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

Centers for Disease Control and Prevention (CDC) logo

Centers for Disease Control and Prevention (CDC)

Status

Completed

Conditions

HIV

Treatments

Behavioral: Telephone Outreach for Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00139087
CDC-NCHSTP-3010

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 hour to 2 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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