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MaxART: Early Access to ART for All in Swaziland (MaxART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909218
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Ministry of Health, Swaziland
STOP AIDS NOW! (SAN!)
Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA)
Southern African AIDS Information Dissemination Service (SAfAIDS)
Southern African Centre for Epidemiological Modelling and Analyses (SACEMA)
University of Amsterdam
Harvard School of Public Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Early Access to ART for All Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3485 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Swaziland
Swaziland Ministry of Health
Mbabane, Swaziland
Sponsors and Collaborators
Clinton Health Access Initiative Inc.
Ministry of Health, Swaziland
STOP AIDS NOW! (SAN!)
Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA)
Southern African AIDS Information Dissemination Service (SAfAIDS)
Southern African Centre for Epidemiological Modelling and Analyses (SACEMA)
University of Amsterdam
Harvard School of Public Health
Investigators
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Principal Investigator: Velephi Okello, MD Ministry of Health, Swaziland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clinton Health Access Initiative Inc.
ClinicalTrials.gov Identifier: NCT02909218    
Other Study ID Numbers: MaxART
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Clinton Health Access Initiative Inc.:
HIV/AIDS, Swaziland
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases