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ISRCTN
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ISRCTN94133652
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ClinicalTrials.gov identifier
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Public title
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Counselling and entry into HIV care
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Scientific title
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Assessing the effect of extended counselling on uptake and adherence to pre- antiretroviral care: A longitudinal, randomised controlled trial
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Acronym
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pre-ARV
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Serial number at source
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MUSPH 06012009
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Study hypothesis
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Extended counselling is associated with increased uptake and adherence to pre-antiretroviral therapy (ART)
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Lay summary
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Not provided at time of registration
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Ethics approval
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1. Makerere University School of Public Health Higher Degrees Research and Ethics Committee approved on the 6th of January 2009
2. Uganda National Council for Science and Technology approved
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Study design
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Longitudinal double blind multicentre randomised controlled trial
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Countries of recruitment
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Uganda
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Disease/condition/study domain
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Pre-ARV care adherence
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Participants - inclusion criteria
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Adult patients (>18 yrs) who test HIV positive at the ART centres at the start of the study (November 2009)
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Participants - exclusion criteria
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1. Patients undergoing Prevention of Mother-To-Child Transmission (PMTCT) therapy
2. Patients who are not of sound mental status
3. Those who are expected to leave the district during the period of follow-up
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Anticipated start date
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02/12/2009
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Anticipated end date
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02/06/2010
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Status of trial
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Completed |
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Patient information material
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Please contact Dr Muhamadi Lubega [dlmuhamadi@yahoo.co.uk] to request a patient information sheet
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Target number of participants
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400
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Interventions
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Newly screened HIV positive persons will be followed and monitored for uptake and adherence to the pre-ART care for a period of 5 months depending on the frequency of enrolment of eligible subjects. The HIV positive persons from three centres will be classified into two arms.
1. Control arm: HIV positive persons will receive the current format and text of counselling
2. Intervention arm: HIV positive persons will receive a specially packaged continuum of extended counselling
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Primary outcome measure(s)
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Proportion of HIV positive persons with extended counselling who adhere to pre-ART care
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Secondary outcome measure(s)
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Proportion of HIV positive persons not lost to follow up during subsequent HIV care
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Sources of funding
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Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20022131
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21794162
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Contact name
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Prof
Fred
Wabwire-Mangeni
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Address
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Makerere University
School of Public Health
PO BOX 7072
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City/town
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Kampala
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Zip/Postcode
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256
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Country
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Uganda
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Email
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fwabwire@musph.ac.ug
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Sponsor
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Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden)
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Address
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Karolinska institutet
Stockholm
c/o Makerere University
PO BOX 7072
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City/town
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Kampala
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Zip/Postcode
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256
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Country
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Uganda
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Email
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stefan.peterson@ki.se
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Sponsor website:
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http://www.sida.se
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Date applied
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01/06/2010
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Last edited
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22/11/2011
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Date ISRCTN assigned
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13/07/2010
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