SS_Part B. doc

Community Context Matters Study

Supporting Statement B

OMB No. 0920-1038

April 26, 2016

Project Officer:

Dawn Smith, MD, MS, MPH

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

Division of HIV/AIDS Prevention/Epidemiology Branch

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop E-45

Atlanta, GA 30333.

Voice: (404) 639-5166

Fax: (404) 639-6127

Email: [email protected]

B. Collection of Information Employing Statistical Methods

This information collection request does not employ statistical methods. The following is a description of data collection procedures.

B.1. Respondent Universe and Sampling Methods

This study will be conducted with a total of 600 English-speaking men and women in Chicago, Washington, DC, Jackson, MS, and Philadelphia. Our sample will be drawn with non-probability purposive selection methods. Each participant will be interviewed only once.

Survey interviews will be conducted with: 1) 680 persons recruited using street-intercept methods in community catchment areas for one clinic in each city that is initiating a new HIV prevention clinical service, daily oral pre-exposure prophylaxis (PrEP) and 2)120 opinion leaders (key stakeholders) nominated by clinic staff and community members.

B.2. Procedures for the Collection of Information

B.2.1. Recruitment

1) Neighborhood Interviews (street-recruited): catchment areas for the four clinics will be provided clinic staff. Study staff will visit these areas to determine patterns/places/times of public traffic and activities appropriate for intercept interviews. Specific rules for approaching persons will be developed (e.g., select the xth approaching walker on the left side of the street) to reduce interviewer-introduced selection bias.

2) Key Stakeholder Interviews: In each of the 4 cities, clinic staff and persons intercepted in the community for neighborhood interviews will be asked to nominate opinion/thought leaders whose attitudes, knowledge, and/or occupational position make them “influentials” with regard to HIV prevention through health care provision. This list will be assessed for number of times an individual is nominated, gender, and other factors to prioritize 10 persons per site per year to contact for interview.

B.2.2. Screening and Scheduling Procedures

1) Neighborhood Interviews (street-recruited): When study staff approaches a potential participant, they will ask for their age and make a determination whether they have difficulty with English. Age 18 years or older and English fluency are the only inclusion criteria. If eligible, the “Neighborhood Interview Recruitment Script and Informed Consent” (Attachment 3) will be administered.

2) Key Stakeholder Interviews: Persons nominated and selected for these interviews will be contacted by phone to determine their willingness to be interviewed using the “Key Stakeholder Telephone Recruitment Script” (Attachment 4). Up to three calls will be made before selecting a replacement from the nominated list. If willing to be interviewed, a date, time, and place will be established for the conduct of the interview.

B.2.3. Data Collection Methods

Surveys will be conducted with two categories of participants:

200 interviews for the first year (4 clinics) and 240 per year will be conducted for the next two years(40 neighborhood survey interviews X 5 clinic neighborhoods plus 10 key stakeholder interviews in each of 4 cities = 240interviews per year).

1) Neighborhood Interviews (street-recruited): Consenting persons will complete an audio-computer assisted interview (ACASI) on a tablet with earphones provided for privacy. The survey will take about 20 minutes to complete. Interviewers will remain present to answer questions and retrieve the table at the end of the interview.

2) Key Stakeholder Interviews: At the beginning of the scheduled interview, consenting persons will be offered two options for completion of the interview, ACASI or computer-assisted personal interview (CAPI) where the interviewer asks the questions and enters the responses on the tablet.

For both surveys (neighborhood and key stakeholder), no personal identifiers will be collected during the consent or interview. At the end of each interview, the tablet will encrypt the interview data and transfer it wirelessly to a secure server for data management, storage, and analysis.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

For neighborhood (street-intercept) interviews, community observations prior to survey conduce will assist in selecting appropriate areas and times for recruitment to achieve acceptable response rates. This will be monitored closely during annual survey periods to allow making timely adjustments. In addition, the provision of the $20 gift card as a token of appreciation is planned to maximize survey and item response rates.

For Key Stakeholder interviews, study staff will contact those nominated to establish a date and time convenient for the interview, if they agree to be interviewed. Up to two additional calls will be made (leaving messages if indicated) to determine their willingness to participate.

The use of tablets (and earphones) for interview data collection will increase privacy of responses, especially important for sensitive questions, and the novelty of the experience may increase interest in completing the survey.

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

This submission is a request for authorization to conduct tests of procedures and methodologies typical in methods and instrument development.

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

No other individuals were consulted on the statistical aspects or analysis of data from this sub-collection.