Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00084045
First received: June 4, 2004
Last updated: October 26, 2012
Last verified: October 2012

June 4, 2004
October 26, 2012
November 2004
Not Provided
  • Time required to obtain informed consent
  • time from initiation of HIV pre-test counseling until test results are available
  • proportion of test evaluations completed before delivery
  • proportion of test evaluations completed before hospital discharge
  • proportion of women who agree to HIV testing
  • proportion of women identified as HIV infected during labor who accept ARV prophylaxis
  • proportion of women identified as HIV infected after birth who accept ARV therapy for their infants
  • timing of infant ARV prophylaxis initiation after birth, as a proportion of infants born to women identified as HIV infected after birth and as a continuous variable
  • timing of mother ARV initiation as a proportion of women identified as HIV infected during labor and as a continuous variable
  • qualitative measures (defined as available space, study staff allocation, support for counseling and testing, and women's perceptions and opinions of counseling and testing)
Not Provided
Complete list of historical versions of study NCT00084045 on ClinicalTrials.gov Archive Site
  • Proportion of women with undocumented HIV infection who are tested and determined to be HIV infected peripartum
  • performance of rapid HIV tests as measured by sensitivity and specificity
  • proportion of infants who complete the Week 6 study visit and efforts needed to accomplish this visit
  • proportion of infants being fed according to the method chosen at discharge (defined as exclusive breastfeeding, exclusive formula feeding, or mixed feeding), as reported by the mother at Week 6
  • proportion of HIV-exposed infants who acquire HIV infection during delivery and after birth
  • acceptance of HIV counseling and testing among clinical personnel at primary, secondary, and tertiary care facilities
Not Provided
Not Provided
Not Provided
 
Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission
Mother Infant Rapid Intervention at Delivery (MIRIAD)

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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Procedure: Intrapartum HIV counseling/testing
  • Procedure: Postpartum HIV counseling/testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
December 2006
Not Provided

Inclusion Criteria for Women:

  • Unknown HIV infection status
  • At least seven months pregnant
  • Women in active labor who have planned induction or Caesarean delivery or any other condition requiring planned delivery

Inclusion Criteria for Infants:

  • Mother is participating in study
  • Mother is HIV infected

Exclusion Criteria for Women:

  • Women in labor who need immediate delivery
  • Obstetrical emergencies in which the woman is medically unstable or requires emergency delivery
  • Diagnosed fetal death or fetal condition requiring abortion
Female
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00084045
PACTG P1031A, MIRIAD
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Robert Maupin, Jr., MD Louisiana State University Health Science Center
Study Chair: Mitchell Besser, MD Department of Obstetrics and Gynecology, Groote Schuur Hospital Observatory
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP