Project Determination

Project Determination

PS22-2208 Strengthening Syringe Services Programs - Component 2

Project ID:	0900f3eb82108a82
Accession #:	NCHHSTP-SIT-2/7/23-b17cb
Project Contact:	Renee Brocker
Organization:	OS/OS/OSI
Status:	Pending Regulatory Clearance
Intended Use:	Project Determination
Estimated Start Date:	09/30/22
Estimated Completion Date:	09/29/27
CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:

Description

Priority

Standard

Date Needed

04/07/23

Determination Start Date

03/28/23

Description

The project serves as a coordinated and accountable mechanism for distribution of funding to syringe services programs (SSPs) to support implementation and expansion of services in areas of the United States, Territories, and Tribal Nations disproportionately affected by infectious disease consequences of injection drug use. Project activities will directly contribute to establishing and expanding a national SSP infrastructure and prevention of infectious disease consequences of drug use. CDC has funded the National Alliance of State and Territorial AIDs Directors (NASTAD) to implement this project. NASTAD, in partnership with University of Washington will collect monitoring and evaluation data from funded SSPs through their internal mechanisms, both for their internal evaluation as well as to report annual project performance reports and stratified aggregate data to CDC.

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

No

IMS Activation Name

Not selected

Select the primary priority of the project

Not selected

Select the secondary priority(s) of the project

Not selected

Select the 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

Goals/Purpose

The project aims to increase access to harm reduction services for people who currently inject, or have a history of injecting, drugs (PWID) and reduce incidence of infectious diseases and other complications of injection drug use. In addition, project activities will increase support and resources to SSPs for implementation of syringe distribution and disposal; testing, treatment, and prevention of infectious diseases and infectious complications from injection drug use; and mitigation of other harms due to drug use.

Objective

Objectives associated with provision of funding for SSP implementation include 1) increase ability of SSPs to recruit and retain staff to perform core functions like distribution and disposal of sterile supplies, infectious disease prevention and control, and facilitation of comprehensive social and medical service referrals and 2) provide support for comprehensive SSP services, such as expanded vaccination services, HIV and viral hepatitis testing and linkage to care, naloxone distribution, syringe distribution and disposal, and care coordination within SSPs. Funding SSP implementation will expand the reach of SSPs across the United States, increase access to harm reduction services, and prevent infectious consequences of drug use and overdose. NASTAD will submit stratified aggregate monitoring and evaluation data annually to CDC to track these objectives.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been excluded or marginalized and/or decreasing disparities?

Yes

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

Not selected

Methods to Improve Health Equity Research and Practice

Yes

Other

Not selected

Activities or Tasks

New Collection of Information, Data, or Biospecimens; Programmatic Work

Target Population to be Included/Represented

American Indian or Alaska Native; Asian; Black or African American; Hispanic or Latino; Native Hawaiian or Other Pacific Islander; White; Female; Male; Transgender; Adult 18-24 years; Older adults > 64 years-

Tags/Keywords

Harm Reduction; Drug Users; Hepatitis C; HIV

CDC's Role

CDC employees will provide substantial technical assistance or oversight; CDC is NOT a recipient or provider of private data, specimens, materials or services; CDC is providing funding

Method Categories

Technical Assistance

Methods

NASTAD will submit an evaluation plan to CDC outlining when and how evaluation data will be collected from SSPs that they fund through a competitive RFP process. CDC will collect aggregate SSP data based on measures and outcomes in the PS22-2208 NOFO from NASTAD annually via the APR.

Collection of Info, Data, or Bio specimens

NASTAD will collect SSP monitoring and evaluation data via their grants management software, Foundant, as well as through discussions and periodic meetings with funded SSPs for internal evaluation purposes and to report to CDC. CDC will collect aggregate information from NASTAD via REDCap for the APR.

Expected Use of Findings/Results and their impact

The data collected will inform NASTAD's internal evaluation of programmatic activities related to funding SSP implementation. The results will inform PS22-2208 measures and outcomes and demonstrate to CDC how funding SSPs can help better serve people who use drugs and reduce infectious disease consequences of drug use.

Could Individuals potentially be identified based on Information Collected?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award	Budget Amount
CDC Cooperative Agreement	Strengthening Syringe Services Programs	CDC-RFA-PS22-2208	2022	5

HSC Review

HSC Attributes

Other - This activity has been reviewed by NCHHSTP OADS and was determined to not meet the definition of research as defined in 46.102(l). The purpose of this activity is to increase access to harm reduction services for people who currently inject, or have a history of injecting, drugs (PWID) and reduce incidence of infectious diseases and other complications of injection drug use.

Yes

Regulation and Policy

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

No

Institutions
Institution	FWA #	FWA Exp. Date	IRB Title	IRB Exp. Date	Funding #
NASTAD
University of Washington
Voices of Community Activists and Leaders (VOCAL-NY)

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
Aleta Christensen	09/23/2023		12/18/2021		Technical Monitor	[email protected]	770-488-3956	STRATEGY AND IMPLEMENTATION TEAM
Brittany Price	n/a	n/a	n/a	n/a	Project Coordinator	[email protected]		University of Washington
Laura Pegram	n/a	n/a	n/a	n/a	Program Official	[email protected]		NASTAD
Logan Benton	n/a	n/a	n/a	n/a	Project Coordinator	[email protected]		NASTAD
Monica Adams	05/21/2024		10/29/2017		Program Lead	[email protected]	404-718-5092	STRATEGY AND IMPLEMENTATION TEAM
Renee Brocker	02/15/2025				Project Officer	[email protected]	- -	STRATEGY AND IMPLEMENTATION TEAM
Ryan Drab	10/03/2025				Project Coordinator	[email protected]	404-718-3525	STRATEGY AND IMPLEMENTATION TEAM
Zach Ford	n/a	n/a	n/a	n/a	Project Coordinator	[email protected]		Voices of Community Activists and Leaders (VOCAL-NY)

DMP
Proposed Data Collection Start Date	04/03/23
Proposed Data Collection End Date	09/29/27
Proposed Public Access Level	Non-Public
Reason for not Releasing the Data	Other- Data are used for evaluation of program performance.
Public Access justification	Data received by CDC are for internal use only to evaluate program performance and recipient/sub-recipient needs.
How Access Will Be Provided for Data	Data are non-public, for internal use only; no access will be provided to APR data.
Plans for archival and long-term preservation of the data	CDC program will collate and retain APR data for duration of the CoAg.

Spatiality (Geographic Location)
Country	State/Province	County/Region
United States

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Not Research / Other 45 CFR 46.102(l) Other - This activity has been reviewed by NCHHSTP OADS and was determined to not meet the definition of research as defined in 46.102(l). The purpose of this activity is to increase access to harm reduction services for people who currently inject, or have a history of injecting, drugs (PWID) and reduce incidence of infectious diseases and other complications of injection drug use.	03/24/23	Dodson_Janella R. (jhd7) CIO HSC
PRA: PRA Applies		03/28/23	Bonds_Constance (akj8) CTR OMB/PRA Coordinator