Att 15_Baseline data collection variables list

The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)

Att 15_Baseline data collection variables list

OMB: 0920-1357

Document [docx]
Download: docx | pdf

Form Approved

OMB No. 0920-xxxx

Exp. Date xx/xx/XXXX



GAIN Baseline Data Variables

*Time will be reported in days


Public reporting burden of this collection of information is estimated to average 4 hours 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: OMB-PRA (0920-New)



Gay City PrEP Clients

  1. Sex assigned at birth

  2. Gender

  3. Race

  4. Ethnicity

  5. Time from first contact to first PrEP visit

  6. Time from first contact to first screening appointment

  7. Time from first contact to first PrEP visit

  8. Time from first contact to PrEP entry visit

  9. HIV status at first visit

  10. Time from first PrEP visit to HIV testing (linked to #9, expect this to be the same value as #7)

  11. Source of HIV test from #9

  12. Whether PrEP was prescribed at the first visit

  13. Time from first PrEP visit to date PrEP was prescribed

  14. Time from first PrEP visit to self-reported date PrEP was started

  15. Time from first PrEP visit to date of connection to main health care provider

  16. Time from first PrEP visit to Month 1 Visit

  17. HIV status at Month 1

  18. Whether connection to main health care provider was established at Month 1

  19. Time from first PrEP visit to Month 3 Visit

  20. HIV status at Month 3

  21. Whether connection to main health care provider was established at Month 3

  22. Time from first PrEP visit to Month 6 Visit

  23. HIV status at Month 6

  24. Whether connection to main health care provider was established at Month 6

  25. Whether this is an instaPrEP client (from Sarah’s records)

  26. Client status (i.e., lost to follow-up, graduated to PCP, Active, PrEP re-start)

  27. Time from first PrEP visit to Week 1 follow-up call

  28. Was Week 1 follow-up call successful?

  29. Time from first PrEP visit to Month 1 follow-up call

  30. Was Month 1 follow-up call successful?

  31. Time from first PrEP visit to Month 3 follow-up call

  32. Was Month 3 follow-up call successful?

  33. Time from first PrEP visit to Month 6 follow-up call

  34. Was Month 6 follow-up call successful?


Gay City Clients Newly Diagnosed with HIV

  1. Time from first positive/reactive test to Month 1 phone call

  2. Whether or not a rapid HIV test was ordered

  3. Result of rapid test

  4. Whether or not a laboratory test was ordered

  5. Result of laboratory test

  6. Whether client was referred to HIV care

  7. Time from first positive/reactive test to date of first HIV care referral

  8. Did client attend HIV care visit? Asked 1 week, 2 weeks, then 1 month after first reactive

  9. Time from first positive/reactive to self-reported ART start date

  10. Does participant know if they are virally suppressed (self-reported) at Month 1

  11. Virally suppressed (self-reported) at Month 1?

  12. Time from first positive/reactive to self-reported date of last viral load test at Month 1.

  13. Does participant know if they are virally suppressed (self-reported) at Month 3

  14. Virally suppressed (self-reported) at Month 3?

  15. Time from first positive/reactive to self-reported date of last viral load test at Month 3.

  16. Does participant know if they are virally suppressed (self-reported) at Month 6

  17. Virally suppressed (self-reported) at Month 6?

  18. Time from first positive/reactive to self-reported date of last viral load test at Month 6.


Gay City Clients Living with HIV (established)

  1. Confirmed HIV+ status

  2. Whether client has HIV care provider

  3. Whether client is currently on ART

  4. Whether client is undetectable (self-reported)

  5. Time from first positive/reactive to self-reported ART start date

  6. Does participant know if they are virally suppressed (self-reported) at Month 1

  7. Virally suppressed (self-reported) at Month 1?

  8. Time from first positive/reactive to self-reported date of last viral load test at Month 1.

  9. Does participant know if they are virally suppressed (self-reported) at Month 3

  10. Virally suppressed (self-reported) at Month 3?

  11. Time from first positive/reactive to self-reported date of last viral load test at Month 3.

  12. Does participant know if they are virally suppressed (self-reported) at Month 6

  13. Virally suppressed (self-reported) at Month 6?

  14. Time from first positive/reactive to self-reported date of last viral load test at Month 6.


Gay City Clients

  1. Was a syphilis RPR done?

  2. Syphilis RPR result

  3. New or old infection

  4. RPR titer

  5. GC rectal done

  6. CT rectal done

  7. GC rectal result

  8. CT rectal result

  9. GC throat done

  10. CT throat done

  11. GC throat result

  12. CT throat result

  13. GC vaginal done

  14. CT vaginal done

  15. GC vaginal result

  16. CT vaginal result

  17. GC urine done

  18. CT urine done

  19. GC urine result

  20. CT urine result

  21. Sex at birth

  22. Gender

  23. Shifted visit date (randomly shifted)

  24. Calculated age at visit

  25. Race

  26. Ethnicity

  27. Insurance status


Madison Clinic Patients

  1. Shifted visit date

  2. Time from first visit (Those with first positive, those with any detectable viral loads (200 copies/mL), PEP episodes (need to filter out women), HIV testing, anyone with PrEP visits) in time period to first prescription ordered

  3. Time from first prescription ordered to prescription refill

  4. Duration/refill amount of any medications for PrEP, ART, or PEP

  5. Time from first visit to the collection date for any HIV POC or rapid test

  6. Time from first visit to the collection date for any HIV-1 RNA/viral load test

  7. Time from first visit to the collection date for any DNA/TNA results

  8. Time from first visit to the collection date for any HIV EIA (4th gen) results including supplemental testing

  9. For HIV-negative patients only:

    1. CT or GC PCR/NAT result (three sites)

    2. Time from first visit to collection date

    3. CT or GC collection site

    4. Syphilis EIA or RPR results

    5. RPR titer

  10. Insurance status

  11. Sex based on license/ID

  12. Gender (still figuring out whether this will include looking at prescription hormones and/or diagnosis codes since this is not properly recorded in EPIC)

  13. Calculated age at visit

  14. Race

  15. Ethnicity

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorLauren R. Violette
File Modified0000-00-00
File Created2022-09-25

© 2024 OMB.report | Privacy Policy