Barriers to participating in an HIV vaccine trial: a systematic review of qualitative studies

Article type
Authors
Mills E, Wilson K, Cooper C, Guyatt G
Abstract
Objective: To systematically review the literature to identify barriers to participation in HIV vaccine trials. Design: We undertook systematic searches of: AMED, Campbell Collaboration, CinAhl, Cochrane Library, Embase, E-Psyche, Health Technology Assessment, ERIC, MedLine, and NHS EED, sought unpublished research through the National Research Register (UK) and Clinicaltrials.gov, and searched bibliographies of reviews.

Main Outcome Measures: Articles in any language using interviews, focus groups and surveys to address barriers or negative attitudes to participating in HIV vaccine trials. Two appraisers independently reviewed studies for validity and content. An additional reviewer resolved discrepancies if they arose. Results: Of 26 eligible studies 5 used semi-structured qualitative interviews, 2 used open-ended qualitative questionnaires, 4 used structured quantitative interviews, and 15 used structured quantitative questionnaires. Major barriers to paticipation included fear of side effects (ranging from short term local effects to contracting HIV from the vaccine); concerns about testing HIV positive; and social discrimination. Based on pooled analysis, barriers relating to safety (P=<0.01) and discrimination/social risk (P=0.02) are under-represented in quantitative studies when compared to the frequency with which participants in qualitative studies raise these issues in.

Conclusions: The findings of this study should aid vaccine trialists in developing strategies to optimize participation and co-operation in HIV vaccine trials while adequately informing and protecting prospective participants.