STUDY AIMS AND METHODOLOGY
3.3 STUDY METHODOLOGY
3.3.4 ACCESSING INTERVIEWEES
It has been noted that participants who share a particular experience of a specific phenomenon can be difficult to access and careful engagement and rapport-building with core gatekeepers may be required (Smith, Flowers & Larkin, 2009). Principal investigators and site-staff were approached from all five preventive HIV vaccine sites in the country (including sites that had much experience with HIV vaccine trials and sites with less experience) that were implementing two particular HIV vaccine trials – a phase I trial and a phase IIB trial.
More specifically, the phase I HIV vaccine trial explored safety and immune responses in vaccine recipients versus placebo recipients and enrolled participants at low-risk of acquiring HIV infection; whereas the phase IIB explored vaccine efficacy by assessing HIV infection, and viral load set-point, in vaccine recipients versus placebo recipients (in addition to evaluations of safety and immunogenicity) and enrolled participants at high-risk of acquiring HIV infection. These trials were selected because it seemed helpful to elicit accounts of experiences with ancillary care in actual trials rather than reflections about hypothetical or abstract trial scenarios. These two trials were selected because it was anticipated that their implementation would coincide with the period of data collection for the study. These two trials were also selected because they might possibly provide contrasting scenarios in which site-staff could reflect on ancillary care.
Representatives from all five CABs at the sites were approached. Representatives from the network were also approached. The network was responsible for securing funds from the sponsor, and for coordinating the conduct of HIV vaccine trials, and for taking on some responsibilities delegated to them from the sponsor such as development of informed consent forms. REC members at all four committees that had ‘jurisdiction’ over the relevant
States sponsor organisation that provided overall trial financing was also approached, however, email-efforts to liaise with the point person to secure a short-list of potentially interested persons to invite were not successful and after several emails the outreach was terminated.
The process for inviting potential interviewees was collaboratively designed, in order to minimize disruption to organizational processes and respect organisational procedures as far as possible (cf. UNAIDS/AVAC, 2011). In order to invite site-staff for interviews, a visit was arranged to describe the overall study, to identify concerns, to ascertain if there was broad interest, and to inquire about the best method to approach site-staff to take part in interviews. Concerns were tabled in visit reports and included concerns that interviewees may not be very familiar with ethical requirements, perhaps representing concerns that interviewees’ ethical knowledge would be ‘tested’ in some way, and that interviewees should not be overly burdened by the time commitment required. There were questions about the possible impact of the research (representing occasional misunderstanding of this research as a form of an audit to establish compliance with ethical requirements). There were also questions about how to ensure that individual sites could get feedback if they so requested it without threatening the anonymity of particular interviewees, and discussion about how to ensure credible site-level data if only a few persons agreed to be interviewed per site.
A report was drafted for each site’s principal investigator, describing the questions raised, how they were responded to and setting out the strategy proposed by attendees to invite potentially interested site-staff take part in the interviews (as well as CAB members, see below). The preferred strategy declared by site-staff was largely by email invitation. After approval by site principal investigators to proceed was received, email invitations were extended to site-staff to take part in interviews. Invited site-staff included principal investigators and site investigators, unit managers, study clinicians, and community liaison officers. In addition, letters were sent to site principal investigators, requesting access to documents for the two selected HIV vaccine trials – including protocols, ethics applications, informed consent forms, and other relevant documents (see Appendix 2).
For CAB members, presentations were made to CAB members at all five HIV vaccine trial sites; their questions addressed (see below) and their preferred strategy to be invited was identified, which was largely via cell phone. Most CABs elected not to send the full list of cell phone contacts but rather sent a ‘short-list’ of representatives willing to be contacted, after discussing amongst themselves the nature of the research, and the suitability and interest of individual members.
For network representatives, an email was sent to the representative of the organization, requesting the opportunity to approach interested potential interviewees. After this request, a list of names of persons willing to be contacted was received. Those persons were sent an email inviting them to take part in interviews. The network was also requested to release master protocols for two HIV vaccine trials being conducted in South Africa at that time, which they did.
For RECs, an email was sent to the Chair of all four RECs that had reviewed HIV vaccine trial protocols in South Africa. The email requested access to the contact list of members, and made assurances that the list would not be circulated and would only be used for study purposes. In most cases, the Chair provided access to the entire list of members, however, in one case, the Chair provided access to a shorter list of members who had agreed to be approached. Members were sent an email inviting them to take part in interviews.
This strategy for identifying (collaboratively) with potential participants the most appropriate manner to approach people to be invited must have some impact on the interview data. One could speculate that the ‘short-list’ approach adopted by most CAB approached for the study, and by one REC, might mean that some self-presentational work was being done whereby persons considered best able to represent the views of the group were asked to consider participating; or more benignly it might mean that only persons sufficiently interested or motivated allowed themselves to be named for a subsequent approach.