ZIRP Puerto Rico Study
Zika Virus RNA Persistence in Pregnant Women and Congenitally Infected Infants in Puerto Rico (ZIRP)
Supporting Statement: Part B
OMB # 0920-XXXX
September 21, 2017
Sascha Ellington, MSPH
Telephone: 770-488-6037
Fax: 770-488-6391
E-mail: frk5@cdc.gov
Pregnancy and Birth Defects Task Force
CDC Zika Virus Response Team
Centers for Disease Control and Prevention
Atlanta, Georgia 30341
Table of Contents
B. Collections of Information Employing Statistical Methods
|
|
|
|
|
|
Attachments
Section 301 of the Public Health Service Act (42 U.S.C. 241)
30-Day Federal Register Notice
Screening and Data Collection Instruments
Pregnant Women Screening Form
Pregnant Women Enrollment Questionnaire
Pregnant Women Symptoms Questionnaire
Pregnant Women Follow-up Questionnaire
Infant Enrollment and Delivery Questionnaire
Infant Follow-up Questionnaire
Confidentiality and Non-disclosure Agreements
Assurance of Confidentiality Agreement
FTE nondisclosure agreement
Agreement to Abide By Restrictions on Release of Zika Pregnancy and Infant Outcomes Surveillance and Surveillance-Related Data Collected and Maintained by the Centers for Disease Control and Prevention (CDC)
IRB Approval
IRB Approval Letter (CDC)
IRB Approval Letter (UPR)
IRB Approval Letter Amendment 1 (CDC)
ABBREVIATIONS
CDC Centers for Disease Control and Prevention
EOC Emergency Operations Center
IgM Immunoglobulin M
IRB Institutional Review Board
mL Milliliter
MRI Magnetic Resonance Imagining
OB Obstetric
PRDH Puerto Rico Department of Health
PI Principal Investigator
POC Point of Contact
PRDH Puerto Rico Department of Health
RNA Ribonucleic acid
rRT-PCR Real-time reverse transcription–polymerase chain reaction
USZPR US Zika Pregnancy Registry
ZAPSS Zika Active Pregnancy Surveillance System
ZIKV Zika Virus
B. Collections of Information Employing Statistical Methods
B.1. Respondent Universe and Sampling Methods
The objective of our study is to determine the prevalence and duration of persistent ZIKV RNA in pregnant women infected with ZIKV and their congenitally exposed infants. In order to achieve this, using a hypothetical estimate of the prevalence of ZIKV RNA persistence of 5% after 12 months, and a two-sided 99% confidence interval width of 10% (or margin of error (ME) of ±5%), a sample size of 125 ZIKV positive pregnant women and congenitally-infected infants will be needed. Table B.1.1 shows different scenarios of potential sample sizes that were considered for the study.
Figure B.1.1. Sample Size calculations for different proportions of pregnant women with prolonged detection of ZIKV RNA within a finite population in Puerto Rico, 2017
|
Estimated Proportion of Pregnant Women with Persistent Detection of Zika Virus (ZIKV)RNA |
||||
Confidence Level (%) |
3% |
5% |
15% |
30% |
45% |
95% |
45 |
73 |
193 |
313 |
367 |
80% |
20 |
32 |
84 |
137 |
161 |
90% |
32 |
52 |
137 |
223 |
261 |
97% |
55 |
89 |
235 |
381 |
446 |
99% |
77 |
125 |
328 |
528 |
617 |
99,90% |
125 |
202 |
524 |
834 |
969 |
99,99% |
174 |
280 |
717 |
1129 |
1304 |
The sample size is tentatively estimated, given that there is little information on prevalence of ZIKV RNA persistence rates available in literature. The final sample size of 150 ZIKV positive pregnant women and their congenitally exposed infants is estimated for evaluation of the primary objectives of the study
B.2. Procedures for the Collection of Information
Pregnant women of any gestational age at the time of ZIKV diagnosis and their infants will be invited to participate. The Pregnant Women Screening Form (Att C.1) will be administered to potential participants by trained ZIRP research staff, and will be used to confirm participant eligibility prior to consent.
The pregnant woman will consent for her participation. Following consent, information will be collected at baseline regarding demographics and risk factors for ZIKV through the Pregnant Woman Enrollment Questionnaire (Att C.2) and a Pregnant Woman Symptom Questionnaire (Att C.3). Pregnant women will then be serially tested for ZIKV RNA in blood (7.5mL) and/or urine samples by rRT-PCR and ZIKV Immunoglobulin M (IgM) every two weeks . The blood samples will consist of one venous blood collection (via venipuncture) every two weeks and a one-time collection of capillary blood (via finger prick) at enrollment. If these visits do not coincide with a typical prenatal care visit, they will be asked to come in for a laboratory-only visit to obtain samples and to complete the Pregnant Woman Follow-up questionnaire (Att C.4).
Samples will be collected every two weeks until blood and urine samples are all rRT-PCR-negative on two subsequent collection dates to confirm negative results. Once a woman tests rRT-PCR negative on two subsequent collection dates, she will be tested monthly for ZIKV through 1 month post-delivery. All women will continue to have study visits through 3 months post-delivery.
