All data release and sharing must be consistent with the
confidentiality certificates and assurances under which the data were collected or generated. These data will be pared with stored
specimens in a biorepository made available to CDC researchers, and, through Research collaborations or Materials Transfer, to
external partners following guidelines developed by the technology transfer office. Where applicable, for data underlying scientific
publication, CDC and/or the recipients will make the data available coincident with publication of the paper, unless the data set is
already available via a release or sharing mechanism.

How Access Will Be Provided for Data:

CDC will develop a Data sharing/analysis proposal template through which the grantees and external partners can request access
to the data once it is delivered to CDC. No interim data will be available except to CDC and either UW or JHU staff funded for the
project. While data collection is ongoing CDC staff will require that local IRB approval for research activities is obtained by the
University of Washington and Johns Hopkins University to cover all activities which involve interaction with human subjects. The
recipients will be responsible for collecting all data for this program. All digital data collected in the computer-assisted self-interview
will be stored in an electronic high-security password-protected environment that has undergone a security assessment and meets
requirements set forth by the CDC/OCISO. To ensure that respondents# 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, the recipient is required to implement security procedures for any recipient systems, and information
contained therein that cover all aspects of data handling for hard copy and electronic data: # Ensure project data are secured
against improper disclosure or unauthorized use of information. # Access information only on a need-to-know basis when necessary
in the performance of assigned duties. # Notify their supervisor, the Project Director, and the organizational Security Officer, within
one (1) hour or less, 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 organizational Security Officer all contacts and
inquiries concerning information from unauthorized staff and non-research team personnel.

Plans for Archival and Long Term Preservation:

Six months before the end of the of the cooperative agreement, the recipients 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. CDC will receive only deidentified data and specimens. Data will be stored at CDC in secure servers with access limited
to CDC staff who request it through the data sharing/analysis proposal process. Specimens will be archived and stored in the CDC
Biorepository

Spatiality
Country

State/Province

County/Region

United States

Washington

King

United States

Maryland

Baltimore

Dataset

Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date