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

February 20, 2019 updated by: Unity Health Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1074

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 & 2
  1. Retrospective chart review: HIV testing rates
  2. Prospective cohort group: HIV testing rates
Procedure: HIV screening in pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Mark H Yudin, MD MSc, St. Michael's Hospital & the University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

October 26, 2006

First Submitted That Met QC Criteria

October 26, 2006

First Posted (Estimate)

October 27, 2006

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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