Project Determination

Print Date: 2/15/23

Title:

PS22-2208 Component 1 SSP Survey

Project Id:

0900f3eb81fd8d55

Accession #:

NCHHSTP-SIT-9/16/22-d8d55

Project Contact:

Renee M Brocker

Organization:

NCHHSTP/DVH/SIT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

11/01/2022

Estimated Completion Date:

09/30/2027

CDC/ATSDR HRPO/IRB Protocol #:
0920-1359

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

11/8/22

Dodson_Janella R. (jhd7) CIO HSC

11/9/22

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 3/18/22
OMB Expiration date: 12/31/24

11/9/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

11/01/2022

Determination Start Date:

09/21/22

Description:

The CDC, with the support of Research Triangle Institute (RTI), the National Harm Reduction Coalition, the University of
Washington, Heluna Health, and the North American Syringe Exchange Network (NASEN), plan to conduct the National Syringe
Service Program (SSP) Evaluation, an annual survey with syringe services programs (SSPs) nationwide. The project does not
require human subjects approval, as it is program surveillance for which CDC plans to administer an ongoing, annual survey. PRA
does apply and the 60-day FRN was published on February 25, 2021. OMB approval for the National Syringe Service Program
(SSP) Evaluation was obtained 12/15/2021 and expires 12/31/2024. This program surveillance effort is based on the Dave
Purchase Memorial Survey which is a national survey of syringe services programs (SSPs) that collects data on program operations
and outcomes. The survey was conducted annually by Dr. Don Des Jarlais and his staff and NASEN since the mid-1990s, but the
survey has not been conducted consistently since 2014. In 2022 CDC conducted this national SSP survey, with the support of
University of Washington, Dr. Don Des Jarlais, and NASEN. This project aims to improve the ability of CDC and local and state
partners to monitor SSPs nationally, with the overall goal of supporting, sustaining, and improving SSPs nationwide. Over the
course of the next two years, three years, the the National Syringe Service Program Survey will continue to be conducted annually
by CDC and its partners to help build a stable foundation for SSP monitoring, establish a system for program improvement, and
ensure quality service delivery at SSPs nationwide.

IMS/CIO/Epi-Aid/Lab-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

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected
The primary purpose of the program surveillance project is to strengthen and improve the capacity of SSPs to conduct regular
monitoring to ensure that comprehensive prevention services are provided to meet the needs of PWID and reduce infectious

Goals/Purpose

Objective:

disease and other harms related to injecting drug use (IDU). The primary goal of the project is to: 1) assess and monitor Syringe
Services Programs (SSP) operational characteristics and services, client characteristics and drug use patterns, funding resources,
community relations, and key operational and programmatic successes and challenges, and 2) support timely analysis and
dissemination of national program evaluation survey findings.
The objectives of the project are to: 1) collect data on program operations including service delivery, and characteristics to support
quality service delivery at SSPs nationwide; and 2) to inform planning and evaluation of prevention programs that aim to reduce
injection-related adverse health outcomes among people who inject drugs.

Does this project include interventions, services, or Yes
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:

Yes

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Not Selected

SDOH Education:

Not Selected

SDOH Health Care Access:

Yes

SDOH Neighborhood and Environment:

Not Selected

SDOH Social and Community Context:

Yes

SDOH Indices:

Not Selected

Other SDOH Topics:

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Syringe Service Programs

Tags/Keywords:

HIV ; Hepatitis C ; Drug Users

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; 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

Method Categories:

Survey

SSPs in the United States, who have registered in the NASEN Directory and given permission to be contacted by email, will be sent
a letter of invitation to complete an approximately 35-minute survey about their program. Potentially up to 600 SSPs will be reached
annually. A letter of invitation will be sent to SSPs, and will include a description of the survey, instructions for completing the
survey, web-link to the survey itself (if program managers/staff would prefer to complete it that way), and details about how to
access the incentive upon completion of the CDC National Syringe Service Program Evaluation Survey. SSPs can complete the
survey two ways: Option 1: The SSP can enter responses to survey questions via a secure, web-based application, for example the
Research Electronic Data Capture (REDCap) for which a survey link will be provided in the letter of invitation. Option 2: The SSP
can provide responses to survey questions via phone or videoconferencing, using a scheduling link provided to coordinate date and
time with an interviewer. The recipient will compile the data, clean it, and run an initial surveillance report analysis. A final dataset
will be securely transferred to CDC where it will be checked for accuracy and stored for additional analyses.

Methods:

Collection of Info, Data or Biospecimen:

A program manager or staff member designated by the SSP will complete a 35-minute program survey via the options described
above. A web-based application like REDCap that allows both self-administered and interviewer-administered survey data collection
will be used for all data entry and storage. The program survey will be administered over the course of approximately 3 months and
will be administered annually. The survey will collect the program name and location. No individual-level or personally identifying
information (e.g., name, date of birth, social security number) will be collected. The main data collection components for this
program survey include basic aggregate client characteristics and program operational characteristics, service delivery, funding
resources, community relations, operational successes and challenges, and impact to operations and services due to COVID-19.
The respondents are an SSP program manager or their designee. Respondents may refuse to answer questions or stop
participation at any time without penalty.

