Contact information
Type
Scientific
Primary contact
Dr Frank Johnstone
ORCID ID
Contact details
Dept of Obstetrics and Gynaecology
University of Edinburgh
37 Chalmers Street
Edinburgh
EH3 9EW
United Kingdom
+44 (0)131 229 2575 x2315
fdj@srv1.med.ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/24/11
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Infection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS); Pregnancy and childbirth: Pregnancy
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/04/1995
Overall trial end date
31/07/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3024
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/04/1995
Recruitment end date
31/07/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Obstetrics and Gynaecology
Edinburgh
EH3 9EW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1999 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/10350448
Publication citations
-
HTA monograph
Simpson WM, Johnstone FD, Boyd FM, Goldberg DJ, Hart GJ, Gormley SM, Hamilton BA, A randomised controlled trial of different approaches to universal antenatal HIV testing: uptake and acceptability and Annex: Antenatal HIV testing - assessment of a routine voluntary approach., Health Technol Assess, 1999, 3, 4, 1-112.