Assessment of a QDS Data Collection System to Conduct a Community-level Evaluation of an HIV Prevention Program
Generic Information Collection request under 0920-0840
Supporting Statement A
May 6, 2011
Contact
Gene Shelley, PHD
Centers for Disease Control & Prevention
Division of HIV/AIDS Prevention
Program Evaluation Branch
Phone (404) 639-0901
Fax (404) 639-0929
Table of Contents
Section
A. Justification
Circumstances Making the Collection of Information Necessary
Purpose and Use of the Information Collection
Use of Improved Information Technology and Burden Reduction
Efforts to Identify Duplication and Use of Similar Information
Impact on Small Businesses or Other Small Entities
Consequences of Collecting the Information Less frequently
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
Explanation of Any Payment or Gift to Respondents
Assurance of Confidentiality Provided to Respondents
Justification for Sensitive Questions
Estimates of Annualized Burden Hours and Costs
Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
Annualized Cost to the Government
Explanation for Program Changes or Adjustments
Plans for Tabulation and Publication and Project Time Schedule
Reason(s) Display of OMB Expiration Date is Inappropriate
Exceptions to Certification for Paperwork Reduction Act Submissions
Exhibits
Exhibit 12.A Estimated Annualized Burden Hours
Exhibit 12.B Estimated Annualized Burden Costs
Exhibit 14.A Estimated Cost to the Government
Exhibit 16.A Project Time Schedule
B. Collection of Information Employing Statistical Methods
1. Respondent Universe and Sampling Methods
2. Procedures for the Collection of Information
3. Methods to Maximize Response Rates and Deal with Nonresponse
4. Tests of Procedures or Methods to be Undertaken
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
List of Attachments
Attachment 1. QDS Survey
Attachment 2. Screener Form
A. JUSTIFICATION
A.1 Circumstances Making the Collection of Information Necessary
The Centers for Disease Control and Prevention proposes to evaluate the feasibility of utilizing handheld devices and laptop computers to collect HIV-related behavioral risk information from individuals who may have been exposed to the messages of a community-level HIV prevention program. The objective of this project is to replace staff-administered surveys completed on paper with self-administered electronic surveys when collecting behavioral risk and message exposure data from the general public.
Because HIV-related behavioral 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 self-administered handheld device reported five times as many sexual partners as the number of partners reported by individuals who were interviewed by agency staff (1). Thus, allowing people to self-administer an electronic survey may result in the collection of data that is more representative of real-world behaviors, compared to when staff-administered surveys are used.
In this project, we will compare the behavioral risk and message exposure data collected with mobile devices (hand held or laptop) using a self-administered survey to the behavioral risk and message exposure data collected via staff-administered surveys in the original research efficacy trials for this HIV prevention program. The exploratory findings from this project will assist CDC in determining the utility and acceptability of self-administered, electronic data collection equipment when collecting highly-sensitive information from individuals in communities where CDC-funded HIV prevention programs are implemented.
A.1.2 Privacy Impact Assessment
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.
A.1.3 Overview of the Data Collection System
Information will be collected electronically with handheld computerized devices and laptop computers using the Questionnaire Development System (QDS) software version 2.6. 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.
The responders will be volunteers who are recruited from the community that is served by each funded agency.
The evaluation will involve quantitative data collection and will evaluate the use of self-administered QDS surveys on mobile electronic devices when collecting behavioral risk and message exposure data. This project is limited in scope and will only involve data collected from the 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.
The QDS survey will collect demographic, behavioral HIV risk, psychosexual, and community cohesion information from individuals in the target populations served by the three agencies. The survey will also include questions about level of exposure to the CDC-funded community-level intervention. (See Attachment 1 for a paper version of the survey.)
The information collected by each of the three funded agencies will not include any personally identifiable information.
Please note that we are not asking the three agencies to collect any information that they would not otherwise be collecting under the terms of their cooperative agreements and for purposes associated with serving members of their respective communities. QDS data will be encrypted and submitted to CDC via the Secure Data Network.
The information collected for this project will be maintained and stored locally under strict access controls limited to the local project manager and relevant staff. Project data will be stored separately from consent forms at each agency.
A.1.5 Identification of Websites and Website Content Directed at Children Under 13 Years of Age
This information collection does not involve websites or website content directed at children less than 13 years of age.
A.2. Purpose and Use of Information Collection
The purpose of the “Assessment of a QDS Data Collection System to Conduct a Community-level Evaluation of an HIV Prevention Program” project is to replace the current method for collecting highly-sensitive HIV behavioral risk information and message exposure data from individuals during community-level assessments. Findings from this project are intended to 1) improve CDC’s ability to process data collected from the target populations served by CDC-funded agencies information and provide timely feedback to agency staff, and 2) improve the quality of behavioral risk and message exposure information reported by individuals in the target populations served by CDC-funded HIV prevention programs.
A.3. Use of Improved Information Technology and Burden Reduction
Participant reactions will be evaluated using a survey developed by CDC with QDS software version 2.6 (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, and submit the file to CDC via the Secure Data Network.
A.4. Efforts to Identify Duplication and Use of Similar Information
NCHHSTP has verified that there are no other federal generic collections that duplicate the data collection tools and methods included in this request.
A.5. Impact on Small Businesses and Other Small Entities
Community-based organizations receive federal funds to conduct this evaluation.
A.6. Consequences of Collecting the Information Less Frequently
The activities involve a one-time collection of data. There are no legal obstacles to reducing the burden.