Expected Use of Findings/Results and their impact:

The data collected will establish a surveillance system for ongoing program monitoring and evaluation of SSPs. Data will also help
ensure quality service delivery at SSPs nationwide.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Strengthening Syringe Service Programs

CDC-RFA-PS22-2208

2022

5

HSC Review

Regulation and Policy

Budget Amount

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

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

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 #

Research Triangle International

CDC-RFA-PS22-2208

North American Syringe Exchange Network

CDC-RFA-PS22-2208

Heluna Health

CDC-RFA-PS22-2208

University of Washington

CDC-RFA-PS22-2208

National Harm Reduction Coalition

CDC-RFA-PS22-2208

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Alex Kral

n/a

n/a

n/a

Barrot
Lambdin

n/a

n/a

Don Des
Jarlais

n/a

Elizabeth
Adams

n/a

Technical
Monitor

akral@rti.org

Research Triangle
International

n/a

n/a

Principal
Investigator

blambdin@rti.org

Research Triangle
International

n/a

n/a

n/a

Technical
Monitor

don.desjarlais@nyu.edu

n/a

n/a

n/a

n/a

Program
Lead

etroutmanadams@rti.
org

Research Triangle
International

Erica Browne

n/a

n/a

n/a

n/a

Program
Lead

ebrowne@rti.org

Research Triangle
International

Hansel
Tookes

n/a

n/a

n/a

n/a

Technical
Monitor

hetookes@med.miami.
edu

Jamie
Humphrey

n/a

n/a

n/a

n/a

Program
Lead

jhumphrey@rti.org

Research Triangle
International

Julia Brinton

n/a

n/a

n/a

n/a

Technical
Monitor

jbrinton@rti.org

Research Triangle
International

Kathryn
Greenwell

n/a

n/a

n/a

n/a

Project
Coordinator

kgreenwell@rti.org

Research Triangle
International

Lynn Wenger

n/a

n/a

n/a

n/a

Program
Lead

lynndee@rti.org

Research Triangle
International

Monica
Adams

05/21
/2024

Principal
Investigator

ydy7@cdc.gov

10/29/2017

Phone

4047185092

Organization

STRATEGY AND
IMPLEMENTATION TEAM

4047187205

Nathan
Furukawa

06/05
/2023

04/23/2024

07/22/2021

Project
Officer

nmt6@cdc.gov

Orisha
Bowers

06/05
/2023

04/23/2024

07/22/2021

Technical
Monitor

bowers@harmreduction.
org

National Harm Reduction
Coalition

Paul
LaKosky

n/a

n/a

n/a

n/a

Technical
Monitor

paul@nasen.org

North American Syringe
Exchange Network

Renee
Brocker

n/a

n/a

n/a

n/a

Project
Officer

odj7@cdc.gov

Ricky
Bluthenthal

06/05
/2023

04/23/2024

07/22/2021

Technical
Monitor

rbluthen@usc.edu

Sara Glick

n/a

n/a

n/a

n/a

Technical
Monitor

snglick@uw.edu

University of Washington

Sheila Patel

n/a

n/a

n/a

n/a

CoInvestigator

svpatel@rti.org

Research Triangle
International

Stephanie
Prohaska

n/a

n/a

n/a

n/a

Technical
Monitor

stephanie@nasen.org

North American Syringe
Exchange Network

Talia Pindyck

n/a

n/a

n/a

n/a

Principal
Investigator

nrb1@cdc.gov

Terry Morris

06/05
/2023

04/23/2024

07/22/2021

Technical
Monitor

tmorris.contractor@rti.
org

Data
DMP
Proposed Data Collection Start Date:

1/1/23

Proposed Data Collection End Date:

9/30/27

Proposed Public Access Level:

Public

6148498933

4047186809

STRATEGY AND
IMPLEMENTATION TEAM

STRATEGY AND
IMPLEMENTATION TEAM

STRATEGY AND
IMPLEMENTATION TEAM

Heluna Health

Public Access Justification:

These data may help public health officials and partners in public health planning, implementation, and evaluation. The data do not
contain any individual identifying information and is not protected by an assurance of confidentiality. CDC will not receive the names
of SSPs. SSPs may be identifying based on the geographical information for SSPs in a rural or underserved area. A concept
proposal review committee will review data requests to determine what level of granularity for location is needed to complete the
analysis.

How Access Will Be Provided for Data:

Access to the data can be requested through a concept proposal review process as outlined in the data management plan
developed by the CDC and the awardee.

Plans for Archival and Long Term Preservation:

After completion of the project performance period, the awardee will retain a copy of the data based on a data sharing agreement
and data management plan generated under the cooperative agreement with the CDC. The CDC will also retain and store a clean
dataset, consistent with existing CDC standards for long-term preservation of data.

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role
Zirger_Jeffrey
(wtj5)
ICRO Reviewer

Date Added

Description

Supporting Info Type

Supporting Info

11/09/2022

NOA 0920-1359 (2022)

Notice of Action

0920-1359_2022.pdf

Collection End
Date

Current

Furukawa_Nathan
(nmt6)
Project Contact

09/21/2022

NOFO

Notice of Funding Opportunity

CDC-RFA-PS22-2208 (Revised Final).pdf