CEPI Supporting Statement B 952014

CEPI Supporting Statement B 952014.docx

PROCESS ASSESSMENT REVIEW OF THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME (DAIDS) CRITICAL EVENTS POLICY IMPLEMENTATION (CEPI) PROGRAM (NIAID)

OMB: 0925-0712

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Supporting Statement B for:


PROCESS ASSESSMENT REVIEW OF THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME (DAIDS) CRITICAL EVENTS POLICY IMPLEMENTATION (CEPI) PROGRAM

OPCRO, DAIDS, NIAID, NIH, HHS




September 5, 2014









Name: Lynda Lahl, RN, MS
Address: 5601 Fishers Lane, RM 9B25
Rockville, MD 20852
Telephone: 240-292-4887
Fax: 240-627-3111

Email: [email protected]


National Institute of Allergy and Infectious Diseases

National Institutes of Health

U.S. Department of Health and Human Services







Table of contents



B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B.1 Respondent Universe and Sampling Methods

B.2 Procedures for the Collection of Information

B.3 Methods to Maximize Response Rates and Deal with Non-response

B.4 Test of Procedures or Methods to be Undertaken

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting

and/or Analyzing Data




List of Attachments:


Attachment 15: Recruitment Email to potential focus group participants

Attachment 18: DAIDS Staff Survey Screenshots

Attachment 19: Extramural Researchers/External Stakeholders Survey Screenshots

Attachment 20: Focus Group Opening Script and Questions

Attachment 21: CEPI Pilot survey results




B.1 Respondent Universe and Sampling Methods


DAIDS Staff members (n =100) and Extramural researchers/external stakeholders (n = 400) will be identified and recruited by NIAID/DAIDS project staff to participate in the CEPI survey. Ideally, we expect the same 500 participants will complete the survey at both T1 and T2. More than likely, however, we will experience a 10 percent attrition among both groups (See Table 1-1 for estimated number of participants at each time point). Given that we plan to furnish incentives (for external stakeholders and extramural researchers) for participation at both T1 and T2, we expect the response rate to be approximately 80% at both time points. Altogether, we anticipate a cumulative percent response rate of 72 percent (i.e. respondents who complete both T1 and T2 surveys). A pilot survey was conducted during February-March 2014. We had a response rate of 22 percent. See Attachment 21 for additional information on the pilot survey results.


A probability-based sample will not be utilized for this research. Though we are interested in three target populations (i.e., DAIDS staff, extramural researchers, and external stakeholders), as well as a number of population subgroups (e.g., DAIDS Staff, contracted-DAIDS Staff, PPD-DAIDS Site Monitors, Network Extramural Researchers, Non-Network Extramural Researchers, International Extramural Researchers, Domestic Extramural Researchers, Pluripotent Extramural Researchers, International External Stakeholders, and Domestic External Stakeholders), it is most practical to rely on a convenience sample.


Table1-1. Estimated number of participants at Time 1 and Time 2



Time 1

Time 2

DAIDS

80

72

Extramural Researchers/External Stakeholders

320

288




B.2 Procedures for the Collection of Information


A probability-based sample will not be utilized for this research. Though we are interested in three target populations (i.e., DAIDS staff, extramural researchers, and external stakeholders), as well as a number of population subgroups (e.g., DAIDS Staff, contracted-DAIDS Staff, PPD-DAIDS Site Monitors, Network Extramural Researchers, Non-Network Extramural Researchers, International Extramural Researchers, Domestic Extramural Researchers, Pluripotent Extramural Researchers, International External Stakeholders, and Domestic External Stakeholders), it is most practical to rely on a convenience sample.


Surveys will be collected from the sample of 500 participants twice during the project period. Time 1 (T1) will occur during the fall and/or winter of 2014 depending on the date OMB clearance is received. Time 2 (T2) will occur one year later during the fall/winter of 2015. Each collection point will remain “open” online for three months, encouraging maximum participation. These two time points will allow measurement of any increases in knowledge of the policy and supplemental resources, increases in awareness and understanding of the policy, application of the policy, and participation in dissemination activities. See Attachments 18, 19, and 20 for DAIDS staff and Extramural Researchers/External Stakeholders survey questions and focus group opening script and questions.


Frequencies and distributions will be run for all variables and examined for data that are out of range. By running queries against the related data tables, we will identify duplicate records, incorrect formats, and other anomalies. Using these methods, Social Solutions is able to guarantee the integrity of our datasets and subsequent analysis. After conducting a thorough quality check in which a random sample of 15% of observations’ spreadsheet data are compared against the data collected through the online survey via Survey Monkey; the spreadsheet data will then be exported to our analysis database. If, in the unlikely event, discrepancies are determined between the data collected via Survey Monkey and the data exported to Stata and Dedoose, Social Solutions will manually verify all data entered and re-enter if necessary.


