Family Practice Advance Access originally published online on February 1, 2006
Family Practice 2006 23(2):188-191; doi:10.1093/fampra/cmi109
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Lessons learned from recruiting young female students to a randomised controlled trial of chlamydia screening
Community Health Sciences, St George's, University of London, London SW17 0RE, UK
Correspondence to Pippa Oakeshott; Email: oakeshot{at}sgul.ac.uk
Received 24 June 2005; Accepted 18 December 2005.
Ivaz S, Brennan S, Dean S, Hay S, Hay P, Kerry S and Oakeshott P. Lessons learned from recruiting young female students to a randomised controlled trial of chlamydia screening. Family Practice 2006; 23: 188–191.
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Abstract |
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Background. Recruitment is a problem in many trials. Two female medical students offered to help with recruiting problems in a community-based trial of chlamydia screening to prevent pelvic inflammatory disease. We need to recruit 2500 sexually active female students and ask them to provide a self-taken low vaginal swab and complete a questionnaire with follow-up after a year.
Objectives. To identify recruitment difficulties in a community-based trial of chlamydia screening and to investigate how they might be overcome.
Design. Descriptive study.
Setting. London South Bank and Kingston Universities.
Methods. The students observed the recruitment methods used for the first 4 months of the trial. This comprised single researchers recruiting individual women in student bars and common rooms. With the researchers they piloted a new method of group recruitment with pairs of researchers making announcements at the end of lectures after first sending out all male students and those aged >25 years. This involved extra time planning and liaising with the lecturers in advance of recruitment sessions.
Results. The recruitment rate had been averaging only 25 participants per week. Many students were ineligible: never been sexually active, too old, recently been tested for chlamydia. Many eligible students were reluctant to take part because of embarrassment or anxiety about providing a swab. Using a new method of group recruitment after lectures we recruited 192 participants in 2 weeks.
Conclusion. For a study on a sensitive topic, two researchers recruiting women in groups after lectures may be a more effective and cost-effective way than individual recruitment by researchers working alone.
Keywords. Recruitment, randomised controlled trial, chlamydia, screening.
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Background |
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Recruiting people to randomised controlled trials is often problematic, particularly in studies involving healthy volunteers. From the point of view of a potential participant, barriers may include the time and effort involved, lack of interest or familiarity with research, embarrassment if the topic is sensitive, and concerns about information and consent.1 Participants' views of the intervention are also important. We report our experience of recruiting female students to a trial of chlamydia screening.
The Prevention of Pelvic Infection (POPI) study is a community-based trial using new non-invasive tests to see if screening and treatment of chlamydial infection reduces the incidence of pelvic inflammatory disease (PID) over 12 months. The only previous trial was conducted over 10 years ago in an American population using tests that can be considered outdated.2 We are targeting a high-risk young, sexually active, multi-ethnic, hard-to-access female student population, and need to recruit 2500 individuals. Participants are asked to fill in a consent form, complete a questionnaire on sexual health and provide a self-administered vaginal swab with follow-up by postal questionnaire after 1 year. After recruitment the swabs are randomised and half are tested for chlamydia and infected women referred for treatment. The remaining swabs are stored and not tested for a year. The main outcome is the incidence of clinical PID by 12 months.
For ethical reasons it is vital that participants understand that half the swabs are being stored for a year and that if they have been at risk of sexually transmitted infection they should attend a health care facility to get tested. This is explained in the patient information leaflet and reiterated during recruitment. After recruitment an extra copy of the patient information sheet is posted to the address provided by the participant.
As in many trials recruitment has been much more difficult than expected1,3 particularly when compared with the pilot conducted among female medical students in the bar at St George's Hospital Medical School4 where it took only 90 minutes to recruit 25 students. In April 2005 two medical students (SI and SB) offered to help with recruitment for their final year Special Study Module. Their aim was to identify recruitment difficulties associated with a trial of chlamydia screening and to devise practical methods to overcome them.
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Methods |
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The students helped with recruiting for 2 days and observed the problems encountered. Then with the research nurses (SH and SD) they devised and piloted a new method of group recruitment at the end of lectures.
Initial recruitment
Recruitment started in September 2004 at one-day Freshers' Fairs at Kingston and Southbank Universities. After this the two part-time research nurses (SH and SD) worked 2 and 3 days per week, respectively. Initially students were recruited on an individual basis by a single recruiter approaching students in bars and common rooms. The problem with this approach is that it was extremely time-consuming for the number of participants recruited, and the high number of those ineligible or who did not want to take part was demoralising for the recruiters.
New method of recruitment
We devised a new method of recruiting after lectures by pre-arrangement with faculty staff. As the researchers had not met them previously, this involved time liaising with individual lecturers and finding which courses had a higher proportion of young women. In order to deal with large numbers of students at the same time it was necessary to have at least two recruiters, preferably female. It was possible to make group announcements explaining the purpose of the study and how to obtain the sample which saved a lot of time. Individual attention was given with completion of consent forms and checking eligibility and ensuring participants understood the need to be tested for sexually transmitted infections elsewhere if they had been at risk. We found it helpful to ask male students, and the females over the age of 25, to leave prior to the announcement. It also helped if the lecturer was enthusiastic about the importance of medical research and passed that on to the students. However, male lecturers were also asked to leave for the comfort of the participants.
