10/17/2007
Center Submission
Supporting Statement A: Justification
for Paperwork
Reduction Act Submission
for
Qualitative Evaluation of HIV Counseling, Testing, and Referral Services in Non-Health Care Settings: Eliciting Consumer Views
New OMB Application
Technical Monitor: Dorothy Gunter, MPH
Senior Advisor,
Science and Program Integration
Address:
1600 Clifton Rd, NE
MS D21
Atlanta, GA
30333
Telephone: 404-639-6436
Fax: 404-639-1950
E-mail:
dorothy.gunter@cdc.hhs.gov
Date: October 17, 2007
A. Justification 1
1. Circumstances Making the Collection of Information Necessary 1
2. Purpose and Use of Information Collection 4
3. Use of Improved Information Technology and Burden Reduction 6
4. Efforts to Identify Duplication and Use of Similar Information 6
5. Impact on Small Businesses or Other Small Entities 7
6. Consequences of Collecting the Information Less Frequently 8
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 8
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 8
9. Explanation of Any Payment or Gift to Respondents 9
10. Assurance of Confidentiality Provided to Respondents 10
11. Justification for Sensitive Questions 13
12. Estimates of Annualized Burden Hours and Costs 16
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 17
14. Annualized Cost to the Government 18
15. Explanation for Program Changes or Adjustments 19
16. Plans for Tabulation and Publication and Project Time Schedule 20
17. Reason(s) Display of OMB Expiration Date is Inappropriate 21
18. Exceptions to Certification for Paperwork Reduction Act Submissions 21
References 22
Tables
Table A12. Estimated Annualized Burden Hours and Costs
Table A14. Annualized Cost to Government
Table A16. Project Time Schedule
Table B1. Distribution of FGs by Audience Segment and Subgroup
Attachments
1.
Authorizing Legislation and Other Relevant Laws
2. 60 Day Federal Register Notice
3A. CDC IRB Approval
3B. RTI IRB Approval
4. Consent Form for Adults
5. Assent for Adolescents
6. Screening Instrument
7. Recruitment Print Advertisements
8. Electronic Bulletin Board Advertisement
9. Recruitment Flyers
10. Recruitment E-mail
11. Reminder Letter/E-mail
12A. Facilitator Guide - Adult Past Clients (HIV-negative)
12B. Facilitator Guide - Adult Past Clients (HIV-positive)
12C. Facilitator Guide - Adult Potential Clients
12D. Facilitator Guide - Adolescents (HIV-positive)
12E Facilitator Guide - Adolescents (HIV-negative)
Qualitative Evaluation of HIV Counseling, Testing, and Referral
Services
in Non-Health Care Settings: Eliciting Consumer Views
The Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention, requests OMB approval for a new research study. The focus group (FG) study will support CDC’s efforts to develop new evidence-based guidelines for HIV counseling, testing, and referral (CTR) in non-health care settings, 1 and we expect the study to occur in 2008. The purpose of this study is to explore consumer opinions about HIV CTR services in non-health care settings to understand how to improve efficacy, acceptability, availability, and accessibility. The study will involve 21 FGs with past and potential CTR clients who are either HIV-positive or at risk for HIV/AIDS.
In addition to directly supporting the development of the CTR guidelines, this project supports CDC’s Health Protection Goal of Healthy People in Every Stage of Life. It also addresses the Healthy People 2010 Focus Area-13 (HIV) Objective 15 (extend the interval of time between an initial diagnosis of HIV infection and AIDS diagnosis in order to increase years of life of an individual infected with HIV). Finally, it corresponds to the Division of HIV/AIDS Prevention Strategic Plan Goal #2, which states that by 2010, the proportion of HIV-infected people in the United States who know they are infected with HIV will be increased through voluntary counseling and testing.
Historically, HIV prevention efforts have targeted people at risk for HIV infection with the goal of keeping those who are HIV negative from becoming infected. However, the epidemic has changed with the introduction of highly active anti-retroviral therapy (HAART). People with HIV are now living longer, and with a steady incidence and increasing prevalence, an estimated 1,039,000 to 1,185,000 people are now living with HIV/AIDS in the United States (Glynn and Rhodes, 2005). Particularly worrisome is that an estimated 25% of HIV-infected persons may be unaware of their infection (Fleming et al., 2002). Early knowledge of HIV infection and access to care and treatment has become critical components in controlling the spread of HIV infection. Awareness of HIV infection has been shown to reduce high risk sexual behaviors in some populations (Marks et al., 2005). Therefore, CTR services can play a significant role in reducing HIV transmission.
