When free condoms and spermicide are not enough: barriers and solutions to participant recruitment to community-based trials

While randomised controlled trials remain the accepted 'gold standard' in medical research, participant recruitment is often problematic, particularly with primary care trials or those requiring healthy volunteers. Such difficulties can jeopardise the trial, leading to early abandonment, reduced statistical power or timetable and budget overruns. Substantial changes in recruitment plans may reduce the generalisability of the research. In order to overcome some of the more common recruitment difficulties, it is important that researchers share their recruitment strategy successes and failures. We report our experience of recruiting healthy volunteers to a condom trial, based within primary care and community populations. This was an RCT of the effect that using an additional spermicidal lubricant has on condom failure. We originally aimed to recruit entirely from Family Planning Clinics, but eventually required a wide variety of strategies. Targeted mailings, newspaper coverage and electronic 'posters' were among the most successful we used to bolster clinic recruitment. Concerned at our slow recruitment rates, we conducted a questionnaire survey investigating the reasons for participation and non-participation in the research completed by 101 trial participants, 112 decliners and 90 controls (total 303). The most important reasons given for taking part included 'considering the research to be important' (85%), 'wanting to help the researchers' (70%), 'having time to help' (62%) and 'getting free condoms and lubricant' (56%). The most popular reasons for declining were 'not wanting to use condoms' (38%), 'partner's unwillingness to take part' (29%), 'not wanting to alter usual contraceptive practice' (27%), 'not having time' (21%). Contrary to expectations, embarrassment and fears about confidentiality were relatively unimportant factors in this decision. In conclusion, the key to attaining recruitment targets was the core research team taking an active part, working closely with clinic staff and maintaining tight control of the process. Altruism remains a powerful motivation for participants, supported by incentives and procedural details to minimise personal inconvenience. Even for intimate research topics, these general factors outweigh specific issues. (C) 2004 Elsevier Inc. All rights reserved.