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Rapid HIV Tests for Women Late in Pregnancy and During Labor

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00046436
First Posted: October 1, 2002
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
September 30, 2002
October 1, 2002
June 3, 2013
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Complete list of historical versions of study NCT00046436 on ClinicalTrials.gov Archive Site
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Rapid HIV Tests for Women Late in Pregnancy and During Labor
Mother-Infant Rapid Intervention at Delivery (MIRIAD)
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.

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.

Observational
Time Perspective: Prospective
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7500
March 2004
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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
Sexes Eligible for Study: Female
13 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
Puerto Rico
 
NCT00046436
PACTG P1031
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National Institute of Allergy and Infectious Diseases (NIAID)
  • Centers for Disease Control and Prevention
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Robert Maupin, Jr., MD Louisiana State University Health Sciences Center in New Orleans
National Institute of Allergy and Infectious Diseases (NIAID)
May 2013