In 2003, CDC launched “Advancing HIV Prevention: New Strategies for a Changing Epidemic” (CDC, 2003). The intent of this initiative was to reduce barriers to early diagnosis and increase access to and use of quality medical care, treatment, and prevention services for HIV-positive individuals. A key strategy was to improve access to HIV testing by making it a part of routine medical care. Additionally, new models of HIV CTR were needed to support HIV testing for high-risk persons who may not have access to medical care in traditional medical settings.
In 2006, CDC released updated HIV testing recommendations for health care settings. The new recommendations encourage health care providers to provide routine, voluntary HIV testing to all persons 13–64 years of age. The goal of this strategy is to increase screening of patients including pregnant women; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States.
CDC is currently in the process of developing new guidelines for HIV CTR in non-health care settings. The proposed title of the new guidelines is “Recommendations for HIV Counseling, Testing and Referral Services in Non Health-Care Settings” and we anticipate publication in 2008. To ensure that the new guidelines are relevant and appropriate, CDC plans to implement multiple evidence-gathering activities, such as consultations, literature reviews, key informant interviews and surveys, and program observations2. In addition, CDC is proposing to use FGs to collect data from consumers about their experiences with, attitudes toward, and preferences for CTR services in non-health care settings. Insight gathered from consumers will be used in conjunction with information collected from other activities to develop evidence-based strategies for CTR in non-health care settings.
We have identified no other qualitative studies that included standardized data collection procedures and parallel focus group discussion topic areas with diverse populations at risk for HIV. Additionally, no other CTR FG studies have focused on non-health care settings. Finally, some important elements of CTR, such as informed consent, remain completely unaddressed by the literature.
The following section of the U.S. Federal Code (see Attachment 1) is relevant to this data collection: 42 USC 241, Section 301 of the Public Health Service Act authorizes conduct of “research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man.”
The purpose of this study is to explore consumer opinions about CTR services delivered in non-health care settings and to understand how they can be improved to increase their efficacy, acceptability, availability, and accessibility. The study’s main research objectives are to identify: (1) facilitators and barriers to using CTR services in non-health care settings; (2) ideal service components to decrease barriers to early diagnosis, decrease risk behaviors, link people with follow-up care, and ensure client rights; (3) perceived risks and benefits of CTR; and (4) preference for providing informed consent. In practical terms, the information obtained from the proposed data collection activities will assist CDC scientific and program staff in developing evidenced-based, culturally appropriate recommendations for HIV CTR services in non-healthcare settings which will complement the recently released guidelines for HIV testing in health-care settings. This data collection has already been funded by CDC and represents a key component of a multifaceted evidence gathering initiative including consultations, literature reviews, key informant interviews and surveys, and program observations. The intended end-users of the data collection and the guidelines will be public- and private-sector policy makers and service providers of HIV CTR in non-health care or non-traditional settings (e.g., community-based or outreach settings, such as homeless shelters or bars).
We are proposing to conduct 21 FGs. This study is unique in that we will engage, in a standardized format, diverse CTR consumers who have varied CTR experiences. The FGs will be segmented by (1) HIV-positive past CTR clients, (2) HIV-negative or status unknown past CTR clients, and (3) potential CTR clients. Participants will be diverse in terms of gender, age, race/ethnicity, sexual orientation, and risk behavior. We have developed 5 semi-structured facilitator guides for:
Adults who are HIV-positive past clients
Adults who are HIV-negative or status unknown past clients
Adults who are potential clients
Adolescents who are HIV-positive past clients (15-17 years old)
Adolescents who are HIV-negative or unknown status or potential clients (15-17 years old)
Participants who have not been tested or who received a negative HIV test over 5 years ago (i.e., potential clients) will discuss the decision-making process for getting an HIV test, presumptions about testing including ideal services in terms of setting, informed consent, test types, and receiving results, counseling and referrals. They will also be asked about barriers specific to non-medical settings, and the benefits of testing. Those who have received a test in the past, including those who are HIV-positive, will discuss their past testing, counseling, and referral experiences rather than presumptions.
