Changes to Adult Case Report Form

Adult/Adolescent Case Report Form (ACRF) Changes from the Currently Approved HARS Form to eHARS Compatible Form

Title: HIV/AIDS was changed to HIV

Any section that included dates has a notation next to the header: (record all dates as mm/dd/yyyy)

Sections are no longer numbered on the revised form.

Section I:

Notes: Section 1. State/Local Use Only on HARS form now Patient Identification section on eHARS form.

Change

Patient Identifier Information is not transmitted to CDC to *Information NOT transmitted to CDC

Asterisks added before field name for fields not transmitted to CDC

Name order previously last, first, middle now first, middle, last

Alternate name type added to match eHARS

Address type added to match eHARS

Medical Record No. moved from HARS form Section VII

Additional ID field added to match eHARS

Section II:

Notes: Section II. Health Department Use only on HARS form now Health Department Use Only & Facility Providing Information sections on eHARS form.

Changes

Date Received at Health Department added to match eHARS

eHARS Document UID added

State Patient No. from HARS form changed to State Number on new form

Reporting Health Department State on HARS form not on current form (auto completed in eHARS); retained city/county on new form

Report source on HARS form now Document Source

Report Status on HARS form not on current form

Surveillance Method added to match eHARS

Did this Report Initiate a New Case Investigation added to match eHARS

Report Medium added to match eHARS

Facility Providing Information section added, with facility name, street address, city, county, state/county and zip code. Additional options were added to indicate facility type

Person Completing the Form & Phone number moved from HARS form Section VII

Facility setting removed

Section III:

Notes: Section III. Demographic Information on HARS form now Patient Demographics section on eHARS form.

Changes

Order of variables changed to match eHARS

Diagnostic status removed

Age at diagnosis removed

Sex from HARS form changed to Sex assigned at Birth variable in eHARS

Country of Birth changed from four options to two

Alias Date of Birth added from eHARS

Name changed from Current Status to Vital Status; Unknown removed as option for Vital Status

State/Territory of Death changed to State of Death

Current Gender Identity added

Extended Ethnicity field added to match eHARS

Race (select one or more) to Race (check all that apply)

Extended race field added to match eHARS

(Add additional addresses in Comments) added next to Residence at Diagnosis

Address Type added to qualify Residence of Diagnosis to match eHARS; Check if SAME as Current Address added as an option

Added under residence at diagnosis for address type (check all that apply to the address below)

Street Address included with Residence of Diagnosis

Section IV:

Notes: Section IV Facility of Diagnosis on HARS form is also Facility of Diagnosis section on eHARS form

Changes

Diagnosis Type added to qualify Facility of Diagnosis to match eHARS; Check if SAME as Facility Providing Information added as an option; Added (add additional facilities in Comments)

Added under diagnosis type (check all that apply to the facility below)

address field added

Phone Number added to match eHARS

Zip code added to match eHARS

Included additional options to indicate facility type

Provider Name added to match eHARS

Provider Phone added to match eHARS

Specialty added to match eHARS

Facility setting removed

Section V:

Notes: Section V. Patient History on HARS form is also Patient History section on eHARS form

Changes

Option to indicate Pediatric Risk included in Section header

Sub Header on HARS form “After 1977 and Preceding First Positive Antibody test or AIDS Diagnosis, this Patient Had” has been replaced with “After 1977 and before the earliest known diagnosis of HIV infection, this patient had”

Clotting factors on HARS form specified- on eHARS form users just asked to specify with a write in and date received

Heterosexual risk section highlighted

Heterosexual risk section capitalization of HETEROSEXUAL for emphasis

Heterosexual risk section variable “heterosexual contact with person with hemophilia coagulation disorder” updated to include at end “with documented HIV infection”

Day for mm/dd/yyyy added for Received transfusion of blood/blood components (other than clotting factor); added (document reason in Comments section) for this field

(specify occupation) under “Worked in a health-care or clinical laboratory setting” changed to “If occupational exposure is being investigated or considered as primary mode of exposure, specify occupation and setting”

Other Documented Risk added to match eHARS

Section VI:

Notes: Section VI. Laboratory Data on HARS form is also Laboratory Data section on eHARS form.

Changes

The Laboratory Data header was updated with “record additional tests in Comments section”

Additional responses were added to allow users to record multiple tests of the same test type

The “HIV Antibody Tests at Diagnosis” header was changed to HIV Antibody Tests (Non-type differentiating) and (Type differentiating) to reflect changes in testing technology

“Indicate first test” and “Record earliest test” were removed from the HIV Antibody Tests at Diagnosis and HIV Detection Tests sections

“Positive” and ”Negative” were changed to “Positive/Reactive” “Negative/Nonreactive”, respectively

“Not Done” was removed as response option under the “HIV Antibody Tests at Diagnosis” section

“Test Date” was changed to “Collection Date” for clarity

A place holder for day was added to all collection dates.

