Clinical trial NCT01414413: Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi
Official title: Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
AIDS
Antiretroviral therapy
Community-based study
Cluster-randomised trial
HIV testing
Africa
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: London School of Hygiene and Tropical Medicine
name: Ministry of Health and Population, Malawi
First posted: 2011-08-11
Enrollment: 16660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV.

Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.


Eligibility criteria: 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.

Primary outcomes:
measure: ART Initiation
timeFrame: First six months following introduction of home-based HIV testing
Secondary outcomes:
measure: Uptake of Home-based HIV Testing
timeFrame: The first 6-months following home assessment and initiation of ART being made available
measure: Reporting of HIV-positive Results
timeFrame: The first 6-months following availability of home-based HIV testing
measure: Loss to Retention
timeFrame: The first 6-months following availability of home-based HIV testing
measure: Adherence to ART
timeFrame: First 6-months following availability of home-based HIV testing
measure: Adult Mortality
timeFrame: The first 6-months following availability of home-based HIV testing
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
state: Chichiri
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: Peter MacPherson, MBChCB MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, Butterworth AE, van Oosterhout JJ, Desmond N, Thindwa D, Squire SB, Hayes RJ, Corbett EL. Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):372-9. doi: 10.1001/jama.2014.6493.