The implications of not including clean needles in the participants’ prevention package could have skewed the trial results to dampen or falsely increase the perceived efficacy of PrEP compared to its actual efficacy, depending on how lack of access to clean needles may or may not have affected the behaviors of the participants enrolled. In addition to this logistical effect on trial results, the other implications were that the study was perceived as unethical and therefore the results were not to be trusted. Even worse, the outcome of this lack of trust from one particular study likely could be later associated with future studies run by the same (or even different) biomedical research institutions attempting to learn more about other possible interventions for HIV prevention. However, to play devil’s advocate, not including the needles in the trial did likely maintain good relations between the local government and the researchers, since the researchers did not push any illegal agenda by including these clean needles against the wishes of the government. Obviously that relationship benefit does not outweigh the costs of not providing the needles, but it is important to recognize all stakeholders when considering the situation.
As for how researchers could engage stakeholders to better negotiate these prevention packages, I think that soliciting input from diverse kinds of stakeholders is critical: everyone from local government officials to previous trial participants to advocacy groups for people who may be represented in the study population, to community members living at the trial site, and even to the media, both local and global. If we want to tailor these packages and the options within to the particular needs of diverse subgroups, then we will need to consult with stakeholders and members of each of those subgroups in forums like focus groups, online or in-person surveys, inviting these folks to come on board community advisory groups and assist in protocol development, and other formative research opportunities as well. Only by asking and listening can we be sure to integrate all of the necessary and appropriate tools into a given trial site’s prevention package. The package should also be something that is able to evolve on an ongoing basis during the trial, by encouraging stakeholders to continue to provide their feedback and opinions about its effectiveness and comprehensiveness during the trial.
