Rapid HIV Tests for Women Late in Pregnancy and During Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2004-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes