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Clinical Trials/NCT03789448
NCT03789448
Completed
Not Applicable

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

Till Bärnighausen0 sites3,019 target enrollmentSeptember 1, 2014
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Till Bärnighausen
Enrollment
3019
Primary Endpoint
Total healthcare expenditures (for hospitalization and primary care)
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
August 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Till Bärnighausen
Responsible Party
Sponsor Investigator
Principal Investigator

Till Bärnighausen

University Hospital Heidelberg

University Hospital Heidelberg

Eligibility Criteria

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)

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)

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