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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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28 August 2023 |
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Main ID: |
NCT03149237 |
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Date of registration:
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03/05/2017 |
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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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Partners-based HIV Treatment for Couples Attending Antenatal Care
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Scientific title:
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Partners-based HIV Treatment for Sero-concordant Couples Attending Antenatal Care |
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Date of first enrolment:
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November 16, 2017 |
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Target sample size:
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2160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03149237 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Mozambique
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Contacts
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Name:
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Erin Graves, MPH, BSN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Couples, one HIV+ pregnant woman and her infected male partner, will be eligible to
participate if the woman's due date is >2 weeks from enrollment. Both persons must
also be 18 years or older, able to give consent, willing to consent to an infant
record search, and must agree to enroll in ART together.
Exclusion Criteria:
- Couples will not be eligible to participate in the study if the woman is not pregnant,
if both persons are not HIV+, if either person is younger than 18 years, if one member
of the couple is unwilling to enroll in ART or consent to the infant record search, or
if one member of the couple is unable to give consent due to mental limitations.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus
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Intervention(s)
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Behavioral: Couples-based services
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Primary Outcome(s)
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Proportion of Days With Medication Among Male Partner
[Time Frame: 12 months]
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Proportion of Time on Medication Among Pregnant Women
[Time Frame: 12 months]
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Secondary ID(s)
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170365
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R01MH113478-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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