Survivor Questionnaire - Pilot/A/B

Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease Survivors in Sierra Leone

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FEMALE Participants Survivor Questionnaire - Module B

OMB: 0920-1064

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A5 Page 23 - Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease Survivors



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Form Approved

OMB No. 0920-XXXX

Exp. Date xx/xx/xxxx

Attachment 5 Survivor Questionnaire (Initial Study Visit and Follow-up) Questionnaire for the initial study visit: Pilot and Combined Module A/B


[COMPLETE THIS PAGE AT STUDY ENROLLMENT AFTER INFORMED CONSENT]


A1. Participant’s unique study ID number: ____________________


A2. Study enrollment date: _____________________


A3. Participant’s sex (male or female): _____________________


A4. Participant’s age at study enrollment (in years): _____________________


A5. Participant’s home residency (village/district/subcounty): _____________________


A6. Participant’s contact information (address/es): ______________________________________________________


A7. Participant’s contact information (telephone/s): ________________________________________


A8. Participant’s contact information (email/s): _____________________________________________


A9. Participant’s contact information (other): _____________________________________________



[CONFIRM THESE DETAILS USING ETU DISCHARGE CERTIFICATE, IF POSSIBLE]


A10. Name/clinical ID of ETU where participant was treated for EVD: _____________________


A11. Date of ETU admission: _____________________


A12. Date of ETU discharge: _____________________


A13. Date of 1st blood test positive for Ebola: _____________________


A14. Date of 1st blood test negative for Ebola: _____________________


A15. Date of 2nd blood test negative for Ebola: _____________________


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Public reporting burden of this collection of information is estimated to average 30 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 Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).


Inquire if the participant was part of a research study. For example, did they receive an experimental drug during their illness, such as ZMapp, did they receive convalescent plasma during their illness, did they receive a vaccine to prevent Ebola infections as part of the STRIVE trial, or did they give convalescent plasma after recovering from their illness.


A16. Was the participant included in a clinical trial related to his/her illness with Ebola Virus Disease?

____ No

____ Yes

____ Don’t know


A17. If yes, specify the name of the trial_____________


A18. If known, specify what intervention that he/she received___________


A19. Today’s date: ____________________


A20. Interviewer name/initials: _____________________


Thank you for participating in this study. I will be conducting your interview today, and it will last about 15 minutes. I ask all participants in this survey the same questions. All of your answers are confidential. I will mark a response to every question, but if you are not comfortable answering any question, you can tell me to mark “no answer.” You can also ask me to go back, or repeat any questions. Are you comfortable proceeding with the interview now?


First, I would like to ask you a few questions about yourself and your family.


B1.

How many years of school have you completed? Choose one.

___ Less than six years

___ Six to eight years

___ More than eight years

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


B2.

About how much money do you normally earn in a month? Fill in the blank.

Amount in Leones (SLL): __(will create categories)_________________

___ Don’t know/not sure

___ No answer


B3.

Who do you live with? Mark all that apply.

___ Alone

___ With friend/s or roommate/s

___ With spouse or partner

___ With parents or extended family member/s

___ Other (specify) ____________

___ Don’t know/not sure

___ No answer


B4.

How many people live in your household, including yourself?

___ Number


B5.

What is your current relationship status? Choose one.

___ Single

___ Long-term relationship

___ Married

___ Separated, Divorced, or Widowed

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer




To be asked of women only (questions B6, B7, and B8):

B6.

How many times have you been pregnant? Choose one.

___ I have never been pregnant

___ One time

___ Two times

___ Three times

___ More than three times (specify) _______________

___ Don’t know/not sure

___ No answer


B7.

Is there any chance you are pregnant today? Choose one.

___ No chance

___ Yes, I am pregnant, and my baby is due on (specify date) _______________

___ Don’t know/not sure

___ No answer


B8.

In the past 7 days, have you breastfed (provided your breast milk to any children, or allowed a child to suckle at your breast)? Choose one.

