CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16,660 enrolled
Drug / intervention
Home assessment and initiation of ART +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01414413
NCT01414413N/ACompleted

Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi

Liverpool School of Tropical Medicine·interventional·Posted Aug 11, 2011·Updated Apr 7, 2014

In Brief

A clinical study evaluating Home assessment and initiation of ART and Clinic-based ART assessment and initiation for HIV. Completed, enrolled 16,660 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesMalawi

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2011
Enrollment StartJan 1, 2012
Primary CompletionNov 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.9 years ago

Interventions

Home assessment and initiation of ARTother

Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.

Clinic-based ART assessment and initiationother

Participants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor.