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

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

HIV Infections

Treatments

Procedure: Postpartum HIV counseling/testing

Procedure: Intrapartum HIV counseling/testing

Study type

Interventional

Funder types

NIH

Identifiers

NCT00084045

PACTG P1031A

MIRIAD

Details and patient eligibility

About

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.

Full 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.

Enrollment

283 patients

Sex

Female

Ages

14+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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