The data to be collected for this focus group study have practical utility in that developers of the new guidelines will be able to identify and recommend strategies and approaches endorsed by focus group participants for multiple components of CTR such as prevention counseling, testing technology, informed consent, and referral. Possible client-level facilitators and barriers for CTR programs to consider when providing services will be described in the guidelines. There may be some unique preferences, facilitators, and barriers by client population, which can also be described in the guidelines. Though this information is intended to aid the development of the new guidelines for CTR in non-health care settings, findings will also be directly available to service delivery programs via a final study report and publication in a peer-reviewed journal. Program staff can interpret how best to transfer insight gathered from this study to their own program delivery strategies.
Though the focus group methodology prohibits wide generalization, the in-depth qualitative data will facilitate a more contextualized perspective. Further, the exploratory research questions are best answered with qualitative data, such as that yielded by focus group methodology. Users of the guidelines will be referred to a thorough description of the study methods and population so that they can determine for themselves how best to transfer findings to their own service delivery settings. The main negative consequence of not collecting this information would be CDC’s inability to assess diverse CTR consumers’ experiences, needs, and preferences in a systematic manner. Consequently, this critical information would not be available to inform the revised guidelines for HIV testing in non-health care settings.
Telephone screening will be conducted to reduce the amount of time, effort, and financial costs incurred from participating. Participants will be reminded of their upcoming FG by email or telephone. Although options for electronic reporting of responses were considered, FGs are most appropriate for this formative study because they generate information on wide sets of issues in a single application (Trotter & Schensul, 1998; Fern, 2001). Further, by approximating a natural discussion format, FGs provide the opportunity to observe the interaction and potential influence of group participants providing further insights into attitudes, perceptions, and opinions of respondents that would otherwise be unlikely to emerge in the absence of group dynamics.
CDC staff conducted several activities to identify duplication and use of similar information. One significant effort has been a review of the literature. The review was limited to studies conducted in the United States within the last 10 years. Much of the CTR literature demonstrates the effect of HIV counseling and testing on various risk behaviors (Wolitski, et al., 1997; Kamb, et al., 1998; Weinhardt, et al., 1999; Amaro, et al., 2005). Some research has examined barriers and facilitators to HIV testing and counseling from the perspectives of at-risk populations (Speilberg F, et al. 2001). The majority of these studies, however, have been limited in the types of populations (e.g., men who have sex with men [MSM] or injection drug users [IDUs]) and settings (e.g., STD clinics, drug treatment settings, or bathhouses). Most studies have also been conducted in a single geographic area and in health care settings. Several reports also show that rapid HIV testing in emergency departments and urgent care centers are highly effective at increasing testing and knowledge of HIV serostatus (Hutchinson & Farnham, 2003; Kelen, Shahan, Quinn, & the Project Educate Work Group, 1999; Kroc et al., 2002; & Kroc et al., 2003; Walensky et al., 2003). Taken as a whole, the findings indicate that there are personal (e.g., denial of HIV risk, fear of finding out they have HIV), structural, and programmatic factors that act as barriers to HIV testing. Very few studies have examined strategies to expand HIV CTR in non-health care settings. We identified no research that specifically addressed essential characteristics of HIV counselors or the essential elements of informed consent.
The proposed research study is innovative in its inclusion of a variety of client types (e.g. past or potential), at-risk populations, and geographic locations. Additionally, it is important to understand the role that new HIV test technologies can have in decreasing barriers to testing. This study will also identify barriers and facilitators to consumer utilization of CTR in non-health care settings.
No small businesses will be involved in this study.
There are no legal obstacles to reduce the burden for respondents. Data will be collected from participants during one screening phone call, and if eligible, during a single FG session. If these data were not collected, it would not be possible to ensure that CDC’s new recommendations for HIV CTR in non-health care settings reflect consumer’s opinions. Collecting this information is an important step towards developing appropriate and relevant guidelines to increase utilization of HIV CTR services in non-health care settings.
This information collection fully complies with all guidelines of 5 CFR 1320.5 There are no special circumstances contained within this application.
A 60-Day Federal Register notice published on January 22, 2007 (Volume 72, Number 13, page 2696) solicited comments on Formative Research to Inform the Development of New Recommendations for HIV Counseling, Testing, and Referral Services in Non-Health Care Settings. A copy of the 60-Day Federal Register notice can be found in Attachment 2. We received three requests for the data plans and research instruments, and we sent these materials to each requestor. We received one comment regarding the use of taxpayer funds for this type of research. No action was taken regarding this comment. No other comments or requests were received.
