Supporting Statement A

Goals of the study: The goals of this qualitative research study are to explore: 1) how black/African-American men who have sex with men with men (BMSM) define and perceive concepts of “community,” “gay community,” and “black gay community;” 2) the relevance and importance of self-defined concepts of “community” for engaging BMSM in actions/interventions to improve sexual health, and specifically STD prevention efforts; and 3) insights and lessons learned by BMSM who have been engaged in activism or collective action to improve the sexual health of MSM.
Intended use: Findings from this qualitative assessment will be used to inform the development of strategies to prevent and reduce syphilis transmission and promote sexual health among BMSM.
Methods to be used to collect data: Data will be collected from 40 individuals through semi-structured, in-depth qualitative phone interviews.
The subpopulation to be studied: Data will be collected from 30 BMSM (15 per city), and 10 key informants (5 per city) who have been identified as BMSM sexual health activists. Respondents will be recruited from New Orleans, LA and Washington, DC.
How data will be analyzed: Qualitative coding and thematic analysis of 40 in-depth interview transcripts using computer-assisted qualitative data analysis software.

Supporting Statement

A. Justification

Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention’s (CDC) Division of STD Prevention, (DSTDP) requests OMB approval for a qualitative extramural research study entitled, “Project Engage: Engaging Gay “Community” Activism for Syphilis Prevention” in New Orleans, LA and Washington, DC under “Formative Research and Tool Development” Generic Clearance OMB #0920-0840 (expires 1/31/2019). CDC will sponsor this data collection activity. Data collection will be carried out by CDC’s cooperative agreement partner, National Network of Public Health Institutes (NNPHI), in conjunction with its subcontracting local partners, the Louisiana Public Health Institute (LPHI), in New Orleans and the Institute for Public Health Innovation (IPHI), in Washington, DC).

The notion of “community,” whether conceived of as “place” or “network,” is important to understand because it relates to constructs such as social identity and social cohesion that have implications for social norm diffusion and change. Understanding individuals’ perceptions of “community” can inform STD prevention efforts and intervention development. Findings from interviews with MSM in Australia (Holt 2011), Europe (Ross 2013), and the US (Goltz 2014; Rowe 2008) suggest that although the term “community” has always evoked ambivalence among MSM, in the pre-antiretroviral (ART) era, AIDS activism was viewed to a large degree as a unifying aspect and collective purpose, and that developments such as widespread availability of ART, the decline of funding for AIDS service organizations, and other recent social changes have eroded this value. In more recent years, generational shifts and changes in the way MSM meet and socialize, due to the proliferation of social media sites and mobile apps, and broader sociocultural changes, including social assimilation and “mainstreaming” of gay culture, make it necessary for STD programs to re-evaluate the salience of this concept for current STD prevention efforts.

Syphilis rates have increased dramatically in the United States since 2000, with most of the increases among MSM. In 2015, over 90% of primary and secondary syphilis cases occurred among men, with 81.7% of cases among males reporting a male sex partner (CDC 2015). Syphilis increases the risk of HIV transmission and acquisition; in 2015, nearly half of MSM with syphilis were HIV-positive. According to sentinel surveillance data, 33% of MSM syphilis cases were among BMSM, a disproportionate burden of disease (CDC 2015).

Untreated syphilis can lead to serious sequelae, including neurosyphilis, which has increased in recent years. Cases of ocular syphilis, which can lead to permanent blindness, have been reported among MSM in recent months (CDC 2016). The reasons for syphilis increases among MSM are not entirely clear; however, sex without condoms, sero-sorting among HIV positive men, and the perception among some men that syphilis is relatively benign and easily cured, are factors. The increased availability and use of PrEP (pre-exposure prophylaxis), which protects against HIV transmission but not STDs, further increases the need for STD programs to devise new and effective strategies for engaging MSM in STD prevention efforts.

Among BMSM, social isolation compounded by racism, homophobia, high prevalence of HIV and STD in sexual networks, and lack of access to health care also increases vulnerability to syphilis and other STDs (Maulsby 2014). The findings from this project will help ensure the relevance of prevention efforts, including but not limited to influencing dissemination strategies and identifying appropriate content.

Purpose and Use of the Information Collection

The purpose of this information collection is to conduct in-depth interviews among BMSM and BMSM who have been engaged in activism or collective action to improve the sexual health of MSM (key informants) to explore: 1) how BMSM define and perceive concepts of “community,” “gay community,” and “black gay community;” 2) the relevance and importance of self-defined concepts of community for engaging BMSM in actions/interventions to improve sexual health, and specifically STD prevention efforts; and 3) insights and lessons learned by BMSM who have been engaged in activism or collective action to improve the sexual health of BMSM.

