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Volume 9 Supplement 2

AIDS Vaccine 2012

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

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.

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Correspondence to P Munseri.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Ngatoluwa, M., Munseri, P., Janabi, M. et al. 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. Retrovirology 9, P153 (2012). https://doi.org/10.1186/1742-4690-9-S2-P153

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Keywords

  • Poor Adherence
  • Laboratory Abnormality
  • Community Engagement
  • Police Force
  • Education Session