Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.
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The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.
Condition | Intervention |
---|---|
HIV |
Behavioral: Telephone Outreach for Therapy |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial. |
- Neonatal adherence to zidovudine syrup measured as self report of the mother or caregiver AND drug level measured in heel stick specimens collected at 2, 4 and 6 weeks of life.
Estimated Enrollment: | 300 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | March 2005 |
The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.
Ages Eligible for Study: | up to 2 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mother-infant pairs in which the mother was identified as HIV-infected in the MIRIAD Study
Exclusion Criteria:
- Mother-infant pairs in which the infant is expected to be hospitalized for >2weeks after birth
No publications provided
ClinicalTrials.gov Identifier: | NCT00139087 History of Changes |
Other Study ID Numbers: | CDC-NCHSTP-3010 |
Study First Received: | August 29, 2005 |
Last Updated: | August 29, 2005 |
Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on October 16, 2012