Racial differences in willingness to participate in HIV prevention clinical trials amongst university students in KwaZulu-Natal, South Africa.

Abstract

Introduction Willingness to participate in clinical trials is a crucial element in recruitment of suitable participants for intervention trials. Measurement of willingness to participate assists in determining community preparedness for clinical trials, such as HIV vaccine trials. Therefore, researchers have developed a Clinical Research Involvement Scale (CRIS) to assess willingness to participate modelled on the Theory of Reasoned Action. The CRIS was tested in the USA and was noted that it would benefit from additional testing in other populations. Aim The purpose of this study is to determine whether racial differences exist in willingness to participate and explore potential factors associated with willingness to participate in HIV prevention research. Methods A cross sectional analytic study was conducted. The CRIS was administered to university students aged 18-45 at the University of KwaZulu-Natal in South Africa. The CRIS was administered online with a demographic questionnaire to facilitate evaluation of possible associations between willingness to participate and age, gender, relationship status, parity, religion, education status, student status, employment status and access to private health care. Participation was once-off at the time of completing the scale. Results The study enrolled 636 participants, two thirds being female. An effective sample size of 509 was considered for analysis after data was cleaned for accuracy and completeness. The results indicated that all students across all race groups were willing to participate in HIV prevention research. However, when considering factors that affected willingness to participate, statistically significant differences were noted. Based on the differences amongst these factors, Black students expressed greater intention to participate compared to White and Indian students. The CRIS was deemed a reliable instrument in this population; however in its current structure it did not show strong validity. Validity improved if the factors of motivation to comply and outcome evaluations were removed in this population. Discussion The study findings are specific to students of the University of KwaZulu-Natal and cannot be generalized to other populations. The racial differences in factors that affect willingness to participate indicate differences in risk perception and seeking access to better quality healthcare. Recommendations The CRIS should be used in other student populations to assess its validity. (350 words)