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CompletedNCT00139087Updated Aug 31, 2005

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

An interventional study of Telephone Outreach for Therapy in HIV, sponsored by Centers for Disease Control and Prevention. Completed. Open to participants aged 1 Hour to 2 Weeks. Per ClinicalTrials.gov, last updated 2005-08-31.

Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
1 Hour to 2 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV
03

In context

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 2 Weeks
Sexes eligible
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

Exclusion Criteria:

  • Mother-infant pairs in which the infant is expected to be hospitalized for >2weeks after birth
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants

Interventions

  • BehavioralTelephone Outreach for Therapy
06

What researchers measure

Primary outcomes

  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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00139087
Lead sponsor
Centers for Disease Control and Prevention
First posted
Aug 31, 2005
Start date
Jan 2002
Completion
Mar 2005
Last update
Aug 31, 2005

Study contacts

Susan P Danner, BA
study director · Centers for Disease Control and Prevention
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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