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HIV InfectionsNCT00084045

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

A study testing Intrapartum HIV counseling/testing and Postpartum HIV counseling/testing in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 14 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Intrapartum HIV counseling/testing and Postpartum HIV counseling/testing
Type of treatment
Surgery or procedure
How many people
283 participants
Where
2 sitesSouth Africa
Study dates
Nov 2004to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • Mother is participating in study
  • Mother is HIV infected

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Hottentots Holland Hospital

    Cape Town, 7505

  • Maccassar Community Health Clinic

    Cape Town, 7505

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
Intrapartum HIV counseling/testing, Postpartum HIV counseling/testing
Keywords
HIV Seronegativity, Treatment Naive, Pediatric HIV, Perinatal Transmission
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrapartum HIV counseling/testingProcedure or surgery

  • Postpartum HIV counseling/testingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time required to obtain informed consent

  2. time from initiation of HIV pre-test counseling until test results are available

  3. proportion of test evaluations completed before delivery

  4. proportion of test evaluations completed before hospital discharge

  5. proportion of women who agree to HIV testing

  6. proportion of women identified as HIV infected during labor who accept ARV prophylaxis

  7. proportion of women identified as HIV infected after birth who accept ARV therapy for their infants

  8. 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

  9. timing of mother ARV initiation as a proportion of women identified as HIV infected during labor and as a continuous variable

  10. 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 outcomes (6)

  1. Proportion of women with undocumented HIV infection who are tested and determined to be HIV infected peripartum

  2. performance of rapid HIV tests as measured by sensitivity and specificity

  3. proportion of infants who complete the Week 6 study visit and efforts needed to accomplish this visit

  4. 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

  5. proportion of HIV-exposed infants who acquire HIV infection during delivery and after birth

  6. acceptance of HIV counseling and testing among clinical personnel at primary, secondary, and tertiary care facilities

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2004 (estimated)
  2. Study startNov 2004
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084045
Sponsor's protocol ID
PACTG P1031A
Other IDs
MIRIAD
Status last verified
Oct 2012
First submitted
4 Jun 2004
Last updated
30 Oct 2012
Results posted
No

Publications

  • Leroy V, Sakarovitch C, Cortina-Borja M, McIntyre J, Coovadia H, Dabis F, Newell ML, Saba J, Gray G, Ndugwa Ch, Kilewo Ch, Massawe A, Kituuka P, Okong P, Grulich A, von Briesen H, Goudsmit J, Biberfeld G, Haverkamp G, Weverling GJ, Lange JM; Ghent Group on HIV in Women and Children. Is there a difference in the efficacy of peripartum antiretroviral regimens in reducing mother-to-child transmission of HIV in Africa? AIDS. 2005 Nov 4;19(16):1865-75. doi: 10.1097/01.aids.0000188423.02786.55.

    PubMed 16227795

  • McIntyre J. Strategies to prevent mother-to-child transmission of HIV. Curr Opin Infect Dis. 2006 Feb;19(1):33-8. doi: 10.1097/01.qco.0000200290.99790.72.

    PubMed 16374215

  • Newell ML. Current issues in the prevention of mother-to-child transmission of HIV-1 infection. Trans R Soc Trop Med Hyg. 2006 Jan;100(1):1-5. doi: 10.1016/j.trstmh.2005.05.012. Epub 2005 Oct 7.

    PubMed 16214193

  • Bulterys M, Jamieson DJ, O'Sullivan MJ, Cohen MH, Maupin R, Nesheim S, Webber MP, Van Dyke R, Wiener J, Branson BM; Mother-Infant Rapid Intervention At Delivery (MIRIAD) Study Group. Rapid HIV-1 testing during labor: a multicenter study. JAMA. 2004 Jul 14;292(2):219-23. doi: 10.1001/jama.292.2.219.

    PubMed 15249571

  • Jamieson DJ, O'Sullivan MJ, Maupin R, Cohen M, Webber MP, Nesheim S, Lampe M, Garcia P, Lindsay M, Bulterys M. The challenges of informed consent for rapid HIV testing in labor. J Womens Health (Larchmt). 2003 Nov;12(9):889-95. doi: 10.1089/154099903770948113.

    PubMed 14670168

Questions about this trial

What is this clinical trial studying?

A study testing Intrapartum HIV counseling/testing and Postpartum HIV counseling/testing in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time required to obtain informed consent. The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00084045, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.

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