An interventional study of Early Access to ART for All in HIV/AIDS, sponsored by Clinton Health Access Initiative Inc.. Completed at 1 site in Swaziland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Health services research
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.
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.
2,041 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 3,485 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Clinton Health Access Initiative Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
HIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging
Other: Early Access to ART for All
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.
Retention
Proportion of individuals retained in care or on ART at 12 months
Time frame: 12 months
Viral suppression
Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART
Time frame: 6 months
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
Time frame: 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
Time frame: 36 months
Drug resistance
Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing
Time frame: 36 months
Tuberculosis
Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).
Time frame: 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
Time frame: 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
Time frame: 12 months
HIV infection
Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints
Time frame: 36 months
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
Clinton Health Access Initiative Inc.