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

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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.

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