Assessment of QDS System - supporting statement A

Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation

Generic Information Collection request under 0920-0840

Section A: Supporting Statement

April 19, 2010

Contact

Holly Fisher, PhD

Centers for Disease Control & Prevention

Division of HIV/AIDS Prevention

Program Evaluation Branch

Phone (404) 639-1940

Fax (404) 639-0929

hfisher@cdc.gov

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

27. B. Collection of Information Employing Statistical Methods

28. 1. Respondent Universe and Sampling Methods

29. 2. Procedures for the Collection of Information

30. 3. Methods to Maximize Response Rates and Deal with Nonresponse

31. 4. Tests of Procedures or Methods to be Undertaken

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

36. List of Attachments

37. Attachment 1. QDS Survey

38. Attachment 2. Consent Forms

39. Attachment 3. Screener Form

44. Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation

46. Supporting Statement

48. A. JUSTIFICATION

50. A.1 Circumstances Making the Collection of Information Necessary

52. The Centers for Disease Control and Prevention proposes to evaluate the feasibility of utilizing handheld devices and laptop computers to collect behavioral risk information directly from individuals at the point of interviewer-respondent interaction. The objective is to replace provider-administered surveys, interviews, or provider observations to collect client-level behavioral risk information.

54. Because behavioral HIV-related risk information tends to be highly-sensitive and personal in nature, individuals may be more likely to report their actual risk behaviors when they can administer the survey to themselves in a private manner. One study of HIV testing found that people using a client-administered handheld device reported five times as many sexual partners as the number of partners reported by clients who were interviewed by agency staff (1).

56. This project will compare the client-level behavioral risk information collected by means of the existing methods to the information collected using the mobile devices (hand held or laptop) pre-programmed with the survey instrument to:

58. 1) compare differences in self-reported behavioral risk patterns across the two data collection systems, and 2) determine the feasibility of using client-administered handheld devices and laptop computers when collecting HIV behavioral risk information.

60. The exploratory findings from this project will assist CDC in determining the utility and acceptability of client-administered, electronic data collection equipment when collecting highly-sensitive behavioral risk data from participants of CDC-funded HIV prevention programs.

63. A.1.2 Privacy Impact Assessment

65. CDC will not receive any personally identifiable information. Any individually identifiable information collected by funded agencies will not be submitted to CDC. No data pertaining to participant contact information or the consent process will be collected or stored via QDS.

68. A.1.3 Overview of the Data Collection System

70. Information will be collected electronically with handheld computerized devices and laptop computers using the Questionnaire Development System (QDS) software version 2.5. Electronic surveys downloaded on the handheld devices will utilize QDS Handheld Assisted Personal Interview software. Electronic surveys downloaded on the laptop computers will utilize QDS Computer Assisted Personal Interview software. The survey content will be identical for each type of device.

71. The responders will be volunteers who are recruited from the target population served by each funded agency.

72. The evaluation will involve quantitative data collection and will evaluate the use of QDS surveys and handheld electronic devices when collecting client-level risk data. This project is limited in scope and will only involve data collected from three agencies currently funded by CDC. However, the development of new, efficient methods for collecting HIV-related information from the general public could be used in future HIV-related research and evaluation projects and may ultimately improve the quality of behavioral risk data and reduce the burden of future data collections.

75. A.1.4 Items of Information to be Collected

77. The QDS survey will collect demographic, behavioral HIV risk, and psychosexual information (see Attachment 1 for a paper version of the survey).

79. The information collected by each of the three funded agencies may include personally identifiable information, such as name and contact information, in order to provide continuity of service, follow-up of referrals, and other outreach activities. Please note that we are not asking the three agencies to collect any information that they will not otherwise be collecting under the terms of their cooperative agreements and for purposes associated with serving their clients. Personally identifiable information will be kept in a separate location and will be accessible only to appropriate agency staff. Any individually identifiable information collected by funded agencies will not be submitted to CDC. QDS data will be encrypted and submitted to CDC via the Secure Data Network.

81. The information collected for this project will be maintained or stored locally under strict access controls limited to the local project manager and relevant staff. Project data will be stored separately from personally identifiable information. Under no circumstances will an individual be identified using a combination of variables such as gender, race, birth date, and/or other descriptors.

84. A.1.5 Identification of Websites and Website Content Directed at Children Under 13 Years of Age

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

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

91. The purpose of the “Assessment of a QDS Data Collection System in HIV Prevention Program Evaluation” project is to replace the current method for collecting highly-sensitive HIV behavioral risk information from at-risk individuals. Findings from this project are intended to 1) improve CDC’s ability to process client-level risk information and provide timely feedback to agencies that implement CDC-funded HIV prevention programs and 2) improve the quality of behavioral risk information reported by clients of HIV prevention programs.

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

95. Responder reactions will be evaluated using a survey developed by CDC with QDS software version 2.5 (Handheld Assisted Personal Interview and Computer Assisted Personal Interview software modules). Project participants will complete the QDS survey on a handheld device or laptop computer. Upon survey completion, agency staff will upload the survey data to a desktop computer, encrypt the data file, and submit the file to CDC via the Secure Data Network.

98. A.4. Efforts to Identify Duplication and Use of Similar Information

100. NCHHSTP has verified that there are no other federal generic collections that duplicate the data collection tools and methods included in this request.

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

105. Community based organizations and local health departments receive federal funds to conduct this evaluation.

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

109. The activities involve a one-time collection of data. There are no legal obstacles to reducing the burden.

112. A.7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5

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

117. A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies

119. A federal register notice for the umbrella collection was published on March 9, 2009.

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

124. All project participants will be offered incentives in cash or kind depending upon the practices at the local communities. The tokens of appreciation will not exceed $40 per person per hour.

