CHAPTER FOUR RESULTS
4.2 RECONCILING
elevated blood pressure or at least ask them to come back in a week to re-check the blood pressure something. You have to do something… [p/other] [c2, site-staff, site A].
In summary, the findings captured under this master theme indicate that stakeholders made sense of researcher responsibilities to help participants in very particular ways. (The helping- based responses that researchers actually implemented are outlined in the next theme as well as the final theme). They tended to root responsibilities to help in accounts of the relationships that researchers establish with participants (‘reciprocating for participants’
contributions’, ‘staying involved with participants’, ‘benefitting and serving participants’, and
‘responding to patients’). More specifically, they invoked relationship-centered accounts of these responsibilities. They saw that researchers should help participants with their HIV needs because it represented a ‘return’ for participants’ significant contributions. They saw that researchers should help participants with their HIV and non-HIV needs because it represented relating respectfully in a non-using and non-abandoning way. They recognized providing services as way to add value to participants’ lives. They also (infrequently) volunteered the understanding that researchers should help participants because they were clinicians faced with patients. That is, in conceptualizing the duties of researchers to help participants with their medical needs, several relationship-centered ideas appeared to be at work – the first was that researchers were in a reciprocal relationship with participants, the second was that researchers were in a respectful relationship with participants, the third was that researchers were able to serve participants in seemingly modest but significant ways, and the last (and least frequent) was that select research staff were in a clinical relationship with patients.
various implicit strategies (how they characterize or understand what they are doing) and explicit strategies (the steps they take to help address participants’ medical needs). This theme also sets out subtle conflicts regarding the demands of scientific versus care roles.
Researcher and network representatives characterized many steps to address participants’
needs as primarily servicing the scientific business of the trial (‘understanding steps as for science’). For the condition of HIV, for example, they saw the measurement of participants’
CD4 counts and viral loads as necessary to establish the experimental vaccine’s impact on disease-progression (for the phase IIB protocol). For the condition of pregnancy, they saw the follow up of pregnancies and infant outcomes as necessary to establish the safety record of the vaccine. For needs such as STIs, they recognized that recording and reporting these as adverse events would help establish vaccine safety. Across a broad range of needs identified in trials, these interviewees made sense of many of their responses by invoking their primary research mission – they were implementing a certain response or practice because it meant rigorous science would be promoted.
Site staff perceived in some instances that the steps they took for science did in fact have certain important collateral benefits for participants (‘understanding steps for science as also helping’). That is, they made sense of the response they were implementing as primarily serving the scientific interests of the trial; however, they also saw it as having a helping effect on participants in significant ways. For example, some site-staff representatives characterized close monitoring of HIV disease-progression indices to meet scientific objectives in the phase IIB trial as also benefitting participants by early referral for care. In this instance, it was recognised that the primary rationale is scientific, but a striking spin-off benefit was asserted – namely closer monitoring and referral means ‘not getting lost’ in the system, as evidenced in the quote below:
…the participant is locked into regular monitoring of their immune system, as well as their virological load, etcetera, etcetera. And these are not inexpensive tests. So, in the public sector, this is not done well you know, it happens infrequently, if at all, and often patients are lost into the, you know, the sort of, chasm of HIV wellness that sort of moments before your positive test and when you need antivirals, and it often is that people will be lost in the cracks during that time, and they turn up back into care when
they are almost at death’s door, or have some opportunistic infection, or whatever [p/HIV] [c11, site-staff, site E].
Network representatives and site-staff at all sites implemented a range of explicit responses across a spectrum of needs (HIV, sexual and reproductive, and general needs) that were explicitly ‘extra-scientific’ in nature; that is, these steps were about helping participants to get their needs addressed in ways that had little to do with promoting scientific integrity (‘taking helping steps’). That, is, in addition to responses that were implemented to answer scientific questions, many responses were implemented that were about helping participants get the care that they needed. More specifically, for HIV infection, site-staff at all five sites reported providing intensive counselling to participants onsite. Site-staff at all sites reported referring participants for ART to either co-located PEPFAR-funded clinics (three sites) or to the public sector (two sites) following national treatment guidelines, addressing opportunistic infections by referral to co-located PEPFAR-funded clinics or the public sector, and addressing PMTCT needs by referral to public-sector clinics. (They also reported testing participants regularly for HIV using a testing algorithm that excluded VISP but saw this response as grounded in the scientific need to detect true infections, as well as the need to offset complications introduced by the research intervention itself).
Representatives from all sites described numerous steps to help participants to access HIV care, including checking participants’ referral preferences, counselling participants to overcome denial and access HIV care, securing participants’ permission to share medical information about HIV, sharing letters and medical information with referral sites, reaching agreements with referral sites about sharing information, developing detailed plans for referral, requesting feedback from participants about HIV care at referral sites, and building relations with referral sites by providing training or posting staff and collaborating on educational events. Some sites reported additional practices, for example, booking appointments, alerting referral sites, accompanying participants, and intervening at referral sites.
