Non-Substantive Change Request to OMB Control No. 0920-1118:
Emergency Zika Package V: Assessment of Interventions Intended to
Protect Pregnant Women in Puerto Rico from Zika virus Infections
CDC
requests approval for a non-substantive change to OMB Control No.
0920-1118: Emergency Zika Package V: Assessment of Interventions
Intended to Protect Pregnant Women in Puerto Rico from Zika virus
Infections
These
changes are being made to improve comprehension of questions and flow
of the interview. The project protocol has not changed. IRB review is
not required.
Estimates
of annualized burden hours for this change request remain the same.
The burden estimate for the forms included in OMB Control No.
0920-1118 is 892 hours for the overall assessment, 67 hours of which
are estimated for the Case-Control Interview section (Project 2).
Changes
to the questionnaire were based on pilot testing and a change in the
expected data available from the dataset (we were unable to access
the dataset until after IRB and OMB clearance had occurred). We
adjusted the questionnaire to adapt to missing data.
Below
we describe changes to the questionnaire and provide the rationale
for changes. Additionally, a table is provided which shows the old
version of questions side by side with the new version.
Current Question
|
Requested Changes - 1/23/21
|
Would you be willing to
talk with me for a few minutes (less than 20 minutes) about your
experience and the types of Zika prevention services you received
in the past few months? It will help us know how we can do a
better job of helping you and other pregnant women in Puerto Rico.
No
Yes, [If
yes, are you over 18 years of age]
|
Would you be willing to
talk with me for a few minutes (less than 25 minutes) about your
experience and the types of Zika prevention services you received
in the past few months? Everything we discuss will be kept
confidential. It will help us know how we can do a better job of
helping you and other pregnant women in Puerto Rico.
No
– thank you for your time! Have a nice day. [End interview]
Yes, [If
yes, are you over 18 years of age]
|
Your doctor reported that
you had blood drawn for a Zika test on <specimen collection
date>. Is that correct?
No
Yes –
continue
|
Your doctor reported that
you had blood drawn for a Zika test on <specimen collection
date>. Is that correct?
No
[Stop the interview]
Yes
– continue
|
I also see here that you
received information or materials about Zika Prevention Kit from
WIC on <ZPK receipt date>. Is that correct?
No or if unsure what ZPKs
are: The Zika Prevention Kit is a tote bag that contains
educational information from the Puerto Rico Health Department and
the Centers for Disease Control and Prevention about how to
prevent Zika infection while you are pregnant along with items
that could help prevent Zika virus infection. Items in the kit
include: a mosquito bed net, mosquito repellent, condoms, and
some include mosquito dunks (larvicide) and thermometers.
Do you remember
receiving anything like that?
No – stop interview
Yes – Great!
|
First, I’d like to
ask you questions about materials or supplies you might have
received from the WIC program.
1. Have
you heard of Zika Prevention Kits?
☐ Yes
continue to question 2 (ZPK receipt)
☐ No
No
or if unsure what ZPKs are: The Zika Prevention Kit is a tote bag
that contains educational information from the Puerto Rico Health
Department and the Centers for Disease Control and Prevention
about how to prevent Zika infection while you are pregnant along
with items that could help prevent Zika virus infection. Items in
the kit include: a mosquito bed net, mosquito repellent, condoms,
and some include mosquito dunks (larvicide) and thermometers.
2. Have
you received a Zika Prevention Kit?
☐ No
– skip to Q11 (Did you attend an educational session about
Zika?)
☐ Yes
What
day did you receive the ZPK?
Date:
__________________
|
4. Did you open your Zika
Prevention Kit?
Yes
a. What
did the information in the kit say you need to do? (Probe for use
repellents, use bed net, use condoms, etc.)
a. Use
insect repellant
b. Sleep
under bed net
c. Put
mosquito dunks in standing water
d. Use
condoms/don’t have unprotected sex
e. Go
to doctor if ill
f. Other,
please specify: ________________________
b. What
items were included in the kit? (Do not read, tick all mentioned)
Repellent
Bed
net
Mosquito
dunks
Condom(s)
Thermometer
Educational
materials
Other,
please specify:
No,
why not?
Refused
|
4. Did you open your Zika
Prevention Kit?
