HIV/AIDS
Conditions
Keywords
Antiretroviral Treatment
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.
Interventions
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
Sponsors
Clinton Health Access Initiative Inc.
Till Bärnighausen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 hours | 24 hours | Total Hours per day spent on income generation activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants with current employment | At 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 household | 12 months | Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.) |
| Household Assets Ownership and Living Standards Index | At 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 |
Outcome results
None listed