41. Willingness to join an anal cancer screening and prevention trial

Abstract

Background: HIV-infected men and women are at elevated risk for developing anal cancer. The AIDS Malignancy Consortium is designing a 5-year randomised controlled trial to determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL) can prevent anal cancer. HIV-infected men and women over 35 years of age will be screened and those with anal HSIL will be randomly assigned to have their HSIL removed (intervention arm) or not removed (monitoring arm). Both arms would be monitored for progression to cancer at regular intervals for 5 years, and cancer incidence in the two arms will be compared. Methods: The present study sought to assess willingness to participate in such a trial through focus groups with 241 HIV-infected men and women in 10 US cities, and a survey of 257 HIV-infected men and women in 20 cities. Results: 87% of survey respondents reported that they were ‘likely’ or ‘very likely’ to participate in the trial. Altruism and gratitude towards previous AIDS trial cohorts were the most cited motivations for participation. Over half (51.5%) of survey participants expressed equipoise, viewing participation in either arm as beneficial. Of the remaining respondents, 71.8% expressed a preference for the intervention arm if given a choice. Concerns expressed in the focus groups about randomisation to the monitoring arm centred on the conflation of HSIL with cancer, suggesting a need for ongoing education and psychological support. Conclusions: High levels of expressed interest and motivation to participate in the study suggest that recruitment and retention over 5 years will be feasible.