MaxART: Early Access to ART for All in Swaziland

HIV/AIDS Clinical Trial

— MaxART  

Official title:

MaxART: Early Access to ART for All in Swaziland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909218
• Other study ID #: MaxART
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: July 2018
• Source: Clinton Health Access Initiative Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3485
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Swaziland	Swaziland Ministry of Health	Mbabane

Sponsors (8)

Lead Sponsor	Collaborator
Clinton Health Access Initiative Inc.	Harvard School of Public Health, Ministry of Health, Swaziland, Southern African AIDS Information Dissemination Service (SAfAIDS), Southern African Centre for Epidemiological Modelling and Analyses (SACEMA), STOP AIDS NOW! (SAN!), Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA), University of Amsterdam

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Proportion of individuals retained in care or on ART at 12 months	12 months
Primary	Viral suppression	Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART	6 months
Secondary	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
Secondary	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
Secondary	Drug resistance	Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing	36 months
Secondary	Tuberculosis	Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).	36 months
Secondary	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
Secondary	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
Secondary	HIV infection	Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints	36 months