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CompletedNCT00393302Updated Feb 22, 2019

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

An observational study in HIV, AIDS Virus and Pregnancy, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,074
Ages
16 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.
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Conditions studied

  • HIV
  • AIDS Virus
  • Pregnancy

Keywords

  • HIV testing in pregnant women
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In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 1,074 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

Exclusion Criteria:

  • Any pregnant women obtaining antenatal care at other health care facilities.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,074 participants (actual)

Groups and cohorts

  • 1 & 2

    1. Retrospective chart review: HIV testing rates 2. Prospective cohort group: HIV testing rates

    Procedure: HIV screening in pregnancy

Interventions

  • ProcedureHIV screening in pregnancy
06

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
07

References and documents

Publications

  • 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. doi: 10.1097/01.AOG.0000267497.39041.06. PubMed 17601900 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00393302
Lead sponsor
Unity Health Toronto
First posted
Oct 27, 2006
Start date
Sep 2003
Primary completion
Jan 2006
Completion
Feb 2006
Last update
Feb 22, 2019

Study contacts

Mark H Yudin, MD MSc
principal investigator · St. Michael's Hospital & the University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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