Components of HIV/AIDS Case Surveillance: Case Report Forms and

Sources

Developing a Case Report Form In developing a Case Report Form, One Must: Select the WHO surveillance case definition to be used in the country

Determine the clinical events to be captured

Select the unique identifier or set of identifiers

WHO Case Definition: HIV Infection HIV infection surveillance includes reports of all persons with HIV infection, regardless of clinical stage

Persons should be reported if they: Are newly diagnosed regardless of clinical stage Were previously diagnosed but not previously reported

Were previously diagnosed and reported at clinical stage 1 or 2 and progressed to stage 3 or 4

The report should include the clinical stage at diagnosis

HIV Case Reporting Data Outputs The distribution of patient demographic and risk characteristics

Capture the spectrum of key events in course of HIV disease

Monitor levels of and trends in: Diagnosis of HIV (infection or advanced infection)

Clinical stage at time of diagnosis Use of ART and prophylaxis HIV- and non-HIV-related deaths Development and types of opportunistic illness

Time between most recent negative HIV test and diagnosis

Function of the HIV Case Report Form The case report form is used to standardise the collection of information that is obtained on all reported HIV cases

An HIV case report form is designed to:

Collect information that promotes understanding of HIV infection, morbidity, and mortality

Facilitate reporting an HIV case

Standardise the collection of variables

HIV Case Report Form Links Surveillance Inputs to Outputs

Developing the Case Report Form A case report form should be designed with the following in mind: The feasibility of completing the form The need for reporting to be complete The current and future needs of case reporting data

Maintaining the integrity of the reporting system

The acceptability of the form to persons responsible for submitting reports

The overall simplicity of the form

Factors to Consider in Designing the Case Report Form Availability of data Consistency of data collected from the reporting sources

Validity of data Sources of reports Persons completing the form Minimizing burden to staff completing the form

Ensuring Quality Data Case report forms must be completed correctly and in a timely fashion

Persons reporting cases must: Have forms readily available Know how to complete the form

Have instructions included with the form Include information on who to call with questions and where form should be submitted

Elements of a Case Report Form A comprehensive case report form contains: Reporting source information

Individual reporting the case Facility from which case is reported Date of report

Elements of a Case Report Formcontinued

Patient information Personal identifier (e.g. name) Date of diagnosis Demographic and risk characteristics Vital status HIV testing HIV clinical stage and immunologic status at diagnosis and progression from stages 1 or 2 to advanced HIV infection

Treatment and care

Patient Identifier, Demographic, and Vital Status Information

C: PATIENT INFORMATION Patient’s first name:

Patient’s maiden name (if applicable):

Patient’s last name:

Patient’s coded unique identifier (if applicable):

Day Mo. Year

Actual Date of birth: / / Or Estimated DOB: / /

Sex: MALE FEMALE

Current city/town of residence:

Current country of residence:

Country of birth:

Nationality:

Education completed: NO FORMAL SCHOOLING PRIMARY SECONDARY TECHNICAL/VOCATIONAL UNIVERSITY AND HIGHER

Occupation Status: EMPLOYED UNEMPLOYED

Race/Ethnicity:

Is this patient currently pregnant (females only): YES NO UNKNOWN Current Status:

ALIVE DEAD UNKNOWN Day Mo. Year

Date of death: / / Cause of death: HIV-RELATED OTHER/UNKNOWN

HIV Risk Character Information

D: RISK FACTORS/EXPOSURES Preceding the first positive HIV test, this patient had (respond to all categories): YES NO UNKNOWN

Had sex with male(s) in the past 12 months

Had sex with female(s) in the past 12 months

Had sex with person(s) of known HIV-positive status in the past 12 months

Had sex with sex worker(s) in the past 12 months

Exchanged sex for money, drugs or material gain in the past 12 months

Injected nonprescription drugs in the past 12 months

Used non-injected illicit drug (e.g. crack, cocaine, marijuana, hallucinogenics, etc) in the past 12 months

Any history of incarceration in prison in the last five years

Perinatal exposure to HIV

Received transfusion(s) of blood, blood products or clotting factors

Received a transplant of tissue or organ or artificial insemination

Occupational exposure while working in a health care setting or laboratory or providing safety or emergency services

HIV Clinical Stage, Immunologic Information, and HIV Testing History

Identifying Reporting Sources

LOCATION WHERE WHAT DATA VCT Site • VCT

Counseling and Testing Form

• Administrative information• Demographic information• Behavioural risk factors• Diagnosis information

