Nigeria prep demonstration study who adult hiv staging System Visit Code 01. 00

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WHO Adult HIV Staging System Visit Code 01.00

Screening ID:

Site Study Screening Number

Participant ID:

Site Study Couple I/P Chk

Visit Date:

dd mm yy

Instructions: Mark all that apply. A participant’s WHO Stage cannot decrease. For example, once a participant has reached Stage 3, the participant's stage cannot ever again be Stage 1 or 2.

WHO Adult Stage 1

Asymptomatic HIV Infection

Persistent Generalized Lymphadenopathy (PGL)

WHO Adult Stage 2

Moderate weight loss (<10% of presumed or measured body weight)

Minor mucocutaneous manifestations (seborrheic dermatitis, prurigo, fungal nail infection, recurrent oral ulcerations, angular cheilitis)

Herpes zoster

Recurrent or chronic upper respiratory tract infections (bacterial sinusitis, bronchitis, otitis media pharyngitis)

WHO Adult Stage 3

Severe weight loss ( > 10% of presumed or measured body weight)

Severe bacterial infections (e.g., pneumonia, pyomyositis, empyema, bone or joint infections)

Unexplained chronic diarrhea > 1 month

Pulmonary tuberculosis (PTB)

Unexplained prolonged fever > 1 month

Oral hairy leukoplakia (OHL)

Oral candidiasis (Thrush)

Necrotizing ulcerative stomatitis, gingivitis, or periodontitis

Unexplained anemia, neutropenia, or thrombocytopenia

WHO Adult Stage 4

HIV wasting syndrome (Severe weight loss and either unexplained chronic diarrhea or unexplained prolonged fever > 1 month)

Chronic orolabial, genital or ano-rectal herpes simplex virus infection > 1 month

HIV encephalopathy

Invasive cervical carcinoma

Primary CNS lymphoma or B cell non-Hodgkin’s Lymphoma

Any disseminated endemic mycosis (e.g. histoplasmosis)

Progressive multifocal leukoencephalopathy (PML)

Candidiasis of the esophagus or airways

Cryptosporidiosis or isosporiasis with diarrhea > 1 month

Cytomegalovirus (CMV) retinitis or disease of other organs

Disseminated non-tuberculous mycobacterial infection

Toxoplasmosis of the brain

Symptomatic HIV nephropathy or cardiomyopathy

Cryptococcal meningitis, cryptococcosis

Recurrent severe bacterial pneumonia (more than 2 episodes within 1 year)

Recurrent septicaemia (including non-typhoidal Salmonella)

Pneumocystis carinii pneumonia

Extra-pulmonary tuberculosis (EPTB)

Kaposi’s sarcoma

Atypical disseminated leishmaniasis

Completed by: (initials/date) _________________________________________

Forms Instruction

The WHO Adult HIV Staging System is not an interviewer-administered CRF. Please do not read all items to the participant.

This CRF should be completed by a clinician or appropriate clinical staff. Accurate completion of this CRF may require a physical examination, primarily of the oral cavity and skin. If findings requiring revision of WHO staging are found at Enrollment, document the findings on the Index Physical Exam CRF, and revise WHO staging (including initials and date) on the Index Enrollment Medical History CRF.
Item-specific Instructions:

Screening ID

Screening IDs will be assigned from the site list and are unique to the individual. They are numeric and should be assigned sequentially. The Index Screening ID is assigned to the HIV-positive participant, and the Partner Screening ID is assigned to the HIV-negative participant.

Participant ID

Participant IDs are assigned from a list provided by the PROJECT. They are assigned once eligibility has been determined and the subject has been enrolled. The Participant ID should be left blank until the eligibility status of the participant is known. If eligible, the Participant ID should be entered and initialed and dated (if being added on a different date). If the participant is not eligible, then the Participant ID should be left blank.

Items 1–4

Mark all that apply across all four sections. If the condition is listed in more than one stage, only mark the box for the most severe stage. (For example, do not mark “moderate weight loss” under Stage 2 and “severe weight loss” in Stage 3. Only “severe weight loss” should be marked.)

Item 3

Mark the box for pulmonary tuberculosis if the participant has a current diagnosis of PTB. Do not mark this box if the participant only has a history of distant or childhood PTB which preceded HIV infection.

Item 4

Do not limit to current conditions. Stage 4 conditions should be marked if the participant has ever had these diagnosed. For example, if a participant has had two episodes of severe bacterial pneumonia in the past year, that box should be marked, even if the participant does not have pneumonia at the time this form is completed.

If participants meet any of the criteria for WHO Adult Stage 3 or 4 HIV disease, they are ineligible for the study. Refer for ARV initiation.

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