CHAPTER FOUR RESULTS
4.3 PRIVILEGING
responses for participants, as required for fetal safety, and questioned whether these practices might conflict with participants’ real reproductive choices:
And then also for some of the protocols the extended period of contraception makes it difficult because a lot of our participant are in the reproductive age and want to have children at some point. So it’s difficult to expect someone to know that ‘I will definitely not have children for the next two years’ because things may change, relationships may change and so very often there is turmoil between what they’ve promised to do for the study and what is needed in their personal relationships [p/contraception] [c7, site-staff, site D].
In summary, the findings captured under this master theme suggest that researchers and network representatives try to reconcile tensions between research and care roles through a number of implicit and explicit strategies. Implicitly, they understand some steps for science as also being of clinical benefit to participants, they see that helping responses also strengthen the science, and they characterize some responses as having both a dual scientific and helping function. They also explicitly take a number of ‘extra-scientific’ steps to address needs. That is, these findings show that researchers take many steps to address participants’ needs that are not merely to advance the scientific objectives of the trial nor to keep participants safe – these are helping practices. These findings under this master theme do not support the view that researchers feel acutely conflicted by the contrasting demands of implementing the research versus helping participants with their health needs however subtle conflicts remain.
stakeholders regarding the issue of ‘special treatment’ for participants in relation to non- participants (both general citizens and citizens who present for screening but are not enrolled).
Certain site-staff held the view that participants deserve something from researchers that citizens do not, however, they seemed uneasy about how much special treatment participants should enjoy. They experienced some ambivalence about this issue that was recognized by them as such (‘questioning special treatment for participants’). One respondent noted that the national treatment guidelines for ART-initiation had recently been changed to an earlier initiation (at a CD4 count of 350 instead of 200) and questioned whether participants should in fact receive even earlier ART-initiation than general citizens.
…we’ve been a protagonist of [earlier initiation] that since, you know, sort of 2004 or 5, so it’s long overdue in our books and, you know, they’re very important public health moves, so we fully support that. And, I guess it has been a reason for anxiety in the past, in terms of, you know, should our standard of care within our prevention centres be different? (…) because that obviously then provides an inequality that is quite vast you know (…) it does mean that you’re creating a ‘have and a have not’… [p/HIV] [c11, site staff, site E].
Many site-staff and REC representatives felt that participants deserve special steps compared to those that citizens might receive, that is, something of a better deal than citizens.
However, they were not in agreement between themselves about precisely what was owed to participants. In other words, there was not a uniform view of what was owed to participants or what degree of special treatment they deserved (‘Endorsing special treatment but not agreeing on the response’). More specifically, some asserted that participants should get closer disease-monitoring than citizens, some asserted that they should get better psycho-social support than citizens, whereas others perceived they should receive care in specialized non-public health care environments. Still others endorsed the view that participants’ HIV care should follow national treatment guidelines (identical to guidelines governing citizens) but there should be ‘assisted referral’ or special steps to link participants to national care (non-identical to steps for citizens).
Representatives from RECs characterized ‘assisted referral’ as preventing the phenomenon of the ‘disappeared participant’ –
I think there we would be more interested in saying, ‘Well are they just going to/ are these people just going to disappear into the system again? We should make sure, in some way, whether that’s linking directly to treatment services at the same site, or follow up or something. So that we don’t just kind of say, ‘Oh well, treatment’s available, you know. Go find it. Here’s a letter’ [p/HIV] [c5, REC, jurisdiction over site E].
Certain REC representatives endorsed the view that following national treatment guidelines for HIV provided HIV patients with sound care:
I think the provision of treatment regimens that we have available in South Africa currently is reasonable for participants who have not been exposed to drugs previously and do not demonstrate any resistance. The South African guidelines are fairly close to what is the best possible treatment internationally (…) as we’re committing people to many decades of treatment complete aligning to good treatment provided by the local guidelines is correct [p/HIV][c20, REC, jurisdiction over site B].
No stakeholder appeared concerned that special treatment for participants in the form of assisted referral steps (for example, booking appointments or escourting participants to appointments) might make citizens worse off but rather that citizens may be excluded from benefits that participants get.
