2020-18276. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Community-Based Organizations' Changes in Preparedness and Resources for Support of Biomedical HIV Prevention to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 9, 2020 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Community-Based Organizations' Changes in Preparedness and Resources for Support of Biomedical HIV Prevention—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Antiretroviral (ARV) medications can be effectively used to reduce the number of new HIV infections. In persons without HIV infection, ARVs can be given: (1) For 28 days following a potential HIV exposure through sexual or injection behaviors as nPEP, or (2) before potential sexual HIV exposures and taken daily for months to years as PrEP. In persons with HIV infection, beginning treatment with ARVs early in their infection (e.g., with high CD4 cell counts) can greatly lower their risk of transmitting infection to uninfected sexual partners; this is also called treatment as prevention or TasP. PrEP is 99% effective at reducing the risk of HIV through sexual contact when taken daily. PrEP is also 74%-84% effective at reducing the risk of HIV infection through injection drug use when taken daily. Persons living with HIV who are taking ARVs as prescribed, as well as achieving viral suppression, effectively have no risk for transmitting the virus to an HIV-negative partner through sexual contact. CDC is working with various jurisdictions with high HIV prevalence to increase capacity of ARV provision, build collaborative efforts between health departments and community-based organizations, and engage multi-sector provider systems to reach individuals with high risk of HIV infection as part of the End the HIV Epidemic Initiative. CBOs will play a crucial role in the End the HIV Epidemic Initiative. In a previous survey conducted by CDC's Division of HIV/AIDS Prevention, CBOs reported high awareness of nPEP, PrEP, and TasP, but their ability to meet client need was low. Although clinical CBOs were more prepared to support the expansion of biomedical HIV prevention interventions, the likelihood that all CBOs would incorporate these interventions if they had additional resources was somewhat high.

Research is needed to better understand the capacity of CBOs to incorporate biomedical HIV prevention interventions into their existing infrastructure. It is unclear whether the provision of and capacity to provide nPEP, PrEP, and TasP has increased among CBOs since the original survey was conducted. Furthermore, it is unclear whether non-clinical CBOs have achieved parity in linking clients to biomedical HIV prevention interventions with their clinical counterparts. This new survey will assess current capacity and provision of nPEP, PrEP, and TasP among CBOs providing HIV services to populations with increased risk for HIV acquisition. In addition, the results of this survey will be compared to the results of the 2015 survey to assess differences in awareness, capacity, and provision of biomedical HIV prevention interventions. Respondents will include organizations engaged in HIV prevention and outreach. Up to 330 respondents (n=330; 175 funded CBOs and 155 CBOs that did not receive funding) will be recruited to complete the survey. This project will employ a cross-sectional survey design. Executive level staff members of all CBOs within each of the two strata (mentioned above) will receive phone calls, using publicly available information, to elicit interest in participating in the survey. If the executive level staff member is not interested or is unable to complete the survey, he or she may nominate a direct client service provider and provide this person's email address to study staff. Potential respondents will be contacted from a list of CBOs that completed the 2015 survey. Potential respondents from CBOs that received DHAP funding through PS15-1502 and PS17-1704 will also be contacted to determine their interest in participating in the data collection effort. Each organization's representative will be sent an email with a link to the survey website (created with Survey Monkey). One link will be used for CBOs directly funded by CDC and a separate link will be used for unfunded CBOs. The email will instruct the recipient on how to complete the survey. Three email reminders will be sent to organizations for those that do not complete the survey. Email reminders will be sent two weeks, one month, and two months after the initial email if the potential respondent does not compete the survey. The survey should take approximately 30 minutes to complete.

Where possible, data from the 2015 survey will be combined with data from the 2020 survey. Analyses will include completeness (non-response rates per item) as well as frequency of item responses for awareness, intentions, and provision of PrEP, nPEP, and TasP will be assessed for all respondents combined. Frequency and differences in item responses will be analyzed for relationship to CBO characteristics (e.g., clinical CBOs vs non-clinical CBOs). Frequency and differences in item responses will be analyzed across survey years. We will perform multivariable analysis as needed (to assess interactions between time and type of CBO).

The total annualized burden hours is 165 hours. There are no other costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
	Community Based Organization HIV Prevention Needs Assessment Survey	330	1	30/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.