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Completed

NCT Number: NCT02909218

MaxART: Early Access to ART for All in Swaziland

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swaziland Ministry of Health

Mbabane, Eswatini

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Access to ART for All

Other

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.

Primary outcomes

  1. Retention

    Time frame: 12 months

    Proportion of individuals retained in care or on ART at 12 months

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Drug resistance

    Time frame: 36 months

    Proportion of drug resistance among ART-ineligible clients with two virological failures who have received genotype resistance testing

  4. Tuberculosis

    Time frame: 36 months

    Proportion of HIV-positive individuals diagnosed with new tuberculosis following enrollment (recurrent and newly incident).

  5. 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

  6. 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

  7. HIV infection

    Time frame: 36 months

    Mathematical modeling to estimate the number of new adult HIV infections using empirical data from the primary endpoints

Sponsors and collaborators

Lead sponsor

Clinton Health Access Initiative Inc.

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Ministry of Health, Swaziland
  • STOP AIDS NOW! (SAN!)
  • Southern African AIDS Information Dissemination Service (SAfAIDS)
  • Southern African Centre for Epidemiological Modelling and Analyses (SACEMA)
  • Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA)
  • University of Amsterdam

Registry information

Acronym: MaxART

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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