SSB_Just_BART 10_27_10

Behavioral Assessment Component of the Behavioral Assessment and Rapid HIV Testing (BART) Project

Supporting Statement B

October 27, 2010

Peter Thomas, PhD, MPH

Project Officer

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

Division of HIV/AIDS Prevention

Behavioral and Clinical Surveillance Branch

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop E-46

Atlanta, GA 30333

Voice: (404) 639-6266

Fax: (404) 639-8640

Email: [email protected]

TABLE OF Contents

Section B Justification

1 Respondent Universe and Sampling Method

2 Procedures for the Collection of Information

3 Methods to Maximize Response Rates and Minimize Nonresponse

4 Tests of Procedures or Methods to be Undertaken

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

TableS

Table 1 Estimated Numbers of Participants

LIST OF ATTACHMENTS

Attachment 1 Public Health Law

Attachment 2 60 Day Federal Register Notice

Attachment 3 Consent Statement

Attachment 4 Behavioral Assessment Instrument Guide

Attachment 5a Data Collection Instrument - Eligibility Screener

Attachment 5b Data Collection Instrument- Behavioral Assessment

Attachment 6 Assurance of Confidentiality Documentation

Attachment 7 Agreement to Abide by Restrictions on the Release of Surveillance Data

Attachment 8 IRB approval

Attachment 9a Initial 60-Day Notice

Attachment 9b Comment to Initial 60-Day Notice

Attachment 9c 30-Day Notice

Justification

B. Collections of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Method

Statistical methods will not be used to select respondents for this project. However, part B has been completed to describe data collection procedures, as per instructions.

A contractor will be responsible for the selection of local health agencies to conduct behavioral assessment and rapid HIV testing activities. The contractor will be required to choose event sites based on geographical diversity and HIV/AIDS prevalence (< 8 AIDS cases /100,000 persons), according to CDC National HIV/AIDS Surveillance data. In collaboration with CDC staff, the contractor will obtain approval to conduct the behavioral assessment and rapid HIV testing from the sponsors of targeted social and cultural events and will establish partnerships with local and state public health departments to establish arrangements for these agencies to collect the data and offer rapid HIV testing. Data collection is planned at 8 to 15 events per year.

The BART project is specifically designed to characterize persons attending specific cultural and social events who allow themselves to be approached, who meet eligibility criteria, who are willing to participate in an interview regarding HIV testing and risk behaviors, and who allow themselves to be offered the opportunity to receive an HIV test at the event. The project is not intended to yield representative data about any group except those who meet the above description (i.e. high-risk persons who might be reached through efforts to offer HIV testing at social and cultural events in low to moderate HIV prevalence areas).

The convenience sample of persons selected to participate in this project will be persons attending gay pride, minority gay pride and black spring break events, as well as persons attending social or cultural events that attract large numbers of African Americans. Eligibility will be determined according to information provided by clients during a screening interview. The populations of interest for the events described above are men who have sex with men (MSM), minority MSM, African American young adults and African Americans. Eligible persons will be recruited as described below in the section titled, “Selection of Respondents.” Through an informed consent process, selected persons will be asked to participate in an interview. After completing the interview, respondents will be offered a free rapid HIV test.

Respondent eligibility criteria

Participant Inclusion Criteria

Gay Pride Events

To be eligible, potential participants must:

• Be at least 18 years old

• Be able to speak and understand English

• Have the capacity to provide informed consent for participation

• Have been born male

• Self- identify as male

Minority Gay Pride Events

To be eligible, potential participants must:

• Be at least 18 years old

• Be able to speak and understand English

• Have the capacity to provide informed consent for participation

• Have been born male

• Identify as being of a race or ethnicity other than Non-Hispanic White (e.g., African American, Asian, Hispanic) or having some ancestry that is other than non-Hispanic White

• Self-identify as male

Events that attract a large number of African Americans

To be eligible, potential participants must:

• Be at least 18 years old

• Be able to speak and understand English

• Have the capacity to provide informed consent for participation

• Identify as being African American or of some African American ancestry

Festivals that attract a large number of young African Americans

To be eligible, potential participants must:

• Be at least 18 years old and not older than 35 years

• Be able to speak and understand English

• Have the capacity to provide informed consent for participation

• Identify as being African American or of some African American ancestry

Participant Exclusion Criteria

Gay Pride Events

Persons will be ineligible for participation if they:

• Are younger than 18 years of age

• Are unable to speak and understand English

• Do not have the capacity to provide informed consent for participation

• Were not born male or do not currently identify themselves as male

Minority Gay Pride Events

Persons will be ineligible for participation if they:

• Are younger than 18 years of age

• Are unable to speak and understand English

• Do not have the capacity to provide informed consent for participation

• Were not born male or do not currently identify themselves as male

• Do not identify as having some racial or ethnic ancestry other than non-Hispanic White

