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ISRCTN
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ISRCTN40371436
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of different approaches to universal antenatal Human Immunodeficiency Virus (HIV) testing: acceptability, costs and benefits
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 93/24/11
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Study hypothesis
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With increasing optimism about the benefits of antenatal HIV testing, particularly in terms of measures that greatly reduce the risk of infection to the baby, there is a demand for effective, acceptable testing programmes and appropriate patient information. This randomised controlled trial (RCT) was designed to compare different ways of offering testing to all pregnant women, with the aim of acquiring information about what predicts uptake and how women respond to the offer of testing, in order to define the optimal approach.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Infection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS); Pregnancy and childbirth: Pregnancy
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Participants - inclusion criteria
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Participants were 3024 pregnant women, of whom 2704 (89%) completed a questionnaire which determined acceptability of testing, at their booking appointment. A sub-sample of the participants (n = 788) also completed a questionnaire at their 32-week appointment.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/04/1995
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Anticipated end date
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31/07/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3024
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Interventions
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The setting was a hospital antenatal clinic covering the majority of the population of Edinburgh City. The target group was all pregnant women booking at the clinic over 10 months. The design was an RCT involving four combinations of written and verbal communication, followed by the direct offer of an HIV test with written consent required for testing.
Women were sent either a specific leaflet about HIV testing in pregnancy or a leaflet containing information about HIV testing amongst information on the other antenatal blood tests. At the clinic, a core group of ten trained midwives offered the test, following either minimal or comprehensive pre-test discussion protocols printed on cards. The control group received no information and no direct offer of a test, although testing was available on request (the pre-trial situation).
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Primary outcome measure(s)
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The main outcome measures were uptake of HIV testing, knowledge of HIV and other antenatal tests, satisfaction with the consultation, anxiety, attitudes towards pregnancy and perceived benefits of testing. Opinions about testing during pregnancy were also sought using both quantitative and qualitative measures. Midwives' knowledge and attitudes were assessed to investigate their effect on women's uptake of testing.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1999 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/10350448
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Contact name
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Dr
Frank
Johnstone
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Address
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Dept of Obstetrics and Gynaecology
University of Edinburgh
37 Chalmers Street
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City/town
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Edinburgh
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Zip/Postcode
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EH3 9EW
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Country
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United Kingdom
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Tel
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+44 (0)131 229 2575 x2315
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Fax
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+44 (0)131 229 2408
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Email
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fdj@srv1.med.ed.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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28/08/2009
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Date ISRCTN assigned
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25/04/2003
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