_The planned study design will sample 40 BMSM to discuss the notion of community and its relevance to sexual health activism. _{Respondents
will be selected from two Metropolitan Statistical Areas (MSAs) with
high HIV and syphilis prevalence: New Orleans, LA and Washington, DC.}The sample will be stratified by city (New Orleans and Washington, DC), age (18+) and individual identification as engaged in sexual health activism. In each city, we will recruit five BMSM aged 18-25, five BMSM aged 26-40, five BMSM over the age of 40, and five key informants who have been identified as BMSM sexual health activists, loosely defined as participating in a collective action or advocacy for improving sexual health for BMSM.

We will use qualitative, in-depth phone interviews to collect data for this study (Attachment 5b). The in-depth interviews will primarily include open-ended questions with some closed-ended questions designed to elicit information on HIV prevention, care and treatment among BMSM in the jurisdictions (Attachment 5b). Key variables to be explored through the interviews are described in Exhibit 2.1 below. All data collection instruments have been approved by the

MPHI Institutional Review Board (Attachment 6).

CDC, in partnership with partner staff, will identify and develop appropriate dissemination opportunities for these findings. The results of this study are not to produce statistical results that may be generalizable to the larger population, but the lessons and findings may indeed be generalizable. Information collected will be used to revise, augment or finalize communication campaign platforms and systems.

Exhibit 2.1: Overview of Key Variables

BMSM and Key Informants (Attachment 5b)

Demographics
Community
Sexual Health /STD Prevention Strategies
Health Activism /Engagement

Use of Improved Information Technology and Burden Reduction

NNPHI will conduct individual phone interviews at a time and location that is convenient to the selected respondents. Telephone interviews will reduce burden on respondents’ time and resources from having to travel to a physical location to participate in this data collection, as well decrease study recruitment costs. After asking for and receiving permission from the respondent, NNPHI will audio-record the interviews and transcribe recordings after the interview. This also limits the burden on the respondent (no additional burden after completing the interview) and allows the interviewer to focus on building and maintaining rapport with the respondent.

Efforts to Identify Duplication and Use of Similar Information

The interviews will collect key information that the Agency believes is not captured elsewhere. The Agency believes no other data collection effort has been conducted or has been planned to collect similar information for these populations. CDC conducted a review of similar studies prior to the issuance of the cooperative agreement, and determined that this study is collecting unique information from the populations. Therefore, our study requires the collection of this new primary data. There would be no reason for another Federal Agency to conduct a similar study this.

Impact on Small Businesses or Other Small Entities

This study will partner with local partners (the Louisiana Public Health Institute, LPHI, in New Orleans and the Institute for Public Health Innovation, IPHI, in Washington, DC) to facilitate recruitment to aid in recruiting potential respondents by identifying eligible potential respondents through their routine and regularly occurring activities and referring them to the study. We do not anticipate substantial burden.

Consequences of Collecting the Information Less Frequently

The present study will provide the primary qualitative data needed to understand barriers and facilitators to HIV/STI prevention, care and treatment among BMSM at the greatest risk for HIV/STI infection and transmission in the U.S. If this evaluation were not conducted, it would not be possible to identify barriers and facilitators and to use this information to strengthen HIV/STI prevention, care, and treatment with these vulnerable populations. The length of data collection is 2-4 months and data will only be collected once.

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This data collection effort does not involve any special circumstances.

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

8a. For sub-collection requests under a generic approval, Federal Register Notices are not required and none were published. A 60-Day Federal Register Notice for the generic clearance 0920-0840 was published on 06/25/2015, Vol. 80 No. 122, pages 36540-36542, exp. 01/31/2019.

In addition, the following partnering staffs at NNPHI were consulted for the development of this study. There were no unresolved issues associated with the consultation process. Aside from the official 60-day public comment period for the Generic data collection, there were no other public contacts or opportunities for public comment on this information collection.

8b. NNPHI consultants on this project include:

