Clinical trial NCT03789448: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Antiretroviral Treatment
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Clinton Health Access Initiative Inc.
First posted: 2018-12-28
Enrollment: 3019
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Total healthcare expenditures (for hospitalization and primary care)
timeFrame: 12 months
measure: Total productivity hours
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of participants with current employment
timeFrame: At study completion, an average of 1.5 years
measure: Total sum of self-reported monthly expenditures of the participant's household
timeFrame: 12 months
measure: Household Assets Ownership and Living Standards Index
timeFrame: At study completion, an average of 1.5 years
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.