Optimizing patients' management in HIV clinical trials: a new support system implemented in two trials of antiretroviral initiation (ANRS 129 and 130)

Background: Advanced HIV disease, opportunistic infections and recent HIV diagnosis are factors that contribute to weaken patients. These factors can lead to a lack of adherence to treatment and to follow-up. Two ANRS trials (129 BKVIR and 130 APOLLO) targeted patients initiating antiretroviral treatment in the context of tuberculosis disease or severe immunosupression, and aim at assessing new therapeutic combinations. A specific system of care called “support consultation” was proposed to included patients in order to provide them with a multidisciplinary support.
Methods: Multidisciplinary teams in charge of adherence consultations in clinical sites were identified during the trials setup. The support system comprises an initial consultation followed by support consultations. The former was proposed after the investigator had explained the trial to patient and before the consent signature. The consultations aimed at explaining the trial, the disease, the treatment to patients, and at addressing their questions and problems.
Results: 31 clinical teams (66%) participated in the support consultation and performed 324 support consultations with 120 patients (35 patients in the BKVIR trial and 85 in the APOLLO trial). 73 patients participated in the initial consultation on the same day as consent signature for 50 cases or before it in 23 cases (median delay, 4 days). Overall, a study or regimen discontinuation, as defined in the protocols, was reported in 50/263 (19%) patients included in the trials. Proportion of study/regimen discontinuation was lower (7%) in patients who participated actively in the support system than in patients who did not (22%) (p=0.007).
Conclusion: A majority of clinical sites participating in the trials ANRS 129 BKVIR and 130 APOLLO included patients in the support care system. This approach allowed a multidisciplinary management of patients included in the trials. Our data suggest a positive impact of this support procedure on trial adherence.

C. Fagard1, C. Roussillon1, C. Castets2, L. Baumard3, C. Grondin1, C. Boucherie1, V. Joly2, O. Lortholary4, G. Chêne1
1INSERM U897, Bordeaux, France, 2Hopital Bichat-Claude Bernard, Paris, France, 3Hopital Avicenne, Paris, France, 4Hopital Necker, Paris, France