Addressing missed visits to improve retention of young South African women in clinical trials

Abstract

In clinical trials, a vital protocol requirement for participants is adherence to scheduled visits. A substantial number of missed visits and the resultant missing data could affect generalisability of the findings and undermine the scientific conclusions. We aimed to investigate the extent of and reasons for missed visits in the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in order to optimise recruitment and retention practices. Despite being a multi-country study, we investigated missed visits only at Setshaba Research Centre in Soshanguve, Tshwane, South Africa. Of 810 participants enrolled at Setshaba Research Centre, 94 (11.6%) participants missed visits and 231 missed visits were recorded. Of the 94 participants who missed visits, 53 (56.4%) missed at least two visits; 37 (39.4%) missed three or more visits, and of these, 32 (86.5%) missed at least two visits for the same reason. Overall, the main reasons for missed visits were: participant had to work (60; 26.0%), unable to contact participant (60; 26.0%), participant relocated (32; 13.9%), and participant travelled out of area (23; 10%). The large proportion of participants who missed two or more visits indicates that participants who miss a single visit are likely to miss even more, often for the same reason. Site staff need to be vigilant to detect any trends in missed visits early and innovative in developing personalised strategies to minimise missed visits and retain participants until completion of their scheduled visits. Significance: • Despite trial site staff developing strategies to minimise missed visits, they will not be able to anticipate all scenarios. • Participants’ work commitments, loss of contact with participants, and participants’ travel/relocation to distant areas were the main reasons for missing visits, and site staff need to consider the potential for these to arise during the course of the study when assessing potential participants at enrolment and at each follow-up visit. • Case report forms designed for multi-country studies should be adapted to reflect the most likely reasons for missed visits for the local situation, so that trends in missed visits can be identified and addressed early.

Keywords

• clinical trials
• retention
• protocol adherence
• missed visits