Rapid HIV Tests for Women Late in Pregnancy and During Labor
Rapid HIV Tests for Women Late in Pregnancy and During Labor
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.
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