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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01891799 |
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Date of registration:
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28/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Swaziland Safe Generations
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Scientific title:
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Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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2518 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01891799 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Swaziland
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Contacts
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Name:
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Elaine J Abrams, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women at least 18 years of age
- Documented pregnancy (per routine ANC protocol in this setting)
- Documented HIV-infection (per routine ANC protocol in this setting)
- Infants born to eligible and enrolled women
Exclusion Criteria:
• Women already on ART when entering ANC
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
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Intervention(s)
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Other: Option B+
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Primary Outcome(s)
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Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum
[Time Frame: Up to 24 months]
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Secondary Outcome(s)
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Proportion of women and children retained in HIV care at 12 and 18 months postpartum
[Time Frame: Up to 24 months]
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Duration of ART/ARV received prior to delivery
[Time Frame: Up to 24 months]
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Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
[Time Frame: Up to 24 months]
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Secondary ID(s)
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AAAL0661
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AID-OAA-A-12-000020
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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