Rapid HIV Tests for Women Late in Pregnancy and During Labor

HIV Infections Clinical Trial

Official title:

Mother-Infant Rapid Intervention at Delivery (MIRIAD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00046436
• Other study ID #: PACTG P1031
• Status: Terminated
• Phase: N/A
• First received: September 30, 2002
• Last updated: May 31, 2013
• Est. completion date: March 2004

Study information

• Verified date: May 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7500
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
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)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bulterys M, Jamieson DJ, O'Sullivan MJ, Cohen MH, Maupin R, Nesheim S, Webber MP, Van Dyke R, Wiener J, Branson BM; Mother-Infant Rapid Intervention At Delivery (MIRIAD) Study Group. Rapid HIV-1 testing during labor: a multicenter study. JAMA. 2004 Jul 14;292(2):219-23. — View Citation

Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Dransfield K, Bray D, Mmiro F, Jackson JB. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999 Sep 4;354(9181):795-802. — View Citation

Jamieson DJ, O'Sullivan MJ, Maupin R, Cohen M, Webber MP, Nesheim S, Lampe M, Garcia P, Lindsay M, Bulterys M. The challenges of informed consent for rapid HIV testing in labor. J Womens Health (Larchmt). 2003 Nov;12(9):889-95. — View Citation

Kelen GD, Shahan JB, Quinn TC. Emergency department-based HIV screening and counseling: experience with rapid and standard serologic testing. Ann Emerg Med. 1999 Feb;33(2):147-55. — View Citation

Minkoff H, O'Sullivan MJ. The case for rapid HIV testing during labor. JAMA. 1998 Jun 3;279(21):1743-4. — View Citation

Shaffer N, Chuachoowong R, Mock PA, Bhadrakom C, Siriwasin W, Young NL, Chotpitayasunondh T, Chearskul S, Roongpisuthipong A, Chinayon P, Karon J, Mastro TD, Simonds RJ. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group. Lancet. 1999 Mar 6;353(9155):773-80. — View Citation

External Links

•   Click here for more information about HIV and Pregnancy
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