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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01414413 |
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Date of registration:
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10/08/2011 |
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Primary sponsor: |
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Public title:
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Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi
CONDA-YAPA |
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Scientific title:
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Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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16800 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01414413 |
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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, Masking: Open Label, Primary Purpose: Health Services Research
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Peter MacPherson, MBChB MPH MRes |
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Address:
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Telephone:
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+265 191 9304 |
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Email:
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p.macpherson@liverpool.ac.uk |
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Affiliation:
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Name:
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Peter MacPherson, MBChB MPH |
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Address:
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Telephone:
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+265 191 9304 |
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Email:
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p.macpherson@liverpool.ac.uk |
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Affiliation:
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Name:
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Peter MacPherson, MBChCB 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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Liverpool School of Tropical Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Usual resident of an eligible cluster
- Has had a positive HIV test (regardless of source) and requests facilitated access to
HIV care from the resident community counsellor
- Confirmatory HIV test is positive
- No previous ART treatment, or less than one month's treatment in the past (including
PMTCT interventions) and not currently receiving HIV care
- No contraindications to receiving ART (as defined by Integrated Management of Adult
Illnesses, HIV Department, WHO)
- No acute danger signs requiring hospital referral
- Aged 18 years or older
- Written or witnessed informed consent to participate in the study
Exclusion Criteria:
- Not a usual resident of an eligible cluster
- No previous HIV test, or HIV infection not confirmed by home-based ART nurse
- Already receiving ART, or has had more than 1 month's treatment in the past
- Known contraindication to firstline ART (known hypersensitivity, renal failure,
chronic liver disease)
- Acute danger sign present (as defined by Integrated Management of Adult Illnesses,
HIV Department, WHO)
- Age younger than 18 years
- Not willing to accept home-based ART initiation
- Suspected or confirmed TB disease will not be an exclusion criteria, but will be an
indication for deferral, until completion of the screening algorithm, with initiation
of TB treatment if indicated.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Other: Clinic-based ART assessment and initiation
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Other: Home assessment and initiation of ART
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Primary Outcome(s)
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ART initiation
[Time Frame: First six months following introduction of home-based HIV testing]
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Secondary Outcome(s)
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Adherence to ART
[Time Frame: First 6-months following availability of home-based HIV testing]
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Adult mortality
[Time Frame: The first 6-months following availability of home-based HIV testing]
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Disclosure of HIV-positive results
[Time Frame: The first 6-months following availability of home-based HIV testing]
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Retention on ART
[Time Frame: The first 6-months following availability of home-based HIV testing]
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Uptake of home-based HIV testing
[Time Frame: The first 6-months following home assessment and initiation of ART being made available]
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Secondary ID(s)
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MLW-089673
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WT089673/B/09/Z
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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