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Rapid HIV Tests for Women Late in Pregnancy and During Labor

This study has been terminated.
Sponsor:
Collaborators:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00046436
First received: September 30, 2002
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women accept being tested for HIV late in pregnancy and during labor. For women with positive test results, the study will look at whether or not these women accept anti-HIV drugs and which drugs they receive.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Mother-Infant Rapid Intervention at Delivery (MIRIAD)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 7500
Study Completion Date: March 2004
Detailed Description:

A simple HIV test design and easily interpretable, fast results are logistical advantages in clinical settings such as the labor and delivery unit. A fast test result means that a woman can make important choices about her and her baby's medical care before she delivers her baby. If a woman finds out she has HIV, she can decide to take antiretroviral drugs before delivery to decrease the risk of passing HIV to her baby. These advantages are also important for women with little or no prenatal care who present for care late in pregnancy, but may not be inclined to return for a standard test result or adhere to subsequent prenatal visits.

Eligible women who elect to participate in this study will be enrolled in either the Late Presenter Group (women who are not in active labor, and for whom delivery is not imminent) or the Peripartum Group (women who are in active labor with anticipation of delivery within 24 hours). Step I for all women will include rapid HIV testing with OraQuick HIV 1/2 and standard testing with enzyme-linked immunosorbant assay (EIA) or Western blot. Women with a positive HIV test and their infants will be offered preventative antiretroviral therapy and enrollment into Step II. Step II will include clinical evaluations, laboratory evaluations, and an adherence assessment for the women and their infants. Women in the Late Presenter Group who participate in Step II will have one prenatal visit, a visit at labor and delivery, and three postpartum visits. Women in the Peripartum Group who participate in Step II will have three postpartum visits. All infants in Step II will have five study visits through 24 weeks of age.

All antiretroviral drugs will be obtained by prescription and will not be provided through this study.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

Late Presenter Group:

  • Unknown HIV serostatus
  • >= 34 weeks gestation

Peripartum Group:

  • Unknown HIV serostatus
  • >= 24 weeks gestation
  • In active labor or delivery expected within 24 hours

Infants:

  • Maternal Step I enrollment
  • Positive maternal OraQuick and/or EIA/Western blot result

EXCLUSION CRITERIA

Late Presenter Group:

  • Previous or current antiretroviral therapy for treatment of HIV infection
  • In active labor
  • Evidence of ruptured membranes

Peripartum Group:

  • Previous or current antiretroviral therapy for treatment of HIV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046436

Locations
United States, Pennsylvania
Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Robert Maupin, Jr., MD Louisiana State University Health Sciences Center in New Orleans
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00046436     History of Changes
Other Study ID Numbers: PACTG P1031
Study First Received: September 30, 2002
Last Updated: May 31, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS Serodiagnosis
Pregnancy Complications, Infectious
Anti-HIV Agents
Disease Transmission, Vertical

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014