Early Access to ART for All in Swaziland: Effects on Economic Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes

Detailed Description
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The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/NCT02909218. This registration is specific to the economic evaluation of the MaxART study which aims to quantify the causal impacts of early ART initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.

Official Title
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MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Early Access to ART for All


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study Exclusion Criteria: All HIV-positive individuals who are <18 years of age All HIV-positive pregnant or breastfeeding women All HIV-positive individuals who did not consent to participate

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: National HIV Treatment Guidelines<br>HIV-positive individuals are offered ART per Swaziland's national treatment guidelines | |
| Experimental: Early Access to ART for All<br>HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women) | Other: Early Access to ART for All<br>* All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total healthcare expenditures (for hospitalization and primary care) | Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...) | 12 months | 
| Total productivity hours | Total Hours per day spent on income generation activities | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with current employment | Employment rate among participants, including full-time and part-time salary work | At study completion, an average of 1.5 years | 
| Total sum of self-reported monthly expenditures of the participant's household | Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.) | 12 months | 
| Household Assets Ownership and Living Standards Index | Aggregated index based on ownership of assets (e.g., refrigerator, TV, table, phone...) and living standards (e.g., flush toilet, cooking facilites, floor/wall/roof material...), total scale score is determined via principal component analysis and averaged around 0 | At study completion, an average of 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral Treatment