Formative Research to Develop HIV Social Marketing Campaigns for Healthcare Providers
Supporting Statement B
Reinstatement
OMB No. 0920-1182
April 23, 2021
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: [email protected]
The purpose of this information collection is to conduct formative research that will be used to inform the development and/or revision of healthcare provider-focused messages, concepts, and materials focused on HIV prevention, testing, and care for the Let’s Stop HIV Together campaign and in support of the Ending the HIV Epidemic plan. The information collection will focus on healthcare providers in the United States, including physicians, physician assistants, and nurses who practice primary care or relevant specialties, including HIV medicine and infectious disease.
Qualitative methods provide flexible in-depth exploration of the participants’ perceptions and experience, and the data collection yields descriptions in the participants’ own words. Qualitative methods also allow the interviewer flexibility to pursue relevant and important issues as they arise during the discussion. Furthermore, a qualitative approach will allow us to capture subtle nuances in participants’ attitudes, beliefs, and feelings related to the campaign materials. Our data collection guides (exploratory, messages, concepts and materials testing) include probes to ensure that we obtain input on specific items of interest, while open-ended questions ensure that participants’ responses and perceptions are fully addressed and captured (Attachments 4-7).
Before the qualitative interviews, the participants will take a brief, 15-minute web-based survey (Attachments 3 and 3a). Data collected by the brief survey will provide a source of quantitative data supplementing the qualitative data collected during the interviews. The survey will collect basic background information about the participant’s type of practice, volume and type of patients seen, professional development activities, information needs, use of different forms of media to communicate information to patients, types of information, frequency and challenges with communicating HIV-related information to patients.
Because this is a qualitative data collection, the sample will be a nonprobability-based, purposeful sample rather than a probability-based sample. Therefore, the results are not generalizable to all healthcare providers. We anticipate screening 1,138 individuals to obtain 569 individuals who will participate in a 1-hour in-depth interview and complete a 15-minute web-based survey. Each interview will be conducted only one time.
Participants will be recruited from locations (states, counties, and territories) identified as priorities in the Ending the HIV Epidemic plan.
Statistical power is not applicable because this is a qualitative study.
The audience for this information collection will consist of healthcare providers, including physicians, physician assistants, and nurses who practice primary care or relevant specialties, including HIV medicine and infectious disease.
Contractor staff or professional recruitment firms, under the oversight of the contractor, will recruit participants for the in-depth interviews using a screener (Attachment 9) to identify eligible participants.
As participants are recruited for the in-depth interviews, recruitment grids will be prepared to keep track of recruitment. The recruitment grids will list participants’ first names and some sociodemographic information obtained from the screener. The grids will not contain any identifying information. The recruitment grids will be stored in a locked file cabinet or on a password-protected project share drive at the contractor’s worksite and at professional recruitment firms. The professional recruitment firms will destroy their copies of the recruitment grids after data collection is completed; however, RTI and CDC will retain the recruitment grids in order to describe the study sample. These copies of the recruitment grids will be kept in locked file cabinets or on a password protected project share drive at the contractor’s worksite and CDC for the duration of the study.
Recruitment will begin at least 4 weeks before the in-depth interviews are scheduled. The contractor will closely communicate with the 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 recruiting facilities and 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 one 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 the in-depth interview participants 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 facility and at the contractor’s worksite, the screener forms will be kept in locked file cabinets or on secure servers. All PII (name, address, telephone number) 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. If hard copy, the last page of the screener will be torn off and destroyed after the in-depth interviews are conducted. If electronic, the last page will be deleted. 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 recruitment firms after the interviews are completed, and the professional recruitment firms will not send any identifying information to the contractor or CDC.
Before data collection, we will send potential participants a reminder letter or e-mail that also gives directions to the study site. We will also make confirmation calls or send emails 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, he/she will provide consent. The participant will be offered a copy of the consent form to keep for his/her records, if they wish, and we will proceed with the interview. 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 patient-centered care (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).
All participants will be reminded that they can refuse to answer any question and they can stop participating at any time, without penalty. Contractor staff will FedEx or personally take all forms back to their facility after the interviews are completed in a particular location. The consent forms will be stored in a locked file cabinet or scanned and saved to a secure project share drive at the contractor’s facility for the project’s duration. Once the project ends, all forms will be destroyed.
On an annual basis, 569 individuals will participant in a one-hour, in-depth interview. The interview participants will also complete a 15-minute survey. The in-depth interviews will be conducted in-person or virtually by a professionally trained interviewer. The location of the data collection may include professional focus group facilities, clinics, contractor offices, other locations convenient to participants, or virtual telephone or video interviews. Flexibility in data collection location is important when working with healthcare providers with extremely demanding schedules, particularly those that serve rare groups or minority populations at increased risk for HIV acquisition and transmission.
Each data collection will last a total of 1 hour and 15 minutes (1 hour for the in-depth individual interview and 15 minutes for the web-based survey). In addition to the interviewer, 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 either through a one-way mirror or virtually by phone or live video streaming. All in-depth interviews will be audio-recorded for the purpose of completing the analysis and 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. No links will be maintained to any identifying information.
The following procedures will be used to maximize cooperation and to achieve the desired participation rates:
Reminder letters/e-mails will be sent with directions to the data collection site and reminder phone calls placed or emails sent 1-2 days prior to the scheduled data collection. Participants will not be contacted again after the in-depth interview is over.
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 healthcare 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 |
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 |
Jennifer D. Uhrig, PhD, MHA RTI International Center for Communication Science 3040 Cornwallis Rd. Research Triangle Park, NC 27709 (919) 316-3311 |
Pamela Williams, PhD RTI International Center for Communication Science 3040 Cornwallis Rd. Research Triangle Park, NC 27709 (919) 316-3936 |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Peyton Williams |
| File Modified | 0000-00-00 |
| File Created | 2021-10-10 |