Drawing on a framework developed by Grol and Wensing , Table 5 shows the first level of analysis, which describes the implementation stages. For each stage of the PITC implementation process, we identified key factors that that may have shaped successful deployment of the PITC intervention. Building on this initial analysis, we used the theoretical constructs of the NPM to discuss the dynamic interaction of these factors and how they may have influenced the normalisation of the new PITC intervention and the trial outcomes. These findings are summarised in Table 6.
Interactional workability: to what extent did the new PITC intervention maintain and/or enhance existing norms?
The new PITC intervention was initiated by the senior manager responsible for the development of integrated service delivery for HIV, STI and TB services. This manager lobbied top management to support the introduction of the PITC intervention and to use it to demonstrate feasibility and influence a policy shift. She convened all the stakeholders and took the leadership role in driving the planning and implementation process. Prior to initiating the PITC project, the senior manager outlined her vision for change in HIV testing services . She called for a ‘paradigm shift’ away from treating HIV as an exceptional disease and spoke of the need to increase opportunities for HIV testing in the clinic setting: ‘Treating HIV testing in this exceptional way contributes to the secrecy and stigma associated with HIV, discourages HIV testing and limits access to the credible treatment options available’ . She elaborated on how the new PITC intervention could dovetail with a range of existing clinical services, including STI treatment: ‘Within a medical context this translates to more routine, service provider-initiated HIV testing as part of the standard of care provided in a range of services including the management of sexually transmitted infections, antenatal, reproductive health and TB services, amongst others’ .
The strong leadership role of the senior manager could be described as that of a project ‘champion’ (a term used in literature on diffusion of innovations ), and the term ‘champion’ will henceforth be used to refer to the senior manager. The data extracts above show how the project champion framed the new intervention as both responding to a service need (to increase HIV testing opportunities) and to the need to routinise HIV testing within standard clinical practice. Based on routine operational data, she demonstrated that the numbers of lay counsellors available were not sufficient to expand routine HIV testing to all STI patients and that this gap could be filled through minor changes to STI nurse practice.
In effect, the champion framed the new PITC intervention as not only a requirement, but also as a feasible and desirable way of improving HIV testing service delivery. The framing of PITC as both an opportunity to address a service gap and an opportunity to improve the standard of STI care may have strengthened the willingness of nurses to consider its implementation. Nurses were acutely aware that the current VCT system did not provide optimal access and resulted in missed opportunities for HIV testing for STI patients. Appeals to improving clinical care resonate with professional norms about providing quality services and, as such, are likely to have strengthened the acceptability and the interactional workability of the new intervention. A STI nurse explained her experience of the gap in HIV testing for STI patients: ‘When I used to refer them [STI patients] for VCT, they always say: “Oh, how long will I have to wait? Do I have to see a counsellor?”’ The nurse elaborated: ‘That was always an issue. They would say: “I am willing to take the test, but if I have to go to the lay counsellor, I’m not going to test”… it's too time consuming for them.’
Although the new PITC intervention initially required a paradigm and practice shift, the project champion was able to frame this as not only congruent with, but as enhancing STI clinical practice. This congruence with professional roles may have contributed to nurses internalising the need for change more easily, thus improving the chance of the new intervention becoming embedded in routine practice.
Nevertheless, not all of the stakeholders were supportive of the new intervention, and some disagreements posed a threat to the normalisation of the intervention. During the planning of and training for the new intervention, disagreements emerged between stakeholders about the utility and ethics of PITC, as well as about the changes in role-divisions. STI nurses were now asked to expand their set of tasks to include routinely offering an HIV test, obtaining informed consent, doing a ‘test readiness’ assessment, and performing the finger prick blood test for HIV. Except for the blood test, all of these tasks were previously performed by lay counsellors. Lay counsellors initially felt that the changes in role divisions threatened their job security, but were reassured by their continued and extended role in relation to post-test counselling. However, two other concerns, mainly from HIV trainers, were less easily resolved. One was an ethical concern about reducing pre-test counselling requirements (an issue raised in broader debates on the ethics of PITC [37, 38]). The other related concern was about whether nurses had the appropriate skillset to offer HIV testing and, in particular, whether nurses would be able to facilitate ‘true’ patient informed consent. An HIV trainer explains: ‘Already overburdened staff may jeopardise the objectives of this new model because they have a lot of other things to do and the patient may not feel they can refuse.’
As a compromise, the project leadership agreed to expand the clinical guideline that was developed to support nurses. The guideline was expanded to have a greater focus on assessing test readiness and patient informed consent. In practice, this meant that the nurse was required to ask more questions, provide more HIV information and engage more with the patient, which resulted in a guideline that would take more time than in the original intervention design. As will be discussed later, the longer clinical guideline may have contributed to reducing the feasibility of the intervention on the level of the clinical consultation (see ‘Skillset workability’).