☐ No
(skip to Q7, educational session)
Why
not? _______________________________________________________
☐ Refused
☐ Yes
5. What
did the information in the kit say you need to do? (Probe for use
repellents, use bed net, use condoms, etc.) [Don’t read
options – wait for response]
☐ Use
insect repellant
☐ Sleep
under bed net
☐ Put
mosquito dunks in standing water
☐ Use
condoms/don’t have unprotected sex
☐ Go
to doctor if ill
☐ Other,
please specify: ________________________
6. What
items were included in the kit? (Do not read, tick all mentioned)
☐ Repellent
☐ Bed
net
☐ Mosquito
dunks
☐ Condom(s)
☐ Thermometer
☐ Educational
materials
☐ Other,
please specify: _____________________________________
|
Now, I’m going to ask
more questions about your use of these items AFTER receiving the
kit, but before you got blood drawn for the Zika test. For most
of the questions, I’ll be asking from now on, think about
what you did in that period of time.
|
Now, I’m going to ask
more questions about your activities in the 3 months before you
got blood drawn for the Zika test. It might be helpful to look at
a calendar to help remember this time period. For most of the
questions, I’ll be asking from now on, think about what you
did in that period of time.
|
6. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, how often did you put mosquito repellent
on skin that was not covered by clothing?
Never
or almost never
Seldom
or rarely
Sometimes
Often
Usually
or most of the time
Always
or almost always
Refused
If
yes to any repellant use: Did you use the repellant from the ZPK?
Yes
No
Refused
|
12. During the time three
months before you had blood drawn for the Zika test, how often did
you put mosquito repellent on skin that was not covered by
clothing?
Never
or almost never
Seldom
or rarely
Sometimes
Often
Usually
or most of the time
Always
or almost always
Refused
12a.
If yes to any repellant use and received ZPK: Did you use the
repellant from the ZPK?
Yes
No
Refused
|
7. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, how often did you wear long pants?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
|
13. During that same time,
how often did you wear long pants?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
|
8. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, how often did you wear a long-sleeved
shirt?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
|
During
that same time, how often did you wear a long-sleeved shirt?
Never
or almost never
Seldom
or rarely
Sometimes
Often
Usually
or most of the time
Always
or almost always
Refused
|
9. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, how often did you or somebody else in
your household remove accumulated water and cover up or screen
water containers inside and around your home (on your property)?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
|
15. During that same time,
how often did you or somebody else in your household remove
accumulated water and cover up or screen water containers inside
and around your home (on your property)?
o. Never
or almost never
p. Seldom
or rarely
q. Sometimes
r. Often
s. Usually
or most of the time
t. Always
or almost always
u. Refused
|
10. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did you ever put a mosquito dunk, or
larvicide, in accumulated water around your home?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
If
yes, did you use the mosquito dunk from the Zika Prevention Kit?
Yes
No
Refused
|
16. During that same time,
did you ever put a mosquito dunk, or larvicide, in accumulated
water around your home?
v. Never
or almost never
w. Seldom
or rarely
x. Sometimes
y. Often
z. Usually
or most of the time
aa. Always
or almost always
bb. Refused
16a.
If yes and received ZPK, did you use the mosquito dunk from the
Zika Prevention Kit?
Yes
No
Refused
|
11. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did you usually sleep under a mosquito
net when you slept or took a nap?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
If
yes, did you use the mosquito net from the Zika Prevention Kit?
Yes
No
Refused
|
17. During that same time,
did you usually sleep under a mosquito net when you slept or took
a nap?
a. Never
or almost never
b. Seldom
or rarely
c. Sometimes
d. Often
e. Usually
or most of the time
f. Always
or almost always
g. Refused
17a.
If yes and received ZPK, did you use the mosquito net from the
Zika Prevention Kit?
Yes
No
Refused
|
The next questions are
about sexual relations with your husband or male partner.
|
The next questions are
about sexual relations with your husband or male partner. Again,
everything we discuss will be confidential.
|
12. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did you have sexual intercourse [that is,
vaginal, anal, or oral (mouth-to-penis) sex] with your male
partner?
No,
After
recording response, go to question 15
Yes
Prefer
not to answer
|
18. During the three months
before you had blood drawn for the Zika test, did you have sexual
intercourse [that is, vaginal, anal, or oral (mouth-to-penis) sex]
with your male partner?
No,
After
recording response, go to question 21
Yes
Prefer
not to answer
|
13. When you had sex during
the time between when you received the Zika prevention kit and
when you had blood drawn for the Zika test, how often did you use
a condom?
Every
time I had sex Go to question 14
Sometimes
when I had sex Go to question 14
I
never used a condom when I had sex Go to question 15
Prefer
not to answer
|
19. When you had sex during
that same time, how often did you use a condom?
Every
time I had sex Go to question 22
Sometimes
when I had sex Go to question 22
I
never used a condom when I had sex Go to question 23
Prefer
not to answer
|
14. Did you use condoms
from the Zika Prevention Kit?
Yes
No
Refused
|
20. If used condoms and
received ZPK, Did you use condoms from the Zika Prevention Kit?
Yes
No
Refused
|
15. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did you use up any of the items that were
included in the Zika prevention kit? (or have you needed to
replace any items that came in the kit?) Which items?
