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
About this trial
This is an interventional health services research trial for HIV/AIDS focused on measuring Antiretroviral Treatment
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
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
NCT ID
NCT03789448
First Posted
December 16, 2018
Last Updated
January 3, 2019
Sponsor
Till Bärnighausen
Collaborators
Clinton Health Access Initiative Inc.
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
Learn more about this trial
Early Access to ART for All in Swaziland: Effects on Economic Outcomes
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