SS_Part A

Clinic Context Matters Study

Supporting Statement A

OMB No. 0920-new

December 16, 2014

Project Officer:

Dawn K. Smith, MD, MS, MPH

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of HIV/AIDS Prevention/Epidemiology Branch

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop E-45

Atlanta, GA 30333.

Voice: (404) 639-5166

Fax: (404) 639-6127

Email: [email protected]

Table of Contents

Section

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of the Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less frequently

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

9. Explanation of Any Payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

14. Annualized Cost to the Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

17. Reason(s) Display of OMB Expiration Date is Inappropriate

18. Exceptions to Certification for Paperwork Reduction Act Submissions

20. Exhibits

21. Exhibit 12.A Estimated Annualized Burden Hours

22. Exhibit 12.B Estimated Annualized Burden Costs

23. Exhibit 14.A Estimated Cost to the Government

24. Exhibit 16.A Project Time Schedule

26. Attachments

27. 1	Authorizing Legislation
    2	60-Day FRN
    3	Clinician Interview Invitation
    4	Clinician Consent and Interview (Screenshots)
    5	Public Comment

28. A. JUSTIFICATION

30. A.1. Circumstances Making the Collection of Information

31. Necessary

33. The Centers for Disease Control and Prevention (CDC), requests a 3-year approval for a new data collection entitled, “Clinic Context Matters Study”. The collection will look at the characteristics of respondents and the characteristics, knowledge, attitudes and practices of the clinical practice staff as they relate to the introduction of a new clinical intervention (PrEP) in their clinics.

35. The daily use of specific antiretroviral medications by persons without HIV infection, but at high risk of sexual or injection exposure to HIV, has been shown to be a safe and effective HIV prevention method. The Food and Drug Administration approved the use of Truvada® for preexposure prophylaxis (PrEP) in July 2012 and PHS has issued guidelines for its use. With approximately 50,000 new HIV infections each year, increasing rates of infection for young MSM, and continuing severe disparities in HIV infection among African-American men and women, incorporation of PrEP into HIV prevention is important. However, as a new prevention tool in very early stages of introduction and use, there is much we need to learn about how to implement PrEP in a real world setting.

37. CDC is authorized to collect the data described in this request by Section 301 of the Public Health Service Act (42 USC 241). A copy of this enabling legislation is provided in Attachment 1.

39. A.2. Purpose and Use of Information Collection

41. The goal of the proposed information collection is to learn about clinician’s knowledge, attitudes, and practices related to a new intervention (PrEP) during the period of its initial introduction in their clinics. Because PrEP is new, and highly effective, additional efforts to inform clinicians, and to design tools and methods to support its safe and effective delivery in clinical settings are critical. The knowledge gained will be used to refine measurement instruments and methods, develop training and educational resources and tools for use by CDC/DHAP (Division of HIV/AIDS Prevention)-funded partners, and other organizations supporting delivery of PrEP in clinical settings. The results of this survey may be shared by presentation at scientific meetings, distribution to technical assistance providers for clinical HIV prevention partners, and publication of a report on a CDC website or in a journal.

44. A.3. Use of Improved Information Technology and Burden Reduction

46. The survey will be created using the Survey Monkey platform, which is extremely user friendly. Most of the questions are closed ended questions and require little effort to answer- often just a simple click on the device. When participants are finished with the survey, they simply click “submit” and they are finished.

48. A.3.1. Overview of the Data Collection System

50. Surveys will be conducted with Survey Monkey, an online survey tool that has received information security clearance for the collection of data by CDC.

1. 3.2. Items of Information to be Collected

72. Surveys will collect items of information related to: professional roles and demographic characteristics of respondents, clinical practice characteristics, knowledge, attitudes and practices related to introduction of a new clinical intervention (PrEP) in their clinics.

74. A.3.3. Identification of Websites and Website Content Directed at Children Under 13 Years of Age

76. This information collection does not involve websites or website content directed at children less than 13 years of age.

79. A.4. Efforts to Identify Duplication and Use of Similar

80. Information

82. Literature searches were conducted to identify duplicate information collections. No similar information is currently available for the purposes of this study. As far as we know, this information collection does not duplicate any existing efforts. This study will provide us with an understanding of the knowledge, attitudes, and organizational factors related to pre-exposure prophylaxis (PrEP) and its provision by clinicians at local clinics over time and an assessment of the utility of new measures developed or adapted to collect this information.

