MaxART: Early Access to ART for All in Swaziland (MaxART)
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|ClinicalTrials.gov Identifier: NCT02909218|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Other: Early Access to ART for All||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3485 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||MaxART: Early Access to ART for All in Swaziland|
|Actual Study Start Date :||September 1, 2014|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
No Intervention: National HIV Treatment Guidelines
HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
Experimental: Early Access to ART for All
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 [ Time Frame: 12 months ]Proportion of individuals retained in care or on ART at 12 months
- Viral suppression [ Time Frame: 6 months ]Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART
- 12-month mortality rate [ Time Frame: 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 [ Time Frame: 36 months ]Proportion of missed visits as a number of scheduled appointments among ART-ineligible clients by end of follow-up
- Drug resistance [ Time Frame: 36 months ]Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing
- Tuberculosis [ Time Frame: 36 months ]Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).
- ART uptake among those who are eligible [ Time Frame: 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 [ Time Frame: 12 months ]Bottom-up and top-town costing of the patient lifetime cost to test, treat, link, and retain individuals on ART
- HIV infection [ Time Frame: 36 months ]Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909218
|Swaziland Ministry of Health|
|Principal Investigator:||Velephi Okello, MD||Ministry of Health, Swaziland|