Some site-staff and CAB representatives worried that ensuring special treatment for participants might make citizens too willing to ‘cross over’ into being participants. They were concerned about whether steps for participants might unduly influence, ‘bribe’ (or even
‘coerce’) citizens into becoming participants. Their anxieties here centered on whether the steps taken for participants represented something that was ethically distasteful, insofar that these steps would make citizens want to become participants too uncritically (‘Worrying about the consequences of special treatment’) as exemplified in the following quote:
Now if you put such things there I don’t know whether I should say it but you know it entices people that if you come here you are going to get this and this, it doesn’t sound nice. It seems you are bribing people, you are telling people that ‘now if you take part in this you are going to get this and this’ and then the way I understand it there shouldn’t be payment for participation. For a study to be credible, people should not be bought to take part in it, but if you bribe people to come and take part the credibility of the study reduces [p/HIV] [c12, CAB, site C].
As set out in a previous master theme (‘Reconciling’), site-staff did in fact see participants as benefitting in ways that citizens do not, stemming either from the research procedures (for example, serial monitoring of CD4s means earlier referral for ART) or from some site strategy (for example, onsite dispensing treatment for STIs or treatment for other ailments means less time-wasting and less stigma) (‘Recognizing some privileging of participants over citizens’).
However, because site-staff were unsure about the degree of special treatment for participants and the impact privileging might have on sound decision-making, they were ambivalent about advertising ways in which participants are treated differently from citizens.
They appeared in some instanced to endorse a stealth approach where such benefits are omitted from key documents. As one site-staff representative stated:
I think those are some of the benefits for a participant to be in the study, because, you know, going to the clinic, and just sitting there for just a minor flu, while we can actually provide medication. So, somehow it’s also a benefit for that particular person, to be treated here, in the clinic (…) one of the benefits, though we won’t put them in the consent form [p/other] [J1, site-staff, site B].
Site-staff viewed participants as receiving benefits from trial participation, but maintained a relative silence about possible benefits in written materials (both consent forms and protocols). This held for benefits linked to scientific responses, for example, serial monitoring leading to earlier referral, and benefits linked to care responses, for example, onsite dispensing of treatment leading to less time-wasting. Site-staff saw far more benefits for participants than were declared in written materials. Site-staff seemed somewhat conflicted about committing to paper the ways in which participants may be advantaged in relation to non-participants. They appeared conflicted about the acceptable degree of special treatment
for participants versus citizens. They also seemed conflicted about whether declaring special treatment might act as an inappropriate incentive for potential participants, and appeared to address this latter conflict indirectly by omitting such advantages in consent materials. (There is more on omissions in written documents under the final theme ‘Partnering’).
Site-staff also appeared to manage their discomfort with the privileging of participants in relation to non-participants by other strategies, such as trying to do more for citizens who volunteer but may not be enrolled, and trying to do more for regular citizens. That is, they offset some concerns that participants are prioritized by invoking the various ways in which they also provided some services to non-participants, or helped non-participants with important health concerns (‘helping non-participants’).
More specifically, they took some steps for volunteers who presented for screening but were not necessarily enrolled in HIV vaccine trials. For HIV needs identified at screening, site-staff reported providing counselling onsite, referring for HIV care at co-located PEPFAR-funded clinics (two sites) or to the public sector (three sites) and providing letters and results (but not providing CD4s or viral load measures). Some assisted referral steps were described, but not the range described for participants. The HIV treatment fund was reportedly not available for screen-outs. For STI needs, they addressed STIs by referral to the public sector (one site) versus providing volunteers with onsite treatment (three sites, including both implementing the phase I HVT) and at one site the strategy was unclear. Various strategies were used to support onsite treatment, namely purchasing drugs using a ‘site kitty’, PEPFAR funds, or procuring from the Department of Health. For contraceptive needs, hormonal contraception was ensured by referral to public-sector facilities (two sites) and by onsite provision of free hormonal contraceptives (three sites). In the main, sites successfully managed to partner with the Department of Health to secure hormonal contraception for onsite provision. For more general ailments (such as hypertension), site-staff reported addressing these by referral to the public sector (four sites) versus providing onsite treatment (one site).
Site-staff at all sites also reported taking a number of steps to help general citizens in the community with some of their health needs. Reported steps from various sites included providing HIV education initiatives, providing HIV testing and counselling services to
individuals and partners, providing screening for TB, providing contraceptive awareness- raising, providing sexual health services, and providing cholesterol, glucose and blood pressure screening.