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

129. Respondents’ will be told that all individually identifiable information collected by the implementing agencies will not be submitted to CDC. A master list of assigned Client IDs with client names will be stored in a locked file cabinet and is intended for agency use only (and will not be submitted to CDC). Participant names will not be recorded on any other data collection document and will not be stored on any handheld device or laptop.

131. Project data storage will be maintained in a secure area at all times at each agency in a locked file cabinet in the office of the project coordinator. All electronic data will be password-protected and accessible only to project staff and direct supervisors. Data will be stored located on network drives which are regularly backed up by staff.

133. Participation in this project is strictly voluntary. The consent process will be implemented according to local/state policy. Consent forms for the three funded agencies involved in this activity are provided in Attachment 2. The consent process will generally involve agency staff providing a brief overview of the project, including a description of benefits and barriers to participation. Participants will be assured that the information they provide will be protected to the maximum extent permitted by law. Interested participants will sign a consent form prior to participation. Participants at two of the agencies will also be required to sign a HIPAA Privacy Statement. Consent and HIPAA forms will not be labeled with Client IDs and will be stored separately from the QDS data.

136. A.11.Justification for Sensitive Questions

138. This request covers the collection of HIV behavioral risk data. Thus, participants will be asked to report on sensitive and private matters pertaining to their sexual practices and substance use. Some of the questions will ask about involvement in illegal activities (e.g., use of illegal substances, having sex in exchange for money or drugs) and about past HIV/STD diagnoses. This information may be considered by some participants to be highly sensitive in nature. However, in order to effectively compare the QDS data collection system to PEB’s existing data collection system, it is necessary to include questions about sexual activity and substance use as they pertain to HIV transmission.

140. In no case will a participant’s social security number be obtained by agency staff.

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

145. A.12.A. Estimated Annualized Burden Hours

147. The annualized response burden for this sub-collection (generic IC) is estimated at 443 hours. Exhibit A.12.A provides details about how this estimate was calculated. Timings were conducted during the instrument development process to support the overall burden per respondent. Administration of the screening instrument is estimated to take 5 minutes. Survey completion is estimated to take 30 minutes maximum. It is estimated that during a single year, 1000 screening forms will be completed (83 hours) and 720 surveys will be completed (360 hours), totaling 443 hours.

149. Exhibit A.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)
     General public	Screener	1000	1	5/60	83
     General public	Survey of Individual	720	1	30/60	360
     Total					443

153. A.12.B. Estimated Annualized Costs

155. Three community-based organizations have received federal funds to implement this project. The annualized cost to the respondent is described in Exhibit A.12.B.

156. The United States Department of Labor, Bureau of Labor Statistics May, 2005 (http://www.bls.gov/oes/current/ oes291069.htm) was used to estimate the hourly wage rate for the general public for the purpose of this generic request. The figure of $20.00 per hour was used as an estimate of average hourly wage across the country. Thus, the total anticipated annual cost to participants for collection of information in this project will be $8,860.

157. Exhibit A.12.B. Annualized Cost to Respondents

     Activity	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
     Screener (Public)	83	$20.00	$1,660
     Survey of Individuals (Public)	360	$20.00	$7,200
     Total			$8,860

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

163. None. There will be no start up or other related costs to private entities.

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

168. This activity will involve participation of one CDC project officer (GS-13 level) who will be responsible for project design, project oversight, and analysis and dissemination of the results. The CDC project officer will provide remote and onsite technical assistance to the agencies implementing the data collection. Three contractors will also provide technical assistance to agencies throughout the project period. Travel may be required to provide this technical assistance. An estimated average cost per individual activity is listed below.

170. Exhibit 14.A Estimated Cost to the Government

171. Expense Type	Expense Explanation	Annual Costs (dollars)
     Direct Costs to the Federal Government
     	CDC Project Officer (GS-13, 0.5 FTE)	$49,875
     	CDC Travel (4 trips)	$5,200
     	Subtotal, Direct costs	$55,075
     Cooperative Agreement or Contract	Cooperative Agreement	$489,341
     	Contractor Program Coordinator (0.50 FTE)	$31,994
     	Contractor Program Coordinator (0.50 FTE)	$31,994
     	Contractor Program Coordinator (0.50 FTE)	$31,994
     	Contractor Travel (8 trips)	$10,400
     	Subtotal, Cooperative Agreement or Contract costs	$595,723
     	TOTAL COST TO THE GOVERNMENT	$650,798

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

176. Not applicable – request is for a sub-collection under a generic approval.

179. A.16.Plans for Tabulation and Publication and Project Time Schedule

181. Exhibit 16.A Project Time Schedule

     Activity	Time Schedule
     Training of data collection methods using QDS survey and handheld devices/laptop computers	Within one month of receiving OMB approval
     QDS data collection begins	Within one month of receiving OMB approval
     QDS data submission to CDC	Monthly
     QDS data collection ends	12 months after receiving OMB approval

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

185. OMB Expiration Date will be displayed.

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

189. There are no exceptions to the certification.

195. References

197. 1. Sheon N, Gonzalez I, Gluth D, Facente S, Carraher N. PalmIT: Localizing a Structural Intervention to Improve HIV Test Counseling and Client Data Collection. Paper presented at the 2008 Centers for AIDS Prevention Studies Conference, San Francisco, CA. Available at: http://www.caps.ucsf.edu/conference/2008/pdf/Sheon2008CAPSConf.pdf. Accessed March 1, 2010.