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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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26 October 2021 |
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Main ID: |
NCT03052010 |
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Date of registration:
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05/02/2017 |
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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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The Partners Scale-Up Project
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Scientific title:
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Delivery of Integrated PrEP and ART for Couples in Kenya |
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Date of first enrolment:
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February 6, 2017 |
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Target sample size:
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4898 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03052010 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Jared Baeten, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Name:
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Kenneth K. Mugwanya, MBChB, MS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For HIV-1 uninfected members of the couple
- Age =18
- Able and willing to provide consent for follow-up in the cohort
- HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
- Not currently using PrEP
For HIV-1 infected members of the couple
- Age =18
- Able and willing to provide consent for follow-up in the cohort
- HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines
- Not currently using ART
For both members of the couple - Meet criteria for initiating PrEP as per Kenya national
guidelines, including:
- HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not
virally suppressed based on a viral load test done at the clinic as per Kenya national
guidelines or
- Trying to conceive
For key delivery informants
- Able and willing to provide consent
Exclusion Criteria:
- Otherwise not eligible based on the above inclusion criteria
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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HIV-1-infection
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Intervention(s)
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Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy
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Drug: ART
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Drug: PrEP
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Primary Outcome(s)
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Facilitators and barriers to implementation of integrated PrEP and ART
[Time Frame: up to 36 months]
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Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
[Time Frame: up to 36 months]
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ART adherence
[Time Frame: up to 6 months]
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Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
[Time Frame: up to 36 months]
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PrEP adherence
[Time Frame: up to 6 months]
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ART initiation
[Time Frame: up to 36 months]
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HIV-1 uninfected partners staying HIV-1 uninfected.
[Time Frame: up to 36 months]
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PrEP delivery operational tools
[Time Frame: 24 months]
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PrEP initiation
[Time Frame: up to 36 months]
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Secondary ID(s)
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STUDY00002183
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2R01MH095507
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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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