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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early Access to ART for All
Sponsored by
Till Bärnighausen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring Antiretroviral Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    National HIV Treatment Guidelines

    Early Access to ART for All

    Arm Description

    HIV-positive individuals are offered ART per Swaziland's national treatment guidelines

    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)

    Outcomes

    Primary Outcome Measures

    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...)
    Total productivity hours
    Total Hours per day spent on income generation activities

    Secondary Outcome Measures

    Rate of participants with current employment
    Employment rate among participants, including full-time and part-time salary work
    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.)
    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

    Full Information

    First Posted
    December 16, 2018
    Last Updated
    January 3, 2019
    Sponsor
    Till Bärnighausen
    Collaborators
    Clinton Health Access Initiative Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03789448
    Brief Title
    Early Access to ART for All in Swaziland: Effects on Economic Outcomes
    Official Title
    MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    August 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Till Bärnighausen
    Collaborators
    Clinton Health Access Initiative Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS
    Keywords
    Antiretroviral Treatment

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3019 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    National HIV Treatment Guidelines
    Arm Type
    No Intervention
    Arm Description
    HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
    Arm Title
    Early Access to ART for All
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Early Access to ART for All
    Intervention Description
    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 Measure Information:
    Title
    Total healthcare expenditures (for hospitalization and primary care)
    Description
    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...)
    Time Frame
    12 months
    Title
    Total productivity hours
    Description
    Total Hours per day spent on income generation activities
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Rate of participants with current employment
    Description
    Employment rate among participants, including full-time and part-time salary work
    Time Frame
    At study completion, an average of 1.5 years
    Title
    Total sum of self-reported monthly expenditures of the participant's household
    Description
    Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)
    Time Frame
    12 months
    Title
    Household Assets Ownership and Living Standards Index
    Description
    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
    Time Frame
    At study completion, an average of 1.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33107430
    Citation
    Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.
    Results Reference
    derived
    PubMed Identifier
    33074097
    Citation
    Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.
    Results Reference
    derived
    PubMed Identifier
    32831169
    Citation
    Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2128-8

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

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