Brittany Bickford, MPH

Project Manager

National Network of Public Health Institutes

1100 Poydras St., Suite 950

New Orleans, LA 70163

504.872.0755 bbickford@nnphi.org

Aaron Alford, Ph.D., MPH

Principal Investigator

National Network of Public Health Institute

1300 Connecticut Ave., NW, Suite 510

Washington, DC 20036

202.830.0771 aalford@nnphi.org

Jennifer Edwards, PhD

Project Assistant

National Network of Public Health Institutes

1100 Poydras St., Suite 950

New Orleans, LA 70163

703.776.9022 jedwards@nnphi.org

Nicole Waller, MPH

Project Assistant

National Network of Public Health Institutes

1100 Poydras St., Suite 950

New Orleans, LA 70163

504.224.9089 nwaller@nnphi.org

Explanation of Any Payment or Gift to Respondents

Interview respondents will each receive a $25 token of appreciation in the form of an electronic Amazon gift card. Although there has been some debate on the necessity of offering tokens of appreciation, numerous studies have shown that tokens of appreciation can significantly increase response rates, and the use of modest tokens of appreciation is expected to enhance survey response rates without biasing responses (Abreu & Winters 1999; Shettle 1999). Additionally, offering tokens of appreciation is cost-efficient, decreasing cost to government by reducing the number of contact attempts necessary to gain participation when no token of appreciation is offered (Bricker 2014).

Offering tokens of appreciation is necessary to recruit minorities and historically underrepresented groups into research. In a recent study of recruitment and retention of BMSM by a Community Based Organization (CBO), recruiters found it difficult to obtain information from the BMSM because many were reluctant to provide their names and contact information because of concerns about being seen giving these personal details to an HIV prevention program (Painter et al 2010). Some of those who were screened provided incorrect contact information, making it difficult or impossible to locate them later. In this study, offering a token of appreciation improved participation among BMSM (Painter et al 2010). A meta-analysis of 95 studies published between January 1999 and April 2005 describing methods of increasing minority persons’ enrollment and retention in research studies found that remuneration enhanced retention among this group (Yancey, Ortega, & Kumoniyka 2006).

Remuneration has been used in other HIV-related CDC data collection efforts, such as for National HIV Behavioral Surveillance (OMB 0920-0770, exp. 5/31/2014) and the Testing Brief Messages for Black and Latino MSM Study (OMB 0920-14SY under 0920-0840, exp. 1/31/2019), which included similar populations and had a similar length of time for completing the client interview as in this proposed research. In all of these other projects, tokens of appreciation were used to help increase participation rates.

Although phone interviews may eliminate the need to travel, participating in a 60-minute in-depth interview still requires a considerable investment of personal time on the part of the respondent, with the potential for inconvenience to the respondent. Data quality depends on being able to recruit engaged respondents who are willing to spend time and share their perspectives with the interviewer. The study team feels that anything less than $25 is likely to hamper recruitment and would not be reflective of the level of appreciation warranted by the respondent’s contribution to the study aims.

Protection of the Privacy and Confidentiality of Information Provided by Respondents

The NCHHSTP PRA Coordinator has reviewed this project and determined the Privacy Act does not apply since personally identifiable information (PII) will not be transmitted to the CDC.

We will inform respondents that their responses will be kept private to the extent permitted by the law. All respondents interviewed will be informed that the information collected will not be attributable directly to the respondent and will only be discussed among members of the research team. Terms of the CDC contract authorizing data collection require the contractor to maintain the privacy of all information collected. Accordingly, individuals’ data will be kept private and protected to the extent permitted by law.

Institutional Review Board (IRB) and Justification for Sensitive Questions

IRB Approval:

This study has been reviewed and approved by the MPHI Institutional Review Board IRB (Attachment 6).

Sensitive Questions:

This study is an initiative aimed to inform the development of strategies to prevent and reduce syphilis transmission and promote sexual health among BMSM. We do not plan to collect any sensitive information from respondents. However, all cooperative agreement partner staff will be trained to provide respondents with city-specific hotlines for HIV/STI and mental health care organizations as needed. We will inform all respondents that they may skip any question or stop participation at any time for any reason.

Estimates of Annualized Burden Hours and Costs

Exhibits 12.1 and 12.2 provide details about how the estimates of burden hours and costs were calculated. We calculated the overall burden per respondent by multiplying the frequency of response by the time to complete each data collection item. We anticipate that screener forms will take 5 minutes to complete. We anticipate 50 percent of BMSM screened will be eligible for the study. Key Informants will be referred to the study by cooperative partners, so they will not be screened. The in-depth interviews for BMSM and key informants are expected to take a total of 60 minutes (1 hour) each. We will complete interviews for BMSM and 10 key informants in New Orleans, LA, and Washington, DC. We anticipate screening 60 potential respondents. The total number of burden hours is 45.

Estimated Annualized Burden Hours

Exhibit 12.1: Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses Per Respondent	Average Burden Per Response (in Hours)	Total Burden Hours
General Public- Adults	Eligibility Screener (Att. 5a)	60	1	5/60	5
General Public- Adults	Interview Guide (Att. 5b)	40	1	60/60	40
Total					45

Estimated Annualized Burden Costs

The annualized costs to the respondents are described in Exhibit 12.3. The United States Bureau of Labor Statistics’ employment and wages estimates from May, 2015 (http://www.bls.gov/oes/current/oes_nat.htm) were used to estimate the hourly wage rate for the general public for the purpose of this GenIC request. The total estimated cost of the burden to respondents is approximately $1,045.35. This cost represents the total burden hours of general respondents multiplied by the average hourly wage rate ($23.23).

