MaxART: Early Access to ART for All in Swaziland
- Conditions
- HIV/AIDS
- Interventions
- Other: Early Access to ART for All
- Registration Number
- NCT02909218
- Lead Sponsor
- Clinton Health Access Initiative Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3485
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Access to ART for All Early Access to ART for All HIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging
- Primary Outcome Measures
Name Time Method Retention 12 months Proportion of individuals retained in care or on ART at 12 months
Viral suppression 6 months Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART
- Secondary Outcome Measures
Name Time Method 12-month mortality rate 12 months 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
Visit adherence among those initiated on ART 36 months Proportion of missed visits as a number of scheduled appointments among ART-ineligible clients by end of follow-up
Drug resistance 36 months Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing
Tuberculosis 36 months Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).
ART uptake among those who are eligible 3 months Proportion of HIV-positive individuals who are eligible for initiation who are successfully initiated to ART within 1 and 3 months of becoming eligible
Cost per patient per year 12 months Bottom-up and top-town costing of the patient lifetime cost to test, treat, link, and retain individuals on ART
HIV infection 36 months Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints
Trial Locations
- Locations (1)
Swaziland Ministry of Health
🇸🇿Mbabane, Swaziland