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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789448
• Other study ID #: MaxART Economic Evaluation
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2019
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 3019
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Other:
• Early Access to ART for All
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Till Bärnighausen	Clinton Health Access Initiative Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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...)	12 months
Primary	Total productivity hours	Total Hours per day spent on income generation activities	24 hours
Secondary	Rate of participants with current employment	Employment rate among participants, including full-time and part-time salary work	At study completion, an average of 1.5 years
Secondary	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.)	12 months
Secondary	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	At study completion, an average of 1.5 years