CDC recognized the need to solicit input from CTR providers in the community prior to developing the research protocol and study design. CDC conducted a workshop at two national meetings (HIV Prevention Leadership Summit, June 20, 2006, Dallas, TX and US Conference on AIDS, September 23, 2006, Hollywood, FL) to gather input from external partners, including staff from state and local health departments, community-based organizations, and other HIV prevention providers. The workshop participants provided important information on the challenges of conducting HIV CTR in non-health care settings and identified issues that should be addressed in the new CTR guidelines for non-health care settings.
In addition, a seven-member CDC study team collaborated with RTI International (RTI) staff on the focus group study design, screening instrument, and focus group facilitator guides. The names and titles of the collaborators are listed in Section B.5. RTI staff is trained and experienced in focus group methodology as well as knowledgeable about current HIV testing research. CDC staff held weekly conference calls with RTI from September through December 2006 to assure that the study design and data collection instruments were appropriate. No major problems were identified that could not be resolved. The Division of HIV/AIDS Prevention, CDC, is the primary funding source for HIV CTR in non-health care settings in the nation and is the primary stakeholder for the findings of this project.
The use of monetary incentives has been shown to increase FG participation and response rates (Abreu & Winters, 1999; Shettle & Mooney, 1999; Greenbaum, 2000). Provision of an incentive that takes into account the duration of participation and the procedures involved helps to demonstrate respect and appreciation for the respondent’s role in the research process (Grady, 2005). The study’s validity depends upon the inclusion of a broad representation of the population at risk for HIV. To motivate participation, FG participants will receive a cash incentive of $50. This amount was selected based on the duration of the focus group and the level of work required of participants. This amount is consistent with incentives provided in other similar studies (e.g., a FG study of consumer opinions on partner HIV counseling and referral services). If fewer than 4 people attend a FG, the participants will receive $15 for their effort; however, the FG will not be conducted.
This project was approved by the CDC Institutional Review Board (IRB) on May 21, 2007 (see Attachment 3A for the approval email). We have also received approval from RTI’s IRB (see Attachment 3B).
The Privacy Act reviewer has determined that the privacy act does apply to this project. The proposed focus group study will involve collecting of sensitive and personally identifying information. The study will include persons who are HIV-infected and who are at risk for HIV to ensure that new HIV counseling, testing, and referral (CTR) guidelines for non-health care settings are relevant to their needs. It is necessary to ask prospective participants’ sensitive questions about their HIV status, sexual and injection drug use behaviors to determine eligibility for the study (see Attachment 6). As explained in Section B2, staff from RTI and professional FG firms will screen and schedule FG participants. No matter where the screening occurs, staff will implement identical procedures to assure that the data are treated in a secure manner. Each FG firm located in the study cities will designate a project manager, who will be responsible for secure data management.
During screening, we will collect contact information (e.g., phone number, first name, month/year of birth) so that we can remind participants about their FG session. The contact information sheet will be separated from the screening instrument once the person is determined to be eligible and the two documents will subsequently be stored separately in a locked filed cabinet. If the screening is conducted by RTI staff, the two documents will be stored in the RTI project director’s office. When screening is conducted by FG firm staff, the documents will be stored in the project manager’s office. Participants’ contact information sheets will be destroyed within 2 weeks of the FG. A check-in sheet with participants’ first names and month/year of birth will be compiled before the FG. The check-in sheets will be destroyed within 2 weeks of the FG. Recruitment grids containing key information (such as first name, month/year of birth, age, ethnicity, race, gender, sexual identity, testing history, location of testing, and risk status) will be developed to track the demographic characteristics of participants. The grids will be securely maintained separately from other study materials (in locked file cabinets in either RTI project director’s office or the project manager’s office at the FG firm). Identifying information (first name and month/year of birth) will be removed from the recruitment grids within 2 weeks of the FG and will be destroyed. The grids developed by the FG firm staff will be handed over to RTI staff immediately after the FG (during the data collection visit in each city).
When participants arrive at the FG site, they will be administered written consent/assent (see Attachments 4 and 5 for consent/assent). The consent/assent documents will outline the procedures in place to protect data and explains that there are limits to the privacy of the data. During the data collection phase, the signed informed consent documents will be kept in locked filed cabinet in the RTI project director’s office which will be accessible only to select project staff. No identifying information will be contained in screeners, audiotapes, transcripts, or notes.
