Perceived Barriers to Participation in HIV Vaccine Trials Among Eligible Men Who Have Sex With Men

Abstract

ABSTRACT Background: Enrollment of participants is a vital step in the conduct of clinical trials to test candidate HIV vaccines. In order to efficiently enroll participants in vaccine trials, there is a need for investigators to adequately understand and address concerns or perceived barriers of potential participants. Methods: Between December 2010 and March 2011, HIV Vaccine Trials Network (HVTN) carried out a mixed methods study among men who have sex with men (MSM) with the aim to better understand their attitudes towards getting involved in biomedical HIV prevention research. This study was a supplement to HVTN505, a phase IIb vaccine trial recruiting MSM in the US. Data collection among MSM included a survey with 1,835 respondents and six focus group discussions with a total of 62 participants in six cities in the US (Boston, Denver, Chicago, New York, Houston and Los Angeles). Results: Of 324 survey respondents that were asked to rate their willingness to participate in an HIV vaccine trial on a four-point scale (very, somewhat, not sure and not at all willing), only 70 (21.6%) cited "very willing". Among those who did not cite "very willing", perceived side effects of vaccination (78%), perceived risk of iatrogenic HIV infection from vaccination (42%) and Vaccine-induced HIV Seropositivity (VISP) (37%) emerged as their topmost three barriers to participation. Reassurance about vaccine safety and more information about HIV vaccine research emerged as the two most important possible motivators for the respondents not very willing. Focus group participants cited barriers similar to those indicated by survey respondents. They expressed concern about not having sufficient information about the potential side effects of study vaccines, were skeptical that study participants could not be infected with HIV from study vaccines, and cited several physical, social and financial concerns regarding VISP. Conclusion: Focusing efforts on increasing awareness among MSM (especially most at risk groups i.e. African Americans and Latinos) regarding HIV vaccine research might increase willingness. Explaining key vaccine trial concepts to communities might dispel perceived barriers and misconceptions about HIV vaccine trials.