ETHIKasabati

Phase 2 trial of Oral Tenofovir use as a chemoprophylaxis for HIV infection in Nigeria: The outcome of community involvement with the scientific research process

Report of the outcome of dialogue between the community and researchers involved with the phase 2 oral Tenofovir trial in Nigeria / A report by the Nigeria HIV Vaccine and Microbicide Advocacy Group (NHVMAG) - 2005

The document summarizes the ongoing dialogue between community activists, researchers and other stakeholders involved with the phase 2/3 Tenofovir trial in Nigeria. Tenofovir, a drug used for the management of HIV infection is been tested for possible prophylactic effect against HIV infection in uninfected individuals.

Concerns raised by community activists about the trial include:

1. The need for the study deign to ensure long term care for trial participants who become HIV positive while participating in the study

2. Defining the criteria of success for the trial

3. Explanation on why a phase 1 trial was skipped when no such study had been done on assessing TDF use in non infected individuals

4. The need for community preparedness before the trial begins

5. Need for the establishment of a community Advisory Board to monitor the trial

6. Addressing the issue of informed consent for trial participant

7. Guaranteeing the long term care and safety of trial participants participating in a novel trial

8. Defining the subject/community benefits from the trial especially in terms of ensuring access to the trial drug once proven effective

9. How does the trial ensure 'patient confidentiality?'

10. How the study is being monitored and evaluated independent of the study sponsors

11. How thorough was the review process done by the various review bodies in view of the limited understanding of issues related to new HIV prevention technologies

12. What was the depth of government's involvement with this trial?

13. How much community involvement was there in the design and implementation of the trial?

14. The need for transparency and continued dialogue with the community on the outcome of the research

The report also summaries the outcome of the dialogue with the authorities of the University College Hospital, Ibadan as well as the recommendation made by NHVMAG on the research process.

To download this document, click the following link: NHVMAG-Tenofovir-2005