All other project materials, such as hard copy signed consent/assent forms, audiotapes, and screener forms will be maintained in a locked file cabinet in the RTI project director’s office. These will be transferred to a locked RTI storage facility at the end of the project and destroyed three years later. All electronic project files at RTI are stored on a limited-access project share drive on RTI’s secure network servers and backed up nightly; only project staff authorized by the project director can access the share drive. All project related files will be archived following completion of the project and will be maintained for three years.
Although RTI staff will be managing the research activities and implementing the actual FGs, FG firms, CBOs, and CDC will also be involved in various aspects of this study. Each of these entities has procedures to protect the security of the data as outlined below:
FG Firms. FG firms will assist with recruiting and screening participants and will host some of the FGs in their facilities. The FG firms have security procedures in place to protect proprietary information; similar to procedures employed by RTI. Additionally, all study staff from FG firms will sign a confidentiality agreement that will be returned to RTI. The FG firms will hand RTI staff the screener form and the recruitment grid during the field visit.
CBOs. CBOs will assist with passive recruitment of study participants (i.e., handing out study flyers to their clients) and in some instances, FGs will be conducted in their facilities. CBOs generally prevent unmonitored access from the street or beyond the lobby for safety and to protect confidential client information. Participant’s access to the facility will be limited to the room where the FG is being held and to restrooms. We will ask CBO staff to remove confidential client information from areas where we will be conducting research activities and to refrain from discussing clients in front of study staff, and study staff will not discuss participants in front of CBO staff.
CDC. RTI will provide CDC with a copy of the recruitment grids (without first names and month/year of birth) and the FG transcripts after all FGs are completed. The dataset will be stored at CDC on a shared drive that is backed up nightly. Only authorized staff will have access to project data on the shared drive through password protected computers. CDC will maintain electronic files for 3 years after the study ends.
This study will include persons who are HIV-infected and who are at risk for HIV to ensure that the new guidelines are relevant to their CTR needs in non-health care settings. Therefore, it is necessary to ask prospective participants sensitive questions about their HIV status and sexual and injection drug use behaviors to determine eligibility for the study (see Attachment 6 for screening instrument). In addition, this information will help describe the study population in future reports. These questions are located in multiple parts of the screening instrument based on client segmentation; however, we will ask a prospective participant each question only once.
Sensitive questions in the screening instrument include:
HIV Status - Questions 1.7a, 2.6, 3.2, 4.2 - (If respondent reports ever being tested for HIV): “The next question is about the result of your HIV test. We are recruiting people who are positive and negative for the study. With that in mind, what was the result of your most recent HIV test?”
Justification: This question is necessary for focus group segmentation: some focus groups will discuss CTR experiences when diagnosed with HIV and it is important that each person in those groups be HIV-positive. Also, past HIV test clients who are HIV-positive do not need to meet any risk criteria to be eligible for this study and will not be asked questions about sexual behavior or injection drug use.
Injection Drug Use - Questions 1.5, 2.12a, 3.7a – “The next question is about injecting, “shooting,” or “skin popping” drugs. This means injecting drugs with a needle or a syringe yourself or having someone who isn’t a health care provider inject you. Do not include hormones or drugs that were given or prescribed by a health care professional for things like allergies, diabetes, or HIV medications. Please remember your answer will be kept private. In the past twelve (12) months, have you injected drugs?”
AND, If respondent reports injection drug use in the past 12 months
Sharing of Paraphernalia - Questions 2.12b, 3.7b, 4.8a - “In the past 12 months, have you ever shared needles, syringes, or other injection equipment with someone else?”
Justification: This question is necessary to determine study eligibility. Injection drug use is an important risk factor for HIV transmission. In 2005, 24% of HIV/AIDS cases were related to injection drug use (CDC, 2005). Sharing contaminated injection equipment, such as needles/syringes, cotton, or cookers, is a major risk factor for HIV (Des Jarlais, D., Friedman, S., and Hopkins, W, 1985).
Sexual Behavior – More than Two Sex Partners – Questions 2.12c, 3.7c, 4.8b, 5.1a, 7.2a –
“In the past 12 months, have you had unprotected vaginal or anal sex with 2 or more partners? By unprotected sex, we mean any sex without a condom.” Note that questions about sexual behavior are prefaced by a definition of ‘sex’: “For the purpose of these next couple questions, sex refers to either vaginal or anal sex. By vaginal sex, we mean when someone puts their penis into their partner’s vagina. By anal sex, we mean when someone inserts their penis into a partner’s butt.”