Nevertheless, nurses, as the main implementers, were willing to proceed despite their own concerns about how the new tasks might add to their workload. Nurses in a focus group at the start of the intervention were generally positive toward the change. A STI nurse commented: ‘There are limitations, like the time constraints, but we should go ahead. We should integrate routine screening to all parts of medical care.’
Relational integration: to what extent was there accountability for the deployment of, and confidence in, the utility of the new PITC intervention?
A project governance structure was created at the start of the project, in the form of a Project Steering Committee (PSC). The Committee was chaired by the project champion. The PSC had representation from a range of stakeholders, including frontline nursing staff and lay counsellors, their clinical supervisors, HIV counselling trainers, and facility management. The committee was responsible for the planning, coordination, monitoring and evaluation of the project. It remained active throughout the lifespan of the project and provided both ongoing motivation and continuity.
The PSC seemed to have played a central role in strengthening the implementation process. Senior management leadership of the PSC meant there was high-level responsibility for implementation, which would have contributed to its legitimacy. This and the consultative planning process would have inspired confidence in the intervention among participants. Some of the ways in which the PSC supported implementation include raising awareness and keeping participants motivated throughout; identifying and resolving conflicts; strengthening ownership of the intervention; building trust among participants; as well as providing a mechanism for continuous monitoring.
Normalisation was also supported by the appointment of a dedicated project manager, who provided logistical support for implementation and for monitoring and evaluation. Project support was delivered via site visits at clinics as well as through quarterly ‘cluster’ meetings with smaller groups of staff from two or three clinics at a time. These cluster meetings were considered a key mechanism for promoting accountability and confidence amongst staff, as the project manager explained: ‘The cluster meetings were the “engine” of the implementation process. It was used to share best practice and staff made it their responsibility to bring information to the meeting. They reviewed their monthly and quarterly statistics, they did problem solving and it was considered a team approach.’
While implementation leadership and support would have strengthened staff confidence, nurses may also have been motivated by their own sense of the utility of the new intervention. When asked to reflect on the purpose of the new intervention, a nurse pointed to the opportunity to improve healthcare delivery: ‘This is to be able to treat STI fully. It will ensure that clients are offered all services, even HIV testing… we want to offer complete care and treatment’. Another nurse commented on the feasibility of the PITC intervention, highlighting the close fit with the routine clinical care that she delivered: ‘With me, even though there wasn’t this project, whenever I was treating an STI, I always talked about HIV. So it’s not a new thing. The only opportunity I have now is that I have to do the HIV test’. These positive perceptions of the new intervention were commonly expressed in focus groups with nurses at the beginning, during implementation, and at the end of the project – an indication that they believed in the utility of the intervention and saw it as congruent with their existing knowledge, practices and relationships. This suggests that the intervention had strong relational integration, a factor that would have supported normalisation.
Skillset workability: to what extent did the required skillset fit with existing skillsets and the division of labour?
When asked to reflect on their capacity for implementing these new tasks, nurses consistently pointed to the congruence with standard STI care. As one nurse explained:
‘I think that we always did talk about HIV. People know it’s a virus, they know it has to do with sexual transmission. But I think we spend more time now pointing to the benefit to the patient of testing. Previously we would refer them to VCT and because we weren’t really involved with the testing, we didn’t go into depth such as discussing issues like, “How this is going to benefit you. What services are available for an HIV-positive patient, whether they know how they can prolong their life.”’
While nurses perceived congruence with standard care and did not identify specific training gaps, in practice there were challenges with executing tasks efficiently. Observation of their clinical practice indicated that although they were able to perform all the new tasks (such as offering the HIV test, getting written informed consent, and performing the rapid test) they struggled to do so in an integrated manner. Most commonly, there was an awkward sequencing of tasks in terms of timing and flow, leading to a fragmented approach and a lack of smooth integration with STI tasks. For instance, nurses would sometimes separate their assessment of the patients’ risk for STI from risk assessment for HIV; and health education for prevention of STI and HIV was often separated into different conversations. One of the tasks that took up a good portion of nurses’ time was sharing basic HIV awareness information with the patient, which they did in fairly formulaic fashion, even when this did not seem to be required. As a result of these challenges, the additional HIV-related tasks added more time to the consultation than nurses and the project leadership had planned for.
