Participant characteristics and clinical trial decision-making factors in AIDS malignancy consortium treatment trials for HIV-infected persons with cancer (AMC #S006)

Abstract

Background. Overall, people living with HIV/AIDS (PLWHA) are living longer, but compared with the general population, they are at elevated risk for numerous AIDS-defining and non-AIDS-defining cancers. The AIDS Malignancy Consortium (AMC) is dedicated to conducting clinical trials aimed at prevention and treatment of cancers among PLWHA. Objective. To examine patient-level characteristics and perceptions that influence decision-making regarding AMC treatment trial participation. Methods. PLWHA diagnosed with cancer or anal high-grade intraepithelial neoplasia who were ≥ 18 years old and offered participation on a therapeutic AMC clinical trial were eligible. Participants completed a 17-item survey assessing sociodemographic and other factors potentially influencing decision-making regarding trial participation. Results. The sample of 67 participants was mainly male (n = 62, 92.5%), non-Hispanic (89.5%) and white (67.2%), with a mean age of 48.3 years. About half of participants were screened for lymphoma studies. Nearly all (98.5%) of the participants learned about AMC clinical trials from a medical provider, most (73.1%) knew little about clinical trials in general, and half decided on trial participation on their own. Altruism was the most frequently cited reason for trial participation. Participant recommendations for improving AMC trial accrual included systems changes to speed access to clinical trials and reduce participant burden. Conclusions. This formative study highlights the perceived benefits to others, i.e., altruism, as an important factor in trial decision-making, little knowledge about clinical trials in general, and the role of physicians in informing participants about clinical trials. Future research should address knowledge barriers and explore systems- and provider-level factors affecting accrual to AMC trials.

Practices of patient engagement in drug development: a systematic scoping review

“…As a result of this evaluation the financial assistance program was considered effective and suitable for being implemented as a part of future trials. Another example, similarly illustrative of the boundaries pre-set for the patient input in the consultation format, is a formative study conducted by a non-profit organization to improve recruitment in its trials [ 32 ]. In this initiative people living with HIV/AIDS (PLWHA) diagnosed with cancer and invited to participate in a trial were offered to complete a survey about factors influencing their decision-making regarding trial participation and asked for recommendations about how to improve the organization’s trial accrual.…”

Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions

“…Regarding the first debate—trust and emotion-based decision—several studies have identified the health professional as potentially the most challenging variable to influence patients' participation in CTs (for cancer, HIV and cardiovascular disease, surgery) [ 12 , 47 , 28 , 25 35 ]. In Western countries [ 9 ], patients usually trust healthcare professionals but distrust the healthcare system [ 15 ]. That was the case in our results, where PLWH distrust the public system but there is a general atmosphere of social confidence in the CRS.…”