Completed

Mother Infant Rapid Intervention at Delivery (MIRIAD)

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 14 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2004
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleMother Infant Rapid Intervention at Delivery (MIRIAD) 
NCT00084045
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

283 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Hottentots Holland Hospital

Cape Town, South AfricaSee the location
Suspended

Maccassar Community Health Clinic

Cape Town, South Africa
Completed2 Study Centers