Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00139087
• Collaborator: (none)
• Enrollment: 300
• Duration (Months): 37.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV	Behavioral: Telephone Outreach for Therapy	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.
• Study Start Date: Jan 1, 2002
• Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Hour to 2 Weeks
• Sexes Eligible for Study: All
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centers for Disease Control and Prevention

Investigators

• Study Director: Susan P Danner, BA, Centers for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139087
• Other Study ID Numbers: CDC-NCHSTP-3010
• First Posted: Aug 31, 2005
• Last Update Posted: Aug 31, 2005
• Last Verified: Aug 1, 2005

Study Results

No Results Posted as of Aug 31, 2005