Supporting Statement B

SSB Project Engage.docx

Formative Research and Tool Development

Supporting Statement B

OMB: 0920-0840

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Project Engage: Engaging Gay “Community” Activism for Syphilis Prevention


Generic Information Collection Request under OMB #0920-0840





Section B: Supporting Statement





March 15, 2017



CONTACT

Monique Carry, PhD, MA
Behavioral Scientist

Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention
1600 Clifton Road, NE, Mailstop E-44
Atlanta, GA 30329
Phone: 404-639-2275

Fax: 404-639-8622
E-mail: mcarry@cdc.gov





TABLE OF CONTENTS




EXHIBITS



  1. Respondent Universe and Sampling Methods


We plan to recruit approximately 40 black/African American MSM (BMSM) to discuss the notion of community and its relevance to sexual health activism. 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 plan to recruit five BMSM aged 18-25, five BMSM aged 26-40, five BMSM over the age of 40. In addition, we will recruit and interview five key informants who have been identified as BMSM sexual health activists. Sexual health activists are defined as participating in a collective action or advocacy for improving sexual health of BMSM.


Sampling Methods


The overall sampling strategy for this study is specifically designed for qualitative analysis. Recruiting a probability sample is unnecessary for this type of research and findings could be misleading to the broader scientific community and the general public. We intend to use a purposive sample that is designed to ensure that a wide range of experiences are available.


Sampling Plan BMSM


This study will utilize purposive sampling to select BMSM to participate in the study. Purposive sampling is based on strong theoretical reasons for the choice of cases to be included in the sample. Rather than using probabilistic methods (i.e., random selection with known, non-zero chances of selection for each unit in the population) to generate a sample, non-probability sampling requires researchers to use their subjective judgments, drawing on theory (i.e., the academic literature) and practice (i.e., the experience of the researcher and the evolutionary nature of the research process). Unlike probability sampling, the goal is not to achieve objectivity in the selection of the sample, or necessarily attempt to make statistical inferences from the sample being studied to the wider population of interest. Instead, a qualitative research design that includes purposive sampling, tends to be interested in the intricacies of the sample being studied. To select a representative probability sample, it would be necessary to find or build a sampling frame of BMSM in the cities of interest, which is not currently available and -- if feasible -- would require a long lead time.  Therefore, using a non-representative sample shortens the period of data collection and allows for quick analysis of results, thus meeting the research goals. Exhibit 1.1 shows the sampling targets BMSM and key informants.


Potential respondents will be screened for eligibility until each target is met in each city. During data collection, study staff will assess whether adjustments to these proposed targets are needed in order to reach 40 respondents. The following inclusion and exclusion criteria will be used to determine eligibility BMSM to participate in this study:


MSM participant inclusion criteria:

Eligible respondents will be:

  • 18 years or older

  • Male

  • Non-Hispanic, black/African American

  • Had oral or anal sex with a male in the past 12 months

  • Lives in the metropolitan statistical areas of Washington, DC or New Orleans, LA

    • For Washington, DC: Resident of either Montgomery County, District of Columbia, Prince George’s County, Arlington County, or Alexandria County.

    • For New Orleans, LA: Resident of either Orleans Parish, Jefferson Parish, or St. Bernard Parish

MSM participant exclusion criteria:

Respondents will be excluded from the study if they are:

  • 17 years or younger

  • Identify as female or transgender

  • Not non-Hispanic, black/African American

  • Unable to converse easily in English

  • Have not had at least one reported instance of oral or anal sex with a male in the past 12 months

  • Are from an area outside of the MSA for the target cities.

Recruitment strategies will vary by target group (i.e., BMSM and key informants) and are described below:

Recruitment of BMSM

NNPHI will work with local partner the Institute for Public Health Innovation, IPHI, in Washington, DC and hire an intern with evaluation experience as well as significant experience working with MSM to facilitate recruitment in New Orleans, LA. We anticipate recruiting potential respondents through a variety of community venues in both jurisdictions, using both active (i.e., venue outreach) and passive (i.e., referral, flyers) recruitment techniques. Examples of community venues to be used for both active and passive recruitment of respondents will include local bars, clubs, university/college groups, house/ballroom communities, faith-based centers, community organizations and social events where BMSM are known to congregate as well as virtual internet-based venues such as social media and/or sexual networking websites or mobile apps, if necessary.

  1. Active Recruitment

Active recruitment by the recruitment support staff (New Orleans intern and IPHI staff members) will consist of attending venues and approaching potentially eligible respondents and providing them with an information flyer that states a telephone number for NNPHI study staff and basic information regarding the study (see Attachment 3a and 3b). All recruitment materials indicate the voluntary nature of the study and will include information about the purpose, target audience, time commitment, notification that it is a recorded telephone interview, contact information, and the token of appreciation. Staff will then conduct a brief eligibility screener (see Attachment 5a) using questions included in the outreach recruitment procedures and, if eligible, request contact information to be provided to NNPHI staff to schedule the study interview at a later date. If eligibility screening is not possible during active recruitment, recruiters will collect limited contact information (e.g., first name, initial of last name, phone number, email address) in order for recruitment support staff or NNPHI staff to contact and screen potential respondents on the phone at a more convenient time. If contact information is not collected from a potential participant at the recruitment venue, the recruitment support staff will encourage the individual to use the flyer (Attachment 3a and 3b) to contact NNPHI staff at a later time for eligibility screening.

  1. Passive Recruitment

Passive recruitment will consist of two main types: 1) referrals/word-of-mouth and 2) posting of project information via flyers, posting via Facebook or other on-line announcements, and print advertisements. These are the same study materials used for active recruitment (Attachment 3a and 3b). Referrals and word-of-mouth techniques will occur through local agencies and organizations that provide programs and services for BMSM, community advisory board members, and previous study respondents. Agencies and community advisory board members will be advised to use only the language included in the flyers as a guide when describing the study to potential referrals.

The second passive recruitment technique will include the posting of flyers in locations frequented by BMSM, including local agencies serving this population, after obtaining permission to do so. If feasible and necessary, we will place recruitment flyers in print and online media, such as craigslist, social media, sexual networking apps, local gay newspapers, magazines, and other local LGBT websites or community boards.

Since the sample size for each city is relatively small for the recruitment of BMSM (N=15), recruitment support staff will make a concerted effort to diversify the venues utilized for active and passive recruitment. No one venue will be the sole or predominant source of recruitment for the majority of the sample. If necessary, estimated targets of 2-3 MSM per venue can be established, for instance, and estimated further based on the pool of total potential venues in the sampling universe.


Recruitment of Key Informants


Key informants will be recruited using multiple recruitment strategies:

Recruitment support staff will each recruit approximately five individual key informants by 1) identifying community and/or grass roots organizations that do sexual health activism targeting BMSM in their jurisdictions and selecting 1-2 key players or lead organizers from within each to recruit as key informants, and/or 2) identifying individuals they have worked with in the past and whom they know to be BMSM sexual health activists, defined for this study as someone involved in activism related to a collective action or advocacy for improving sexual health for BMSM. Recruitment support staff will provide this list of individuals, their roles and description of work to NNPHI to vet and review with CDC approval. After NNPHI/CDC review and approval, recruitment support staff will then contact the key informants to provide them with information about the study and to notify them that they have been identified as a sexual health activist from whom we would like to gain their perspective on the research objectives. If they agree to participate, recruitment support staff will pass along their contact information to NNPHI who will ask for their availability to participate and to schedule the interview. If selected key informants decline participation, then recruitment support staff will continue the selection process until sample size is reached per jurisdiction. If necessary, a snowball sampling method may also be implemented should recruitment support staff be unable to identify a sufficient number of interested activists. At the conclusion of each interview respondents will be asked if they are willing to share contact information for other activists who may be interested in Exhibit B1.1.

Exhibit B1.1: Summary of Recruitment Targets

Age

New Orleans

Washington DC

18-25

5

5

26-40

5

5

>40

5

5

Engagement in sexual health activism (18+)

5

5

Total Desired Number of Respondents

40


  1. Procedures for the Collection of Information


Recruitment staff will be provided and instructed to utilize recruitment flyers to garner participation in the study (Attachment 3a and 3b). Recruitment flyers will provide potential respondents with information about the study and a phone number to call to be screened for study eligibility. After completion of each screening/recruitment session, NNPHI staff will use limited contact information (e.g., name, email, telephone number) to set up appointments to complete the informed consent process and up to a 1-hour audio recorded telephone interview at a mutually convenient time. Limited contact information will be kept in a secured location (locked in filing cabinet in locked office when not in use). At the time of the interview, staff will review the study procedures, after which respondents will be read the informed consent (Attachment 4).


