Annual vs semi-annual follow-up in low complexity virologically suppressed people with HIV: a randomized interventional trial.

Authors

Iván Chivite, M J Merino-Peñas, Ana González-Cordón, María Martínez-Rebollar, Berta Torres, Lorena de la Mora, Alexy Inciarte, Alberto Foncillas, Julia Calvo, Juan Ambrosioni, Abiu Sempere, Leire Berrocal, José Luís Blanco, José M Miró, Roger Llobet, Emma Fernandez, Esteban Martínez, Josep Mallolas, Elisa de Lazzari, Montserrat Laguno

Published in

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. Aug 19, 2026. Epub Aug 19, 2026.

Abstract

The increasing heterogeneity in people with HIV makes it necessary to evaluate new follow-up strategies tailored to clinical/social complexity.
Prospective, single-center, randomized, non-inferiority clinical-trial comparing two follow-up strategies - semi-annual standard care (SoC) or annual visits for 24 months- in virologically suppressed people with HIVand low-complexity profile, according to the GeSIDA "HIV Patient Stratification System". The primary endpoint was non-inferiority (prespecified lower margin: -4%) in virological control (viral load <50 copies/mL; FDA snapshot). Secondary outcomes included adherence, quality of life, satisfaction, and healthcare costs.
Of 394 eligible candidates, 71 declined participation (48% preferring to maintain SoC) and 321 were randomized (162 SoC, 159 Annual). Participants were predominantly male (89%), MSM (78%), Spanish (63%), median age of 45 years and 13 years of HIV follow-up, without baseline differences between groups. Overall, 283 (88%) completed the study; 25 switched to long-acting therapy and 10 were lost or transferred. Virological control was similar in SoC and Annual arms: 86.42% vs 86.79% (ITT) and 98.29% vs 97.87% (PP), although non-inferiority was not statistically demonstrated. During the study, the increment from baseline in the proportion of highly satisfied participants was significant in the Annual arm (p=0.001). Reductions in HIV-related direct costs (-25.3%; p<0.001) were greater in the Annual group.
Among people with HIV and low complexity, annual follow-up achieved virological outcomes clinically comparable to semi-annual care, despite not meeting the formal non-inferiority threshold. Annual follow-up was associated with significant increment in patient satisfaction and lower HIV direct-related costs.

PMID:
42617095
Bibliographic data and abstract were imported from PubMed on 20 Aug 2026.

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