MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,019
- Primary Endpoint
- Total healthcare expenditures (for hospitalization and primary care)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
National HIV Treatment Guidelines
HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
Early Access to ART for All
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)
Intervention: Early Access to ART for All (Other)
Outcomes
Primary Outcomes
Total healthcare expenditures (for hospitalization and primary care)
Time Frame: 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 hours
Time Frame: 24 hours
Total Hours per day spent on income generation activities
Secondary Outcomes
- Household Assets Ownership and Living Standards Index(At study completion, an average of 1.5 years)
- Rate of participants with current employment(At study completion, an average of 1.5 years)
- Total sum of self-reported monthly expenditures of the participant's household(12 months)
Investigators
Till Bärnighausen
University Hospital Heidelberg
University Hospital Heidelberg