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Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 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 Red Carpet Entry RCE Program Implementation ProjectNew National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention NCHHSTP, Centers for Disease Control and Prevention CDC.
Background and Brief Description This project involves original, implementation research on the Red Carpet Entry RCE Program to link persons with HIV to care within 72
hours of their diagnosis or their return to care after being out of care. Originally developed and implemented in Washington DC by Whitman Walker Health and the DC Department of Healths HIV/AIDS, Hepatitis, STD, and TB Administration, Red Carpet Entry RCE has been shown to successfully and rapidly link people who tested HIV
positive to an HIV care provider.
Evaluations of RCE found that 70% of newly diagnosed people were linked to care within 72 hours of their HIV test.
It was also shown to work for linking
people who had fallen out of care with an HIV provider. An adapted version of RCE has also been shown to improve health outcomes among adolescents and youths in Kenya by quickly linking to care. The school-based program increased rates of linkage to care from 56.5% to 97.3% and three-month retention in care from 66.0% to 90.0%.
Based on this, the CDC identified RCE
as an evidence-informed structural intervention and included it in CDCs Compendium of Evidence-based Interventions EBIs and Best Practices for HIV Prevention.
Having an evidence-informed intervention like RCE that can be disseminated to the broader HIV health care community is important for several reasons: 1 Antiretroviral therapy ART
is the best way to manage HIV and reduce transmission; 2 ART initiation is only possible when someone enters health care and then is ultimately retained in care; and 3 there are few existing evidenced-based structural interventions to support this process.
This bias in the field of HIV
interventions stems from a focus on individual behavior change interventions to prevent HIV infection.
However, as new and effective treatments have emerged that reduce the likelihood of HIV transmission, HIV
clinics and other healthcare settings have emerged as key contexts for HIV
prevention by making sure that Persons with HIV PWH have immediate access to ART. Therefore, the field has slowly shifted to understanding how providers and health systems can be encouraged to support PWH to reduce HIV.

This study will contribute to the field by creating tools to support clinics and healthcare settings that want to implement the RCE Program to link PWH to care. A toolkit will be created and tested via implementing RCE in two clinics. Lessons from the implementation of RCE will be used to update the toolkit. The final toolkit will be disseminated via CDCs website.
Furthermore, because the study also evaluates the implementation strategies, outcomes, and context when RCE is being used, the study will be able to recommend what is needed to implement RCE with fidelity and success and incorporate these insights into the toolkit. Finally, because tracking costs are also a part of the evaluation, clinics and health systems that are examining potential RCE
adoption will have material information about what is needed to put RCE into practice. An understanding of the actual costs can provide important justification for program planners.
The results of this study will help CDC frame how best to disseminate the RCE Program to the broader HIV health care community. This is important because only federal agencies like CDC
have the resources and infrastructure to broadly disseminate EBIs. Broad dissemination and uptake of EBIs like RCE can help move population rates of HIV suppression which would affect population transmission rates. Linkage to care, in an era of biomedical HIV
prevention, is a prevention linchpin.
CDC requests approval for an estimated 125 annual burden hours. There are no costs to respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of responses per respondent
Average burden per response in hours
Total burden hours
Form name
RCE Clients
RCE Implementation Staff
RCE Implementation Staff

Screener
Staff SurveyPreparation Phase
Staff SurveyImplementation Phase months 1,3,5.
Staff SurveyImplementation Phase months 2,4,6.
Staff Interview GuidePreparation Phase
Staff Interview GuideImplementation Phase months 1,3,5.
Staff Interview GuideImplementation Phase months 2,4,6.
Clinic Leadership Interview Guide
Labor Cost Questionnaire
Non-Labor Cost Questionnaire

180
8 8

1
1 3

5/60
15/60
15/60

15
2 6

8

3

15/60

6

8
8

1
3

1
30/60

8
12

8

3

30/60

12

2
6 2

1
4 9

30/60
1.5
1.5

1
36
27

125

RCE Implementation Staff
RCE Implementation Staff
RCE Implementation Staff
RCE Implementation Staff
khammond on DSKJM1Z7X2PROD with NOTICES

Number of respondents
Type of respondents
Clinic Leadership

Total

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