“You would not be in a hurry to go back home”: patients’ willingness to participate in HIV/AIDS clinical trials at a clinical and research facility in Kampala, Uganda

Abstract

Background Few studies have examined factors associated with willingness of people living with HIV (PLHIV) to participate in HIV treatment clinical trials in Sub-Saharan Africa. We assessed the factors associated with participation of PLHIV in HIV treatment clinical trials research at a large urban clinical and research facility in Uganda. Methods A mixed methods study was conducted at the Infectious Diseases Institute (IDI), adult HIV clinic between July 2016 and January 2017. Data were collected using structured questionnaires, focused group discussions with respondents categorised as either participated or never participated in clinical trials and key informant interviews with IDI staff. A generalized linear model with a logit link function was used for multivariate analyses while the qualitative data were summarized using a thematic approach. Results We enrolled a total of 202 and analysed 151 participants, 77 (51%) of whom were male with mean age of 41 years. The majority 127 (84%) expressed willingness to participate in treatment clinical trials if given an opportunity. At bivariate analysis, willingness to participate was significantly associated with respondents’ perception of a satisfactory compensation package ( P -value < 0.002, 0.08–0.56), special status accorded (P-value < 0.001, 0.05–0.39) and belief that their health status would improve ( P -value< 0.08, 0.03–0.58) while on the clinical trial. At multivariate analysis, a satisfactory compensation package ( P -value< 0.030, 0.08–0.88) and special status accorded in clinical trials ( P -value< 0.041, 0.01–0.91) remained significant. The qualitative data analysis confirmed these findings as participants valued the privilege of jumping the clinic waiting queues and spending less time in clinic, the wide range of free tests offered to trial participants, unrestricted access to senior physicians and regular communication from study team. Additionally, free meals offered during clinic visits meant that participants were not in a hurry to go back home . Barriers to participation included the perception that new drugs were being tested on them, fear of side effects like treatment failure and the uncertainty about privacy of their data. Conclusion We found overwhelming willingness to participate in HIV treatment clinical trials. This was largely extrinsically influenced by the perceived material and health-related benefits. Investigators should pay attention to participants’ concerns for benefits which may override the need to understand study procedures and risks.

Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

“…16 The survey in Uganda also found that side effects like treatment failure and uncertainty about privacy of their data were barriers to participation. 19 This is consistent with our findings that 94.8% of the 344 people who were reluctant to participate in cure research had safety concerns.…”

“…A previous study demonstrated that a satisfactory compensation package significantly influenced participation in HIV treatment clinical trials. 19 The compensation offered during trials may attract more individuals engaging in physical labor than company employees who have a stable income, regular working hours, insurance coverage and likely a more conservative attitude toward risks. Awareness of functional cure may increase the willingness to participate in a trial that offers a possible therapeutic prospect.…”

“…In a previous study of patients' willingness to participate in HIV/AIDS clinical trials in Uganda, 84% of patients expressed their willingness to participate in treatment clinical trials if given an opportunity. 19 In another survey conducted among individuals from fishing communities along Lake Victoria, Uganda, 99.4% expressed willingness to participate in a hypothetical HIV vaccine trial. 20 Among the PLHIV willing to participate in Phase III trials in our study, only 72.6% (371/511) were willing to participate in Phase I clinical trials.…”

“…Gender role expectations and differences in social responsibilities can result in distinct attitudes and behaviors between men and women when engaging in clinical trials. A previous study demonstrated that a satisfactory compensation package significantly influenced participation in HIV treatment clinical trials 19 . The compensation offered during trials may attract more individuals engaging in physical labor than company employees who have a stable income, regular working hours, insurance coverage and likely a more conservative attitude toward risks.…”

“…A total of 718 PLHIV accessed the final quantitative survey. The majority (91.4%, 656 of 718) were male, 52.9% (380 of 718) were aged 30 to 44 years, 54% (388 of 718) had bachelor's degrees, 46.5% (334 of 718) were company employees, 77.9% were unmarried, 66.9% had a body mass index (BMI) in the normal range (18)(19)(20)(21)(22)(23)(24), and 58.4% were homosexual (Table 1). Another 20 PLHIV completed qualitative interviews, and these interviewees exhibited demographic characteristics largely consistent with the quantitative survey participants (Supplemental File 1).…”