Rapid HIV Tests for Women Late in Pregnancy and During Labor

NCT00046436 | Terminated

• 1 other identifier: PACTG P1031
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

AIDS Serodiagnosis; Pregnancy Complications, Infectious; Anti-HIV Agents; Disease Transmission, Vertical

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Centers for Disease Control and Prevention: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

• Minkoff H, O'Sullivan MJ. The case for rapid HIV testing during labor. JAMA. 1998 Jun 3;279(21):1743-4. doi: 10.1001/jama.279.21.1743. No abstract available.

  PMID: 9624029 BACKGROUND

• 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. doi: 10.1016/s0196-0644(99)70387-2.

  PMID: 9922409 BACKGROUND

• 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. doi: 10.1016/S0140-6736(99)80008-7.

  PMID: 10485720 BACKGROUND

• 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. doi: 10.1016/s0140-6736(98)10411-7.

  PMID: 10459957 BACKGROUND

• 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. doi: 10.1001/jama.292.2.219.

  PMID: 15249571 BACKGROUND

• 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. doi: 10.1089/154099903770948113.

  PMID: 14670168 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Robert Maupin, Jr., MD

  Louisiana State University Health Sciences Center in New Orleans

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 30, 2002
• First Posted: October 1, 2002
• Study Completion: March 1, 2004
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

US (1)