The following data collection instruments will be used in this study:


Eligibility Screeners for BMSM: Eligibility screeners will be utilized to identify eligible respondents and take approximately 5 minutes to complete (Attachment 5a). If eligible, request contact information to be provided to NNPHI staff to schedule the study interview at a later date. If eligibility screening is not possible during active recruitment, recruiters will collect limited contact information (e.g., first name, initial of last name, phone number, email address) in order for recruitment support staff or NNPHI staff to contact and screen potential respondents on the phone at a more convenient time. If contact information is not collected from a potential participant at the recruitment venue, the recruitment support staff will encourage the individual to use the recruitment flyer (Attachment 3b) to contact NNPHI staff at a later time for eligibility screening.


In-Depth Interviews: All interviews will be conducted by NNPHI study staff using one interview guide for all respondents (Attachments 5b). One-hour phone interviews will be conducted with respondents in a comfortable, private location of their choosing. The interview instrument will include closed-ended questions to capture basic demographic information but will focus largely on qualitative open-ended questions about their perceptions of community, including their understanding of the gay community and the black gay community. Open-ended questions will allow respondents to respond freely of their own accord. The NNPHI project team member will guide the discussion with probing questions as needed. All interview data will be recorded by study staff with the consent of interview respondents, using a recording service that records over a secure phone line and makes the recording available to the interviewers accessible only by encrypted password, Respondents will be reminded by the interviewer not to use full names or identifying information during the interview. Study staff will perform the transcription of all audio-recordings and maintain all transcripts on password protected/encrypted laptops.


Transcripts will be coded and analyzed used the NVivo qualitative data analysis software program. Information from the structured response questions will be analyzed using the Microsoft Excel and SPSS software programs. Individual transcripts, NVivo files, and other structured response data files will be stored on and edited from a CDC-approved encrypted USB drive plugged into a standalone, non-networked computer without Internet access. Only project staff will have access to the records, study documents, and data.


  1. Methods to Maximize Response Rates and Deal with No Response


We will use the following procedures to maximize cooperation and to achieve the desired response rate:

  • All recruitment materials indicate the voluntary nature of the study and participation is due in part to interest in the study and participation from BMSM.

  • Key informants will be recruited via direct referrals from respondents and study staff.

  • A token of appreciation of $40, in the form of an electronic Amazon gift card, will be provided to respondents upon completion of the interview.

  1. Tests of Procedures or Methods to be Undertaken


Our research team includes experts with experience conducting research with community partners, Lesbian, gay, bisexual, and transgender (LGBT) populations and qualitative research, including screening and interview development and testing. NNPHI staff will conduct pretesting of the screening tool and interviews on at least three mock respondents to assess question wording, skip patterns, question sensitivity, and overall flow of the interview and to estimate response burden for each respondent. Non-CDC members of the research team will be responsible for recruiting respondents and collecting the data in the three cities as well as for generating transcripts that contain no PII.

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


Exhibit B5.1 below lists the project team members who were consulted on the aspects of research design and those who will be collecting and analyzing the data. Please note: The CDC staff are primarily responsible for providing technical assistance in the design and implementation of the research; assisting in the development of the research protocol and data collection instruments for CDC Project Determination and local IRB reviews; working with investigators to facilitate appropriate research activities; and analyzing data and presenting findings at meetings and in publications. The data are primarily qualitative in nature and will be analyzed accordingly.

The CDC staff will be non-engaged in the direct collection of information; CDC staff will neither collect data from nor interact with research respondents (Attachment 7). Data will be collected by members of partner project staff listed. No individual identifiers will be linkable to collected data, and no individually identifiable private information will be shared with or accessible by CDC staff. All members of the research team will work together to analyze the data and generate reports containing summaries of the findings.


Exhibit B5.1: Statistical Consultants

Team Member

Organization

Email

Monique Carry

CDC

Kju8@cdc.gov

Damian Denson

CDC

Dvd5@cdc.gov

Karen Kroeger

CDC

Knk2@cdc.gov

Aaron Alford

NNPHI

AAlford@nnphi.org

Brittany Bickford

NNPHI

BBickford@nnphi.org

Jennifer Edwards

NNPHI

jedwards@nnphi.org

Nicole Waller

NNPHI

nwaller@nnphi.org




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