HIV Testing in Pregnant Women: Evaluating an Opt-Out Testing Strategy

This study has been completed.
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00393302
First received: October 26, 2006
Last updated: July 16, 2008
Last verified: July 2008

October 26, 2006
July 16, 2008
September 2003
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00393302 on ClinicalTrials.gov Archive Site
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HIV Testing in Pregnant Women: Evaluating an Opt-Out Testing Strategy
HIV Testing in Pregnant Women: An Evaluation of an Opt-Out Strategy in an Ambulatory Care Clinic Setting

Mother-to-child transmission of HIV is an important but preventable mode of infection. Prevention depends on identifying pregnant women infected with HIV and offering medications during pregnancy which can dramatically decrease the chances of transmission. Currently universal screening of all pregnant women for HIV is recommended in the province of Ontario. Unfortunately the rates of screening are still low: estimates place the average rate at 50% -60%. We believe that rates in our clinic at the Women's Health Care Centre are significantly higher in part because all our patients have a first obstetrical visit. This is an unhurried visit with a trained obstetrical nurse who offers pre-test counselling and explores reasons why patients refuse testing. We hypothesize that with this system, acceptance rates for HIV screening are significantly higher than the provincial average.

We hypothesize that by having a dedicated and unhurried intake visit with a trained obstetrical nurse, pregnant women will be more likely to accept antenatal HIV testing. We further hypothesize that in our obstetrical clinic at the Women's Health Care Centre, the application of a universal opt-out screening policy will result in a testing rate that is higher than the provincial average.

This is a two part study. The first part will be a retrospective chart review while the second part will be a prospective cohort study. All antenatal patients with first visits at our clinic will be included. For the retrospective portion, 537 charts will be reviewed. For the prospective portion, 537 patients will be enrolled prospectively using a data sheet which will be included in all charts starting when the study begins. For both portions, the following information will be obtained:

  • presence of HIV test
  • result of test
  • if test not performed, the reason documented, in any
  • if testing refused, the reason for refusal

Additional information that will be obtained includes:

  • number of HIV positive pregnant women cared for in our clinic during the study period
  • percentage of positive cases
  • difference in testing (acceptance) rates between the retrospective and prospective (when data sheet in use) portions of the study.
Observational
Observational Model: Cohort
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Non-Probability Sample

All pregnant women attending antenatal intake appointments at the Women's Health Care Centre at St. Michael's Hospital in Toronto, Canada between September 2003 and February 2006.

  • HIV
  • AIDS Virus
  • Pregnancy
Procedure: HIV screening in pregnancy
1 & 2
  1. Retrospective chart review: HIV testing rates
  2. Prospective cohort group: HIV testing rates
Intervention: Procedure: HIV screening in pregnancy
Yudin MH, Moravac C, Shah RR. Influence of an "opt-out" test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol. 2007 Jul;110(1):81-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1074
February 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All pregnant women attending antenatal intake appointments at the Women's Health Care Centre at St. Michael's Hospital in Toronto, Canada between September 2003 and February 2005.

Exclusion Criteria:

  • Any pregnant women obtaining antenatal care at other health care facilities.
Female
16 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00393302
REB 03-326C
No
Dr. Mark Yudin, Obstetrician/Gynecologist, Research Scientist, St. Michael's Hospital
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Mark H Yudin, MD MSc St. Michael's Hospital & the University of Toronto
St. Michael's Hospital, Toronto
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP