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| Sponsored by: |
St. Michael's Hospital, Toronto |
|---|---|
| Information provided by: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT00393302 |
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 IV |
| Study Type: | Observational |
| Study Design: | Cohort |
| Official Title: | HIV Testing in Pregnant Women: An Evaluation of an Opt-Out Strategy in an Ambulatory Care Clinic Setting |
| 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
|
Procedure: HIV screening in pregnancy |
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:
Additional information that will be obtained includes:
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Principal Investigator: | Mark H Yudin, MD MSc | St. Michael's Hospital & the University of Toronto |
More Information
| Responsible Party: | St. Michael's Hospital ( Dr. Mark Yudin, Obstetrician/Gynecologist, Research Scientist ) |
| Study ID Numbers: | REB 03-326C |
| Study First Received: | October 26, 2006 |
| Last Updated: | July 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00393302 |
| Health Authority: | Canada: Ethics Review Committee |
|
HIV testing in pregnant women |
|
Virus Diseases Antibodies HIV Antibodies |
HIV Infections Acquired Immunodeficiency Syndrome Immunoglobulins |
|
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
