• Marina B Klein, Jim Young, David Ortiz-Paredes, Shouao Wang, Sharon Walmsley, Alexander Wong, Valérie Martel-Laferrière, Neora Pick, Brian Conway, Jonathan Angel, Jean-Guy Baril, Chris Fraser, Bertrand Lebouché, TanDarrell H SDHS0000-0002-3069-2875Toronto General Hospital Research Institute, University Health Network, Toronto, Canada., Roger Sandre, Sylvie Trottier, Hansi Peiris, Jayamarx Jayaraman, Joel Singer, and CTN 286 Study Investigators.
• Division of Infectious Diseases and Chronic Viral Illness Service, Department of Medicine, McGill University Health Centre, Montreal, Canada.
• Patient Prefer Adher. 2022 Jan 1; 16: 326732813267-3281.

BackgroundMany people living with HIV struggle to consistently adhere to antiretroviral therapy, fail to achieve long-term virologic control and remain at risk for HIV-related disease progression, development of resistance and may transmit HIV infection to others.ObjectiveTo determine if switching from current multi-tablet (curART) to single-tablet antiretroviral therapy (abacavir/lamivudine/dolutegravir; ABC/3TC/DTG), both combined with individualized adherence support, would improve HIV suppression in non-adherent vulnerable populations.MethodsTriiADD was an investigator-initiated randomized, multicentre, open label study. HIV+ adults with documented non-adherence on curART were randomized in a 1:1 ratio to immediately switch to ABC/3TC/DTG or to continue curART. Both arms received adherence support. The primary outcome was the proportion of participants in each arm with HIV RNA < 50 copies/mL 24 weeks after randomization.ResultsIn total, 50 people were screened and 27 randomized from 11 sites across Canada before the trial was stopped early due to slow recruitment. Participants were predominantly from ethnocultural communities, Indigenous people and/or had a history of injection drug use. The proportion achieving HIV RNA < 50 copies/mL at week 24 was 4/12 (33%) in the curART arm vs 7/13 (54%) in the ABC/3TC/DTG arm; median Bayesian risk difference, 5% (95% CrI, -17 to 28%) higher for those randomized to ABC/3TC/DTG. We encountered difficulties with recruitment of participants without prior drug resistance, retention despite intensive support, reliably measuring adherence and in overcoming entrenched adherence barriers.ConclusionResults of our trial are consistent with a slight improvement in viral suppression in a vulnerable population when a single tablet regimen is combined with patient-level adherence support. Beyond treatment simplicity and tolerability, tailored interventions addressing stigma and social determinants of health are still needed. The numerous challenges we encountered illustrate how randomised trials may not be the best approach for assessing adherence interventions in vulnerable populations.© 2022 Klein et al.

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