___ No

___ Yes

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer / prefer not to answer






For men and women:


B9.

Do you and your main sexual partner use any method of contraception to avoid pregnancy?

__Yes

__No

__No answer

__Don’t know

__Don’t remember

__No sexual partner


If answered yes to the previous question, which method/s are you using?

___ Condom

___ Pill/oral contraception

___ Intrauterine device

___ Injection/hormone shot

___ Other


Now I would like to ask some questions about the time when you were sick with Ebola.


C1.

What was the month and approximate day or date when you first began to feel sick from Ebola? It is ok to guess if you are not sure of the exact date.

___________


C2.

When you were sick with Ebola, did you have vomiting? Choose one.

___ No vomiting

___ Yes, I vomited

___ Don’t know/not sure

___ No answer


C3.

When you were sick with Ebola, did you have diarrhea? Choose one.

___ No diarrhea

___ Yes, I had diarrhea

___ Don’t know/not sure

___ No answer


C4.

When you were sick with Ebola, were you ever too sick to get up to relieve yourself in the toilet (or other usual location)? Choose one.

___ No

___ Yes

___ Don’t know/not sure

___ No answer


C5.

When you were sick with Ebola, were you ever too sick to drink anything for a day or more? Choose one.

___ No

___ Yes

___ Don’t know/not sure

___ No answer


C6.

Were you pregnant during your Ebola illness?

___ No / I am a man

___ Yes

___ Don’t know/not sure

___ No answer



C7.

If yes, did the baby live? Choose one.

___ I was not pregnant during my Ebola illness / I am a man

___ Yes, I am still pregnant now

___ Yes, the baby was born and is living now

___ No, the baby was born alive but died later

___ No, the baby was not born alive / miscarriage / stillbirth

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


C8.

Has anyone else in your family had Ebola?

___ No

___ Yes

___ Don’t know/not sure

___ No answer


If yes, how many of your family members had EBOLA,

____#Please specify their relationship to you

1.

2.

3.


Next I would like to ask about your health today.


D1.

How is your overall health and wellbeing now, compared to before you had Ebola?

___ My overall health now is back to normal or the same as before I had Ebola

___ My overall health now is worse than before I had Ebola

___ My overall health now is better than before I had Ebola

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D2.

Since you recovered from Ebola, do you have any new health problems?

___ No, not that I know of

___ Yes

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D3.

If answer yes to the above question, please specify

___ Eye/vision problems

___ Muscle pains

___ Joint pains

___ Weight loss

___ Feeling depressed (unable to concentrate, feeling very sad, poor appetite, other)

___ Sexual problems (specify) _______________

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer



D4 Since recovering from Ebola, do you have the same level of sexual desire as before you were sick?


___ No

___ Yes

___ Don’t know

___ No answer/prefer not to answer


For men only:



D5 Since recovering from Ebola, have you had any difficult getting or maintaining an erection, or ejaculating?’


___ No

___ Yes

___ Don’t know

___ No answer/prefer not to answer


For men and women:


D6.

Do you have tuberculosis? Choose one.

___ No, not that I know of

___ Yes, I have tuberculosis

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D7.

Do you have diabetes? Choose one.

___ No, not that I know of

___ Yes, I have diabetes

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D8.

Have you ever had a test for HIV? Choose one.

___ No, not that I know of

___ Yes, I have been tested for HIV

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D9.

Do you have HIV? Choose one.

___ No, not that I know of

___ Yes, I have HIV

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D10.

If you have HIV, are you taking any HIV medications (antiretrovirals or ARVs)?

___ No, they weren’t offered to me

___ No, I can’t afford the cost

___ No, I don’t want to take them

___ Yes, I am taking HIV medications

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer


D11.

Do you now have any symptoms of a possible sexually transmitted infection, such as genital (penile, vaginal, or anal) ulcers, sores, lesions, warts, or discharge?

___ No, I do not have any of those symptoms now

___ Yes, I have one or more of those symptoms now

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer

The following section E includes questions that should only be asked to men:


In addition to questions about your health we will ask you how often you have engaged in sexual activity since recovery, if at all. The reason for us asking this questions is to understand more about how any viral remains in your semen could relate to how often you have ejaculated. These questions may disturb you and you can choose not to answer them or any questions that disturb you, at any time.


To be asked to men only:


E1

Since recovering from Ebola, have you resumed sexual activity?


__No (stop here, go to section F below)


__Yes (continue to the next question E2)


If yes:



E2 What was the date/ month you resumed sexual activities? It is okay to guess.

Fill in the blank.

Date: ___________________

___ Don’t know/not sure

___ No answer/prefer not to answer



E3


How often have you engaged in sexual activities with a partner since recovery from Ebola?

__every day

__> 3 times a week

__3 times weekly

__< 3 times weekly

__once every week

__once/one-off meeting

__Never

__No answer/prefer not to answer










To finish the interview we would like to understand what kind of information and advise you received when you left the ETU, and how you have related to that information on sexual activity and also breast-feeding. It is important to us to understand if the information is clear and easy to understand and follow, or if it is sometimes not provided, forgotten easily or difficult to understand or follow.


For men and women:


F1.

Before today, did you receive information from anyone about when it is safe for someone who had Ebola to have sex? Mark all that apply.

___ No

___ Yes, from friends or family members

___ Yes, from leaders in my community

___ Yes, from staff at the clinic where I was treated / other doctors or medical professionals

___ Yes, from public health or government officials

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer



F2.

What advice did you hear about when it is safe for someone who had Ebola to have sex? Mark all that apply.

___ Don’t remember hearing any advice

___ Abstain from sex for ____ days or months

___ Use condoms for ____ days or months

___ Abstain or use condoms for ___ days or months

___ Safe to have unprotected sexual intercourse immediately

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer



F3.

Before today, did you receive information from anyone about when it is safe for someone who has had Ebola to breastfeed? Mark all that apply.

___ No

___ Yes, from friends or family members

___ Yes, from leaders in my community

___ Yes, from staff at the clinic where I was treated / other doctors or medical professionals

___ Yes, from public health or government officials

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer




F4 Did you engage in sexual activity following three first months after recovering from Ebola Ebola recovery

Yes (continue)

_ No (Go to G1 or finish the interview)

___ Don’t know/not sure (Go to G1 or finish the interview)

___ No answer/prefer not to answer (Go to G1 or finish the interview)


If yes:

During the three first months after recovering from Ebola, how often did you use a condom during sex? Choose one.

___ Never

___ Some of the time

___ Every time

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer/prefer not to answer




F5 Where did you get the condoms you used?

Mark all that apply.

___ I did not use any condoms

___ I got them at the ETU where I was treated

___ Free donation from another organization

___ I bought them from a shop/market/pharmacy

___ Gift from a friend/family member/loved one

___ I already had them before I got sick

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer




The following question (G2+3) will be asked of lactating women only:



G1.

What advice did you hear about when it is safe for someone who has had Ebola to breastfeed? Mark all that apply.

___ Don’t remember hearing any advice

___ Resume/continue breastfeeding as soon as possible

___ Do not breastfeed for 2 months

___ Give the child formula instead of breast milk

___ Give the child animal milk instead of breast milk

___ Give the child water instead of breast milk

___ Other (specify) _______________

___ Don’t know/not sure

___ No answer



G2.

Did you receive any ready-to-use infant formula (RUIF) when you were discharged from the ETU? Choose one.

___ No

___ Yes

___ Other (please specify) _____________

___ Don’t know/not sure

___ No answer






Thank you very much for participating in the survey today. Do you have any other comments or concerns you would like to share about these topics?

Specify ___________________________________



For staff use only


Date

Staff initials

Questionnaire administered



Questionnaire checked for completeness



Data entered



Data entry checked for completeness





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