HIV
Conditions
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.
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.
Interventions
BEHAVIORALTelephone Outreach for Therapy
Sponsors
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 2 Weeks
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed