ZEN Columbia - Male Partner Eligibility - English 26MAY2

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).