RESUMO
High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir gel trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17,031 monthly visits. On average women reported five sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2 % compared to the 82.0 % self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials.
Assuntos
Adenina/análogos & derivados , Fármacos Anti-HIV/administração & dosagem , Anti-Infecciosos Locais/administração & dosagem , Infecções por HIV/prevenção & controle , HIV-1/efeitos dos fármacos , Adesão à Medicação , Organofosfonatos/administração & dosagem , Adenina/administração & dosagem , Administração Intravaginal , Adulto , Aconselhamento , Método Duplo-Cego , Feminino , Seguimentos , Géis/administração & dosagem , Infecções por HIV/epidemiologia , Infecções por HIV/transmissão , Infecções por HIV/virologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Entrevista Motivacional , População Rural/estatística & dados numéricos , Comportamento Sexual/estatística & dados numéricos , Fatores Socioeconômicos , África do Sul/epidemiologia , Tenofovir , Resultado do Tratamento , População Urbana/estatística & dados numéricosRESUMO
High adherence is important in microbicide trials, but no adherence interventions to date have demonstrated empiric improvements in microbicide adherence or effectiveness. Approximately midway during the CAPRISA 004 trial, we implemented a novel adherence intervention (Adherence Support Program-ASP), based on an Information-Motivation-Behavioral Skills model and incorporating a Motivational Interviewing approach. We assessed the impact of the ASP on adherence and tenofovir gel effectiveness using a before-and-after comparison. Of the 889 women in the trial, 774 contributed 486.1 women-years of follow-up pre-ASP and 828 contributed 845.7 women-years of follow-up post-ASP. Median adherence rose from 53.6 % pre-ASP to 66.5 % post-ASP. Detectable tenofovir levels increased from 40.6 % pre-ASP to 62.5 % post-ASP in 64 women who had paired tenofovir drug samples. Gel effectiveness improved post-ASP; HIV incidence in the tenofovir gel arm was 24 % lower pre-ASP compared to 47 % lower post-ASP. Following implementation of the ASP, microbicide adherence improved with a concomitant increase in the effectiveness of tenofovir gel.