“Formative Research to Develop HIV Social Marketing Campaigns for Healthcare Providers”
OMB No. 0920-New
Supporting Statement B
July 7, 2016
Contact Person:
Euna M. August, PhD, MPH
Prevention Communication Branch
Division for HIV/AIDS Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd. NE
Mailstop E-49
Atlanta, GA 30329
Telephone: (404) 639-8297
Fax: (404) 639-2007
E-mail: wvj3@cdc.gov
B. Statistical Methods
Respondent Universe and Sampling Methods
Procedures for the Collection of Information
Methods to Maximize Response Rates and Deal with Nonresponse
Test of Procedures or Methods to Be Undertaken
Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
The purpose of this study is to conduct formative research that will be used to develop health care provider-focused materials for an HIV prevention social marketing campaigns under the umbrella of the larger Act Against AIDS campaign. The 3-year study will consist of a series of in-depth interviews with 600 healthcare providers (i.e., physicians, physician assistants, and nurses) identified by contractor staff and professional recruiting firms (hereafter referred to collectively as “recruiters”). The interviews will be conducted in cities with a high prevalence of HIV such as Houston, TX; Atlanta, GA; Miami, FL; New Orleans, LA; Washington, DC; and Boston, MA.
Because this is a qualitative study, the sample will be a nonprobability-based, purposeful sample rather than a probability-based sample. Therefore, the results are not generalizable to the general population. We anticipate screening 1,200 individuals to obtain 600 individuals who will participate in a 1-hour, in-depth interview and complete a 15-minute computer-assisted personal interview (web-based) survey. All data collections will be conducted only one time. Statistical power is not applicable because this is a qualitative study.
The contractor will select and reserve professional recruitment firms (with CDC’s approval) in each identified city. Contractor staff and the firms, under the oversight of the contractor, will recruit study participants for the in-depth interviews. The recruiters will use a screener (Attachment 9) to identify eligible participants for the in-depth interviews.
Recruitment grids will be prepared to keep track of recruitment efforts. They will list participants’ first names and some demographic information obtained from the screener. The grids will not contain any identifying information. They will be stored in a locked file cabinet or on a password-protected project share drive at the contractor’s facility, at CDC, and at each professional recruitment firm. The professional recruitment firms will destroy their copies of the recruitment grids after data collection is completed in that city; however, RTI and CDC will retain the recruitment grids for the study’s duration. The contractor and CDC will use information gathered on the recruitment grids to describe the study sample.
Recruitment will begin at least 4 weeks before the in-depth interviews are scheduled. The contractor will closely communicate with each professional recruitment firm to monitor their recruitment progress and troubleshoot any problems. The contractor will keep CDC apprised of recruitment progress and will make any necessary adjustments during the recruitment process. Identification of professional recruiting firms as well as recruitment will begin once Office of Management and Budget (OMB) clearance is received. (Approval through a CDC Project Determination has already been granted; see Attachment 11.) Typically, recruitment takes about 1 month, and we will begin recruitment within a week of receiving clearance. Once we receive clearance, we will assign dates to each activity on the timeline for tracking and monitoring purposes.
Personally identifiable information (PII) from potential participants - name, physical and email addresses, and telephone number - will be maintained and protected to the extent allowable by law. At each facility, recruiters will sign a privacy agreement acknowledging the requirement to treat all data in a secure manner and to not disclose any data unless otherwise compelled by law (Attachment 10). At each recruitment firm and at the contractor’s facility, the screener forms will be kept in locked file cabinets. All PII will be recorded on the last page of the screener, which will enable the facility and/or the contractor to send reminder letters, e‑mails, and phone calls. The last page of the screener will be torn off and destroyed after the in-depth interviews are conducted. The recruitment firms will send the screeners they complete (without the last page) to the contractor. All screeners will be stored in a locked file cabinet at the contractor’s facility throughout the project’s duration. Once the project ends, the screeners will be destroyed. No PII will be kept by the contractor or the recruitment firms after the interviews are completed, and neither the contractor nor the recruitment firms will send any identifying information to CDC. The only linkage between forms is a randomly generated user identification number which will be used to link responses for analytic purposes only.
