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

Not Applicable
Completed
Conditions
HIV/AIDS
Interventions
Other: Early Access to ART for All
Registration Number
NCT03789448
Lead Sponsor
Till Bärnighausen
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3019
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Early Access to ART for AllEarly Access to ART for AllHIV-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)
Primary Outcome Measures
NameTimeMethod
Total healthcare expenditures (for hospitalization and primary care)12 months

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...)

Total productivity hours24 hours

Total Hours per day spent on income generation activities

Secondary Outcome Measures
NameTimeMethod
Household Assets Ownership and Living Standards IndexAt study completion, an average of 1.5 years

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

Rate of participants with current employmentAt study completion, an average of 1.5 years

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

Total sum of self-reported monthly expenditures of the participant's household12 months

Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)

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