A limited number of DAIDS staff and extramural researchers/external stakeholders will participate in the focus groups. No more than 9 participants will participate in each focus group, and we anticipate conducting 9 focus groups consisting of a total of 81 participants. NIAID/DAIDS project staff will determine the location, date, and time of the focus group. Focus group interviews will take place in either Bethesda/Rockville, MD or at local, domestic or international network meetings. In addition, NIAID will identify and make initial contact with potential participants (See Attachment 15). A convenience sample approach will be used, drawing from Extramural Researchers in attendance at an existing training or DAIDS meeting, or DAIDS contract staff, and who are willing to participate.  Focus group participants will be allowed to participate in only one focus group. Persons expressing interest in participating in a focus group will then be emailed the informed consent form, which includes additional focus group details. All participants will be asked to complete and sign a consent form prior to participation, bringing the completed form with them to the focus group. Consent forms will be available for signature at the beginning of each focus group, in case a participant forgets to bring the signed consent to the focus group session. Social Solutions will verify completeness of the consent forms prior to the beginning of each of the focus groups to ensure there is no missing information and clarify questions participants may have. Audio-recordings will be made for each focus group discussion. Focus groups will be moderated by Dr. Ami Lynch and transcribed by Mr. Jeremy Braithwaite, both of SSi. Meeting proceedings will be provided to NIAID/DAIDS staff with the necessary electronic and hard copies of the transcripts following each focus group, if requested. These transcripts will be uploaded to Dedoose for future analysis.




B.3 Methods to Maximize Response Rates and Deal with Nonresponse

Response rate shall be calculated by determining the number of individuals who completed both T1 and T2 surveys (numerator figure) and scaling this by the total number of individuals recruited for the survey research (denominator figure). In order to maximize the response rate at both time points, NIAID staff will launch periodic follow-up reminder broadcasts with DAIDS staff, extramural researchers and external stakeholders. For survey point T1, NIAID will send reminder emails to all participants at three points (two to four-week intervals) following the initial blast recruitment email. For survey point T2, Social Solutions will send a reminder email to all T1 participants at three points (two to four-week intervals) following the initial blast recruitment email. A final reminder broadcast will be sent within one week prior to the survey closeout date. In addition to follow-up broadcasts, an incentive of $10 USD will be provided to survey respondents at both time points, increasing the likelihood that respondents who participate at T1 will also participate at T2. Though we expect an 80 percent response rate at both T1 and T2, we must also anticipate a 10 percent attrition between T1 and T2. By utilizing incentives and follow-up broadcasts, as well as offering modal survey heterogeneity (i.e. offering respondents the opportunity to complete the survey as a web-based, as well as hard copy format), we are confident that respondent attrition can be kept at the minimal 10 percent rate. This will yield a response rate of 72 percent, or 360 respondents.



B.4 Test of Procedures or Methods to be Undertaken

A pilot-survey was conducted in late February/early March 2014 in order to garner insights on the survey instrument. Of the 18 contacted individuals, four individuals representative of the study population (2 DAIDS FTE staff and 2 external stakeholders/extramural researchers) responded and completed the pre-test. The pilot-survey consisted of completion of the entire survey tool, in addition to Likert scale and free-response questions assessing survey burden, time to completion, clarity of instructions, clarity of survey questions, flow of survey, suggestions for improvement, and likelihood of participating in a longitudinal survey with offered incentives. These questions were analyzed using univariate statistics (i.e. frequencies and percentages) as well as analyzing short-response questions for common themes.

For the full T1 and T2 surveys, we anticipate estimating pooled cross-sectional time-series equations in which each individual (DAIDS staff member, researcher, stakeholder) is treated as a distinct unit. Because each individual contributes a single observation for each assessment point in the data set, it follows that each individual appears in the data set twice. These two observations per individual cannot be regarded as independent and the pooled cross-sectional time-series model takes this into account. More importantly, these models assess the degree to which changes in the independent variables are associated with changes in the dependent variables. Time-series models allow for much stronger causal claims as they help control for unobserved time-stable characteristics of the individuals and unobserved year-specific influences. This process eliminates potential bias resulting from the exclusion of any variable that either does not change over time or whose influence on the dependent variable does not change over time. Pooled cross-sectional time-series analyses can be modeled as either fixed or random effects. Fixed effects are most appropriate when omitted variables may vary across cases but are constant across time. Random effects offer more efficient estimators and can be useful when some omitted variables are suspected to be constant over time but vary across cases, while others are thought be fixed between cases but vary over time. The Wu-Hausman specification test can be used to determine whether the fixed effects (more conservative) or random effects (more efficient) models are more appropriate.



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


Jenny Namur Karp, MPH

Project Director and Principal Investigator

Social Solutions International, Inc.

Silver Spring, MD 20910

(202) 491-4954


Ami Lynch, PhD

Interviewer

Social Solutions International, Inc.

Silver Spring, MD 20910

(571) 212-8367


Jeremy Braithwaite, MA

Survey Analyst

Social Solutions International, Inc.

Silver Spring, MD 20910

(630) 621-6031










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