A.7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5
This request fully complies with the regulation 5 CFR 1320.5.
A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agencies
A federal register notice for the umbrella collection was published on March 9, 2009, 0920-0840, expiration date 01/31/2013.
A.9. Explanation of Any Payment or Gift to Respondents
All project participants will be offered tokens of appreciation in cash or kind depending upon the practices at the local communities. The tokens of appreciation will not exceed $40 per person per hour.
A.10.Assurances of Confidentiality Provided to Respondents
CDC’s Assurance of Confidentiality for HIV testing does not apply to this project. Respondents will be told that no individually identifiable information collected by the implementing agencies will be submitted to CDC. Participant names will not be recorded on any document or on any handheld device or laptop.
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 on network drives which are regularly backed up by staff.
Participation in this project is strictly voluntary. The consent process will generally involve agency staff providing a brief overview of the project, including a description of benefits and barriers to participation and protections for the participant’s privacy. Respondents will be presented with a yes/no option on the handheld device to consent to the interview. Since there is no personally identifiable information collected, the respondent’s name is not collected for the consent.
A.11.Justification for Sensitive Questions
This request covers the collection of HIV behavioral risk data. Thus, respondents 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 respondents to be highly sensitive in nature. However, in order to effectively evaluate the feasibility of using the QDS data collection system during community-level assessments of CDC-funded HIV prevention programs, it is necessary to include questions about sexual activity and substance use as they pertain to HIV transmission.
Individuals recruited from the community will be pre-screened to determine if they are members of the target population served by each agency and if they meet eligibility requirements for this project. (See Attachment 2 for a paper version of the screener form.)
In no case will participants’ social security numbers be obtained by agency staff.
A.12.Estimates of Annualized Burden Hours and Costs
A.12.A. Estimated Annualized Burden Hours
The annualized response burden for this sub-collection (generic IC) is estimated at 220 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 3 minutes. Survey completion is estimated to take 15 minutes. It is estimated that during a single year, 900 screening forms will be completed (45 hours) and 700 surveys will be completed (175 hours), totaling 220 hours.
Exhibit A.12.A Annualized Burden Hours
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A.12.B. Estimated Annualized Costs
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.
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. Thus, the total anticipated annual cost to participants for collection of information in this project will be $4756.40.
Exhibit A.12.B. Annualized Cost to Respondents
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A.13.Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
None. There will be no start up or other related costs to private entities.
A.14.Annualized Costs to the Federal Government
The total annualized cost to the federal government is $654,661. This activity will involve participation of one CDC project officer (GS-14 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.
Exhibit 14.A Estimated Cost to the Government
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A.15.Explanation for Program Changes or Adjustments
Not applicable – request is for a sub-collection under a generic approval.
A.16.Plans for Tabulation and Publication and Project Time Schedule
Exhibit 16.A Project Time Schedule
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A.17.Reason(s) Display of OMB Expiration Date is Inappropriate
OMB Expiration Date will be displayed.
A.18.Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
References
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.
B. Collection of Information Employing Statistical Methods
This information collection request does not employ statistical methods. The following is a description of data collection procedures.
B.1. Respondent Universe and Sampling Methods
The majority of the respondent universe will be young men of color between the ages of 16 and 29 who report having sex with male partners. Participants will be recruited through convenience sampling.
B.2. Procedures for the Collection of Information
B.2.1. Recruitment
Participants will be recruited for this activity in collaboration with recruitment efforts already in place at each agency. These recruitment strategies will include seeking eligible, interested men at youth-specific venues and other venues that serve the target population. Agency staff may also contact collaborative partners in the community to gain access to groups of young men who have sex with men who are at risk for HIV infection.
B.2.2. Screening and Scheduling Procedures
Interested individuals will be screened, give consent, and complete the survey at the same day and time of recruitment. Participants will
be asked:“do you consent to participate in [the local name of the
survey]”? The screener form is provided in Attachment 2.
Interested participants will be given an overview of the project and then a staff person will complete a screener form to determine eligibility. If eligible, the staff person will reiterate the general purpose of the project, including a description of benefits and barriers to participation and protections for the participant’s privacy. Interested participants will be presented with a yes/no response on the handheld device prior to participation.
B.2.3. Data Collection Methods
Potentially eligible individuals will be screened, consented and complete the QDS surveys at community events, and in other public places such as bars, health fairs, and college campuses. Agency staff will assure participants the necessary degree of privacy during survey completion and will accommodate participants as necessary by providing a private space to complete the survey and ask questions. Participants will always have the choice to end their participation at any time. Participants will be asked: “do you consent to participation in [local name for the survey]?” If participants say yes, the electronic data collection will begin.
The QDS survey will include questions that involve sensitive topics (e.g., HIV testing history, sexual behavior, drug use) which could put the participant at risk of potential harm resulting from breach of privacy. For this reason, no identifying information will be collected from these respondents.
B.3. Methods to Maximize Response Rates and Deal with Nonresponse
Proposed data collection does not employ statistical sampling methods. No additional methods will be employed to improve response rates.
B.4. Tests of Procedures or Methods to be Undertaken
This submission is a request for authorization to conduct tests of procedures and methodologies typical in methods and instrument development.
B.5. Individuals Consulted on Statistical Aspects and Individuals and/or Analyzing Data
No other individuals were consulted on the statistical aspects or analysis of data from this sub-collection.
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| Author | hkh3 |
| File Modified | 0000-00-00 |
| File Created | 2021-02-03 |