Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: Home assessment and initiation of ART
* Other: Clinic-based ART assessment and initiation


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home assessment and initiation of ART<br>Participants with a positive home-based HIV test result will receive a home visit from a study nurse who will complete the following on the first home visit: Confirmatory fingerprick HIV testing TB symptom screening ART eligibility assessment (Word Health Organization clinical staging, sampling of blood for measurement of CD4 count and treatment education) At a second home visit (within 5 days), participants who are ART eligible (as defined in National ART guidelines) will be initiated onto ART (using National Treatment Programme ART regimens). Following home initiation of ART, participants in the intervention arm will receive detailed counselling from the study nurse about the need to attend their first 2-week follow-up appointment at the primary health care clinic that serves their household's residence. They will receive a referral slip detailing the date, time and place of their appointment. | Other: Home assessment and initiation of ART<br>* Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.<br>|
| Other: Clinic-based ART assessment and initiation<br>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. HIV care, including ART, will be started from the primary care clinic. | Other: Clinic-based ART assessment and initiation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART Initiation | Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention. | First six months following introduction of home-based HIV testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of Home-based HIV Testing | Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study. | The first 6-months following home assessment and initiation of ART being made available | 
| Reporting of HIV-positive Results | Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period | The first 6-months following availability of home-based HIV testing | 
| Loss to Retention | Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months | The first 6-months following availability of home-based HIV testing | 
| Adherence to ART | Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period | First 6-months following availability of home-based HIV testing | 
| Adult Mortality | Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention | The first 6-months following availability of home-based HIV testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Antiretroviral therapy, Community-based study, Cluster-randomised trial, HIV testing, Africa