Justification: This question is necessary to determine study eligibility. It is well established that using condoms can prevent HIV transmission (Davis & Weller, 2004; NIAID, NIH, DHHS, 2000). Further, having multiple sex partners has been shown to be a significant risk factor for acquiring HIV and STDs among heterosexuals, adolescents, and MSM. (Koblin et al., 2006; Erbelding et al., 2003; Rosenberg et al.; 1999)
Sexual Behavior – Unprotected Sex with HIV Positive or Status Unknown Partner – Questions 2.12d, 3.7d, 4.8c, 7.2b - “In the past 12 months, have you had unprotected vaginal or anal sex with a person who you knew or thought was HIV-positive? By unprotected sex, we mean any sex without a condom.” (Question is prefaced by definition of ‘sex’ as described above.)
Justification: This question is necessary to determine study eligibility. Findings from the EXPLORE study indicated that men who had an HIV-positive or unknown status primary partner were more likely to become HIV infected compared with men who had an HIV-negative primary partner (Koblin et al, 2006). Studies have also indicated that having a partner who is HIV infected is a risk factor for acquiring HIV, especially among women (Seidlin et.al., 1993).
In addition to the above questions, all prospective participants will be asked about their ethnicity and racial background. In 2005, 49% of all diagnosed HIV/AIDS were among blacks. Asking participants these questions is necessary to assure diversity in the study population. It is also necessary to help us accurately describe the study population.
Prospective participants will be asked to provide verbal consent/assent before we begin eligibility screening over the phone and will be informed that screening will include sensitive questions. Persons who do not provide oral consent/assent will not be screened. The procedures for safeguarding sensitive information collected during screening were explained in Section A.10.
A. The estimated annualized burden hours is 714. Table A12provides details about how this estimate was calculated. Members of the project team timed the screening instrument to determine the overall burden per prospective participant and we estimated that it would take 20 minutes to complete the screener. We anticipate that we will screen 630 people (210 hours) to recruit a maximum of 252 eligible FG participants (or 40% of persons who complete the screening questionnaire). We will allow 4-12 people to participate in each FG, but we are planning to host an average of 9 individuals in each group. Participation in a FG will last approximately 2 hours. Estimated annualized burden costs to respondents are also shown below. Because it is not known what the wage rate category will be for these selected participants (or even whether they will be employed), the figure of $6.00 per hour was used as an estimate of average minimum wage across the country (Bureau of Labor Statistics, 2005). The estimated annual cost to participants for the hour burden for collections of information will be $4,284.
Table A12-. Estimated Annualized Burden Hours and Costs
Type of Respondent |
Form Name |
No. of Respondents |
No. Responses Per Respondent |
Average Burden Per Response (in hours) |
Total Annual Burden in Hours |
Average Hourly Wage Rate |
Total Annual Respondent Cost |
Prospective Participant |
Screener |
630 |
1 |
20/60 |
210 |
$6.00 |
$1,260 |
FG participant |
Facilitator Guide – Adult Past Clients (HIV-negative) |
60 |
1 |
2 |
120 |
$6.00 |
$720 |
FG participant |
Facilitator Guide - Adult Past Clients (HIV-positive) |
60 |
1 |
2 |
120 |
$6.00 |
$720
|
FG participant |
Facilitator Guide - Adult Potential Clients |
60 |
1 |
2 |
120 |
$6.00 |
$720 |
FG participant |
Facilitator Guide - Adolescents (HIV-positive) |
24 |
1 |
2 |
48 |
$6.00 |
$288 |
FG participant |
Facilitator Guide Adolescents (HIV-negative) |
48 |
1 |
2 |
96 |
$6.00 |
$576 |
Total |
|
882 |
|
|
714 |
|
$4,284 |
There are no other costs to respondents or record keepers associated with this study.
With the expected period of performance of 1 year, the annualized cost to the federal government is estimated to be $213,584 (Table A14). The contractor’s costs are based on estimates provided by the contractor who will carry out the data collection activities. The estimated cost also includes the cost of coordination with the CDC, data collection, analysis, and reporting.
