Clinical trial NCT02909218: MaxART: Early Access to ART for All in Swaziland
Official title: MaxART: Early Access to ART for All in Swaziland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS, Swaziland
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Swaziland
name: STOP AIDS NOW! (SAN!)
name: Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA)
name: Southern African AIDS Information Dissemination Service (SAfAIDS)
name: Southern African Centre for Epidemiological Modelling and Analyses (SACEMA)
name: University of Amsterdam
name: Harvard School of Public Health (HSPH)
First posted: 2016-09-21
Enrollment: 3485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Retention
timeFrame: 12 months
measure: Viral suppression
timeFrame: 6 months
Secondary outcomes:
measure: 12-month mortality rate
timeFrame: 12 months
measure: Visit adherence among those initiated on ART
timeFrame: 36 months
measure: Drug resistance
timeFrame: 36 months
measure: Tuberculosis
timeFrame: 36 months
measure: ART uptake among those who are eligible
timeFrame: 3 months
measure: Cost per patient per year
timeFrame: 12 months
measure: HIV infection
timeFrame: 36 months
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: Swaziland Ministry of Health
Study officials:
affiliation: Ministry of Health, Swaziland
name: Velephi Okello, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.