Yes,
which items
Repellent
Condoms
Mosquito
dunks (or other larvicide)
Mosquito
bed net
No
Don’t
know/not sure
Refused
|
7. Did you use up any of
the items that were included in the Zika prevention kit? Which
items?
Yes,
which items
Repellent
Condoms
Mosquito
dunks (or other larvicide)
Mosquito
bed net
No
– skip to Q9
Don’t
know/not sure
Refused
|
16. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did you purchase any items to replace the
items in the kit that you used up (or needed to replace)?
Yes,
which items
Repellent
Condoms
Mosquito
dunks (or other larvicide)
Mosquito
bed net
No,
why not?
Do
not have money to buy
Items
are too expensive (too costly)
Am
embarrassed to buy (e.g., condoms)
Do
not feel I need them (they don’t offer protection)
Other,
please specify:
Don’t
know/not sure
Refused
|
8. Did you purchase any
items to replace the items in the kit that you used up (or needed
to replace)?
Yes,
which items
Repellent
Condoms
Mosquito
dunks (or other larvicide)
Mosquito
bed net
No,
why not?
Do
not have money to buy
Items
are too expensive (too costly)
Am
embarrassed to buy (e.g., condoms)
Do
not feel I need them (they don’t offer protection)
Other,
please specify:_____________
Don’t
know/not sure
Refused
|
17. Is there anything that
we haven’t discussed that you have been doing to reduce the
risk of mosquito bites to avoid getting Zika virus during the time
between when you received the Zika prevention kit and when you had
blood drawn for the Zika test?
No
Yes,
What?
Staying
indoors
I
moved to/spend more time in another location with fewer
mosquitoes, or better housing
I
have sprayed my house with pesticide by myself or my family
I
have had a business come spray my house
Burn
mosquito coils
Use
mosquito zapper rackets
Other,
please specify:
Refused
|
21. Is there anything that
we haven’t discussed that you have been doing to reduce the
risk of mosquito bites to avoid getting Zika virus during the
three months before you had blood drawn for the Zika test?
No
Yes,
What?
Staying
indoors
I
moved to/spend more time in another location with fewer
mosquitoes, or better housing
I
have sprayed my house with pesticide by myself or my family
I
have had a business come spray my house
Burn
mosquito coils
Use
mosquito zapper rackets
Other,
please specify:
Refused
|
20. Did you receive
spraying services at your home? (or has your home been sprayed
already?)
Yes
When
did the spraying services occur? Did they occur…
Before
you received a Zika Prevention Kit?
After
you received a Zika Prevention Kit but before you got your blood
drawn?
After
you received a Zika Prevention Kit AND after you got your blood
drawn?
No
Don’t
know/not sure
Refused
|
23. Did you receive
spraying services at your home? (or has your home been sprayed
already?)
Yes
When
did the spraying services occur?
Date:
________________________
No
Don’t
know/not sure
Refused
|
Questions about mosquitoes
in their environment (environmental stimuli)
For all
the questions I’m about to ask, try to think about the time
from when you received the Zika Prevention Kit to when you had
blood drawn.
|
Questions about mosquitoes
in their environment (environmental stimuli)
For
all the questions I’m about to ask, try to think about the
three months before you had blood drawn.
|
27. Do you currently rent
or own your home?
Own
Rent
Occupy
without paying rent (live with family or friend)
Live
in public housing
Other,
please specify:
Refused
|
26. In those three months,
did you rent or own your home?
Own
Rent
Occupy
without paying rent (live with family or friend)
Live
in public housing
Other,
please specify:
Refused
|
34. During the time between
when you received the Zika prevention kit and when you had blood
drawn for the Zika test, did any members of your household have an
illness with rash, fever, or body pain?
No
Yes
How
many people were ill? ___________________
Did
this include your sex partner or husband? _______________________
Were
they tested for Zika?
No
Don’t
know/not sure
Refused
Yes
Did
a healthcare provider tell them they had Zika?
Yes
No
Don’t
know/not sure
Refused
|
37. During the three months
before you had blood drawn for the Zika test, did any members of
your household have an illness with rash, fever, or body pain?
No
[Skip to question 38]
Yes
How
many people were ill? ___________________
Did
this include your sex partner or husband? _______________________
Were
they tested for Zika?
No
Don’t
know/not sure
Refused
Yes
Did
a healthcare provider tell them they had Zika?
Yes
No
Don’t
know/not sure
Refused
|
Estimates
of annualized burden hours for this change request remain the same.
The burden estimate for the forms included in OMB Control No.
0920-1118 is 892 hours for the overall assessment, 67 hours of which
are estimated for the Case-Control Interview section (Project 2).