Clinical Trials

MainTitle

Rapid HIV Tests for Women Late in Pregnancy and During Labor

This study has been terminated
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
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
History of Changes
Purpose

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)

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes 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

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

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)

Investigators

Study Chair: Robert Maupin, Jr., MD Louisiana State University Health Sciences Center in New Orleans
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00046436   History of Changes  
Other Study ID Numbers: PACTG P1031  
Study First Received: September 30, 2002  
Last Updated: May 31, 2013  

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:
HIV Infections

ClinicalTrials.gov processed this data on December 14, 2018
This information is provided by ClinicalTrials.gov.