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Results |
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We recruited 33 students at the Freshers' Fairs. Then using individual recruitment mainly in the bars, we recruited 306 students in the first 3 months, average 102 per month excluding holidays. Analysis of recruitment forms from the first month of recruitment showed that
70% of 510 students approached were ineligible: no previous sexual intercourse, age >25, inadequate English, or been tested for chlamydia in the past 3 months and no new partner since then. Of those eligible about two-thirds did not want to take part because they were unwilling to provide a self-administered vaginal swab, were ‘not interested’ or did not have time. It was difficult to recruit when male students were present. In addition, when a single person was recruiting a student this often meant that other potential participants left as they could not be accommodated immediately because a lengthy explanation was required or help was needed to complete the questionnaire. Using the new method of group recruitment after lectures, and with two enthusiastic medical students SI and SB, we recruited 192 participants in 2 weeks. Recruitment improved to 388 students in 2 months, average 194 per month, almost doubling the recruitment rate (Fig. 1). By the time students left for exam leave in May 2005 we had recruited 743 students. However, we continue to use individual recruitment if there is an interval between lectures.
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Numbers of students attending lectures and seminars varied from
5 to 150 and number of students recruited from a lecture from 0 to 24. When we started group recruitment we recruited 113 students from 16 lectures, average 7 students per lecture. We noticed there was a difference in response rates of participants depending on the course they were studying. Those studying humanities or subjects such as nursing or childcare seemed much more willing to participate. These courses also had a higher proportion of women students, though sometimes most of them were aged >25. We were surprised to find that offering a lollipop and pen were greater incentives to take part than we had appreciated, particularly when letting them choose the flavour of the lollipop! The enthusiasm of the recruiters is paramount in generating interest in the study. By recruiting after announcements in lecture theatres there is less opportunity for recruiters to become demoralised as there is no immediate rejection as seen in the individual recruitment method. After lectures groups of students would come forward and found it easier to participate when they were amongst their friends. They were also far more likely to encourage other students to take part in the study including ringing them on their mobiles to ask them to come immediately.
Design issues are also important. We decided to increase the upper age limit of participants from 25 to 27: 4% of students recruited to date are in this age bracket. We also decided to extend the number of recruitment sites, increase the number of recruiters and prolong the time spent recruiting from 6 to 18 months. Although not evidence-based, the Box 1 summarises practical lessons learned.
BOX 1 Lessons learned about recruiting female students to a trial of chlamydia screening
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Discussion |
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Principal findings
Recruiting students in groups at the end of lectures using pairs of recruiters was more productive than recruiting individual students using a single recruiter.
Strengths and weaknesses
This is a practical study. It emphasises the importance of persistence and thinking creatively to overcome recruitment problems. Involving medical students of the same age and gender as potential participants brought a different perspective. The main weakness is that we are unable to get reliable data on non-responders, particularly when recruiting after large lectures when many students are in a hurry to leave. The low response rate also means the sample may not be representative. However, this matters less in a trial when participants are randomised than in a prevalence survey. Finally most of the suggestions in the lessons learned box are our impressions rather than evidence-based, e.g. using lollies as incentives, avoiding use of the phrase ‘vaginal swabs’. Testing the effect of such modifications was beyond the scope of the study.
Implications
These results may be helpful for other researchers recruiting young people. It is not directly relevant to inviting people for chlamydia screening as this was a trial in which only half the participants would be tested immediately. Thus, those who had been at risk of infection were advised to get tested elsewhere.
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Conclusion |
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Recruitment for randomised controlled trials can prove extremely difficult. This is an issue common to many trials. Success relies heavily on the enthusiasm, positive attitude and creativity of the recruiters.
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Declaration |
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Funding: The BUPA Foundation
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Acknowledgments |
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We are very grateful to the students and staff at Kingston and London South Bank Universities. We also thank GenProbe for supplying the chlamydia testing kits.
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References |
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1 Gabbay M, Thomas J When free condoms and spermicide are not enough: barriers and solutions to participant recruitment to community based trials. Control clin Trials 2004; 25: 388–399.[Medline]
2 Scholes D, Stergachis A, Heidrich F, Andrilla H, Holmes K, Stamm W Prevention of pelvic inflammatory disease by screening for cervical chlamydia infection. N Eng J Med 1996; 334: 1362–1326.
3 Sellors J, Cosby R, Trim K et al. Recruiting family physicians and patients for a clinical trial: lessons learned. Fam Pract 2002; 19: 99–104.
4 Hay P, Hay S, Oakeshott P Feasibility of recruiting in a student bar for a trial of chlamydia screening in young women. Fam Pract 2004; 21: 223–224.
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