Infants born to women enrolled in the pregnancy cohort will be enrolled when the pregnant woman and the infant’s father sign the infant informed consent form. At birth, the study staff will collect infant information on the Infant enrollment and delivery questionnaire (Att C.5), this information will be related to demographics, vital signs, delivery and abnormalities, laboratory sample collection and imaging. Infants will be tested every month after birth until blood and/or urine samples are all rRT-PCR-negative on two subsequent collection dates to confirm negative results. Infants who test rRT-PCR- negative on two subsequent collection dates will continue to have monthly study visits in which only study forms will be completed until six months of age. Infants who are born PCR-negative will have a confirmatory test at month 1 to ensure they continue to be negative and will complete the Infant follow-up questionnaire (Att C.6),.
B.3. Methods to Maximize Response Rates and Deal with Non-response
Efforts will be made to maximize the response rate. Pregnant women will be encouraged to complete the study throughout the pregnancy up until 3 months post-delivery and their infants up to 6 months of age. To encourage study participation, after being provided with information about the study, potential participants will be given a phone number to call if they have questions about the study. In addition, once a participant is enrolled, study staff will follow-up with participants if a study visit is missed.
There are also a number of ancillary benefits to study participation that are expected to increase participation rates. As a part of this study, participants will have some tests and procedures performed that are not usually available in the standard prenatal care, including serial Zika testing, blood, and urine diagnostic testing. All of these tests and procedures will be paid for by the study as they are not part of the routine clinical care. Participants will also be given any new information gained during the course of the study that might increase their willingness to continue with the study.
Pregnant women and parent(s) may incur extra financial and other costs to participate, as the study will require time for extra clinic and laboratory visits, transportation costs, and the extra time needed to make these visits. To help cover these costs, we plan to offer a $25 gift card for each clinic visit and a $25 gift card for each laboratory visit. Infants will receive a $25 gift card for each clinic visit. These may be given to the participants in the form of cash or transportation tickets to appreciate for their participation.
We anticipate being able to assess non-response bias by examining participation rates. In addition, some information on non-responders may be available from clinics so that we will be able to assess factors associated with non-response.
B.4. Tests of Procedures or Methods to be Undertaken
All data collection instruments were reviewed by medical personnel, laboratorians, epidemiologists and subject matter experts for question working and appropriate and adequate response options.
B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
Data collection instruments were reviewed by medical personnel, laboratorians, epidemiologists and subject matter experts. These included individuals from the CDC Zika Virus Response Team, Pregnancy and Birth Defects Task Force (Margaret Honein, PhD; Sascha Ellington, MSPH; Cristina Valencia, MPH, MSc, EPIET; Abbey Jones, MPH; Carrie Shapiro, PhD, MPH; Dana Meaney-Delman, MD,MPH ), CDC Dengue Branch, Puerto Rico (Jennifer Reed, MD; Jorge Munoz, MD; Janice Perez-Padilla, RN, MPH; Steve Waterman, PhD), University of Puerto Rico (Carmen Zorilla, MD; Alberto de la Vega, MD; Ines Garcia, MD; Juana Rivera, MD) and Puerto Rico Department of Health (Carmen Deseda, MD)
ZIRP Puerto Rico Study designed by:
Pregnancy and Birth Defects Task Force
CDC Zika Virus Response Team
U.S. Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Atlanta, GA 30303
Tel: 770-488-7100
Project Officer: Margaret Honein
E-mail: mrh7@cdc.gov
Puerto Rico Department of Health (PRDH)
Calle Teniente Cesar Luis Gonzalez, 1111
San Juan, Puerto Rico 00927
Tel: (1) 787-765-2929
University of Puerto Rico (UPR)
1187 Calle Flamboyán
San Juan PR 00926-1117
Tel: (1) 787-250-0000
Data collected from 2017-2018 by:
Pregnancy and Birth Defects Task Force
CDC Zika Virus Response Team
U.S. Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Atlanta, GA 30303
Tel: 770-488-7100
Project Officer: Margaret Honein
E-mail: mrh7@cdc.gov
Puerto Rico Department of Health (PRDH)
Calle Teniente Cesar Luis Gonzalez, 1111
San Juan, Puerto Rico 00927
Tel: (1) 787-765-2929
University of Puerto Rico (UPR)
1187 Calle Flamboyán
San Juan PR 00926-1117
Tel: (1) 787-250-0000
Data analyzed by:
Pregnancy and Birth Defects Task Force
CDC Zika Virus Response Team
U.S. Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Atlanta, GA 30303
Tel: 770-488-7100
Project Officer: Margaret Honein
E-mail: mrh7@cdc.gov
Puerto Rico Department of Health (PRDH)
Calle Teniente Cesar Luis Gonzalez, 1111
San Juan, Puerto Rico 00927
Tel: (1) 787-765-2929
University of Puerto Rico (UPR)
1187 Calle Flamboyán
San Juan PR 00926-1117
Tel: (1) 787-250-0000
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Valencia, Cristina (CDC/ONDIEH/NCBDDD) (CTR) |
| File Modified | 0000-00-00 |
| File Created | 2021-01-21 |