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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
© Ngatoluwa et al; licensee BioMed Central Ltd. 2012
Published: 13 September 2012
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.
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.
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.
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.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.