Supporting Statement B

MSM Shigellosis Formative Research_Part B.docx

CDC/ATSDR Formative Research and Tool Development

Supporting Statement B

OMB: 0920-1154

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

Generic Information Collection (0920-1154)









Supporting Statement Part B







Submitted: March 27, 2017











Program Official/Project Officer

Matt Karwowski

Division of Foodborne, Waterborne, and Environmental Diseases, NCEZID

1600 Clifton Rd, NE, Mailstop C-09

404-718-5867

[email protected]





Table of Contents



  1. Respondent Universe and Sampling Methods

A total of 45 participants among men who have sex with men will be recruited for the shigellosis formative evaluation by advertising it through various community and social media outlets as well as healthcare 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. Georgia State University investigators will also use 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 privacy and human subject protections (see attachment 2).


Eligible callers who agree to participate will be offered participation in all applicable focus groups as part of the screening process. Respondents will self-select the group in which they wish to participate until that group is filled, at which point the group will fall out of the available options offered. Georgia State University investigators will conduct all recruitment using the inclusion criteria identified in the screener (attachment 2). Groups of 6–8 men, ≥18 years old of different races (e.g. African American, Hispanic, and Caucasian) and HIV statuses will be recruited for hour-long focus group discussions. Georgia State University investigators will conduct all recruitment, including delivering the screener to potential participants to determine their eligibility prior to the focus groups.


  1. Information Collection Procedures

Focus groups will be conducted by trained moderators in person. Structured moderator guides will be used as the data collection tools (see Attachment 4). Georgia State University investigators will screen, recruit, and schedule all participants for focus groups; 6–8 individuals will participate in each focus group (see Attachments 2–5). Potential participants will be asked for their availability to participate in the focus group. Once a time that works for a sufficient number of participants has been identified, the recruiter will send a calendar invitation. A note taker will be present during each focus group. Focus groups will be audio recorded to serve as a backup to the notes. Focus groups will last approximately 60 minutes.

At the start of the focus group, the moderator will obtain verbal consent from the participants by reading the informed consent statement aloud and obtaining permission to audio record the focus group (see Attachment 5).

  1. Methods to Maximize Response Rates

Georgia State University investigators will conduct all screening and recruitment of eligible participants. Investigators will recruit eight participants for each focus group to ensure at least six participants are available. The focus group moderator guides were designed with particular focus on open-ended questions to allow participants to provide significant detail and participants will have the option to skip questions they are not comfortable answering. Participants also will be informed that they have the right to end their participation at any time.

  1. Test of Procedures or Methods to be Undertaken

The estimate for burden hours is based on previous use of similar data collection instruments developed by Georgia State University investigators. The average time to complete an instrument that tested the same health campaigns domains, including time for reviewing the verbal consent, instructions, and completing the instrument, were approximately 70 minutes. The estimates for burden hours for the screeners are based on pilot tests by the investigators at Georgia State University.

  1. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

  • Eric Wright, Georgia State University

(404) 413-6527; [email protected]

  • Ebony Townshed, Georgia State University

[email protected]




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