When nurses were asked about the challenges posed by the intervention, they indicated that the added time was the main obstacle. The main reason for this, they said, was that they were required to convey too much information: ‘We have to do too much talking and writing’. Related to this was the greater interaction with patients as a consequence of introducing HIV into the STI consultation: ‘We have a lot of information to discuss with them, and the clients are also asking a lot of questions’. Another nurse linked the change in the interaction with patients to an increase in consultation time: ‘I think it boils down to the fact that we are actually spending more time with each client… As you’re talking you win their trust, and they are perhaps giving you information that they wouldn’t have given before’.
On average, the new tasks added 7 to 10 minutes more to the STI consultation time (ranging from 3 minutes in one case to as much as 20 minutes of extra time in another), which would have made it difficult to initiate the HIV test offer with every new STI patient. This may explain the trial finding that the proportion of STI patients offered HIV testing (also referred to as the HIV test coverage) was 76.8% for the intervention arm – less than the 100% coverage anticipated (see Table 1). Reduced HIV test coverage would, in turn, have reduced the potential number of people who could accept HIV testing, thus also limiting the size of the main trial outcome (the number of new STI patients who accepted HIV testing). The proportion of new STI patients who were tested in the intervention clinics was just over half, at 56.4% (see Table 1). This points to the importance of achieving a high level of skillset workability for effective implementation, a challenge that we argue was only partly achieved with the PITC intervention.
To illustrate the challenge of skillset workability further, we provide extracts from two clinical consultations to show the range of ways in which nurses approached the challenge of integrating the new tasks. The level of efficiency of deployment varied among nurses observed, most often resulting in long extensions to consultation times. In one clinic where two nurses were observed, one of the nurses seemed more efficient about integrating the HIV test offer compared with other nurses. She achieved this by introducing the HIV test offer early in the STI consultation and by explaining briefly why HIV testing was a good idea when presenting with an STI complaint. In the extract below, the nurse introduced the topic of HIV testing shortly after asking the patient for the reason for their visit: ‘Have you ever tested (for HIV)? Have you ever heard of HIV?’ To this, the patient answered, ‘Yes’. The nurse continued with a brief explanation of why an HIV test would be an appropriate medical option to consider: ‘HIV is the same as other diseases that are transferred though sex,’ and further, that ‘you could get HIV because you are not using a condom’. After a few more lines of explanation about the importance of HIV testing, the nurse asked the patient directly to consider an HIV test: ‘How do you feel about testing for HIV?’ To this, the patient answered, ‘I could test, there is no problem’. As the patient agreed to test early in the session, the nurse then completed the written consent requirements and was able to integrate the technical task of performing the rapid HIV test more efficiently. For example, during the time required for the HIV test result to be processed (10 to 15 minutes), the nurse continued with the STI examination and other STI tasks.
In an example of less efficient practice, the nurse in the extract below also introduced the topic of HIV early on. However, she did not immediately link it to the offer of an HIV test, thereby missing an opportunity for smooth integration. Instead, she focussed on dispensing HIV information in an apparent attempt to ensure that the patient was ‘fully’ informed: ‘Right then. Here it is important for us to let you know more about what made you come here. The STI means sicknesses affecting your private parts, an example being gonorrhea and others, okay? HIV is also included, like you hear around people talking about HIV and AIDS nowadays’. The patient said, ‘Yes,’ to which the nurse continued, ‘Okay, you must understand that these sicknesses like HIV and STI and TB are all related. They are like cousins, if you understand what I mean’. The nurse then proceeded with a lengthy explanation about HIV transmission and how the virus works in the body. This was done in a way that was at times circuitous. She made the offer of HIV testing only after much time was spent on providing general HIV health education: ‘Okay. So now that I have explained everything to you, would you be interested to be tested today?’ After the patient agreed to test for HIV, the nurse struggled to efficiently integrate the tasks associated with obtaining written patient consent and assessing the patient’s test readiness. The additional time spent on HIV education occupied a considerable proportion of the consultation time, and this, together with the lack of smooth sequencing with STI tasks, resulted in a lengthy extension to the consultation.
As illustrated above, in the context of clinics with high STI patient loads, the interrelated challenges of integrating new tasks and keeping consultations to a manageable length may have limited the nurses’ ability to offer HIV testing more widely. The long length of the clinical guideline for PITC appears to have reduced the skillset workability of the new intervention, making it more difficult to execute it efficiently.
Another factor contributing to reduced skillset workability was the training. There was disagreement between the project leadership and the HIV trainers about the duration and content of the training for the STI nurses. It was evident from participant observation that training focussed on teaching nurses counselling skills so that they could assess patient readiness and facilitate ‘true’ informed consent. Most of the time was spent on trying to rapidly teach nurses to use patient-centred counselling techniques and on how to provide health education to ensure that the patient was fully informed. In contrast, there was little to no guidance in the training on managing the operational challenge of efficiently integrating the new tasks into a standard STI consultation.
