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

Till Bärnighausen3,019 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

3,019

Conditions

HIV/AIDS

Interventions

Early Access to ART for AllOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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...)

Time frame: 12 months

Total productivity hours

Total Hours per day spent on income generation activities

Time frame: 24 hours

Secondary Outcomes

Rate of participants with current employment

Employment rate among participants, including full-time and part-time salary work

Time frame: 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.)

Time frame: 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

Time frame: At study completion, an average of 1.5 years

Data from ClinicalTrials.gov

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