Baseline and Follow-Up Questionnaire - English 29SEP2016

Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)

Att H - Baseline and follow-up questionnaire

Baseline and Follow-Up Questionnaire - Symptomatic

OMB: 0920-1140

Document [docx]
Download: docx | pdf

Form Approved

OMB Control No. 0920-XXXX

Exp. Date: XX/XX/XXXX

Attachment H. Baseline and follow-up questionnaires


#

Question

Options

Skip

Section A. Visit information

Interviewer: Answer A1-A4. Do not read.

A1

ZIP#

_ _ _ _ - _ _


A2

Date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa


A3

Visit code

V01 V02 V03 V04

S06 M02 S10 S12

S14 M04 S18 S20

S22 S24 M06

If (A3 ne V01) skip to B2. If A3=V01, continue to A4a.

A4

Interviewer: do not read question answer it yourself.


Is this a household contact?

0, No

1, Yes

If no(0), skip to A6. If yes (1), continue to A4a.

Household contacts

INTERVIEWER: If household contact ask A4a. Other go to A5.

A5

What is your relationship with the person who gave you a coupon?

1, Sexual partner.

2, Parent.

3, Son/daughter.

4, Sibiling

5, Grandmother/grandfather

6, Other.

7, Someone who lives with me but we are not family.


99, Do not know

77, Refused ot answer

If 1, continue to A5a. Else, skip to A6.

A5a

¿Have you had sex with this person in the last 30 days?

0, No

1, Yes

99, Do not know

77, Refused ot answer


INTERVIEWER: If V01 continue to A6. Other, go to B2.


Participant information

A6

Age

INTERVIEWER: If age <1 years enter “0”.


___ [0-100]



A7

What is your date of birth?

_ _ / _ _ / _ _ _ _

dd/mm/aaaa


A8

What is your sex?

1, Male

2, Female

99, Do not know

77, Refused ot answer

If male (1) or <14, skip to A9. Else, continue to A8a.









A9

Have you visited the United States or another country in the last 30 days?

0, No

1, Yes

99, Do not know

77, Refused ot answer

If yes (1), continue to A9a. Else, skip to B1.

A9a

City

______________




A9b

Country

______________




A9c

Start Date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



A9d

End date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



A10

2º city

_______________

If 2nd city, continue to A10a. Else, skip to B1.

A10a

2º country

_______________


A10b

2º Start Date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



A10c

2º End date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



A11

3ª city

_______________

If 3rd city, continue to A11a. Else, skip to B1.

A11a

3ª country

_______________


A11b

3ª Start Date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



A11c

3ª End date

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



Section B. Clinical Information

B1

Since November 2015 have you had any of the following? Rash, fever, arthralgia and conjunctivitis


INTERVIEWER: Read all the options, except 99 and 77

0, No

1, Yes


99, Do not know

77, Refused ot answer

If B1=0 (no) and A2=V01, skip to C1. If B1=0 (no) and A2 not V01, end survey. Else, continue to B2.

B2

Do you have any of these symptoms now?:

0, No

1, Yes


99, Do not know

77, Refused ot answer

If (A2 ne V01 or B1=0) and B2=0, skip to D4. Else, continue to B3.

B3

Which was your first symptom?


INTERVIEWER: Read all the options, except 99 and 77

1, Fever

2, Rash

3, Arthralgia

4, Conjuntivitis

5, Other

99, Do not know

77, Refused ot answer


B3a

Date you had the first symptom

_ _ / _ _ / _ _ _ _

dd/mm/aaaa



INTERVIEWER:

READ: “Now I'll ask you about a list of symptoms. Tell me if you have had these symptoms since his illness began on the date he gave me. If you have any of these symptoms, I will ask for how many days you have had the symptom.”

B4

Fever


0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B5. Else, continue to B4a.

B4a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B5

Rash

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B6. Else, continue to B5a.

B5a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B5b

Type


INTERVIEWER: Do not read choices. Show flashcard B5 and enter the number with the corresponding picture.

1, Maculopapular

2, Petequial

3, Purpura

4, Other

If other (4), continue to B5c. Else, skip to B6.

B5c

Other rash description:

______________



B6

Eye pain

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B7. Else, continue to B6a.

