Annual vs semi-annual follow-up in low complexity virologically suppressed people with HIV: a randomized interventional trial
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 LagunoAbstract
Background
The increasing heterogeneity in people with HIV makes it necessary to evaluate new follow-up strategies tailored to clinical/social complexity.
Methods
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.
Results
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.
Conclusions
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.