A randomised controlled trial of different approaches to universal antenatal Human Immunodeficiency Virus (HIV) testing: acceptability, costs and benefits
| ISRCTN | ISRCTN40371436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40371436 |
| Secondary identifying numbers | HTA 93/24/11 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Frank Johnstone
Scientific
Scientific
Dept of Obstetrics and Gynaecology
University of Edinburgh
37 Chalmers Street
Edinburgh
EH3 9EW
United Kingdom
| Phone | +44 (0)131 229 2575 x2315 |
|---|---|
| fdj@srv1.med.ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A randomised controlled trial of different approaches to universal antenatal Human Immunodeficiency Virus (HIV) testing: acceptability, costs and benefits |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/1995 |
| Completion date | 31/07/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3024 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 31/07/1998 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dept of Obstetrics and Gynaecology
Edinburgh
EH3 9EW
United Kingdom
EH3 9EW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | HTA monograph | 01/04/1999 | Yes | No |
Editorial Notes
08/11/2022: Internal review.