In sum, it would seem that, on a practical level, the new intervention challenged the conventional provider-patient communication used in the STI consultation. For the most part, nurses used a more provider-centred communication style in which they took the authoritative role of providing knowledge and advice. However, the tasks linked to assessing patient readiness for testing and obtaining patient informed consent required more patient-centred forms of communication and did not fit easily with task-orientated nature of the STI consultation. The tension between these two styles challenged the clinical communication skills of nurses and limited their ability to integrate the tasks efficiently. Poor compatibility between the new requirements, existing skills and the clinical context of the STI consultation points to a problem of reduced skillset workability on an operational level. Within a busy PHC setting, with limited clinical personnel, this could be the underlying reason why nurses did not consistently offer the HIV test to all patients, thus limiting the coverage and impacting on the main trial outcome: the proportion of STI patients who tested for HIV.
Despite these challenges with managing their time and extending the intervention to all patients, nurses continued to deliver the intervention for the full duration of the demonstration project. According to the project leadership (champion and project manager), nurses had internalised the paradigm shift towards providing HIV testing as part of routine medical care (rather than as a specialised service), and this is what kept them motivated to continue. Also, as nurses started to offer HIV testing, their increased exposure to HIV issues may have further reinforced their willingness to continue with this change in their practice. The project champion explains: ‘I think it is due to HIV becoming more of an important issue in the sites. It raised staff awareness. When staff deals with HIV themselves, instead of others dealing with it, it makes them more aware of the urgency of testing and this awareness increased staff willingness to deal with HIV testing’. Although there were important gaps in skillset workability, there was sufficient congruence for this to also be considered a promoting factor. The project manager argued that, despite the increased workload, nurses may have considered the intervention to be an appropriate change in the division of labour and an opportunity to enhance professional practice. She explained:
‘I think staff felt empowered to deal with HIV, which was a “no-go” area for them previously, and the responsibility of a different category of staff [lay counsellors]. Being allowed to offer HIV testing empowered them and made them feel they could deal holistically with patients’.
Nurses also pointed out that the positive reactions of patients provided them with further motivation to continue with the intervention. A patient survey conducted in the early stages of implementation indicated that patients were positive about the PITC intervention . In patient interviews, they expressed appreciation for the opportunity to test for HIV within the STI consultation, finding it more convenient than self-initiated VCT. They expressed appreciation for the nurses’ advice, found it helpful to be reminded of their risk for HIV, and thought the STI consultation was a good opportunity for HIV testing. They reported that they did not experience any sense of coercion in relation to their test decision-making .
Contextual integration: to what extent was the organisational context able to support the new PITC intervention?
The WHO draft PITC guidelines of 2006 signalled a global shift toward the normalising of HIV testing. At the time, the South African National Health Department (NDOH) was beginning to embrace the idea of expanding test uptake in medical settings through revisions to their HIV testing policy . It could be argued that these initiatives provided a receptive international and local context for introducing and executing the PITC intervention in South Africa.
On an organisational level, several other factors may also have contributed toward embedding the new intervention into routine practice, such as appropriate resourcing of the intervention. No extra clinical staff (STI nurses) were made available as it was intended that the intervention be tested in a realistic operational setting where clinical resources were limited. Nevertheless, the dedicated project management support, even if part-time, was an important resource to ensure successful implementation.
Of interest is that the clinic with the smallest STI patient load (Clinic 7 in Table 1) was also the one with the lowest test coverage. Although the study did not investigate nurse practice in this facility, information shared in the cluster meetings indicates that the low test coverage may be due to the absence of a dedicated STI nurse role. The small size of the clinic meant that the one or two nurses in attendance had to treat all types of medical conditions, not only STI patients. This way of organising the service, with a mixed role in a busy setting, may have been an added barrier to nurses offering HIV testing more widely to their STI patients.
Finally, normalisation may also have been strengthened by the role of clinic facility managers as these line managers are responsible for key performance outcomes at clinic level. Rather than only focussing the intervention on nurses as frontline implementers (and on their clinical supervisors), facility managers were integral to the Project Steering Committee. According to the project champion, their involvement and monitoring role were critical to the successful outcome of the intervention: ‘Facility managers wanted to deliver results – and they knew they were being monitored. People are more responsive when having to report regularly’.
In addition, targets for improving HIV test uptake amongst STI patients were introduced by top management during the implementation period. Management made this a key performance area against which all facility managers were evaluated. This responsive organisational context is likely to have contributed to normalisation of the PITC intervention.