HIV Prevention Generic_Supporting Statement B - OMB Final_RevisedDec11_2015

Generic Clearance

Using Qualitative Methods to Understand Issues in

HIV Prevention, Care and Treatment in the United States

Supporting Statement B

OMB No. 0920-New

December 11, 2015

CONTACT

James Carey, PhD, MPH
Division of HIV/AIDS Prevention, Prevention Research Branch
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop E-37
Atlanta, GA 30329
Telephone: 404-639-1903
Fax: 404-639-1950
Email: [email protected]

TABLE OF CONTENTS

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 1

B.1 Respondent Universe and Sampling Methods 1

B.2 Procedures for the Collection of Information 3

B.3 Methods to Maximize Response Rates and Deal with No Response 6

B.4 Tests of Procedures or Methods to be Undertaken 7

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 8

EXHIBITS

Exhibit B2.1. Total Number of RespondentRespondents for the Qualitative Assessments Over a Three Year Period……………………………………………………………………… 6

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B.1 Respondent Universe and Sampling Methods

This proposed data collection will consist of a series of qualitative studies to understand issues related to HIV prevention, care, and treatment in specific communities within the United States. Each of the proposed studies under this Information Collection will involve a focused scope and small or moderate sized samples. The qualitative studies will include multiple well-established methodologies, which may include but not be limited to qualitative in-depth open-ended individual interviews, semi-structured open-ended individual interviews, focus groups, direct observations (for example, of neighborhoods), and document reviews (for example, of testing venue procedures for linking recently diagnosed persons to medical care). In some assessments, additional contextual information may be collected using structured questions, such as information about the respondents’ characteristics, community, workplaces, or organizations and places where they interact.

In studies covered under this generic ICR, obtaining probability-based samples to reach the desired subpopulations of interest will be cost prohibitive and not needed for achieving study goals. Purposeful, targeted sampling and other non-probability sampling designs will be used to develop a pool of potential respondents for a particular region of interest in the US. The target populations for studies included in this generic ICR include, but are not limited to: persons living with HIV who are in treatment; persons living with HIV who are out of treatment and who may or may not be seeking treatment at healthcare facilities; persons at high risk for HIV acquisition (HIV negative) and HIV transmission (HIV positive); persons from groups at high risk for HIV including gay, bisexual and other MSM, transgender persons, and injection and non-injection drug users; persons from racial and ethnic minorities; and healthcare providers or other professionals who provide HIV prevention, care and treatment services. Other populations may include individuals who provide non-HIV services or otherwise interact with persons living with HIV or persons at risk for HIV acquisition. Studies will only provide local contextual information about the barriers and facilitators to HIV prevention, care, and treatment experienced by specific communities at risk for HIV infection, by HIV-positive persons across the HIV care continuum, and by organizations providing HIV prevention, care, and treatment services.

Contractors will use a range of sources to obtain their samples of respondents. Because the samples are not randomly selected, they may be biased and not fully represent the entire study population. The samples of respondents obtained for each study are extremely targeted; therefore respondents will represent some segments, but not all, of the target populations. The qualitative study’s respondents may be different when compared with the entire population of interest. However, detailed information on respondent characteristics will be gathered via brief structured response questions. The brief structured response questions will gather basic socio-demographic items and other respondent characteristics, such as characteristics of respondents’ communities, workplaces, affiliated organizations, or locations, from which we can describe the sample. The collected socio-demographic and contextual information will be used to describe the characteristics of the population in the study and to discuss limitations of generalizability to other populations.

Study outcomes will be communicated to local stakeholders and organizations in positions to consider and implement site-specific improvements in HIV prevention, care, and treatment for each of the study sites examined. For stakeholders/organizations/agencies outside the local affected communities, all communications will include clear discussion of the limitations of the region-specific, qualitative methods and the non-generalizability of the study outcomes. In presenting our findings, given the study methods, it will be clearly stated that any of the practical antidotes developed are not being recommended as policy recommendations or appropriate for widespread adoptions. The methods are intended to allow researchers to gather information for a specific geographic area or subpopulation, and are not being done in a way that is generalizable to other areas or the national population.

B. 2 Procedures for the Collection of Information

Recruiters will consist of contractor staff members of the project team. Partner organizations such as health clinics and community organizations that serve the target populations in the respective geographic locations may be contacted for their assistance in recruitment of potential candidates. Respondents may be identified and selected as key informants and invited to participate by contractor staff members. Respondents may also be recruited using recruitment materials such as but not limited to flyers, emails, ads on websites or referrals from partner organizations until the target total of respondents indicated in each task order is met.

Individuals who are interested in participating will be screened over the phone by members of the Contractors’ recruitment team. If they are eligible to participate in the face-to-face interview, they will be given a detailed explanation of the study, their role in the study, study requirements, time commitment, and any additional questions they may have will be answered. Eligible respondents will be invited to participate in a face-to-face interview, focus group, or some other established method of collecting qualitative data, along with additional structured response data. Prior to beginning the data collection, respondents will be asked to sign an informed consent form that will include an explanation of the study, risks and benefits of participation, duration of participation, contact person for the research including the chair of the IRB, the voluntary nature of participation, and the right to withdraw without penalty. Respondents may ask additional questions they may have. If they choose to participate and sign the consent form they will be given a copy of the form for their records.

