Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion

PROJECT TITLE: Formative Evaluation for Shigellosis Sexual Health Materials for Men Who Have Sex with Men

PURPOSE AND USE OF COLLECTION:

The Centers for Disease Control and Prevention (CDC) is requesting approval for a new generic information collection, Formative evaluation for Shigellosis Sexual Health Materials for Men Who Have Sex with Men.

This information collection involves formative evaluation to understand men who have sex with men’s (MSM) knowledge, perceptions, and behaviors regarding shigellosis and its prevention. Respondents also will provide feedback on initial informational messages and calls-to-action. This information collection focus group discussions and recruitment screeners.

DESCRIPTION OF RESPONDENTS:

• Men who have sex with men.

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

Name: Matt Karwowski

To assist review, please answer the following questions:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [X] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [X] No Not applicable

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [X] Yes [ ] No

Focus group participants will receive a monetary gift of appreciation for their participation. It is assumed that many of these participants be taking time either during work hours or personal time to complete the focus groups. Therefore the monetary gift may serve to offset costs related to participating in the study in the amount of $40 for participation in 60-minute focus group.

BURDEN HOURS

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden Per Response (hours)	Total Burden Hours
MSM	Screener	400	1	5/60	34
	Moderator Guide	45	1	1	45
Total					79

FEDERAL COST:

The total annualized cost to the government is $43,892 and consists entirely of federal staff time on the project.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [X] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

• Focus Groups: Georgia State University will recruit potential respondents by advertising the evaluation through various community and social media outlets as well as health care and social service providers serving the LGBT community in Georgia. Passive recruitment will occur through these partners via printed materials that describe the evaluation and direct interested participants to call the evaluation telephone number. We will also incorporate the snowball method of recruitment, in which callers are asked to share the evaluation’s contact information with their network. All data collected as part of screening is subject to confidentiality and human subject protections. We will conduct six focus group discussions, each lasting up to one hour or until we reach the point of saturation. Focus groups will allow us to determine the knowledge and perceptions of MDR shigellosis infections and shigellosis prevention among MSM, and to assess preferences for the tone and format of shigellosis prevention materials. These discussions will be led using a phase-specific focus group moderators’ guide.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[X] Telephone

[X] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X] Yes [ ] No

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