Hospitals/Health Care Clinics

• Client medical record

• Administrative information

• Demographic information• Diagnosis information• Behavioral risk factors

• Clinical stage • Opportunistic illnesses• Immunologic status• Care and treatment• Vital status

PMTCT/ANC Clinics

• ANC register

• PMTCT register

• Client medical record

• Administrative information

• Demographic information• Diagnosis information• Vital status

ART Clinics • Client medical record

• Administrative information

• Demographic information• Diagnosis information• Behavioral risk factors

• Clinical stage • Opportunistic illnesses• Immunologic status• Care and treatment• Vital status

Identifying Reporting SourcesLOCATION WHERE WHAT DATA Laboratories • Laboratory Test

Request Forms • Laboratory

Result Forms • Laboratory

Registers

• Administrative information

• Demographic information

• Diagnosis information

• Clinical stage • Immunologic status

TB Clinics • Client Medical Record

• Administrative information

• Demographic information

• Diagnosis information

• Vital status

Vital Statistics Registries

• Vital statistic registry/database

• Vital status • Cause of Death

Mobile/Outreach

• Counseling and Testing Forms

• Outreach data collection forms

• Administrative information

• Demographic information

• Behavioural risk factors

• Diagnosis information

Private Doctors

• Client Medical Record

• Administrative information

• Demographic information

• Diagnosis information

• Clinical stage • Immunologic status• Care and treatment• Vital status

Multiple Data Sources, One Case

HIV CASE REPORTING DATABASE

VCT CENTRE(name, sex, dob,

behavioral, residence, date of dx, facility of dx)

LABORATORY(name, sex, dob, date of dx, VL and CD4 near

or at dx)

HOSPTIAL/ART CLINIC

(name, sex, dob, residence, date of dx, facility of

dx, art start date, prophylaxis, clinical staging, behavioural, vital status, VL, CD4)

VITAL STATISTICS REGISTRY

(name, sex, dob, residence, date of death, cause

of death)

PMTCT CLINIC (name, sex, dob,

residence, date of dx, facility of dx, art

start date, prophylaxis, clinical staging, vital

status, VL, CD4)

PRIVATE PHYSICIANS (name, sex, dob, residence, date of dx, facility of dx,

art start date, prophylaxis, clinical staging, behavioural vital status, VL,

CD4)

The Need for a Unique Case Identifier HIV case-based reporting is unique among infectious disease surveillance systems because: A person can acquire HIV only once A person is diagnosed and reported with advanced HIV infection only once

Even if clinical status improves, cases should be reported only at: Initial diagnosis of stage 1 or 2 infection Initial diagnosis of stage 3 or 4 infection

The Need for a Unique Case Identifier, continued In order to accurately measure the level of and trends in disease burden surveillance programmes must identify duplicate cases and retain the report with the earliest date of diagnosis

A longitudinal surveillance database requires Following reported cases over time Identifying progression from stages 1 and 2 to advanced HIV infection

Updating a patient record when additional data are obtained

Selecting A Case Identifier The case identifier must:

Be unique to the individual Not change over time or allow time of change to be known

Be easy to identify from a clinical record Be something that is or is derived from routinely collected data

The case identifier must be able to: Distinguish duplicate reports for the same person Distinguish cases with the identifier who are different persons

Allow follow-up information from the surveillance programme and healthcare provider to be easily connected with existing information

Selecting A Case Identifier, continued The identifier must:

Be available without interviewing the patient

Allow evaluation of the surveillance system: Permit assessing the completeness and timeliness of reporting

Permit assessing validity of data on case report forms

Be evaluated

Mandatory Variables for Counting Cases Only cases that meet the WHO HIV infection or advanced HIV infection surveillance case definitions should be reported

Required on the case report form for the surveillance programme to count a case are: Case identifier (name or code) Sex Date of birth Earliest date of diagnosis Clinical stage and/or CD4 test result Date of death (if applicable)

Summary HIV infection reporting:

Provides data on number and characteristics of persons with HIV and advanced HIV

Is used to determine current and future needs for ART and prevention programmes and to assess their impact

Countries should begin HIV reporting by: Identifying reporting sites, staff and resources Adopting the surveillance case definition Determining who will be responsible for case reporting

Determine desired outputs Develop a case report form with these factors taken into consideration

Thank You

Working Together to Plan, Implement, and Use

HIV Surveillance Systems