N/A
N=16,660
Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01414413 ↗Enrolled (actual)
16,660
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: ART Initiation — 181; 63 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home assessment and initiation of ART (Other); Clinic-based ART assessment and initiation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Liverpool School of Tropical Medicine
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ART Initiation |
181; 63 | — |
| SECONDARY Uptake of Home-based HIV Testing |
5287; 4433 | — |
| SECONDARY Reporting of HIV-positive Results |
490; 278 | — |
| SECONDARY Loss to Retention |
52; 15 | — |
| SECONDARY Adherence to ART |
— | — |
| SECONDARY Adult Mortality |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT01414413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.