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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201112000327297 |
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Date of registration:
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10/10/2011 |
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Primary sponsor: |
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Public title:
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RCT of home-care and routine cryptococcal meningitis screening among patients starting antiretroviral therapy with advanced disease.
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Scientific title:
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Reduction of early morality among HIV-infected subjects starting antiretroviral therapy in Zambia and Tanzania with CD4 count`100 cells per microlite: a randomised trial involving home support and routine screening for cryptococcal meningitis. |
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Date of first enrolment:
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2011-12-01 |
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Target sample size:
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2500 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201112000327297 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Randomisation is computer generated (separately) for each country. ,
Codes are placed in sealed envelopes and opened individually for each patient,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Shabbar
Jaffar |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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020 79272418 |
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Email:
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shabbar.jaffar@lshtm.ac.uk |
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Affiliation:
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Professor of Epidemiology |
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Name:
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Susie
Burdett |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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020 927 2703 |
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Email:
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susanna.burdett@lshtm.ac.uk |
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Affiliation:
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Research Group Administrator |
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Key inclusion & exclusion criteria
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Inclusion criteria: CD4`100 cells/?l
Adult: b18y or more
Antiretroviral naive (as reported by the patient)
Planning to remain in the study area for about 6 months (as reported by the patient)
Exclusion criteria: Requiring immediate in-patient care/admission
Living outside the catchment population of the hospital
Age minimum:
18 Year
Age maximum:
100 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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All-cause mortality
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Secondary Outcome(s)
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Adherence to ART
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Costs of the two strategies to the health service
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Detection of cryptococcal meningitis among patients on ART
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Detection of tuberculosis among patients on ART and their household members
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Frequency of outpatient attendances
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Patient retention on ART
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Rate of hospital admission
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Uptake of HIV voluntary counselling and testing and of TB screening among household member
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Secondary ID(s)
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ISCTRN20410413
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Source(s) of Monetary Support
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EDCTP
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