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
  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 Intervention
HIV Infections
Procedure: Intrapartum HIV counseling/testing
Procedure: Postpartum HIV counseling/testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Mother Infant Rapid Intervention at Delivery (MIRIAD)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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

Enrollment: 283
Study Start Date: November 2004
Study Completion Date: December 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084045

Locations
South Africa
Hottentots Holland Hospital
Cape Town, South Africa, 7505
Maccassar Community Health Clinic
Cape Town, South Africa, 7505
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00084045     History of Changes
Other Study ID Numbers: PACTG P1031A, MIRIAD
Study First Received: June 4, 2004
Last Updated: October 26, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
Treatment Naive
Pediatric HIV
Perinatal Transmission

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014