Supporting Statement B: Comprehensive Understanding of Readiness for Elimination of Hepatitis C in Corrections (Cure-HepC) Survey
Comprehensive Understanding of Readiness for Elimination of Hepatitis C in Corrections (Cure-HepC) Survey
OMB Control Number: 0920-24FU
Supporting Statement B
October 3, 2024
Michtta Jean-Louis, PharmD, MPH, CPH
Division of Viral Hepatitis (DVH)
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention (NCHHSTP)
1600 Clifton Road (MS-)
Atlanta, GA 30329
954.232.2801
Table of Contents
Section
B. Justification
Respondent Universe and Sampling Methods
Procedures for the Collection of Information
Methods to Maximize Response Rates and Deal with Non-response
Tests of Procedures or Methods to be Undertaken
Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
Justification
The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Division of Viral Hepatitis (DVH) requests a three-year approval for new data collection. This project aims to improve the ability of CDC to inform program planning and evaluation of carceral programs that aim to reduce new viral hepatitis infections, reduce viral hepatitis-related morbidity and mortality, and reduce viral hepatitis-related disparities in carceral settings. The data collected will establish a system for ongoing program evaluation and improvement and allow for data-driven resource allocation to areas of greatest need. The primary goals of this project are to: 1) understand practices surrounding hepatitis C virus screening, testing, and treatment practices and the national burden of hepatitis C in carceral settings as well as challenges to testing and treatment of hepatitis C virus, and 2) utilize findings to advance the Division of Viral Hepatitis 2025 Strategic Plan to eliminate viral hepatitis in the nation.
Respondent Universe and Sampling Methods
This voluntary survey will be administered annually to state Departments of Correction (DOCs) and the large jails. The goal is to reach 101 state DOCs and large jails, to include the District of Columbia. Each responding institution will receive a request to complete the web-based survey with advance notification to allow time for record searches. The survey has branching logic to improve efficiency and reduce time burden of survey. Participating institutions will have a set-time period, as determined by ACA, to complete the survey. This survey will be self-administered which we estimate to take between 30 to 80 minutes to complete, with an average time to complete of 55 minutes, to include time for collecting the required data elements into the web-based survey form If preferred, there will be an option to complete an interviewer-administered survey via telephone or videoconferencing with a member of the ACA survey team.
The entire respondent universe will be surveyed to enable a broad understanding of current hepatitis C testing and treatment practices across the nation, which could not be achieved by surveying a sample of institutions. We also need to understand the burden of disease and current challenges to implementation of hepatitis C programming.
Directors/program managers of all state DOCs and large jails in the United States listed as members in the ACA directory (https://www.aca.org) will be contacted to complete a survey about their institution.
Approximately one to two months prior to the launch of the survey, ACA will send a letter of invitation by email to alert participants that the survey is forthcoming. The invitation will provide a description of the survey and instructions for completing the survey. The two options for completing the survey include:
The institution(s) can enter responses to survey questions via a secure, web-based application (e.g., REDCap, Survey Monkey), for which a survey link will be provided.
The institution(s) can provide responses to survey questions via telephone or videoconferencing and coordinate a date and time with a member of the ACA survey team.
Survey respondents will have approximately three months to complete the survey, and those who do not complete the survey via the options provided, will receive up to three follow-up reminders to complete the survey. A final reminder will be sent at the end of the data collection period. At this time, institutions who do not want to participate in the survey will be invited to complete one question about why they chose not to participate.
2. Procedures for the Collection of Information
Prior to extending an invitation to complete the survey, ACA will host a kickoff webinar to explain the intent of the survey and outline the process for completing the survey. Following the kickoff webinar the web-based survey and survey instructions will be distributed via email. The ACA survey team will monitor assigned institutions with the goal of a 100% response rate and will conduct routine follow up to ensure robust survey completion.
No individual-level identifiers will be collected using this survey instrument (e.g., name, social security number). To maintain confidentiality of survey respondents, the data shared with CDC will not include institution name and location will be reported at the regional-level for state DOCs and state-level for large jails.
Data will be collected for a time-period of representing a full calendar year from January 1 to December 31 of the most recent calendar year and includes:
Facility type (e.g., prison, jail, unified system)
Operating capacity (e.g., average daily census)
Aggregate demographic data of the incarcerated or detained population
Hepatitis C screening and testing practices
Prevalence of hepatitis C during intake screening
Prevalence of hepatitis C among the overall incarcerated population
Hepatitis C treatment practices
Access to substance use disorder treatment
Challenges in scaling up hepatitis C testing and treatment
ACA is required to store the data for a period of five years.
Quality Control
Data quality will be ensured through ACA survey team training and regular, close monitoring of all operations, data collection, and data entry. The web-based application (e.g., REDCap, Survey Monkey) will support quality assurance and quality control efforts to include:
Interviewer errors are reduced because interviewers do not have to follow complex routing instructions; the computer does the routing or skip patterns for them.
Respondent errors are also reduced. Consistency checks are programmed into the survey so that inconsistent answers or out-of-range values can be corrected or explained while the survey is in progress.
The use of a web-based application can also reduce coding and coding errors, which makes it possible to prepare the data for analysis faster and with fewer corrections needed.
Data entered into the web-based survey will be transmitted directly to a secure, cloud-based server. ACA will conduct frequent data quality checks and adjust as needed. The survey will include built-in logic checks for key variables. On a rolling basis, ACA will validate the survey data collected by meeting with each survey respondent to ensure complete and accurate data submission. Once validated, the contractor will provide the dataset to CDC for analysis on a continuous basis and send a finalized database to CDC one month prior to the end of the period of performance.
3. Methods to Maximize Response Rates and Minimize Non-response
Approximately one month before data collection begins, institutions will receive an email from ACA inviting them to a webinar that will explain the importance of the survey, how the data will be used, and orient them to the survey and data collection methods. State DOCs and large jails have a high degree of familiarity with and trust in ACA as a supportive partner in their ongoing work in correctional health policies and programming. A couple of survey modalities will be offered to institutions as described previously (including an online, self-administered option via a web-based application like REDCap or interviewer-administration via phone or videoconferencing). Institutions may choose the method that they prefer. Institutions that do not respond to the survey will be sent follow-up reminders during the data collection period. Response rates will be monitored through monthly conference calls between ACA and CDC, offering the opportunity to share strategies for improving response rates.
Characteristics of non-responding institutions, such as geographic region, will be monitored and compared with those of responders to determine potential data gaps. We are aiming for 100% response rate. We anticipate that approximately 20% of invited institutions will decline to complete the survey, yielding approximately 80% completed surveys per year. The addition of an online response method (e.g., REDCap, Survey Monkey) is intended to make survey response easier and thus potentially increase response rates.
We are aware of the sexual orientation and gender identity (SOGI) requirement to include inclusive language to capture gender identity and sexual orientation questions on survey instruments. Unfortunately, due to the limited IT infrastructure of carceral settings which are designed to capture the most basic information to identify and track individuals under their care, we are only able to capture the designation of sex assigned at birth. Race and ethnicity might also be a challenge due to the same limitations. However, for race and ethnicity we did ensure our answer choices aligned with the 7 minimum categories as outlined by SPD-15. We also included an answer choice of “other/missing/unknown” to account for the variability across state department of corrections prisons and large jails in how they can capture race/ethnicity. When we piloted the survey with 7 correctional systems, we identified unique challenges to answering the questions: inadequate data collection systems, challenges with calculating proportions, unanswered survey questions, confusion with some of the wording and flow of the survey. With this feedback, we’ve refined our survey to improve response rate and reduce the number of unanswered questions. The public reporting burden of this collection of information varies from 30 to 80 minutes with an
estimated average of 55 minutes per response. This is outside of the scope of this survey, but it is our hope that through the administration of this survey this might spark internal discussions among state department of corrections prisons and large jails on the type of data being captured and how it is being stored. The scope of this survey is to understand the burden of hepatitis C in carceral settings and to understand screening, testing, and treatment practices.
4. Tests of Procedures or Methods to be Undertaken
The CURE-HepC survey (Attachments 3a) will focus on methods that are feasible and practical, while ensuring that the approach is scientifically sound. Prior to implementation, CDC and ACA project staff will test the skip patterns and responses of the chosen data collection platform to ensure a streamlined data collection instrument that produces valid and reliable data.
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
Individual Consultant on Statistical Aspects
The following individuals consulted on statistical aspects:
N/A
Individuals Collecting and/or Analyzing Data
ACA project staff will be responsible for leading the implementation of the survey with state DOCs and large jails, monitoring data collection, and validating the data.
Contractor Project Staff
ACA project staff can be reached at the following address:
206 N Washington St # 200,
Alexandria, VA 22314
Terri Catlett
Principal staff
CDC Project Staff
All CDC project staff can be reached at the following address and email address:
Division of Viral Hepatitis
Centers for Disease Control and Prevention
1600 Clifton Rd, NE MS --
Atlanta, GA 30333
Michtta Jean-Louis, PharmD, MPH
Epidemiologist
Principal Staff
Email: [email protected]
Lindsey Sizemore, MPH
Health Scientist
Support Staff
Email: [email protected]
Nathan Furukawa, MD, MPH
Senior Advisor
Support Staff
Email: [email protected]
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