Request for Change

Nonmaterial/non-substantive change to an OMB approved information collection

Four non-substantive changes are requested to 201408- OMB #0920-1038, the Community Context Matters Study

1. Minor change in the exit language after completing the key stakeholder survey to indicate next steps for the respondent.

2. Change in the number of neighborhood interview respondents due to the addition of a second study clinic in a different part of Chicago to increase the racial/ethnic diversity of the interview population. This results in 5 clinic neighborhoods rather than the original 4. Therefore the total annual number of neighborhood survey participants (40 per site) increases from 160 to 200 in years 2 and 3.

3. Change in the study sites because 2 of the original clinics (in Newark and Houston) did not provide PrEP (the clinical intervention being studied) and they were replaced by clinics in 2 new cities (Washington DC and Jackson MS). Since there are still 4 study cities, the total annual number of key stakeholder interviews did not change and remains 40 (10 per year per city).

4. The total annual burden hours would increase from 91 to 110. This is within the approved 500 burden hours for the three years of approved data collection per NOA.

Form	Current Question/Item	Requested Change
Key Stakeholder Survey Attachment 7	Thank you for completing this survey.	Thank you for completing this survey. Please hand the tablet back to the interviewer who will ask you for referrals to also complete this interview.
SSA section A.3	Clinics delivering PrEP in each of four cities (Chicago, Philadelphia, Newark and Houston)	Clinics delivering PrEP in each of four cities (Chicago, Philadelphia, Washington, DC and Jackson, MS)
SSA section A.3	200 interviews per year will be conducted (40 Neighborhood Survey interviews plus 10 Key Stakeholder interviews = 50 interviews per site x 4 clinic sites=200 interviews per year.	the total number of interviews for the 3 years would equal 680 (200 for the first year and 240 for the next two years).
SSA section A.10	IRB approvals have been received from NORC (attachment 8), CDC (attachment 9), and Philadelphia Health Department (attachment 10) IRBs. Three sites (Chicago, Newark and Houston) have requested to be covered by the CDC IRB and are completing the required paperwork with the CDC IRB.	IRB approvals have been received from NORC (attachment 8), CDC (attachment 9), and Philadelphia Health Department (attachment 10) IRBs. Four sites (Chicago (2 sites), Washington, DC, and Jackson, MS) are covered by the CDC IRB.
SSA section A.12	The survey, in aggregate response requires approximately 91 burden hours for the 500 respondents (see Table 12A below). For the Key Stakeholder Telephone Recruitment Script (Attachment 4), we estimate we will need to screen a total of 60 participants to achieve our goal of 40 respondents (attachment 7). Also, for the Neighborhood Interview Recruitment Script and Informed Consent (Attachment 3), we estimate we will need to screen a total of 240 participants to achieve our goal of 160 respondents (attachment 6).	The survey, in aggregate response requires approximately 110 burden hours for the 600 respondents (see Table 12A below). For the Key Stakeholder Telephone Recruitment Script (Attachment 4), we estimate we will need to screen a total of 60 participants to achieve our goal of 40 respondents (attachment 7). Also, for the Neighborhood Interview Recruitment Script and Informed Consent (Attachment 3), we estimate we will need to screen a total of 300 participants to achieve our goal of 200 respondents (attachment 6). There is no cost to respondents other than their time.
SSA section 12.B	Thus, the total anticipated annual cost to participants for collection of information in this project will be $4,846.05.	Thus, the total anticipated annual cost to participants for collection of information in this project will be $1920.20 (corrected calculation from respondents to burden hours)
SSB section B.1	This study will be conducted with a total of 600 English-speaking men and women in Houston, Newark, Chicago, 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) 600 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.	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.
SSB section B.2.3	200 interviews per year will be conducted (40 neighborhood survey interviews plus 10 key stakeholder interviews in each of 4 cities = 200 interviews per year).	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 = 240 interviews per year).