B6a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B7

Cough

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B8. Else, continue to B7a.

B7a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B8

Red eye

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B9. Else, continue to B8a.

B8a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B9

Headache

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B10. Else, continue to B9a.

B9a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B10

Intolerance to light

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B11. Else, continue to B10a.

B10a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B11

Yellow eyes or skin

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B12. Else, continue to B11a.

B11a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B12

Enlarged lymph nodes

INTERVIEWER: Flashcard GANGLIOS.


0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B13. Else, continue to B12a.

B12a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B13

Diarrhea

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B14. Else, continue to B13a.

B13a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B14

Nausea

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B15. Else, continue to B14a.

B14a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B15

Vomiting

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B16. Else, continue to B15a.

B15a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B16

Itching

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B17. Else, continue to B16a.

B16a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B17

Swelling

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B18. Else, continue to B17a.

B17a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B18

Dolor o ardor al orinar

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B19. Else, continue to B18a.

B18a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B19

Pain/burning with urination

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B20. Else, continue to B19a.

B19a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B20

Pelvic or groin pain

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B21. Else, continue to B20a.

B20a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B21

Abdomen/lower back pain

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B22. Else, continue to B21a.

B21a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B22

Blood in urine

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B23. Else, continue to B22a.

B22a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B23

Blood in stool

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0) AND age ≥13 (A6 ≥13) AND male (A8=1), skip to B24.

If Yes(1), continue to B23a.

Else, skip to B27.

B23a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)

If no (0) AND age ≥13 (A6 ≥13) AND male (A8=1), continue to B24.

Else, skip to B27.

B24

Painful ejaculation

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B25. Else, continue to B24a.

B24a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B25

Penile discharge

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B26. Else, continue to B25a.

B25a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B26

Blood in semen

0, No

1, Yes

99, Do not know

77, Refused ot answer

If no (0), skip to B27. Else, continue to B26a.

B26a

Duration in days

INTERVIEWER: if symptom started the day of the interview, enter “0”.

__ (0-100)


B27

Other

INTERVIEWER: write in any other symptoms

_______________________



INTERVIEWER: If V01 (baseline) continue a C1. Other go to D1.


Section C. Demographics and household

C1

What is your current marital status? Choose one.

INTERVIEWER: Read all the options, except 99 and 77

1, N/A (e.g. child)

2, Married

3, Living together as married

4, Separated

5, Divorced

6, Widowed

7, Never married


99, Do not know

77, Refused ot answer


C2

What is the highest level of education you completed?


INTERVIEWER: Read all the options, except 99 and 77

1, No school

2, Grades 1 through 8

3, Grades 9 through 11

4, Grade 12 or GED

5, Some college, Associate’s or 6, Technical Degree

7, Bachelor’s Degree

8, Any post graduate studies

99, Do not know

77, Refused ot answer


C3

What best describes your employment status? Are you:


INTERVIEWER: Read all the options, except 99 and 77

0, N/A

1, Child

2, Employed full-time

3, Employed part-time

4, A homemaker

5, A full-time student

6, Retired

7, Unable to work for health reasons

8. Unemployed

9. Other


99, Do not know

77, Refused ot answer


C4

How much time during the day do you spend outdoors?


INTERVIEWER: Read all the options, except 99 and 77

0, Very Little to none

1, Many hours

2, All day


99, Do not know

77, Refused ot answer

If contact (A4=1), skip to C7. Else, continue to C5.

C5

What was your household income last year from all sources before taxes?


INTERVIEWER: Use flashcard.


1, $0 a $9,999

2, $10,000 a $19,999

3, $20,000 a $29,999

4, $30,000 a $39,999

5, $40,000 a $49,999

6, $50,000 a $59,999

7, $60,000 a $79,999

8, $80,000 o más


99, Do not know

77, Refused ot answer


C6

How many people live in your household, including yourself? Household means all of the people that you live with.

__


C7

Do you currently have health insurance or health care coverage?

Do you currently have health insurance or health care coverage?

If contact (A4=1), skip to C12. Else, continue to C8.

C8

How many of the windows in your house have intact screens?

