MaxART: Early Access to ART for All in Swaziland

NCT02909218 | Completed DMC

• 1 other identifier: MaxART
• Study Type: interventional
• Target: 3,485
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV/AIDS, Swaziland

Outcome Measures

Primary Outcomes (2)

• Retention

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

  12 months

• Viral suppression

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

  6 months

Secondary Outcomes (7)

• 12-month mortality rate

  12 months

• Visit adherence among those initiated on ART

  36 months

• Drug resistance

  36 months

• Tuberculosis

  36 months

• ART uptake among those who are eligible

  3 months

Study Arms (2)

National HIV Treatment Guidelines

NO INTERVENTION

HIV-positive individuals are offered ART per Swaziland's national treatment guidelines

Early Access to ART for All

EXPERIMENTAL

HIV-positive individuals are initiated on ART regardless of client's immunological and clinical staging

Other: Early Access to ART for All

Interventions

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.

Early Access to ART for All

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Swaziland Ministry of Health

Mbabane, Eswatini

Location

Related Publications (4)

• 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.

  PMID: 33107430 DERIVED

• 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.

  PMID: 33074097 DERIVED

• 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.

  PMID: 32831169 DERIVED

• 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.

  PMID: 28821264 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Velephi Okello, MD

  Ministry of Health, Swaziland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2014
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)