2014-06317. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call [phone] or send an email to [e-mail]. Send written comments to 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

Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care—New—National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The CDC has entered into a partnership with Walgreen Company (a.k.a. Walgreens pharmacies, a national retail pharmacy chain) and the University of North Texas Health Science Center to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will be implemented at ten sites and will provide patient-centered HIV care for approximately 1,000 persons.

The patient-centered HIV care model will include the core elements of pharmacist provided Medication Therapy Management (MTM) as well as additional pharmacist services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration between pharmacists and medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence.

The expected outcomes of the model program are increased retention in HIV care, adherence to HIV medication therapy and HIV viral load suppression.

CDC requests OMB approval to collect standardized information from ten project sites over the three year project period. CDC also requests approval to conduct retrospective data collection during the first year of the three-year project period. This retrospective data collection will be used to determine both project sites' and participants' baseline characteristics which are needed to compare outcomes before and after program implementation.

Pharmacy, laboratory, and medical data will be collected through abstraction of participant clients' pharmacy and medical records. These data are needed to monitor retention in care, adherence to therapy, viral load suppression and other health outcomes. Program specific data, such as the number of MTM elements completed per project site and project sites' characteristics, will be collected by project site personnel.

The data collection will allow CDC to conduct continuous program performance monitoring. Program performance monitoring will allow adjustment of the model program, as needed, in order to develop a final implementation model which can be used to establish similar collaborations in a variety of clinical settings. The data collection will also allow comparison of project outcomes within the project cohort.

There is no cost to participants other than their time. The total estimated annualized burden hours are 5,113.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Clinic Data Manager	Project clinic characteristics form	10	3	30/60
Pharmacist	Project pharmacy characteristics form	10	3	30/60
Clinic Data Manager	Patient Demographic Information form	10	100	5/60
Clinic Data Manager	Initial patient information form	10	100	1
Clinic Data Manager	Quarterly patient information form	10	400	30/60
Pharmacist	Pharmacy record abstraction form	10	400	30/60

LeRoy 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.