Project Determinatino (24GD)

Print Date: 5/24/24

Title:

Evaluating Funded OD2A Partner Implementation and Impacts of Stop Overdose Campaigns

Project Id:

0900f3eb823164c0

Accession #:

NCIPC-CB-2/23/24-164c0

Project Contact:

Diakima Y Thomas

Organization:

NCIPC/DOP/CB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

07/01/2024

Estimated Completion Date:

09/30/2024

CDC/ATSDR HRPO/IRB Protocol #:

n/a

OMB Control #:

0920-0879

Determinations
Determination

Justification

Completed

Entered By & Role

3/15/24

Angel_Karen C. (idy6) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:

PRA Applies

ICRO:
PRA Applies

OMB Approval date: 8/29/23
OMB Expiration date: 8/31/26

3/15/24

Angel_Karen C. (idy6) OMB / PRA

3/15/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

04/01/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

02/23/24

Description:

To evaluate OD2A partner implementation of CDC"s Stop Overdose campaign materials and products.

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

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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

1.Increase use of Stop Overdose campaign materials and products among OD2A partners; 2.Enhance Stop Overdose campaign
materials and products, dissemination tactics, and support to optimize the use of campaign materials by OD2A partners.

Objective:

1.Assess how and to what extent CDC-funded OD2A partners have implemented Stop Overdose campaigns since their launch; 2.
Assess the perceived effectiveness of Stop Overdose materials and products among OD2A partners for supporting their work; 3.
Identify barriers, facilitators, and areas of need and support for OD2A partners using Stop Overdose campaigns to support their
drug overdose prevention work.

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - OD2A partners (adults 18>)

Tags/Keywords:

Program Evaluation

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

Method Categories:

Survey

Methods:

Online survey to collect quantitative and some qualitative (open-ended) responses

Collection of Info, Data or Biospecimen:

Sample and recruitment. All current OD2A grantee organizations at the time of data collection will be invited to complete one
survey. CDC will advise partners of the pending survey invitation, and the contractor will invite partners to participate through an
email invitation. Partners will be instructed to designate one person to complete the survey on behalf of the organization. The
invitation will include a unique link to the survey and may get input from other colleagues. Participants will receive two reminder
emails after the initial invite. Survey instrument. The survey instrument will measure in six key domains to inform on the delivery of
Stop Overdose campaigns. The survey will take up to 20 minutes to complete and include multiple choice and open-ended items.
The research team will develop the survey, and CDC will approve the final instrument. The Fors Marsh survey team will program,
test, and create a link for the survey. The survey team will collect and clean the data for analysis.

Expected Use of Findings/Results and their impact:

The Fors Marsh will provide CDC with a report within 4 weeks of final data collection. They will provide a written final report in
Microsoft Word with an executive summary, key takeaways, methods, and a summary of evaluation results and findings for each
data collection effort. They will submit all de-identified raw and finalized data. CDC will have the opportunity to provide one round of
feedback, and the research team will address feedback and provide a final report.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Budget Amount

CDC Contract

Drug Overdose Campaign Research

75D30121F11264

2021

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

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

3

4499843.35

Parental permission

No Selection

Alteration of authorization under HIPAA 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

Will you be working with an outside Organization or Institution? Yes
Institution

FWA #

FWA Exp Date

Funding

Fors Marsh Group LLC

FWA00011194

12/05/24

Drug Overdose Campaign Research - 75D30121F11264

Institution

Funding Restriction Percentage

Funding Restriction Amount

Funding Restriction Reason

Funding Restriction has been Lifted

Fors Marsh Group LLC

Institution

Institution Role(s)

Fors Marsh Group LLC

Implementing the Project

Institution Project Title

Institution

Regulatory Coverage

Fors Marsh Group LLC

Conducting Exempt Human Research

Institution

Registered IRB

Institution Project Tracking #

Prime Institution

IRB Review Status

IRB Registration Exp. Date

IRB Approval Status

Fors Marsh Group LLC

Institution
Fors Marsh Group LLC

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

Staff
Staff
Member

SIQT
Exp. Date

Jasmine
Kenney

11/26
/2026

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

01/24/2025

Staff Role

Email

Phone

Organization

Technical
Monitor

hbu2@cdc.
gov

404-6390826

EDUCATION, CAMPAIGNS, AND
IMPLEMENTATION TEAM

Data
DMP
Proposed Data Collection Start Date:

7/1/24

Proposed Data Collection End Date:

8/31/24

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - program evaluation

Public Access Justification:

Data are for program evaluation and would not be useful to the public.

How Access Will Be Provided for Data:

Data files will be stored on contractor secure servers. The contractor will not share individual-level data beyond the immediate
project team. Once data are collected and de-identified, the research team can share the final de-identified dataset as requested by
CDC (e.g., providing de-identified feedback, transcripts or notes). All responses will be maintained separately from participant
demographic responses and any responses to stimuli. Names will not be used in reporting, instead characteristics such as
participant type, gender, and age will be used to describe feedback from participants in the report. During data collection activities
(providing feedback on the digital platform), participants will only be identified by their first name, with no accompanying profile
picture, to protect their privacy and to increase their comfort level with the discussion. Any PII that participants may provide in their
responses will be scrubbed before reporting. None of the questions, prompts, or data elements in the activities will require
participants to share information about themselves that is private or sensitive, although participants may share whatever they
choose. All participants will be informed that all responses are voluntary, and they do not have to respond to any questions that they
do not wish to answer.
The datasets for this project are unlikely to require long-term storage. The contractor#s data retention policy differentiates raw,
interim, and finalized datasets for storage and destruction policies, with the understanding that the Contractor will supervise the

Plans for Archival and Long Term Preservation:

authorized destruction of all raw and interim data and reports within three years from the end of the project. Before destroying any
data, the Contractor will record what data is being deleted (i.e., project name and data elements associated), record what system
the data is being deleted from, and, for electronic files, take a screenshot of the directory structure both before and after deletion.

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

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

03/15/2024

NOA 0920-0879 (2023)

Notice of Action

NOA 0920-0879_2023.pdf

Thomas_Diakima
(nvb7)
Project Contact

03/05/2024

Updated file

Other

nvb7_0900f3eb823164c0_20240305_DTD.docx

Thomas_Diakima
(nvb7)
Project Contact

02/23/2024

Evaluation Survey Questionnaire
Instrument

Other-Evaluation Survey
Questionnaire

DOCR - OD2A Partner Evaluation Survey Instrument .
docx

Current

Thomas_Diakima
(nvb7)
Project Contact

02/23/2024

Evaluation plan

Other-Evaluation plan

DOCR - TB2A - Research Plan - OD2A Partner
Campaign Evaluation.docx