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Completed

NCT Number: NCT03789448

Early Access to ART for All in Swaziland: Effects 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

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Access to ART for All

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Till Bärnighausen

Other

Collaborators

  • Clinton Health Access Initiative Inc.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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