Enrolment and logistical challenges in TaMoVac 01 Phase I/II HIV trial despite the completion of an earlier (HIVIS-03 trial trial) in Dar es Salaam

Abstract

Background Participation of sub-Saharan countries in HIV vaccine trials is important in the fight against HIV/AIDS, and has to be sustained by continued trials. Experiences from earlier trials are expected to influence the design and the performance of subsequent trials. Following completion of HIVIS-03 trial, TaMoVac- 01 trial was initiated. We compare enrolment experiences between the two trials. Methods The HIVIS-03 trial, conducted between 2007 - 2010 recruited 60 volunteers from the Police force in Dar es Salaam. The subsequent TaMoVac- 01 trial has recruited 62 volunteers from the Police and Prisons force, and youths at IDC. Results Enrollment of volunteers into the HIVIS-03 took 12 months while the TaMoVac-01 trial took 13 months. Screened: enrolled ratio was 3:1for HIVIS-03 trail, while for TaMoVac-01 8:1. Reasons for screen-out in the TaMoVac-01 trial were influence of family, misconception, clinical and laboratory abnormalities. Recruitment of females was a challenge in the HIVIS-03 trial, but was unnoticed in the TMV-01 trial, this could be due to inclusion of youths. Misconceptions in the Police force remain an obstacle to recruitment despite regular education sessions. Other challenges were: Poor adherence to schedules, due to competing prioritization of employment requirements; difficulties in communication with volunteers without phones. Most challenges were addressed through collaboration with the concerned authorities in the respective cohorts. Conclusion Recruitment challenges continued in the TMV-01 trial despite our experiences with HIVIS-03 trial. Enhanced Community engagement and timely action by the researchers is necessary to ensure a smooth conduct of the trials.