Events that attract a large number of African Americans

Persons will be ineligible for participation if they:

• Are younger than 18 years of age

• Are unable to speak and understand English

• Do not have the capacity to provide informed consent for participation

• Self-report being transgender

• Do not Identify as being African American or of some African American ancestry

Events that attract a large number of young African Americans

Persons will be ineligible for participation if they:

• Are younger than 18 years of age or older than 35 years of age

• Are unable to speak and understand English

• Do not have the capacity to provide informed consent for participation

• Self-report being transgender

• Do not identify as being African American or of some African American ancestry

Selection of Respondents

True systematic sampling at large events is very difficult to achieve. Thus, convenience sampling will be used to select attendees for participation. However, two procedures will be used to reduce selection bias within the convenience sample. First, the CDC team and the collaborating agency will determine where interviewers will be stationed at the event venues. If possible, grantees and CDC staff will visit event venues before training interviewers and choose locations for the interviewers to be stationed at throughout the venue. By stationing interviewers throughout the venue, the interviewers will have access to the entire population of the attendees, thereby increasing the chance that the approached attendees will be more representative of the event attendees. Secondly, the interviewer will draw an imaginary line across a well-trafficked area and will pick every nth (e.g., 3rd or 5th) attendee who crosses this imaginary line to approach for recruitment. The use of the imaginary line limits interviewer selection bias by preventing interviewers from only choosing people that they feel comfortable approaching. To reduce bias, interviewers will approach individuals as well as members of groups.

Respondents may also self-select. If an attendee approaches the staff at the rapid HIV testing location and wants a rapid HIV test, the rapid HIV testing coordinator should offer the attendee the opportunity to complete the survey. If the attendee is not interested in completing the survey, but would like a test, the rapid HIV testing coordinator should let the attendee know whether or not they have the capacity to test the attendee at that time, as testing slots may be limited. Self-selecting individuals may be included in the sample. The interview instrument can record whether individuals self-selected. Persons who complete the interview will be offered a sticker with the name and year of the event so that interviewers will not repeatedly approach the same individuals. Respondents are only eligible to participate once. Each person will be asked if they have been interviewed previously for the survey; those who indicate that they have been interviewed already will not be interviewed again. The overall response rate will be calculated as the percentage of clients approached who complete the interview. The overall response rate is expected to be approximately 80%, based on reports from the National HIV Behavioral Surveillance system.^1 Acceptance rates are anticipated to be higher at events with fewer attendees and those that take place indoors and lower at events with larger numbers of attendees and that take place in a large, widely dispersed area.

Sample Size

The estimated number of event and survey respondents will be provided by local collaborators affiliated with the implementation sites. The number of persons surveyed at each particular BART event will depend on the number of interviewers the grantee identifies, as well as the event attendance, location, spacing, and acceptance rate. It is expected that project staff will approach 7,000 persons annually and that 5,600 respondents per year will be eligible and agree to participate. Because this project is descriptive, power calculations, which are used in sample size determinations for testing specific hypotheses, were not performed. Sampling frequency will depend on many external factors including the weather, competing event attractions, location of activities at the event, and overall event attendance. However, to guide project partners, a recommended sample size chart for HIV testing and behavioral assessments was developed based on anticipated recruitment and testing capacity, event size and expected prevalence of outcomes of interest

.

Table 1 Estimated Numbers of Participants

Size of social or cultural event *	Small	Medium	Large
Anticipated events per year	2-5	4-6	2-4
Persons attending event	200-999	1,000-4,999	5,000-50,000
Estimated minimum # of persons to be approached	100	600	2,000
Interviews to be completed	50-150	150-325	325-800
Suggested # of interviewers	4-8	8-15	15-30
HIV tests to be administered	30-100	75-250	250-750
Suggested # of HIV testing stations	2-3	3-5	4-8

* Estimates are per event. Numbers are based on previous field experience and will vary by duration of event, level of funding, HIV testing format, and availability of trained staff.

Recruitment scripts developed by CDC will be used by sites to ensure a standardized approach is used for recruitment. Templates for procedures and scripts for recruiting respondents are included in the survey in Attachment 3.

B.2 Procedures for the Collection of Information

Personal Interview

All eligibility screening and interviews will be conducted by trained project staff at the event, in an area that is outside the range of hearing from other event attendees. Participation in this project is voluntary. Respondents may refuse to participate in whole or part. Respondents may refuse to answer questions or stop participation at any time without penalty. Informed consent must be obtained as required by CDC's IRB and state/local IRBs in the project areas. Each person approached will be invited to be screened for eligibility; if eligible, respondents will be interviewed and rapid HIV testing will be offered after the interview has been completed. Persons approached can elect to participate in the interview and not to participate in the rapid HIV testing. Persons who refuse the interview will not be offered rapid HIV testing. Persons approaching the interviewer or testing area will be asked to complete an eligibility screener and an interview prior to testing. However, persons approaching the interviewers or testing area that request a rapid HIV test but do not want to complete the survey will be accommodated as resources allow.