Before data collection, we will send potential participants a reminder letter or e-mail that also give directions to the study site. We will also make confirmation calls 1 to 2 days before the interview to confirm all participants.
After checking in at the study site, participants will be given time to read a consent form (Attachment 8), and trained contractor staff will be available to answer any questions. If participants agree to be in the study, they will each sign a consent form and will be given a copy to keep for their records. The questions for the exploratory round of research will touch on various topics including HIV testing and prevention (both primary and secondary), behavioral screening, retention in care, anti-retroviral therapy (ART) adherence, pre-exposure prophylaxis (PrEP), and working with transgender populations (see Attachments 4a-4c). The questions in the message, concept, and materials testing guides will focus on getting participants’ feedback on pre-developed messages, concepts, and materials that will be developed based on findings from exploratory research (Attachments 5-7). All individuals participating in the individual, in-depth interviews will also take a standardized 15-minute web-based survey (Attachments 3 and 3a for screenshots).
Contractor staff will FedEx or personally take all forms back to their facility after the interviews are completed in a particular city. The consent forms will be stored in a locked file cabinet at the contractor’s facility for the project’s duration. Once the project ends, all forms will be destroyed.
Each on-site data collection will last 80 minutes, which includes 5 minutes for the consent process, 1 hour for the in-depth individual interview, and 15 minutes for the web-based survey. In addition to the moderator, a contractor staff member will attend the data collection to take notes on a laptop computer and to coordinate logistics of checking in participants and obtaining informed consent. CDC staff member(s) also may attend and observe the in-depth interviews. All in-depth interviews will be audio-recorded for the purpose of completing the final reports. Participants will not be contacted again after the in-depth interview is over. The contractor will retain all data, including audio files, on secure servers; only project staff members will be able to access the servers via password-protected computers. All audio files will be destroyed three years after completion of the project.
The following procedures will be used to maximize cooperation and to achieve the desired participation rates:
Recruitment through professional and experienced recruiters.
Reminder letters/e-mails will be sent with directions to the research site and reminder phone calls placed 1-2 days prior to the scheduled data collection.
Provision of a token of appreciation to thank participants for their involvement in the study (please see Section A-9 for more information about the token of appreciation).
To estimate the burden for administering the screener, we consulted two different project team members. The project team members conducted mock screening interviews and provided affirmative responses to most or all questions that branched to further follow-up questions. In this way, the burden estimate most closely resembles a maximum average burden, because almost all screening questions were presented in the interview. In addition, the project team members deliberately read each item slowly. We estimated the time burden for the survey and interview based on our prior experience using similar instruments for data collections with health care providers.
Jo Ellen Stryker, PhD, MA National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention 1600 Clifton Rd. NE Mailstop E-49 Atlanta, GA 30329 (404) 639-2071 gux6@cdc.hhs.gov |
Nancy Habarta, MPH National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention 1600 Clifton Rd. NE Mailstop E-49 Atlanta, GA 30329 (404) 639-2034 eqq1@cdc.hhs.gov |
Jennifer D. Uhrig, PhD, MHA RTI International Center for Communication Science 3040 Cornwallis Rd. Research Triangle Park, NC 27709 (919) 316-3311 |
Julia Kish Doto, PhD, MS RTI International Center for Communication Science 6110 Executive Boulevard, Suite 902 Rockville, Maryland 20852-3907 (301) 468-8280 |
Brian Southwell, PhD RTI International Center for Communication Science 3040 Cornwallis Rd. Research Triangle Park, NC 27709 (919) 541-8037 |
Euna M. August, PhD, MPH National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention 1600 Clifton Rd. NE Mailstop E-49 Atlanta, GA 30329 (404) 639-8297 Wvj3@cdc.hhs.gov |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Peyton Williams |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |