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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: |
NCT02295800 |
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Date of registration:
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15/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
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Scientific title:
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The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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1216 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02295800 |
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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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Rwanda
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Contacts
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Name:
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Emily A. Bobrow, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Elizabeth Glaser Pediatric AIDS Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented HIV infection
- Pregnant, in the last trimester of pregnancy or within two weeks post-delivery.
- Participation in the PMTCT program during antenatal care at one of the study sites
- Planning on remaining in the Kigali area after delivery
- Able and willing to give informed consent for study participation for herself and her
infant(s).
If a pregnant woman is less than 18 years of age and still living with her parents,
informed consent will also be required from one of her parents
Exclusion Criteria:
- Women not willing to provide informed consent to participate
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Mother-to-child HIV Transmission
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Intervention(s)
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Other: Standard of care
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Other: Semi-structured interviews
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Primary Outcome(s)
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18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
[Time Frame: 18 - 24 months]
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Secondary Outcome(s)
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Infants and young children breastfed (exclusive or any breastfeeding) at various ages
[Time Frame: 18 - 24 months]
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HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages
[Time Frame: 18 - 24 months]
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Adherence to the universal antiretroviral therapy (ARV) regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children, including the proportion of study women with HIV RNA < 1000 copies/ml or > 2 log10 copies/mL decrease in viral
[Time Frame: 18 - 24 months]
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Secondary ID(s)
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EGPAF0098
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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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