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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
AIDS Virus
Pregnancy
 Procedure: HIV screening in pregnancy
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: HIV Testing in Pregnant Women: An Evaluation of an Opt-Out Strategy in an Ambulatory Care Clinic Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Enrollment: 1074
Study Start Date: September 2003
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 & 2
  1. Retrospective chart review: HIV testing rates
  2. Prospective cohort group: HIV testing rates
 Procedure: HIV screening in pregnancy

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.
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393302

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Mark H Yudin, MD MSc St. Michael's Hospital & the University of Toronto
  More Information

No publications provided by St. Michael's Hospital, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Mark Yudin, Obstetrician/Gynecologist, Research Scientist, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00393302     History of Changes
Other Study ID Numbers: REB 03-326C
Study First Received: October 26, 2006
Last Updated: July 16, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
HIV testing in pregnant women

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013