INTERVIEWER: Read all the options, except 99 and 77

1, Ninguna

2, Algunas

3, Todas


99, Do not know

77, Refused ot answer


C9

Do you use air conditioning in your home?

INTERVIEWER: Read all the options, except 99 and 77

0, No

1, Yes, in all the rooms

2, Yes, only in the bedrooms


99, Do not know

77, Refused ot answer


C10

How often do you leave your doors or windows open?

INTERVIEWER: Read all the options, except 99 and 77

  1. Never

  2. Daytime only

  3. Night-time only

  4. Always

  5. Other

99, Do not know

77, Refused ot answer


C11

In the past 30 days, have you used mosquito coils (e.g., Cobra, espiral, caracol) OR natural repellents in your house or patio to keep mosquitoes away?


0, No

1, Sí

99, Do not know

77, Refused ot answer


C12

In the past 30 days, how often have you used mosquito repellent?


0, Never

1, Every now and then

2, A few times a week

3, Daily

4, Always


99, Do not know

77, Refused ot answer


Sección D. Adults and emancipated minors

INTERVIEWER: If adult or emancipated minor continue a D4.

Other end the interview.

I will ask you some questions about sexual and injection risk, you may refuse to answer any question.

D4

In the past 7 days, with how many different persons have you had oral, vaginal or anal sex?

____ [0-1000]

If 0 and male, skip to D7. Else, skip to D8.

D5

In the past 7 days, how many times have you had vaginal or anal sex?

____ [0-1000]

If 0 and male, skip to D7. Else, skip to D8.

D6

Of the [fill with “# of times engaged in sex” (q14)] times you had anal or vaginal sex, how many times did you or your partner use a condom?

____ [0-1000]

Continue to D6a.

D6a

In the past 7 days, how many times have you had oral sex without using a condom?

____ [0-1000]

If male, continue to D7. Else, skip to D8.

D7

For men only: In the past 7 days how many times have you ejaculated (had an orgasm) during sex or masturbation?

____ [0-1000]


D8

Have you ever in your life shot up or injected any drugs other than those prescribed for you? By shooting up, I mean anytime you might have used drugs with a needle, either by mainlining, skin popping, or muscling.

0, No

1, Yes

99, Do not know

77, Refused ot answer

If yes (1), continue to D9. Else, end survey.

D9

When was the last time you injected any drug? That is, how many days or months or years ago did you last inject?

[Interviewer: Enter the number below. If today, enter "000" ]

0, Today

1, Last week

2, Last month

3, Last 6 months

4, Last year

5, More tan a year ago

99, Do not know

77, Refused ot answer


END OF SURVEY

INTERVIEWER: Thanks for your time we have finished the interview.

NOTAS



















ZIPER Pregnancy Questions

V01 Pregnancy Section

For all adult women and emancipated female minors, go to pregnancy section after last question in core survey.

#

Question

Choices

Skip

P1

Have you been pregnant since November 2015? This includes if you are currently pregnant, any live births, still births, miscarriage, fetal death, tubal pregnancies, and induced abortions.


Miscarriage: refers to a pregnancy that terminates naturally during the first 5 months (20 weeks) of pregnancy.

Stillbirth: Refers to a baby that is born dead after 6 or more months (>20 weeks).

Tubal pregnancy: Refers to a pregnancy that occurs in the fallopian tube.

Induced abortion: Refers to a pregnancy that is terminated during the first 6 months using induced methods.

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If NO (0), END SECTION.

Else, continue to P2.

P2

Are you pregnant right now?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If NO, DON’T KNOW, or REFUSE (0, 77, 99), SKIP to P7.

Else, continue to P3.

Currently pregnant only



P3

What was the first day of your last menstrual period?


DATE

Don’t know 77

Refuse to answer 99


P4

How many weeks pregnant are you?

NUMBER

Don’t know 77

Refuse to answer 99


P5

Doctor’s information

Name, office, phone number

Name:

Office:

Tel:

Any other notes:


P5

Have you been pregnant any other time since November 2015?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If NO, DON’T KNOW, or REFUSE (0,77,99), END pregnancy section.


If YES (1), continue to P7.

Ever pregnant



P7

How many times have you been pregnant since November 2015? (If you are currently pregnant, do not include now.)

NUMBER

Don’t know 77

Refuse to answer 99

If 0, check skip pattern and confirm.

If 1, continue.

If >1, say, “I am going to ask you about each pregnancy since November. The first time I ask you these questions, please answer based on the first time you were pregnant in that period. The second time, please answer based on the second time you were pregnant in that period. [Add third, fourth, etc. as needed.]”


INTERVIEWER: Repeat “past pregnancy” the number of times.

Past pregnancy

INTERVIEWER: If you are repeating this section, say, “Now we are going to talk about the first (second, third, fourth, etc.) time you were pregnant between November 2015 and now.”

P8

What was the outcome of the pregnancy?


Miscarriage: refers to a pregnancy that terminates naturally during the first 5 months (20 weeks) of pregnancy.

Stillbirth: Refers to a baby that is born dead after 6 or more months (>20 weeks).

Tubal pregnancy: Refers to a pregnancy that occurs in the fallopian tube.

Induced abortion: Refers to a pregnancy that is terminated during the first 6 months using induced methods.

Live birth 1

Still birth, miscarriage, or fetal death (baby died before being born) 2

Ectopic / tubal 3

Induced abortion 4

Other (describe) 5

Don’t know 77

Refuse to answer 99

If 1, skip to P11.

If 2, “I am so sorry for your loss.” Skip to P10.

If 3 or 4, skip to P10.

If 5, continue to P9.

P9

Other (describe)



P10

How long did that pregnancy last?


__ __ number of weeks

Don’t know 77

Refuse to answer 99

If repeat, go back to P8.

Else, end survey.

P11

Are you lactating?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If yes (1), participant will be asked to give breastmilk.


P12

Are you currently breastfeeding?

No 0

Yes 1

Don’t know 77

Refuse to answer 99



END SECTION

Thank you for your time.




Follow-up visits

Follow-up Pregnancy Section

For all adult women and emancipated female minors, go to pregnancy section after last question in core survey.

#

Question

Choices

Skip

PF1

Were you pregnant at our last visit?



No 0

Yes 1

Don’t know 77

Refuse to answer 99


PF2

Are you pregnant right now?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If PF1 = YES (1) and PF2 = YES (1), END SECTION.

If PF1 = YES (1) and PF2 = NO (1), skip to ## (Outcomes).

If PF1 = NO (0) and PF2 = YES (1), skip to PF4 (New pregnancy).

IF PF1 = NO (0) and PF2 = NO (0), continue to PF3.

PF3

Were you pregnant between our last visit and now?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If YES (1), skip to ## (Outcomes).

Else, END SECTION.

New pregnancy only



PF4

What was the first day of your last menstrual period?


DATE

Don’t know 77

Refuse to answer 99


PF5

How many weeks pregnant are you?

NUMBER

Don’t know 77

Refuse to answer 99


PF6

Doctor’s information

Name, office, phone number

Name:

Office:

Tel:

Any other notes:

END SECTION.

Outcomes



PF7

What was the outcome of the pregnancy?


Live birth 1

Still birth, miscarriage, or fetal death (baby died before being born) 2

Ectopic / tubal 3

Induced abortion 4

Other (describe) 5

Don’t know 77

Refuse to answer 99

If LIVE BIRTH (1), skip to PF10.

If 2, “I am so sorry for your loss.” Skip to PF9.

If 3 or 4, skip to PF9.

If 5, continue to PF8.

PF8

Other (describe)





END SECTION.

Thank you for your time.

PF9

How long did that pregnancy last?


Less than 20 weeks (less than 4 months) 1

20 to 28 weeks (4 to 6 months) 2

More than 28 weeks (more than 6 months) 3

Don’t know 77

Refuse to answer 99

END SECTION.

Thank you for your time.

PF10

Are you lactating?

No 0

Yes 1

Don’t know 77

Refuse to answer 99

If yes (1), participant will be asked to give breastmilk.


PF11

Are you currently breastfeeding?

No 0

Yes 1

Don’t know 77

Refuse to answer 99



END SECTION

Thank you for your time.





Shape1

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA 0920-XXXX



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