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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139087
• Other study ID #: CDC-NCHSTP-3010
• Status: Completed
• Phase: N/A
• First received: August 29, 2005
• Last updated: August 29, 2005
• Start date: January 2002
• Est. completion date: March 2005

Study information

• Verified date: August 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Telephone Outreach for Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.