Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission
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|ClinicalTrials.gov Identifier: NCT00084045|
Recruitment Status : Completed
First Posted : June 7, 2004
Last Update Posted : October 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Procedure: Intrapartum HIV counseling/testing Procedure: Postpartum HIV counseling/testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||283 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mother Infant Rapid Intervention at Delivery (MIRIAD)|
|Study Start Date :||November 2004|
|Actual Study Completion Date :||December 2006|
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084045
|Hottentots Holland Hospital|
|Cape Town, South Africa, 7505|
|Maccassar Community Health Clinic|
|Cape Town, South Africa, 7505|
|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|