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

26. oktober 2012 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektioner

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

283

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Sydafrika
- - Cape Town, Sydafrika, 7505
    - Hottentots Holland Hospital
  - Cape Town, Sydafrika, 7505
    - Maccassar Community Health Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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)

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

Studiestol: Robert Maupin, Jr., MD, Louisiana State University Health Science Center
Studiestol: Mitchell Besser, MD, Department of Obstetrics and Gynecology, Groote Schuur Hospital Observatory

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2004

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

4. juni 2004

Først indsendt, der opfyldte QC-kriterier