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

Sponsored by:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00139087

Purpose

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

MedlinePlus related topics: AIDS Caregivers

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	up to 2 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139087

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Study Director:

Susan P Danner, BA

Centers for Disease Control and Prevention

More Information

Study ID Numbers:	CDC-NCHSTP-3010
Study First Received:	August 29, 2005
Last Updated:	August 29, 2005
ClinicalTrials.gov Identifier:	NCT00139087
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 16, 2009