Status:
COMPLETED
Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborating Sponsors:
Kamuzu University of Health Sciences
London School of Hygiene and Tropical Medicine
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
16660 Patients enrolled
Trial Details
Trial ID
NCT01414413
Start Date
January 1 2012
End Date
April 1 2013
Last Update
April 7 2014
Active Locations (1)
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1
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Chichiri, Malawi, 3