NCT00393302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,074

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

October 26, 2006

Last Update Submit

February 20, 2019

Conditions

Keywords

HIV testing in pregnant women

Study Arms (1)

1 & 2

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

Procedure: HIV screening in pregnancy

Interventions

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

HIV TestingPregnancy

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Mark H Yudin, MD MSc

    St. Michael's Hospital & the University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

September 1, 2003

Primary Completion

January 1, 2006

Study Completion

February 1, 2006

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations