Condition category
Infections and Infestations
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

1999 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/10350448

Publication citations

  1. 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.

Additional files

Editorial Notes