Network representatives described that dedicated funding had been sourced from pharmaceutical companies for an HIV treatment fund to purchase ARVs for participants who
could not receive coverage through national ART programs, because funds secured from the sponsor to implement the trials could not be used for treatment purposes:
So there is a fund that [the network] has to pay for antiretrovirals. So if you were sitting in a/ if you were in a situation where there was no access say now there was a clinic in a remote part of South Africa that to get to the HAART clinic it would be impossible you could activate that fund from [the network] to get them to pay for that drugs for you [p/HIV] [c4, site-staff, site B].
Network representatives also described requiring researchers to develop detailed written plans for addressing HIV at their site (the so-called site HIV treatment plan), assisting with the preparation of such plans (covering initiation criteria, availability of first line and second line regimens, management of opportunistic infections, PMTCT), disseminating best practices to researchers about HIV care, and facilitating ART access between sites – the latter evidenced in the quote below:
…there wasn’t a Department of Health access point near [site X] at the time (…) So we made an arrangement with (PI) at the (site Y) that they would essentially do administration so (site Y) is an ART treatment access point. So they made an arrangement by which they could access and ship the treatment to (site X) so that those people could have access right at the site so that was a case of sort of facilitating to make sure that things were happening but/ and that’s happened in other places. So that’s another/ that’s not really a formal process but it is something that we do [p/HIV]
[c10, network].
Site staff also reported taking steps to address participants’ STI, contraceptive and pregnancy needs as well as more general ailments. More specifically, for STIs, site-staff at all sites reported following national syndromic management guidelines, providing STI counselling onsite, and ensuring STI treatment by onsite provision of treatment (four sites) versus referral to public-sector facilities (one site). Sites had implemented various strategies to support onsite provision of treatment, including using a ‘site kitty’, self-purchasing, or procuring from the Department of Health. For contraception, site-staff reported providing contraceptive
counselling onsite. They addressed contraceptive needs by onsite provision of hormonal contraception, procured from Department of Health primarily (four sites) versus referral to public-sector clinics (one site). For pregnancy, site-staff at all sites described providing counselling for pregnancy options if participants tested positive for pregnancy, referring to public-sector pregnancy services (antenatal services or Termination of Pregnancy), and sharing results with referral sites.
For general ailments (such as anemia, hypertension, respiratory tract infections) site-staff described that they addressed such needs by referral (three sites) versus providing onsite treatment (two sites) and at one of these two sites participants were also referred to private care funded by a ‘site kitty’:
They are assessed physically, and if there is anything that we cannot handle, we have agreements with the hospital (…) If there isn’t/ they are not able to help us, we have the private sector. There’s (X) just across the road, it’s a private hospital, so, we refer them there and they just send us a bill and then we take care of that [p/ other] [c4, site-staff, site identifier deleted].
Site-staff at most sites reported soliciting feedback from participants about care received at referral sites. They assessed the functions and capabilities of referral sites and raised awareness about their own capabilities. Many of these responses were implemented by clinical and community-engagement staff hired specifically to take on such functions.
Site and network representatives perceived that when steps were taken to help (that were not strictly necessary for the science) such as providing some care services directly to participants onsite to avoid time-wasting offsite, there are benefits for sites that may well improve scientific outcomes (‘understanding helping steps as soft science’). This perspective was reported regarding the provision of contraceptive services, treatment of STIs and treatment of general ailments onsite. Site staff characterized some of their helping responses as inadvertently (yet importantly) strengthening the scientific initiative, as shown below:
Protocol-related is the retention is very good. You’ve got good rapport with the participants. So you would/ even you data would/ you would collect as much data as you
possibly can. And if it’s a good relationship, that means there is that openness. We’re doing normal, subjective data collection. So, if you’ve built that rapport with them, it’s easier for them to say, ‘You know, last night I actually did not use a condom,’ so, already, that, because we don’t want surprises three months down the line when somebody sero-converts. So we will note it (…) it also helps us in refining the data [p/non-HIV] [c3, site-staff, site B].
There were also numerous instances where site-staff made sense of some responses as being anchored in both a scientific and extra-scientific reason. They appeared in these instances to understand their response as being for a scientific rationale and a helping rationale (‘understanding steps as for science and helping’). Here they did not see the extra-scientific reason as subordinate to the scientific reason, but saw both as critical. For example, site-staff stated that addressing pregnancy-risk by the onsite provision of hormonal contraception helped adherence and helped participants secure a more sophisticated responsive service;
and that addressing STIs with onsite treatment helped reporting and helped participants secure a less judgmental service. Site-staff seemed in these instances to be integrating scientific and non-scientific reasons for adopting a particular response or implementing a certain approach.
Finally, there were a few striking instances where site staff reported taking steps largely to serve science that they perceived to clash with helping participants with their important health needs (‘understanding steps for science as not helping’). In one instance, a site-staff representative described that participants are offered enrolment onto disease-monitoring protocols (when they are identified as HIV-infected in the phase I trial, or when they reach ART-initiation criteria on the phase IIB trial) and questioned whether this practice might discount participants’ potential fatigue at continued trial participation or conflict with participant’s real preferences. In another instance, a site-staff representative described steps to provide pregnancy-prevention counselling to participants and questioned whether the site’s abortion rate might be evidence of an over-zealous counselling process to retain participants ‘on product’ (pregnant participants cannot continue to receive product injections). In another instance, a site-staff representative described pregnancy-prevention
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.