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Objectives

  1. To help participants understand the research process and the role of trial volunteers
  2. To help participants understand the potential outcomes of research
  3. To identify the differences between prevention and treatment research

Key points

  • Developing a new drug or vaccine is a long and complicated process. It can take more than a decade to find one that is both safe and effective. Since potential products are abandoned along the way if they do not look promising, very few of the original candidates make it to late‐stage trials.
  • NPT research is truly a global effort.
  • The majority of trials take place in eastern and southern Africa because these are the regions with the highest incidence rates, and are the populations which would most benefit from NPTs.
  • None of this research would be possible without the willingness and dedication of the study volunteers. Study volunteers go through a careful informed consent process and receive a gold standard of prevention services.
  • A “positive” result in a trial means that the candidate product (vaccine, microbicide etc. being tested) is more effective in preventing HIV transmission than the placebo—but a successful trial may not have a positive result.
  • All clinical trial results are valuable.
  • If the standard prevention package (HIV testing, regular counseling, treating STIs, free condoms) offered in a trial results in lower risk behaviours, the annual HIV incidence rate in the trial sample goes down and researchers actually need a much larger sample size to detect the same level of effectiveness.

Suggested activities

Results of major prevention trials (slide 26)
This exercise has the participants analyze the results of some major prevention trials from the last few years. Have the following trials on pieces of paper (with tape) or sticky notes:

  • Carraguard
  • Male circumcision
  • Cellulose Sulphate
  • N9
  • Diaphragm
  • CAPRISA 004
  • IPrEx
  • PRO‐2000
  • AIDSVAX/ALVAC
  • AIDSVAX
  • Savvy
  • Merck vaccine
  • BufferGel

Have the participants place the trial name in the appropriate box in the grid (projected on the screen or wall). The box that is crossed out (trend toward harm + signs of efficacy) will always be empty because no product can be both effective and cause harm.

The correct boxes for the trials are:

  1. Carraguard (safe and no efficacy)
  2. Male circumcision (safe and signs of efficacy)
  3. Cellulose Sulphate (trend towards harm and no efficacy)
  4. N9 (trend towards harm and no efficacy)
  5. Diaphragm (safe and no efficacy)
  6. CAPRISA 004 (safe and signs of efficacy)
  7. iPrEx (safe and signs of efficacy)
  8. PRO‐2000 (safe and no efficacy)
  9. AIDSVAX/ALVAC (safe and signs of efficacy)
  10. AIDSVAX (safe and no efficacy)
  11. Savvy (trend towards harm and no efficacy)
  12. Merck vaccine (trend towards harm and no efficacy)
  13. BufferGel (safe and no efficacy)