Project Determination: IRB Approval Not Required

Print Date: 7/17/20

Title:

Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting
Consumers Development of Messages for the Lets Stop HIV Together National Campaign

Project Id:

0900f3eb81b3307c

Accession #:

NCHHSTP-RET-4/27/20-3307c

Project Contact:

Erskine_Stefanie (soa5)

Organization:

NCHHSTP/DHAP/TICB/RET

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

06/29/2020

Estimated Completion Date:

06/29/2021

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

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

7/14/20

Dodson_Janella R. (jhd7) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Other - Social Marketing Campaign

PRA:
PRA Applies

7/16/20

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

ICRO:
Returned with No Decision

7/16/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

06/22/2020

Determination Start Date:

06/08/20

Description:

This project determination request is to get approval of this non-research project, which CDC is sponsoring and will get PRA
approval. In support of the Ending the HIV Epidemic initiative, CDC will design, implement, and evaluate concepts, messages, and
taglines for a social marketing campaign to prevent new HIV transmission by promoting proven interventions including condoms,
pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP). The concepts, messages and taglines need to be tested and
verified to ensure their acceptability and effectiveness among populations of all ages, genders, races and ethnicities, and sexual
orientations. These formative activities support the development of new and continuing social marketing resources as part of the
Let's Stop HIV Together campaign.

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

No

IMS Activation Name:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal is to evaluate the acceptability and potential effectiveness of proposed concepts, messages, and taglines for a component
of the Let#s Stop HIV Together campaign focused on HIV prevention that promotes proven, effective prevention strategies, such as
PrEP and TasP, among audiences# ages 18 to 64 years old in the United States.

Objective:

The main objectives are to examine receptivity to messages and perceived credibility among populations exposed to Let#s Stop
HIV Together messages; differences in attitudes, beliefs, and knowledge about HIV among those who report exposure and do not
report exposure to Let#s Stop HIV Together phases and messages; intentions related to HIV prevention; and behaviors among
those who report and do not report exposure to the various Let#s Stop HIV Together messages.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations 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

Tags/Keywords:

Formative Evaluation, consumers, HIV prevention, Social Marketing, Message Testing, Materials Testing, Concept Testing

CDC's Role:

Other

Method Categories:

Convenience Sample; Individual Interview (Quantitative); Needs Assessment; Survey

Methods:

Evaluation data will be conducted via 30-minute closed-ended, online surveys. Potential participants will be recruited through online
survey panel vendors, external partners (e.g., community-based organizations, membership organizations), and the Internet.
Individuals selected from panels vendors contacted by email and asked to complete an eligibility survey. They will be screened for
eligibility using a standardized screening form. If eligible, individuals will be invited to participate and will be shown a consent form
prior to the start of the survey. Those who do not consent will receive a message thanking them for their time and will exit the
website. Those who consent to participation will be immediately directed to the survey screener. Those who are eligible, based on
the inclusion criteria, will then be directed to the survey. Those who are not eligible will receive a message thanking them for their
time and will exit the website. The consent, screener, and survey will be online and accessible on personal computers or devices
with internet access. Repeat submissions will be prohibited by the survey vendor.

Collection of Info, Data or Biospecimen:

We will employ non-probability purposive sampling to recruit participants from cities across the United States. The samples for the
surveys will consist of participants selected from a combination of sources, including (1) online survey vendors with proprietary
panel lists, (2) external partners (e.g., community-based or membership organizations), and (3) the Internet. Inclusion criteria will
depend on the specific project phase being evaluated and the target population for the messaging. The informed consent process
and screener will be combined. Participants who consent will complete the screener, and if eligible, they will be linked to the online
survey. Participants will be offered a token of appreciation of $20-$40 cash or cash equivalent for taking part in a survey; higher
amounts will be offered for data collections involving specific audiences known to be difficult to reach (e.g., MSM, PLWH). By
providing monetary incentives, we can improve coverage of specialized respondents, rare groups, or minority populations, including
MSM, transgender men and women, African Americans, and Hispanics. Including these respondents is important to this study to
improve the generalizability of findings and ensure that the campaign materials reflect the information needs and perspectives of
those at highest risk for HIV. The web-based surveys will be self-administered and accessible any time of day for a designated
period. All data collection materials are at an 8th grade reading level or below due to sample eligibility criteria and CDC
requirements. Each respondent can complete the survey only once.

Expected Use of Findings/Results:

The data obtained will be used to inform CDC, policy makers, prevention practitioners, and researchers about audience receptivity
and the potential effects of campaign concepts, messages, and taglines. While this is an ongoing communication effort, this data
collection will support the development of new concepts and messaging for diverse audiences.

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 an assurance of confidentiality in place or
planned?

No

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding
Type

Funding Title

Funding #

CDC
Contract

PN-0128 and PN-1826 Research and Evaluation of HIVAIDS Prevention Communication Science Programs for General Education,
Testing including Transgender, Prevention and Care Efforts, and Partnership Initiatives

200-2015F-88167

Original
Budget Yr

# Years
Award

2015

5

HSC Review

HSC Attributes
Program Evaluation

Yes

Other - Social Marketing Campaign

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 documents 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 #

RTI

200-2015-F-88167

Staff
Staff
Member

SIQT
Exp.
Date

Euna
August

12/20
/2022

Jennifer
Uhrig

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

Principal
Investigator

[email protected]

4046398297

TECHNICAL INFORMATION AND
COMMUNICATIONS BRANCH

02/21
/2023

CoInvestigator

[email protected]

9193163311

RTI

Pamela
Williams

02/21
/2023

CoInvestigator

pamwilliams@rti.
org

9193163936

RTI

Stefanie
Erskine

02/21
/2023

CoInvestigator

[email protected]

4046394530

RESEARCH & EVALUATION TEAM

11/09/2019

CITI Good Clinical
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

5/11/20

Proposed Data Collection End Date:

5/10/23

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data is intended to improve and guide a CDC program.

Public Access Justification:

Aggregated and translated data will be shared with the public through publications, presentations, and through finalized campaign
assets.

How Access Will Be Provided for Data:

RTI, CDC's evaluation contractor, maintains restricted access to all data preparation areas (i.e., receipt and coding). All data files on
multi-user systems will be under the control of a database manager, with access limited to project staff on a #need-to-know# basis
only. The online vendor panels take the following security measures to ensure separation between participants# identity and their
survey data. First, the survey instrument does not contain PII. The only way a survey is identified is with a digital identification
number. Second, although the invitation method (i.e., e-mail, mail, or direct mail) will inherently have PII information included, this
will not be combined with survey responses so the responses from the survey cannot be linked to the PII. Third, screener data will
be considered part of the survey data. The vendors will provide the results of the screener questions for all panelists, regardless of
whether they qualify for the study. However, they will not retain responses to screening questions for those who are deemed
ineligible for any other purpose outside the scope of this project. Fourth, the vendors will retain study records for the duration of the
study. Upon final delivery of data files to RTI and completion of the project, the vendors will destroy all study records, including data
files, upon request. The vendors will not be able to supply or access this information for any reason, even at the request of RTI,
once destroyed. Finally, data coming directly from the survey engine are stored in a proprietary database. Although these data are
not encrypted, once inside the firewall, they are stored in a relational database protected by several layers of intrusion detection and
access control. Data files delivered to RTI by the vendors will be sent via encrypted files. CDC will not be provided with PII.

Plans for Archival and Long Term Preservation:

Spatiality
Country
United States

Dataset

State/Province

County/Region

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