TableA14. Annualized Cost to Government
Expense Type |
Expense Explanation |
Annual Costs (Dollars) |
Direct Costs to the Federal Government |
15% of FTE GS-14 Public Health Analyst |
$17,878.00 |
|
15% of FTE GS 12 Behavioral Scientist |
$12,723.00 |
|
5% of FTE GS 13 Research Officer |
5,043.00 |
|
5% of FTE GS 12 Research Fellow |
$4,241.00 |
|
5% of FTE GS 13 Public Health Analyst |
$5,043.00 |
|
1% of FTE GS 15 Medical Officer |
$1,402.00 |
|
Subtotal, Direct Costs to the Government |
$46,330.00 |
Contractor and Other Expenses |
Data Collection (Contractor) 781 labor hours and ODCs |
$143,916.00 |
|
Analysis and Reporting (Contractor) 260 labor hours and ODCs |
$23,338.00 |
|
Subtotal, Contracted Services |
$167,254.00 |
|
TOTAL COST TO THE GOVERNMENT |
$213,584.00 |
There is no change in burden requested as this is a new information collection.
Tabulation. Screener data will be used to calculate response (i.e., percentage of persons screened who are scheduled for a FG) and participation rates (i.e., percentage of persons scheduled who participate in a FG). The first stage of informal analysis will include debriefing among the note taker and moderator at the conclusion of the FG and preparation of a brief summary following each FG (to familiarize the analyst with the various topics and themes that emerged). Some a priori themes include facilitators and barriers to various CTR behaviors, past experiences and how they may shape future behaviors, and preferences for informed consent. Transcribed FG data will be analyzed using ATLAS.ti, a qualitative software program that facilitates data organization and analysis and provides a convenient means of manipulating the coded text data. Initial labeling and categorization of the data (Strauss & Corbin, 1990) will be followed by axial coding, where connections are made between the categories identified in the initial open coding. The coding structure will be hierarchically ordered so that additional dimensions can be examined separately and new codes can be added as analysis progresses. Coding and analysis will continue iteratively; as new themes and issues emerge from the analysis, all relevant information will be retrieved and examined for further coding designations (Weitzman & Miles,1995; Krueger, 1994).
Once the coding scheme is developed, multiple analysts will code the same transcripts, to ensure a common understanding of the coding system which will ensure inter-coder reliability and code validity. To begin, two primary analysts will individually code three randomly selected transcripts. A secondary coder will review the coding of the previous two coders and work with them to resolve any discrepancies. Subsequently, each transcript will be coded by two analysts. After data are coded, they will be analyzed along the various dimensions within and across the groups.
Publication Plans. A final report will be prepared by RTI at the conclusion of the study. This report will detail the study’s methods, findings, and conclusions and recommendations to inform future HIV prevention and research efforts. Based on findings from the final report, CDC will also disseminate study results to the public through reports and peer-reviewed journal articles. Finally, the findings will be described and referenced in the revised guidelines for CTR in non-health care settings.
Time Schedule. Once OMB approval is granted, the timeline shown in Table A16 is projected.
Table A16. Project Time Schedule
Project Activity |
Date |
Secure sites for FGs |
Upon receiving OMB clearance |
Recruitment |
Upon receiving OMB clearance |
Conduct FGs |
12 weeks after OMB clearance |
Summary reports for each group due to CDC |
16 weeks after OMB clearance |
Analysis |
20 weeks after OMB clearance |
Final report due to CDC |
30 weeks after OMB clearance |
We do not seek approval to eliminate the expiration date.
There are no exceptions to the certification statement.
Abreu, D.A., Martin, E. & Winters, F. (1999). "Money and Motive: Results of an Incentive Experiment in the Survey of Income and Program Participation." Paper presented at the International Conference on Survey Nonresponse, Portland, Oregon.
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1 In this supporting statement, the term non-health care setting is used to define places outside of medical or clinic-based settings such as outreach locations, community-based agencies, or stand alone HIV testing sites. However, in all participant materials, the term non-medical setting will be used since this may be simpler to understand for consumers.
2 These activities are being conducted separately and are not a part of this project.
| File Type | application/msword |
| File Title | INFORMATION COLLECTION REQUEST SUPPORTING STATEMENT |
| Author | cannada |
| Last Modified By | tfs4 |
| File Modified | 2007-11-27 |
| File Created | 2007-11-14 |