The data collection will take place at a time and place that is convenient to the respondent. Locations will be private. They will be audio-recorded with the consent of the respondent, and transcribed. Location will also be selected based on low ambient sound when possible so as not to interfere with the recording quality. Contractors will also collect data with pencil and paper in situations where audio recordings are not feasible. Two recording devices will be used to ensure no data is lost secondary to an inferior recording. All materials will be kept in locked cabinets in secure locations. All personal identifiable information will be maintained on paper. The exception will be any possible PII provided by the respondent inadvertently in the recorded interview. Transcripts of the data collection will exclude such PII information. Recordings will be kept in locked secure areas. PII information required to conduct the study, such as contact information, will be kept in separate locked cabinets from the paper materials or recordings.

We anticipate that studies under this generic ICR will use mixed methods for data collection. Although the majority of data will be collected by using qualitative open-ended questions, use of brief structured response questions will be appropriate for collecting descriptive information on topics such as the respondents’ age, race/ethnicity, sex and gender identity, sexual orientation, HIV risk behaviors, attitudes, socio-economic status (e.g., education, income, employment, housing, health insurance status), or characteristics of the respondents’ community or workplaces. Use of closed-ended questions to obtain descriptive information will help minimize time burden on the respondent. Regardless of the mixture of open-ended and closed-ended questions being used in each study, all data collection methods will be pre-tested and conducted by trained personnel. For in-depth interviews and focus groups, questions may be open-ended so respondents can reply freely of their own accord. For these types of interviews, the trained data collector will guide the discussion with probing questions as needed. The content of open ended questions will vary by each task order. Qualitative interview guides, focus group guides, and structured response questions will be submitted with each genIC covered under this generic ICR.

Following each collection, project staff will immediately check the quality of the recordings and written notes. If any issues are found, the data collector will immediately fill out the notes from memory to supplement the audio recording (e.g., for parts of the audio recording that could not be heard due to background noise). In the event of an emotional or anxious response from the respondent, respondents will be provided with a city-specific list of mental health care referral services that they may consult as needed. Respondents will also be informed that they may stop the data collection at any time without penalty.

For most ICRs submitted under this generic ICR, we anticipate tokens of appreciation. Small tokens of appreciation may be used, and would include but are not limited to gift certificates to grocery stores or retail pharmacies and cash. The type and amount of the token of appreciation will depend on the burden imposed by different activities. Amounts will be consistent with government-wide practices, including, a $40 incentive for a one-hour cognitive interview (designed to include needs associated with traveling to a facility (e.g., gas, parking, taxi, day care needs)), up to $75 for a 90 – 120 min. focus group (includes travel associated needs. We will include a written justification in the specific genIC request for any tokens of appreciation.

Analysis will include descriptive demographic characteristics of respondents and other relevant data obtained from structured response questions. The bulk of the analysis will be done as traditional qualitative analysis, describing how respondents with different characteristics (e.g. demographics, city, etc.) inform the research question posed within the relevant qualitative study.

Our sample design is based on the assumption of purposeful sampling recruitment strategies for the target populations. Based on previous studies using similar methodological approaches^1,2,3 we conservatively estimate that at least 50% of those screened will be eligible for participation, and among those eligible to participate, 75% will agree to participation.

Exhibit B2.1. Total Number of RespondentRespondents for the Qualitative Studies Over a Three Year Period

Numbers and Cooperation Rates	Three Year Total
Number of respondents to be contacted	4800
Expected cooperation rate	75%
Number of completed data collections	1800

Anderson, J. E., Carey, J. W., & Taveras, S. (2000). HIV testing among the general US population and persons at increased risk: information from national surveys, 1987-1996. American Journal of Public Health, 90(7), 1089.

² Anderson, J. E., Wilson, R., Doll, L., Jones, T. S., & Barker, P. (1999). Condom use and HIV risk behaviors among US adults: Data from a national survey. Family Planning Perspectives, 24-28.

³ Centers for Disease Control and Prevention (CDC. (2010). Prevalence and awareness of HIV infection among men who have sex with men---21 cities, United States, 2008. MMWR. Morbidity and mortality weekly report, 59(37), 1201.

B.3 Methods to Maximize Response Rates and Deal with No Response

The following procedures will be used to maximize cooperation and to achieve the desired high response rate:

• Potential respondents will be identified through targeted recruitment efforts or purposive selection of key informants selected from the relevant study population.

• A token of appreciation in cash or gift card, will be provided to respondents.

• Telephone or face to face screening of interested individuals will be used to determine eligibility and to further identify and recruit potential respondents. Screening questions will be used to determine eligibility.

• All recruitment materials indicate the voluntary nature of the study.

B.4 Tests of Procedures or Methods to be Undertaken

The project team includes experts with the targeted populations and qualitative methods, including screening and data collection development and implementation. To estimate response burden for each respondent, Contractors will conduct mock data collections among trained interviewers who will role-play potential participants and respond to all questions. In this way, the burden estimate will most closely resemble a maximum average burden, since all survey questions were presented in the data collection. The estimated maximum average burden for the study screener is estimated to be 5 minutes per respondent. Contractors will test each data collection survey separately. Any one survey will consist of items that take no more than an average of 60 minutes to complete. All screeners and in-depth interview guide items for each task order will be included in the corresponding genIC. A sample study screener is provided in Attachment 3a. A sample in-depth interview guide is provided in Attachment 3d and 3f.

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

James Carey	CDC	404-639-1903	[email protected]
Deborah Gelaude	CDC	404-639-1905	[email protected]
Damian Denson	CDC	404-639-6125	[email protected]
Jamie Hart	Atlas	512-567-3898	[email protected]
Theresa Spitzer	Atlas	202.717.8716	[email protected]
Dianne Fragueiro	Atlas	202.717.8716	[email protected]
Alisu Schoua-Glusberg	RSS	847-864-5677	[email protected]
Katherine Kenward	RSS	847-864-5677	[email protected]