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

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ClinicalTrials.gov Identifier: NCT03789448
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Clinton Health Access Initiative Inc.
Information provided by (Responsible Party):
Till Bärnighausen, University Hospital Heidelberg

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

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Early Access to ART for All Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3019 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. 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...)

  2. Total productivity hours [ Time Frame: 24 hours ]
    Total Hours per day spent on income generation activities


Secondary Outcome Measures :
  1. 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

  2. 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.)

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Study Documents (Full-Text)

Documents provided by Till Bärnighausen, University Hospital Heidelberg:
Statistical Analysis Plan  [PDF] December 25, 2018


Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Till Bärnighausen, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03789448     History of Changes
Other Study ID Numbers: MaxART Economic Evaluation
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Till Bärnighausen, University Hospital Heidelberg:
Antiretroviral Treatment