2016-28588. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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] or send an email to [e-mail]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color (THRIVE)—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Approximately 40,000 people in the United States are newly infected with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) remain the population most affected by HIV infection in the United States. Among MSM, those who are black and Hispanic comprise 64% of all new infections. Goals of the National HIV Prevention Strategy include increasing the number of MSM of color living with HIV infection who achieve HIV viral suppression with antiretroviral treatment, and decreasing the number of new HIV infections among MSM of color at risk of acquiring an HIV infection. Achieving these outcomes requires that men utilize a broad variety of HIV prevention and care services.

In 2015, CDC developed a cooperative agreement program to promote use and adoption of Targeted Highly-Effective Interventions to Reverse the HIV Epidemic (THRIVE). Awardees are seven state and local health departments that are developing and implementing demonstration projects to provide comprehensive HIV prevention and care services for MSM of color. Each THRIVE awardee is creating a collaborative with community-based organizations, health care, behavioral health, and social services providers in its jurisdiction to strengthen referrals and coordination of HIV testing, prevention, and treatment services. Overall, approximately 80 partner organizations are participating in THRIVE collaboratives.

Each THRIVE collaborative is required to address a total of 24 HIV prevention and care services, including 13 HIV prevention services for MSM of color at substantial risk for HIV infection and 11 HIV care services for MSM of color living with HIV infection. HIV prevention services include: 1. HIV testing that uses lab-based 4th generation HIV tests; 2. Assessment of indications for pre-exposure prophylaxis (PrEP) and non-occupational post-exposure prophylaxis (nPEP); 3. Provision of PrEP and nPEP; 4. Adherence interventions for PrEP and nPEP; 5. Immediate linkage to care, antiretoriviral treatment, and partner services for those diagnosed with acute HIV infection; 6. Expedient linkage to care, antiretoriviral treatment, and partner services for those diagnosed with established HIV infection; 7. STD screening and treatment; 8. Partner services for patients with STDs; 9. Behavioral risk-reduction interventions; 10. Screening for behavioral health and social services needs; 11. Linkage to behavioral health and social services; 12. Navigators to assist utilizing HIV prevention and behavioral health and social services; 13. Navigators to assist enrollment in a health plan.

HIV care services include: 1. HIV primary care, including antiretroviral treatment; 2. Retention interventions; 3. Re-engagement interventions; 4. Adherence interventions; 5. STD screening and treatment; 6. Partner services; 7. Behavioral risk reduction interventions; 8. Screening patients for behavioral health and social services needs; 9. Linkage to behavioral health and social services; 10. Navigators to assist linking to care and accessing behavioral health and social services; 11. Navigators to assist enrollment in a health plan.

CDC requests OMB approval to collect the information needed to monitor and assess the demonstration projects. In general, information collection will be conducted in 2 steps: THRIVE collaborative partners will report information to their respective health department (THRIVE awardee), and THRIVE awardees will provide reports to CDC. The monitoring and evaluation plan is based on semi-annual reports of Monitoring and Evaluation (M&E) Variables, comprised primarily of de-identified or coded client-level data on demographics and services received. The M&E files will be transmitted electronically. Recognizing that THRIVE awardees and partners vary in terms of existing infrastructure, CDC has established guidelines and specifications for M&E content, but is permitting a flexible approach to electronic reporting. A similar approach will be applied to electronic transmission of the annual Funding Allocation Report (FAR). The FAR is only required for THRIVE awardees.

Information collection also includes an Annual Collaborative Process and Outcome Evaluation based on semi-structured interviews and completion of a questionnaire called the Annual Collaborative Assessment Tool. These information collections will allow CDC to assess how successful THRIVE awardees have been in creating, engaging, and sustaining collaborative partnerships and to understand how these partnerships contributed to achieving the goals of the project. Both tools will be submitted to CDC electronically on an annual basis.

CDC will use findings to provide technical assistance to THRIVE awardees and to develop recommendations for the coordination of comprehensive HIV testing, prevention, and treatment services for MSM of color.

OMB approval is requested for three years. Participation is required as a condition of THRIVE funding and there are no costs to respondents other than their time. The total estimated annualized burden hours are 1,543.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
THRIVE Partners	Monitoring and Evaluation Data Elements on HIV Prevention and Care Services	80	2	9
	Qualitative Interview: Collaborative Process Evaluation	80	1	40/60
	Collaborative Assessment Tool	80	1	20/60
THRIVE Awardees	Monitoring and Evaluation Data Elements on HIV Prevention and Care Services	7	2	1
	Qualitative Interview: Collaborative Process Evaluation	7	1	40/60
	Collaborative Assessment Tool	7	1	20/60
	Funding Allocation Report	7	1	20/60

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.