Psychotherapy & Counseling |
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Clinical Trial: Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission
This study is currently recruiting patients.
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Purpose
Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their newborns decrease rates of mother-to-child transmission (MTCT) of HIV. This study will determine the acceptability of HIV counseling and rapid testing prior to delivery and will compare the usefulness of VCT prior to birth versus after birth in preventing MTCT of HIV in pregnant women in Cape Town, South Africa. This study will also determine the acceptability and effectiveness of giving anti-HIV medications to prevent MTCT of HIV.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections | Procedure: Intrapartum HIV counseling/testing Procedure: Postpartum HIV counseling/testing |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Mother Infant Rapid Intervention at Delivery (MIRIAD)
Expected Total Enrollment: 12000
Pediatric HIV infection is a major public health problem in South Africa, and is primarily caused by MTCT of HIV. Strategies to prevent MTCT have been successfully employed when a mother's HIV status is known. However, there is concern in South Africa that it is unethical to offer HIV testing to women in the intrapartum period when they are experiencing the physical and emotional stress of labor. This study will compare the acceptability and accuracy of intrapartum and postpartum VCT in pregnant women of unknown HIV status in Cape Town, South Africa. HIV transmission rates among the two groups will also be compared.
Pregnant women of unknown HIV status coming to a participating hospital to deliver will be asked to enter the trial. Women will be assigned to either intrapartum or postpartum VCT depending on the week during which they come to the hospital. The intervention (intrapartum or postpartum VCT) for the week will be randomly assigned and all women enrolling in the trial in a given week will receive the same intervention.
All women will receive HIV counseling prior to testing. Women in the intrapartum VCT group who are HIV infected will receive antiretrovirals (ARV) prior to delivery to prevent MTCT, and their infants will receive ARV within 3 days of birth. Infants born to HIV infected women in the postpartum VCT group will receive ARV as soon as possible after confirmation of the mother's positive test. All women will receive post-test counseling prior to discharge.
HIV VCT, medical history assessment, and physical exam will occur at study entry. A small subset of both HIV infected and uninfected mothers will be asked for their opinions regarding peripartum HIV VCT and MTCT prevention strategies during qualitative assessments.
Infants will undergo physical exam within 2 days of birth; medical history assessment within 2 days of birth and at 3 additional times between 6 and 14 weeks of age; and HIV testing within 2 days of birth and at 2 additional times between 6 and 12 weeks of age.
Eligibility
Ages Eligible for Study: 14 Years and above, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria for Women:
Inclusion Criteria for Infants:
- Mother is participating in study
- Mother is HIV infected
Exclusion Criteria for Women:
- In labor or having immediate delivery
- Planned induction or Caesarean delivery, or other condition requiring planned delivery
- Obstetrical emergencies in which the woman is medically unstable or requires emergency delivery
- Diagnosed fetal death or fetal condition requiring abortion
Location and Contact Information
South Africa
Hottentots Holland Hospital, Cape Town, 7505, South Africa; Recruiting
Robert Maupin, Jr., MD, Study Chair, Louisiana State University Health Science Center
Mitchell Besser, MD, Study Chair, Department of Obstetrics and Gynecology, Groote Schuur Hospital Observatory
More Information
Click here for more information about HIV and Pregnancy
Haga clic aquí para ver información sobre este ensayo clínico en español.
Publications
Gisselquist D, Potterat JJ, Brody S. HIV transmission during paediatric health care in sub-Saharan Africa--risks and evidence. S Afr Med J. 2004 Feb;94(2):109-16. Review.
Jaspan HB, Garry RF. Preventing neonatal HIV: a review. Curr HIV Res. 2003 Jul;1(3):321-7. Review.
Mofenson LM. Advances in the prevention of vertical transmission of human immunodeficiency virus. Semin Pediatr Infect Dis. 2003 Oct;14(4):295-308. Review.
Pillay T, Khan M, Moodley J, Adhikari M, Coovadia H. Perinatal tuberculosis and HIV-1: considerations for resource-limited settings. Lancet Infect Dis. 2004 Mar;4(3):155-65. Review.
Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. Review.
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.
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.
Record last reviewed: November 2004
Last Updated: April 7, 2005
Record first received: June 4, 2004
ClinicalTrials.gov Identifier: NCT00084045
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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