Change Request Justification

Justification for Nonmaterial/Non-substantive Change Request

National HIV Surveillance System (NHSS) OMB #0920-0573

We are requesting a non-substantive change to the information collection request (ICR) for the National HIV Surveillance System (NHSS) OMB #0920-0573. Specifically, we are requesting modifications to the initial, follow-up, and annual/closeout cluster report forms (CRFs), which are submitted to CDC by health departments.

There is no change to the purpose, use, or methods of data collection, as outlined in the previously submitted Supporting Statement Part A and B. These modifications of questions do not introduce new concepts, but will add depth and result in more accurate and complete responses.

Revisions were made to simplify data collection and entry for health departments, to collect more relevant data that would help health departments track progress in responding to HIV clusters, and to help health departments better communicate their progress and challenges to CDC so that CDC can provide more effective technical assistance and other support for responding to clusters and outbreaks.

These revisions were guided by discussions with health departments. In 2024, CDC hosted three webinars about changes to the forms that were open to all health departments expected to submit CRFs. CDC also sent draft revised CRFs to health departments to solicit written feedback on the changes. Health departments are appreciative of the proposed changes and feel that these modifications will make it easier to complete the forms.

Summary of Proposed Changes in Data Collection Instruments

Streamlining and clarifying forms

We streamlined all forms by removing data elements felt by health departments to be particularly difficult to populate, or which were no longer needed. Some were replaced with data elements that will capture the information more accurately and in a way that providers health departments more flexibility about which data elements to report, depending on the context of the cluster. We also modified some questions and instructions within the form to improve the quality of data collected, based on experience and data gathered since the last ICR submission.

Revision of approach to collecting outcome data

Currently, the forms require health departments to populate outcomes from three specific activities (testing partners of cluster members for HIV, linking cluster members to treatment, and referring partners of cluster members to pre- or post-exposure prophylaxis) for all clusters. The breadth of the questions and the number of required responses varies by form from 4 (follow-up form) to 21 (annual/closeout form).

For this revision, we have modified the collection of outcome results to maximize flexibility for the health departments. We have provided a standardized list of activities in all three forms where health departments can indicate which activities they have implemented in response to the cluster. With the proposed revision, outcome reporting will only be required for the Annual/Closeout form. Furthermore, health departments will have the flexibility to report outcomes for three activities of their choice among those that they implemented. Because there are many possible answer choices, the outcomes questions appear longer. However, in practice, the information requested from health departments is similar in scope and burden. We estimate no change in burden hours for these proposed changes.

Overall tally of questions in forms

The number of questions has been reduced in each of the three forms, as shown below.

Form		Currently approved	Proposed revision
Attachment 3e_Initial Cluster Report Form	Total questions	57	32
	Required questions	21-43	13-25
Attachment 3f_Cluster Follow-up Form	Total questions	25	20
	Required questions	20	4-17
Attachment 3g_Cluster Closeout Form	Total questions	39-42	39
	Required questions	28	21-32

The number of questions a health department will answer on each form varies due to skip patterns and optional questions that health departments may elect to answer or skip.

The specific changes are outlined in the Summary of Proposed Changes in table form document, along with Attachments 3e: Initial Cluster Report Form (clean, track changes), 3f: Cluster Follow-Up Form (clean, track changes), and 3g: Cluster Closeout Form (clean, track changes). Cluster report forms will be captured via REDCap, a secure web application for building and managing online surveys and databases. REDCap allows for auto-population of several fields and reduces burden on health departments, who previously needed to encrypt and upload Excel files. As a result of this change, the forms submitted for OMB review are now in Word rather than in Excel format. We have updated formatting of the questions to make them easier to read.

Attachments:

1. Summary of the Proposed Changes in table form NHSS 0920-0573

2. Attachment 3e Initial Cluster Report Form clean

3. Attachment 3e Initial Cluster Report Form track changes

4. Attachment 3f Cluster Follow-up Form clean

5. Attachment 3f Cluster Follow-up Form track changes

6. Attachment 3g Cluster Closeout Form clean

7. Attachment 3g Cluster Closeout Form track changes