Site-staff described steps that indicated that participants at different sites were getting differences in the quality of care based on referral-site characteristics or because of the strategies sites adopted to address needs. For HIV needs, site-staff recognized that referral to co-located PEPFAR-funded HIV care has certain advantages over referral to public-sector care. A respondent stated ‘our participants are privileged in a way in that they by-pass the public sector rigmarole which is sitting and waiting in long queues for hours, delays in ARVs. [c2, site-staff, site A].
Site staff also recognized that public-sector HIV care in one province may differ from that in another province, alluding to how quality of care may be differentially impacted by referral site conditions. A representative from a site that refers to the public sector in one province reported: ‘we haven’t really struggled with very long waiting lists or major problems (…) So, I must be honest, we’ve never struggled with what I know other sites might have experienced in other provinces’ [c11, site E]. A contrasting report from a site representative that refers to the public sector in another province stated: ‘they will tell you ‘we don’t have this and we’re still waiting for this and that’ and because of the shortage of resources and human resources well I think that hampered progress …’ [c8, site C]. Respondents also reported variable implementation of national policy for ART-initiation (that changed from initiation at a CD4 count of 200 to initiation at a CD4 count of 350 over the course of this qualitative exploration). A site representative reported: ‘we are referring participants to our local clinics here and they don’t have that policy implemented yet’ [c16, site refers to public sector 1]. A contrasting report noted: ‘Yes it has been implemented’ [c16, site refers to public sector 2].
Site-staff perceived that certain practices to address needs are associated with certain advantages. For STI needs, site-staff at most sites recognized the advantages of onsite treatment for participants (less time-wasting and less stigmatizing attitudes than at public- sector facilities). Referring to attitudes from public-sector staff, one respondent remarked:
an STI, you came back again, so we are not going to tolerate this thing.’’ [z4, site-staff, site B].’
(p. 86). For contraceptive needs, site-staff saw advantages for participants of onsite provision of hormonal contraception (more sophisticated counseling, less waiting, better toxicity- tracking). (‘we are technically also providing a better service for participants’) [c11, site-staff, site E]. For general ailments, onsite treatment was understood to be an advantage for participants (involving significantly less time-wasting than at public-sector facilities). One respondent noted ‘they will tell you the security guard sent me away. It happens all the time…’
[c2, site-staff, site A] while another stated ‘They sit there the whole day [laughs]. They miss work’ [c3, site-staff, site B]. At one site (as mentioned earlier) participants were referred to private practitioners, and the bill was footed by the site.
Site-staff did not report feeling conflicted about differences in care between participants at different sites (as they did about differences between participants and citizens) and in fact endorsed the need for variable strategies to address participants’ needs (‘Taking steps that privilege participants across sites’). Put another way, site-staff declared responses that showed privileging of participants at some sites in relation to participants at other sites, but they did not explicitly frame across-site privileging as a conflict, as suggested in the following quote from a site-staff member at the site where private health-care was utilized for participants (a strategy that was not adopted at any other site):
So the fact that we are able to take care of them during the follow-ups, as in they access the health system here, it’s something that they like, and I think they talk about it (…) I think, they themselves confess and say, this is/ ‘the whole year I know I have a medical aid’ [laughs] It’s not really a medical aid, but, it is a medical aid…[p/ other] [c3, site-staff, site B].
In summary, these findings indicate that stakeholders agree that researchers (because of some positive obligation to participants as set out in the first master theme ‘Reciprocating, Engaging, Benefitting’) should take steps for participants that they do not necessarily take for non-participants, however they did not necessarily agree between themselves on what those steps or responses should be. Some were ambivalent about how much special treatment participants should enjoy in relation to citizens. Some questioned the consequences of special treatment on decision-making. Many recognized there are ways in which participants
are advantaged in relation to citizens, but unresolved questions about the correct ‘dosing’ of responses or consequences for decision-making, such as ‘bribery’, or even ‘coercion’, prevented them from committing these to paper. To offset some discomfort about privileging, site-staff implemented helping steps for volunteers as well as general citizens.
They took steps that demonstrably advantaged participants at some sites over participants at others but this was not necessarily experienced as a conflict.