Informed consent will be obtained by having the interviewer read the consent script to the participant and indicating on the handheld computer that the participant provided verbal consent.

Persons who consent to be interviewed will be administered a structured survey (Attachment 5B). The structured survey consists of questions designed to collect self-reported demographics, sexual behavior, drug use, HIV testing history, STD diagnosis, and exposure and access to prevention services from all respondents. Questions on demographics, risk behaviors, and HIV testing behaviors are modeled on questions from the National HIV Behavioral Surveillance System (NHBS, OMB 0920-0990, expires 3/31/2011. Package approved on 3/5/2008). The interview instrument will be programmed into QDS and will be administered face-to-face using hand held computers.

The handheld computers for data collection and laptop computers for data storage during the event will be password protected and the data on them will be encrypted using software approved by the Department of Health and Human Services. No personal identifiers will be included. The interview is expected to take approximately 10-15 minutes.

Respondents will receive HIV prevention materials at the end of the interview and referrals to local HIV/ prevention and care services as requested.

Quality control/assurance

Prior to the event, CDC project staff and the coordinating institution (contractor) will provide a full day of training to the local project staff and volunteer interviewers. The training session will include background information on the purpose of the project, the content of the interview, methods of recruitment and interviewing, and use of the handheld computers. Interviewers will have time to practice recruitment methods, and interviewing using the handheld devices. CDC project staff and the contractors will observe interviewers as they practice these methods and correct mistakes during the practice session. Interviewers will learn about the problems that can occur with the software and hardware that is used for conducting the interviews. The training session will also provide instruction on how to link the survey number to the testing log so that HIV test results may be linked with the behavioral assessment after the event.

In addition to these quality control measures, automated edit checks will be built into the survey interview program used to collect the structured interview data, as a further quality control measure.

In order to avoid data loss, and to ensure data security, after the completion of 5-10 interviews the data will be uploaded to the laptop for storage until the end of the event. After the uploading has occurred, all interview data will be deleted from the hand held computer’s hard drive before beginning the next interview. At the end of each day at the event, the data will be compiled and stored on the laptop. Upon returning to CDC, data will be transferred to a secure data storage drive from the laptop, cleaned and transferred to the local health agency via CDCs Secure Data Network.

B.3 Methods to Maximize Response Rates and Minimize Nonresponse

Potential respondents may be offered an incentive for their participation to increase response rates. Respondents may receive approximately $10 in non-monetary incentives such as personal gifts, gift certificates, or bus or subway tokens. Such financial incentives help raise response rates for sensitive, in-person surveys. Incentives are also useful for populations that are difficult to interview, such as young adults.

The interviewer training that takes place prior to the event instructs interviewers on how to approach potential respondents. Interviewers will have an opportunity to practice recruitment methods and receive feedback on their technique. Recruitment scripts will also be provided as a part of the eligibility screener. These scripts ensure that all respondents are approached in the same manner.

The local collaborating agencies will be responsible for identifying interviewers for the event. The contractor will assist the local agencies in identifying the qualities needed for a local interviewer (e.g., experienced in interviewing, comfortable approaching people to participate in face-to-face interview, etc.). Local agencies will be encouraged to select interviewers that mirror the population of interest (e.g., African American MSM for minority gay pride events) to increase response rates.

B.4 Tests of Procedures or Methods to be Undertaken

The data collection instruments were developed using validated instruments and questions from the National HIV Behavioral Surveillance System (NHBS, OMB 0920-0990, expiration date, 3/31/2011). Since these questions comprising the data collection instrument have been previously validated, tested, and/or used, only internal testing of the computer application is needed. CDC and local project staff will test the skip patterns and responses on the electronic version of the data collection instruments. CDC and local project staff will also conduct mock interviews of staff members using the QDS application on the hand-held computers to interview other project staff.

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

Although this project will follow convenience sampling methods and statistical methods will not be used to select respondents. Dr. Chris Johnson, Mathematical Statistician, was consulted about the sampling strategy and analytic methods.

Chris Johnson

Mathematical Statistician

Statistical Science Team

Quantitative Sciences and Data Management Branch

Division of HIV/AIDS Prevention

Centers for Disease Control and Prevention

1600 Clifton Rd, NE, MS E-48

Atlanta, GA 30333

REFERENCES

1. CDC. Human Immunodeficiency Virus (HIV) Risk, Prevention, and Testing Behaviors --- United States, National HIV Behavioral Surveillance System: Men Who Have Sex with Men, November 2003--April 2005. Morb Mortal Wkly Rep. 2006;55 (SS06):1-16.



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