The list of lab tests was ordered to match eHARS

HIV-1 IFA and HIV-1 Western blot are now separate Antibody tests

Additional categories of HIV antibody tests (non-type differentiating) were added: HIV-1/2 Ag/Ab, HIV-2 EIA, and HIV-2 Western Blot to reflect changes in testing technology.

Added a check box to capture rapid tests in the “HIV Antibody Tests (non-type differentiating)” section.

Additional categories of HIV antibody tests (type differentiating) were added to reflect changes in testing technology: HIV-1/2 Differentiating (e.g. Multispot) along with the results. Result can be captured as: HIV-1, HIV-2, both (undifferentiated), or neither (negative).

The “Positive HIV Detection Test” section was split into two sections: “HIV Detection Tests (Qualitative)” and “HIV Detection Tests (Qualitative viral load)” for clarity.

Changed the “Positive HIV Detection Test” section (culture, antigen, and PCR, DNA or RNA probe) to “HIV Detection Tests (Qualitative)” and changed tests to for clarity: HIV-1 RNA/DNA NAAT (Qual), HIV-1 P24 Antigen, HIV-1 Culture, HIV-2 RNA/DNA NAAT (Qual) and HIV-2 Culture. Removed the “Other, specify” option.

The “Detectable Viral Load test (Record earliest test)” was changed to “HIV Detection tests (Quantitative viral load)” for clarity. Added: “RNA/DNA NAAT (Quantitative viral load)” to differentiate from the qualitative RNA/DNA NAAT.

Added detectable and undetectable results and the log field in the “HIV Detection tests (Quantitative viral load)” section.

Removed the two digit test type response in the “HIV Detection tests (Quantitative viral load)” section.

“Note: include earliest test after diagnosis” was added to the “HIV Detection Tests (Quantitative viral load)” section.

The “Immunologic lab tests” header was changed to “Immunologic Tests (CD4 count and percentage)”

Added a header for the “Documentation of Tests” section

Section VII:

Notes: Section VII State / Local use only on HARS form does not exist on eHARS form.

Changes

Physician name now included with Facility of Diagnosis

Physician phone now included with Facility of Diagnosis

Medical Record number now included with Patient Identification

Hospital / Facility now included with Facility Providing Information

Person Completing the Form and Phone Number now included with Facility Providing Information

Section VIII:

Notes: Section VIII. Clinical Status on HARS form is now the Clinical section on eHARS form.

Changes / New

Remove Clinical Record Reviewed

Remove Date Patient was Diagnosed “Asymptomatic” and “Symptomatic”

Remove “If HIV tests were not positive or were not done, does this patient have an immunodeficiency that would disqualify him/her from the AIDS case definition?”

Pneumocystis carinii pneumonia changed to Pneumocystis pneumonia

Toxoplasmosis of brain changed to Toxoplasmosis of brain, onset at >1 mo. of age

*RVCT CASE NO: changed to †If TB selected above, indicate RVCT Case Number:

Section IX:

Notes: Section IX. Treatments/Services Referrals on HARS form is also Treatments/Services Referrals section on eHARS form.

Changes

Removed “This patient has been enrolled at Clinical Trial / Clinic”

Removed HARS field “This patient’s medical treatment primarily reimbursed by:”

Removed HARS field “ This patient received or is receiving”

Removed HARS field “This patient is receiving or has been referred for”

Child’s state Patient No. is now Child’s state number

Added street address, county, phone number and zip code to hospital of birth to match eHARS

Added Child’s Name to match eHARS

Added Child’s Coded ID to match eHARS

Added “born at home enter “home birth” for hospital name to match eHARS

New Section: HIV Testing and Antiretroviral Use History (if required by Health Department) (record all dates as mm/dd/yyyy)

Changes

Note the new variable called UCTS has not been previously described. The variable UCTS is needed to differentiate the various sources of testing and treatment history information and is the main source of testing and treatment history information.

Variable descriptions for this section are as follows:

Variable description in OMB approved standard HIV Incidence Surveillance data elements	ACRF eHARS Form	Variable Name
New variable not previously described.	Main source of testing and treatment history information (select one)	UCTS
Date information is extracted	Date patient reported information	UQINTD
Ever tested positive	Ever had previous positive HIV test?	UPASTP
Date of first positive HIV test	Date of first positive HIV test	UFPOSD
Ever tested negative	Ever had a negative HIV test?	UNGTST
Date of last HIV negative test before first positive	Date of last negative HIV test	ULSTND
Number of HIV tests in last 2 years before first positive (including first positive test)	Number of negative HIV tests within 24 months before first positive test	UNUMTSTS
Antiretroviral medications within the last 6 months	Ever taken any antiretrovirals (ARVs)?	UHRT
ARV meds taken	If yes, ARV medications:	UHRTA1
Date HAART use began	Dates ARVs taken: Date first began	UHRTBD
Date HAART use ended	Date of last use	UHRTED

Section X: Comments

Notes: No changes

Page 9 05/26/2011