MaxART: Early Access to ART for All in Swaziland

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.

Detailed Description
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The clinical evidence in support of offering antiretroviral treatment (ART) for all HIV-positive individuals to improve patient health outcomes and reduce HIV incidence is building, and the resource-limited countries where this approach could have the biggest impact want to evaluate if this is a feasible and effective intervention to turn the course of their HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system. This is a 3-year randomized stepped wedge design with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each 4-month step. This balanced design will result in approximately one half of the observations being under an intervention clinic, and the other half under control. Power calculations were conservatively based on the estimated number of individuals expected to enroll in the study comparing the first 12-month measure of retention and 6-month of viral suppression on ART of those entering clinics during their control stage versus those that will be entering a clinic during intervention period. A strategic mix of multidisciplinary research methodologies will be applied to meet the study aim, including implementation science, social science research, economic evaluations, and HIV incidence modeling.

Official Title
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MaxART: Early Access to ART for All in Swaziland

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Early Access to ART for All


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ART-naive HIV-positive individuals who are 18 years of age or older - excluding pregnant or breastfeeding women - who attend the health facilities included in the study will be asked for their consent to enroll in the study. Exclusion Criteria: All HIV-positive individuals who < 18 years of age or older and pregnant or breastfeeding women. All HIV-positive individuals who did not consent to participate or who have already been initiated on ART.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: National HIV Treatment Guidelines<br>HIV-positive individuals are offered ART per Swaziland's national treatment guidelines | |
| Experimental: Early Access to ART for All<br>HIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging | Other: Early Access to ART for All<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Proportion of individuals retained in care or on ART at 12 months | 12 months | 
| Viral suppression | Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month mortality rate | mortality rate among clients newly enrolled in or returning to facilities during the standard of care phase is equal to 12-month mortality rate among clients newly enrolled in or returning to facilities during early ART phase | 12 months | 
| Visit adherence among those initiated on ART | Proportion of missed visits as a number of scheduled appointments among ART-ineligible clients by end of follow-up | 36 months | 
| Drug resistance | Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing | 36 months | 
| Tuberculosis | Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident). | 36 months | 
| ART uptake among those who are eligible | Proportion of HIV-positive individuals who are eligible for initiation who are successfully initiated to ART within 1 and 3 months of becoming eligible | 3 months | 
| Cost per patient per year | Bottom-up and top-town costing of the patient lifetime cost to test, treat, link, and retain individuals on ART | 12 months | 
| HIV infection | Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Swaziland