Exhibit 12.2: Estimated Annualized Burden Costs

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
General Public- Adults	Eligibility Screener (Att. 5a)	5	$23.23	$116.15
General Public- Adults	Interview Guide (Att. 5b)	40	$23.23	$929.20
Total $1,045.35

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

There are no other costs to respondents for participating in this survey.

Annualized Cost to the Federal Government

The estimated annualized cost to carry out the data collection activities is $203,017. This estimate includes the cost of recruitment, screening, conducting the interviews, analysis and reporting, as well as the total cost of the tokens of appreciation ($25 per completed interview, for a total of $1,000).

Exhibit 14.1: Annualized Cost to the Government

Expense Type	Expense Explanation	Annual Costs (dollars)
Direct Costs to the Federal Government	CDC Co-Project Lead (GS-14 0.20 FTE)	$23,362
	CDC Co-Project Lead (GS-13, 0.20 FTE)	$19,770
	CDC Scientist (GS-13, 0.10 FTE)	$9,885
	Subtotal, Direct Costs	$53,017
CoAg Costs	Annual Cooperative Agreement (NNPHI # CDC-RFA-OT13-1302)	$150,000
	TOTAL COST TO THE GOVERNMENT	$203,017

Explanation for Program Changes or Adjustments

This is a new GenIC information collection request (ICR).

Plans for Tabulation and Publication and Project Time Schedule

Tabulation will include descriptive characteristics of respondents collected in the first part of the interview (e.g., city, age, education, employment status). Data collection will occur between April to May 2017, analyses will be carried out in June – July 2017, and the final data set and report will be submitted in August 2017. The project timeline is detailed in exhibit 16.1.

Exhibit 16.1: Project Time Schedule

Activity	Time Schedule
Develop data collection tools, sampling and data plans, study protocol, IRB and PD approvals	Sept 2016- Jan 2017
OMB Submission	Feb 2017
Recruitment	After OMB Approval
Data Collection	1-3 months after OMB Approval
Data analysis finalized and report drafted	4-6 months after OMB Approval
Final data set and final report submitted to CDC	7 months after OMB Approval

In compliance with the CDC policy on data management and access, we will develop a final, de-identified (names, other PII, and locations will be removed) qualitative database for this study along with the corresponding data documentation. This database will be made publicly available within 30 months of the end of data collection, if the final de-identified data are of sufficient quality and usefulness, and can be shown to result in generalizable value to science.

Reason(s) Display of OMB Expiration Date is Inappropriate

We do not seek approval to eliminate the expiration date.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exemptions to the certification.

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Arnold EA and Bailey MM. (2009). Constructing Home and Family: How the Ballroom Community supports African-American GLBTQ Youth in the Face of HIV/AIDS. Journal of Gay and Lesbian Social Services 21, 171-188.
Bricker, Jeff (2014) Survey Incentives, Survey Effort, and Survey Costs. Finance and Economics Discussion Series, Divisions of Research & Statistics and Monetary Affairs, Federal Reserve Board, Washington, D.C. https://www.federalreserve.gov/econresdata/feds/2014/files/201474pap.pdf
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2015. Atlanta: U.S. Department of Health and Human Services; 2016.
Goltz, B. (2015). We’re Not in Oz Anymore”: Shifting Generational Perspectives and Tensions of Gay Community, Identity, and Future, Journal of Homosexuality, 61:11, 1503-1528.
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Ross, M. (2014). Gay Community Involvement: Its Interrelationships and Associations with Internet Use and HIV Risk Behaviors in Swedish Men Who Have Sex with Men, Journal of Homosexuality, 61:2, 323-333.
Rowe M. (2008). Sex, love, friendship, belonging and place: Is there a role for ‘Gay Community’ in HIV prevention today? Culture, Health & Sexuality: An International Journal for Research, Intervention and Care, 10:4, 329-344.
Shettle C, Mooney G. Monetary incentives in U.S. government surveys. Journal of Official Statistics 1999;15(2):231-50.
Wilson P, Valera P, Martos A, Wittlin N, Munoz-Laboy M, Parker R. (2016). Contributions of Qualitative Research in Informing HIV/AIDS Interventions Targeting Black MSM in the United States. The Journal of Sex Research. 53:6, 642-654
Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health 2006;27:1-28.

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