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HIV/AIDSMaxARTNCT02909218

MaxART: Early Access to ART for All in Swaziland

A study testing Early Access to ART for All in people with HIV/AIDS, run by Clinton Health Access Initiative Inc. at 1 site in Eswatini.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Early Access to ART for All
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,485 participants
Where
1 siteEswatini
Study dates
1 Sep 2014to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Eswatini1 site

  • Swaziland Ministry of Health

    Mbabane

Other trials in Eswatini

About this study

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.

Read the 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.

Conditions
HIV/AIDS
Being tested
Early Access to ART for All
Keywords
HIV/AIDS, Swaziland
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Access to ART for AllOther

    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.

Study groups in NCT02909218
Study groupRoleWhat they receive
National HIV Treatment GuidelinesNo interventionHIV-positive individuals are offered ART per Swaziland's national treatment guidelines
Early Access to ART for AllExperimentalHIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging
Receives: Other: Early Access to ART for All

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

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

    Measured: 12 months

  2. Viral suppression

    Proportion of individuals whose viral load is below 1,000 copies/ml (virally suppressed) after 6 months on ART

    Measured: 6 months

Secondary outcomes (7)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 36 months

  3. Drug resistance

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

    Measured: 36 months

  4. Tuberculosis

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

    Measured: 36 months

  5. 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

    Measured: 3 months

  6. 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

    Measured: 12 months

  7. HIV infection

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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study start1 Sep 2014
  3. Primary completion31 Aug 2017
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909218
Sponsor's protocol ID
MaxART
Acronym
MaxART
Status last verified
Jul 2018
First submitted
10 Jul 2016
Last updated
18 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.

    PubMed 33107430

  • Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.

    PubMed 33074097

  • Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487.

    PubMed 32831169

  • Walsh FJ, Barnighausen T, Delva W, Fleming Y, Khumalo G, Lejeune CL, Mazibuko S, Mlambo CK, Reis R, Spiegelman D, Zwane M, Okello V. Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial. Trials. 2017 Aug 18;18(1):383. doi: 10.1186/s13063-017-2128-8.

    PubMed 28821264

Questions about this trial

What is this clinical trial studying?

A study testing Early Access to ART for All in people with HIV/AIDS, run by Clinton Health Access Initiative Inc. at 1 site in Eswatini.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909218, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.

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