Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission
Mother Infant Rapid Intervention at Delivery (MIRIAD)
2 other identifiers
interventional
283
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Nov 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2004
CompletedFirst Posted
Study publicly available on registry
June 7, 2004
CompletedStudy Start
First participant enrolled
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 30, 2012
October 1, 2012
June 4, 2004
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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 Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hottentots Holland Hospital
Cape Town, 7505, South Africa
Maccassar Community Health Clinic
Cape Town, 7505, South Africa
Related Publications (5)
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.
PMID: 16227795BACKGROUNDMcIntyre 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.
PMID: 16374215BACKGROUNDNewell 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.
PMID: 16214193BACKGROUNDBulterys 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.
PMID: 15249571RESULTJamieson 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.
PMID: 14670168RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2004
First Posted
June 7, 2004
Study Start
November 1, 2004
Study Completion
December 1, 2006
Last Updated
October 30, 2012
Record last verified: 2012-10