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1 medical monitoring: clinical monitoring and laboratory tests

2 Purpose of monitoring Check on the physical, psychological and emotional condition of the patient Detect other treatable conditions Identify when a patient needs to start antiretroviral or other treatment Indicate the long term outlook for a patient Show whether a patient is at risk for unwanted effects (toxicity) of treatment clinical monitoring and laboratory tests: 1

3 Laboratory monitoring before treatment Basic Antibody tests, red blood cell and white blood cell counts and pregnancy tests. These tests can be done in any medical laboratory. Better equipped lab CD4 cell count to monitor health of immune system Viral load test to monitor amount of virus in blood clinical monitoring and laboratory tests: 2

4 Monitoring in resource-limited settings WHO prioritise currently available tests into four categories: 1 Absolute minimum tests necessary before beginning ARV therapy: HIV antibody test. Haemoglobin or haematocrit level to screen for anaemia. 2 Basic tests used to monitor ARV therapy (preferable but not essential): White blood cell count. Total lymphocyte count. ALT/AST level for liver function. Serum creatinine for kidney function. Serum glucose. Pregnancy test for women. 3 Desirable tests: Bilirubin, amylase, serum lipids and CD4 count. 4 Optional tests: Viral load testing clinical monitoring and laboratory tests: 3

5 Symptoms that indicate need for HIV test Unexplained weight loss or loss of appetite Fever; especially at night Chronic watery diarrhoea; Swollen lymph nodes (generalised lymphadenopathy); Persistent skin disorders including skin rashes, itching, herpes simplex ulcers, herpes zoster (shingles), seborrhoeic dermatitis, warts; anal itching or discomfort. Neurological problems including dementia in patients less than 50 years old, or sudden onsets of unexplained psychosis, peripheral neuropathy, and Bell s palsy; Persistent cough, breathing problems or pneumonia; Severe or recurrent bacteraemias especially pneumococci and salmonellae Tuberculosis OR Development of any AIDS-defining illness clinical monitoring and laboratory tests: 4

6 AIDS-defining illnesses Candida in the oesophagus, trachea, bronchi or lungs. Invasive cervical cancer. Coccidiodomycosis. Cryptococcus outside the lungs. Cryptosporidiosis with diarrhoea lasting for more than one month. CMV disease outside the liver, spleen or lymph nodes. CMV retinitis. Herpes simplex virus involving the lungs or oesophagus. HIV-related encephalopathy. Chronic intestinal isosporiasis lasting longer than one month. Kaposi s sarcoma. Burkitt s, immunoblastic or primary brain lymphoma. Widespread MAI, M kansasii or other species. Pneumocystis carinii pneumonia (PCP). Recurrent bacterial pneumonia. Progressive multifocal leukoencephalopathy. Recurrent salmonella septicemia. Toxoplasmosis of the brain. HIV wasting syndrome. clinical monitoring and laboratory tests: 5

7 Conditions commonly suggestive of HIV disease See handout clinical monitoring and laboratory tests: 6

8 WHO staging system clinical stage one Asymptomatic infection stage one Acute retroviral infection Persistent generalised lymphadenopathy Performance Stage 1: Asymptomatic, normal activity clinical monitoring and laboratory tests: 7

9 WHO staging system clinical stage two Herpes zoster within previous 5 years Unintentional weight loss <10% body weight stage two Minor mucocutaneous manifestations (for example, dermatitis, prurigo, fungal nail infections, angular cheilitis) Recurrent upper respiratory tract infections Performance Stage 2: Symptoms, but nearly fully ambulatory. clinical monitoring and laboratory tests: 8

10 WHO staging system clinical stage three Chronic diarrhoea >1 month Severe bacterial infections Oral candidiasis stage three Prolonged fever >1 month (constant or intermittent) Vulvovaginal candidiasis Unintentional weight loss >10% body weight Oral hairy leukoplakia Pulmonary tuberculosis within the previous year Performance Stage 3: In bed more than normal but <50% of normal daytime during the previous month. clinical monitoring and laboratory tests: 9

11 WHO staging system clinical stage four Kaposi s Sarcoma Progressive multifocal leukoencephalopathy Pneumocystis carinii pneumonia Cytomegalovirus disease of an organ other than liver, spleen or lymph node HIV encephalopathy HIV wasting syndrome Cryptococcosis, extrapulmonary Non-typhoid Salmonella septicemia Performance Stage 4: in bed >50% of normal daytime during previous month. Cryptosporidiosis with diarrhea >1 month Toxoplasmosis of the brain Atypical mycobacteriosis, disseminated stage four Extrapulmonary tuberculosis Herpes simplex virus infection, mucocutaneous Candidiasis of the oesophagus, trachea, bronchi, or lung Isosporiasis with diarrhea >1 month Any disseminated endemic mycosis (for example, histoplasmosis) clinical monitoring and laboratory tests: 10

12 Exercise: the HIV disease course Draw diagonal line from bottom left to top right and label bottom left HIV infection and top right end of life Write in where you think symptoms will occur clinical monitoring and laboratory tests: 11

13 Exercise: recognising symptoms of HIV disease Draw a picture of the human body and show which symptoms of HIV disease you might see in different parts of the body clinical monitoring and laboratory tests: 12

14 HIV antibody testing Two tests of different types should be carried out, one rapid test and one ELISA to confirm the rapid test OR 2 ELISA test OR 1 ELISA plus low CD4 count OR 1 ELISA plus AIDS defining illness Advantage of rapid test: people can be given results quickly too many people do not return Disadvantage: must be confirmed, slightly higher false positive rate clinical monitoring and laboratory tests: 13

15 HIV diagnosis in children Mother s HIV antibodies may persist in child until 18 months of age Viral load test, if available, will identify infection in newborns Alternative: p24 antigen test, looking for viral protein, can confirm, but negative test does not rule out HIV infection If unavailable: use mother s HIV status plus clinical symptoms and immune status clinical monitoring and laboratory tests: 14

16 Monitoring before treatment: protecting against side effects ESSENTIAL TESTS Haemoglobin (using visual scale if necessary) if AZT is included in available regimens Clinical exam for peripheral neuropathy NON-ESSENTIAL BUT DESIRABLE Liver enzymes Neutropenia (low neutrophil count) WHY NEEDED Zidovudine can make anaemia worse Stavudine can make peripheral neuropathy worse The combination of stavudine and didanosine can make peripheral neuropathy worse WHY NEEDED Nevirapine can cause liver enzyme increases; risk highest in those with high baseline levels Zidovudine can make neutropenia worse Pregnancy test if efavirenz is prescribed to women Efavirenz can harm the unborn child clinical monitoring and laboratory tests: 15

17 Exercise: why are we monitoring patients and what monitoring can we do? Why is it necessary to carry out monitoring tests? What tests do we need to do in order to ensure that as many people as possible are treated safely and effectively? clinical monitoring and laboratory tests: 16

18 First clinical assessment of HIV-positive patient (1) Physical examination Weight Skin Lymph nodes Mouth (for signs of thrush, other lesions) Chest Pregnancy test Cough, fever? CD4 cell count if available Conduct these checks at each visit, and check reason for any missed appointments clinical monitoring and laboratory tests: 17

19 Screening for sexually transmitted infections Syndromic management start with signs and symptoms Syphilis Herpes PAP smear for cervical cancer if available STIs are often mixed, requiring syndromic management clinical monitoring and laboratory tests: 18

20 Screening for TB (1) Tuberculosis Sputum samples for active TB if cough or fever for more than 2-3 weeks If two out of three samples positive for TB, treat If one out of three: take more samples If all negative: treat as other chest infection and re-test if cough does not improve Chest x-ray if negative smears in presence of cough or fever clinical monitoring and laboratory tests: 19

21 Screening for TB (2) PPD test for latent TB if no symptoms in any HIV+ patient PPD may be non-reactive in advanced HIV patients 6 month course of isoniazid may be advisable for ALL HIV+ patients clinical monitoring and laboratory tests: 20

22 First clinical assessment of HIV-positive patient (2) What is the home environment? Are there social structures or family members to support them emotionally and in practical ways? Who can the patient tell about their HIV diagnosis? Support from at least one family member is likely to improve a person s ability to take medication correctly. Is the patient employed? What is the patient s financial situation and will he or she be able to afford the costs associated with diagnosis and treatment (including transport, time away from work, child care etc.)? Does the patient face any particular problems because of gender, social position, sexual behaviour, injecting drug use, stigma or discrimination? clinical monitoring and laboratory tests: 21

23 Exercise: First clinical assessment of HIV-positive patient (3) Who should be involved in the first assessment of the patient? Why? Draw a map of all the factors that could affect the patient s ability to take treatment correctly clinical monitoring and laboratory tests: 22

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