84. A.5. Impact on Small Businesses and Other Small Entities

86. No impact on small business and other entities has been identified or is anticipated.

88. A.6. Consequences of Collecting the Information Less Frequently

90. If funding allows, the survey will be conducted once a year for 3 years. For some descriptive analyses, information will be collapsed across the three years but for attitudinal and knowledge measures, responses will be compared across the years for trend, using statistics appropriate to small cell sizes where indicated. If the survey were conducted less frequently, then we would not be able to assess changes over time among the clinicians. These changes over time are key to determine what types of resources need to be invested in assessing and addressing knowledge, attitudes, practices, and organizational factors related to pre-exposure prophylaxis and its provision at local clinics.

92. A.7. Special Circumstances Relating to Guidelines of 5 CFR

93. 1320.5

95. This request fully complies with the regulation 5 CFR 1320.5.

98. A.8. Comments in Response to the Federal Register Notice and

99. Efforts to Consult Outside Agencies

101. A 60 day federal register notice (attachment 2) to solicit public comments was published in the Federal Register on 08/11/2014, Volume 79, Number 154, and Page number 46827. One non-substantive public comment was received and is included in attachment 5. The standard courtesy reply was sent in response to the public comment. No efforts to consult outside agencies were made.

104. A.9. Explanation of Any Payment or Gift to Respondents

106. Respondents will not be paid for survey participation.

109. A.10. Assurances of Confidentiality Provided to Respondents

111. No personally-identifiable information is collected. Survey responses cannot be linked to the individual respondent.

112. A.10.1. Privacy Impact Assessment

114. The clinic survey will be programmed (in Survey Monkey) for administration online to be accessed using a tablet, office, or home computer. The survey will take about 30 minutes to complete. Each clinician will be assigned an ID number (by their clinic) for completion of the online survey. No personal identifiers will be collected.

116. A.11. Justification for Sensitive Questions

118. A few demographic questions may be considered sensitive (i.e., race, age, sexual orientation) but are essential for understanding the population surveyed in relation to the population being provided PrEP.

120. A.12. Estimates of Annualized Burden Hours and Costs

122. This information collection will be collected once per year for three years. Potential respondents will receive an email inviting them to participate with a URL to the consent form and survey (attachment 3). There is no burden associated with the invitation other than reading the invitation. Respondents will consent once they access the link to the survey. The consent form and survey (attachment 4), is estimated to be 88 burden hours for the 175 respondents who will provide one 30-minute response per year.

124. Exhibit 12.A. Annualized Burden Hours

     Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Hours Per Response	Total Response Burden (Hours)
     Clinician	Clinician Consent and Interview Att 4	175	1	30/60	88
     Total					88

126. 12.B. Estimated Annualized Burden Costs

127. The annualized costs to the clinician respondents are described in Exhibit A.12.B. To estimate the participant costs, the hourly wage rate ($90.00) for general internists was used from the United States Department of Labor Statistics May, 2013 (http://www.bls.gov/oes/current/oes_nat.htm).

128. Exhibit 12.B. Annualized Cost to Respondents

     Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
     Clinicians	Clinician Consent and Interview Att 4	88	$90.00	$7,920.00
     Total				$7,920.00

130. A.13. Estimates of Other Total Annual Cost Burden to

131. Respondents and Record Keepers

133. There are no costs to respondents other than their time.

135. A.14. Annualized Costs to the Federal Government

137. The annualized cost to the government is estimated to be $34,700 per year for percentage of FTE time spent on the study. The total cost to the federal government for 3 years planned is $104,100.

139. Exhibit 14.A. Estimated Cost to the Government

140. Expense Type	Expense Explanation	Total Costs per year (dollars)
     Project Officer	CDC Project Officer to monitor progress, review reports, etc. (GS-14 0.15) FTE)	$20,000
     Statistician	CDC Statistician (GS 13 0.05 FTE)	$4,700
     Data Manager	CDC Data Manager (GS 13 0.10 FTE)	$10,000
     	Subtotal, Direct costs	$34,700
     Total Costs to Government		$34,700

144. A.15. Explanation for Program Changes or Adjustments

145. This is a new information collection

150. A.16. Plans for Tabulation and Publication and Project Time

151. Schedule

153. Exhibit 16.A Project Time Schedule

154. Activity	Time Schedule
     Administer survey	1-3 months after OMB approval and then annually for 2 additional years
     Data analysis	4-6 months after OMB approval and then annually for 2 additional years

156. Survey results will be published in a peer-reviewed journal and presented at one or more conferences.

158. A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

160. OMB Expiration Date will be displayed.

163. A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

165. There are no exceptions requested.

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