Supporting Statement B

Hepatitis Testing and Linkage to Care Monitoring and Evaluation System (HEPTLC)

Supporting Statement B

Contact Information:

Jianglan White, M.D., M.P.H.

National Center for HIV, STD, and TB Prevention

Division of Viral Hepatitis/Prevention Branch

Centers for Disease Control and Prevention

1600 Clifton Rd, NE, MS G-37

Atlanta, Georgia 30333

Voice: (404) 718-8551

Fax: (404) 718-8595

E-mail: [email protected]

September 20, 2012

B. Statistical Methods

This collection does not employ statistical methods.

1. Respondent Universe.

Agencies and organizations funded to conduct hepatitis testing and linkage to care activities to increase early identification and linkage to care and treatment of persons with undiagnosed chronic Hepatitis C and/or B infection, with a focus on populations who are disproportionately affected by these infections in multiple settings. Data will be collected from all of these awardees via a web-based Hepatitis Testing and Linkage to Care Monitoring and Evaluation System (HEPTLC).

The target populations and risk factors are identified through surveillance data. The testing participants will be recruited at testing sites. Teams of trained hepatitis counseling and testing staff will provide testing and associated counseling and linkage to care and preventive services to participants at implementation sites. Data will be collected in the process of planning and delivering the testing, counseling and linkage to care services. Data will be collected for every client in every session of testing event, including prevision of testing, counseling and linkage to care. Since all awardees are reporting on all participants, no sampling or respondent selection will be employed in data collection process. Awardees will include approximately 40 sites at multiple settings, such as state and local health departments, community health centers, PWID treatment centers and other settings, including STD, HIV clinics, FQHCs, etc. Test-level data will be submitted to CDC monthly, and aggregated programmatic data will be submitted to CDC quarterly.

The HEPTLC data are used to monitor and evaluate hepatitis testing and linkage to care activities undertaken by funded sites. Data-driven program monitoring and evaluation enables CDC, funded entities, and local program managers to provide valuable insights, feedback and assistance to front-line testing and linkage to care service providers. The HEPTLC data are also used to inform stakeholders, including federal and state executive offices and legislative bodies, based on specific information regarding how public health resources are used programmatically, for what purpose, to whom and to what effect.

2. Procedures for the Collection of Information

Although data elements that will be entered in the HEPTLC system in this ICR are standardized, data collection procedures across grantee’s sites may vary. Awardees will collect both test-level and programmatic data information from test sites. They will then either enter it directly into the HEPTLC system by using HEPTLC system form or by using their own data collection instruments at multiple test sites. Data in HEPTLC will be encrypted and transmitted via the CDC FTP or SDN to CDC. CDC will not have access to Information in Identifiable Form (IIF), as it will be stripped out before reaching by CDC. All grantees are required to use a secure application, for collecting and reporting standardized, sensitive hepatitis testing data.

3. Methods to Maximize Response Rates and Deal with Nonresponse

Not applicable.

4. Tests of Procedures or Methods to be Undertaken.

As part of the HEPTLC development and dissemination, there will be test runs conducted to ensure the functionality and security of the system. The testing procedure will ensure that CDC does not receive IIF and that encryption is sound.

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

The Hepatitis Testing and Linkage to Care (HEPTLC) variables and values have been developed over the past six month by Prevention Branch under the direction of the Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention. The Director of the Division of Viral Hepatitis is Dr. John Ward (404-718-8513). Data will be analyzed by the Prevention Branch staff, to monitor and evaluate the progress and performance under taken by the grantees in meeting objectives outlined in the cooperative agreements,

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