2024-08595. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled REACH: Rural Re-Engagement and Care using Community Health Workers (CHWs) for Persons with HIV. This project is designed to collect standardized program evaluation data from health departments and HIV clinic partners who receive Federal funds for these activities.

DATES:

CDC must receive written comments on or before June 24, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2024-0028 by either of the following methods:

• Federal eRulemaking Portal:www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

Proposed Project

REACH: Rural Re-Engagement and Care using CHWs for Persons with HIV—New—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In rural communities, people with HIV (PWH) may face challenges in accessing consistent HIV care services. In these communities, PWH may also experience health care provider shortages and have fewer providers with expertise in treating HIV. Transportation challenges, where some patients have to travel long distances for care, may also exist. Previous studies have shown community-based or home-based delivery of care is an effective approach to re-engage PWH back into HIV clinical care. This strategy was studied primarily internationally with results showing that community-based delivery of anti-retroviral treatment (ART) significantly increased viral suppression. However, in the US, this model, which may include home visits, has not been implemented as part of routine treatment and care services. Community health workers (CHWs) are frontline public health workers who are trusted members of the community and have a uniquely close understanding of the community served. This trusting relationship enables the CHW to serve as a liaison between health/social services and the community. A CHW approach was assessed as part of the EHE pilot jumpstart initiative which found that CHWs were successful in East Baton Rouge, LA, by facilitating access to HIV treatment for priority populations. Additionally, the use of CHWs has been successful and cost-effective for certain chronic health conditions, particularly when working with low-income persons; people who are medically underserved, and racial/ethnic minority communities to promote disease management in these populations. This demonstration project will provide quantitative and qualitative data on the effectiveness and implementation of a CHW home-based approach to facilitate re-engagement in care and outreach to PWH. The approach aims to improve retention in care and sustained viral load suppression among PWH living in rural communities, to benefit both individual health and reduce community-level HIV transmission. In this demonstration project, recipients are funded to collaborate with HIV care providers to identify PWH in rural communities not in care or not virally suppressed and to implement a CHW-mediated model of re-engagement to care and outreach services for PWH in rural communities. CHWs facilitate re-engagement of PWH who are not in care and outreach to those who are not virally suppressed to provide services that may include ART delivery, sample collection for standard HIV laboratory testing, transfer of self-collected specimens, as well as provide transportation services, arranging and scheduling telehealth visits and/or in person visits with an HIV medical provider and other providers (mental health, primary care) and offer evidence-based medication adherence support.

This collection of deidentified data will allow CDC to assist health departments and their partner HIV clinics in monitoring and evaluating their programs and to identify best practices for provision of implementation of CHW-mediated services for re-engagement to care and outreach for PWH in rural communities. Longitudinal person-level data collection will occur through the clinic's electronic health record (EHR) and a database shared between clinic and the health department, and additional program evaluation data will be collected through client surveys. CDC requests approval for 295 annual burden hours for the recipients to collect, enter or upload, and report client demographic and behavioral characteristics, client data from the EHR, and client and provider surveys. 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 hrs.)	Total burden (in hrs.)
REACH Recipient Data Manager	Electronic Health Record Data Form	5	2	8	80
REACH Recipient Data Manager	Client Info Form	5	2	2	20
REACH Clients	Client Info Form	500	1	6/60	50
REACH Recipient/Clinic Staff	Client Info Form	5	100	6/60	50
REACH Recipient/Clinic Staff	Provider Info Form	5	10	6/60	5
REACH Clients	Client Program Evaluation Survey	100	1	42/60	70
REACH Recipient Data Manager	Client Program Evaluation Survey	5	2	2	20
Total					295

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.