ZEN Columbia - Male Partner Eligibility - English 26MAY2

ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia

Att B7 - Male Partner Eligibility Screen Form_052517_CLEAN

Male Partners - Male Partner Eligibility Questionnaire

OMB: 0920-1190

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Appendix B2 Male Partner Eligibility Form Approved

Last updated 05/19/17 OMB No. 0920-XXXX

Exp. Date xx/xx/20xx




Male Partner Eligibility


Note: Before enrolling a man, make sure you have enough supplies (blood and urine collection materials, paper forms, etc.)


Name of Person Completing the Form: _______________________________________________


Cedula of Male Partner: __________________________________________________


Date of pregnant women’s enrollment: _____/______/________ (DD/MMM/YYYY)


Today’s date: _____/______/________ (DD/MMM/YYYY)

*This date should be within one month of pregnant women’s enrollment


IPS Information


Clinic name: _________________________________________


City:Barranquilla Bucaramanga Tuluá


Male Partner Information


Last names: _________________________________________


First name(s): _________________________________________



Inclusion Criteria


Is the pregnant partner 18 years or older?


Yes No

Did the pregnant partner agree that this man can be asked to be included in the study?

Yes No

Does this man live in the same household as the pregnant partner enrolled in ZEN? (Woman’s ZEN ID #:_____________________)

Yes No

Is this man aged 18 years or older?

Yes No

Does this man speak Spanish?

Yes No


Exclusion Criteria

Is this man incarcerated?

Yes No

Is this man unable to physically or psychologically participate based on clinical judgement?

Yes No









Eligibility Determination


This man is eligible for the study. (All answers to eligibility criteria questions are Yes AND all answers to exclusion criteria are No.)

Yes Eligible

No Not Eligible

Unsure If unsure, then fill out Appendix E1 (contact information) and

follow-up in one week.



Notes about eligibility determination: ____________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

If eligible, please complete the sections below.


Informed Consent Determination

Did the partner receive and provide informed consent for participation?        

  □ Yes          Enroll

Unsure If unsure, then fill out Appendix E1 (contact information) and

follow-up in one week (if still within one month of pregnant women’s

enrollment)

No If no, thank the partner for their time and note that they declined

participation in the study.


Reason(s) for declining (check all that apply):

Not interested

Concerned about study protocol (safety, invasive)

Concerns about time/transportation

Concerns about family member approval (e.g. partner, parents)

Other concern:_____________________________

Zika Study Kit

Did you give the partner a Study Kit before he left?


Yes, he took it

Offered, but he didn’t want/take it

Not offered STOP. Do not enroll if no information sheets are available. Schedule enrollment visit for another day.

If not offered, why?: _______________________________


ZEN Participant and Non-Participant Identification Numbers

If the man was eligible and has consented, assign a ZEN Participant ID. If the man was not eligible or was eligible and did not consent, assign a ZEN Non-Participant ID (see SOP 2-02).


ZEN Participant ID: _ _ _ _ _ _- _ - _ _ _ _ _ _ _ _ _ _ _

ZEN Non-Participant ID: N _ _ _ _ _ _- _ - _ _ _ _ _ _ _ _ _ _ _

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CDC estimates the average public reporting burden for this collection of information as 5 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information 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).


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorJohnson, Candice Y. (CDC/NIOSH/DSHEFS)
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File Created2021-01-22

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