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

January 3, 2019 updated by: Till Bärnighausen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3019

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: National HIV Treatment Guidelines
HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
Experimental: 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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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...)
12 months
Total productivity hours
Time Frame: 24 hours
Total Hours per day spent on income generation activities
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with current employment
Time Frame: At study completion, an average of 1.5 years
Employment rate among participants, including full-time and part-time salary work
At study completion, an average of 1.5 years
Total sum of self-reported monthly expenditures of the participant's household
Time Frame: 12 months
Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)
12 months
Household Assets Ownership and Living Standards Index
Time Frame: 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
At study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Till Bärnighausen

Collaborators

Clinton Health Access Initiative Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaxART Economic Evaluation

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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