Background
Provider-initiated HIV testing and counselling
New STI patient total | Offered HIV testing (%) (Total offered/Total STI) | HIV tested (%) (Total tested/Total STI) | Not tested for HIV (%) (Total declined/Total STI) | Declined HIV testing (%) (Total declined/Total offered) | |
---|---|---|---|---|---|
Intervention clinic
| |||||
1 | 451 | 363 (80.5) | 256 (56.8) | 107 (23.7) | 107 (29.5) |
2 | 520 | 400 (76.9) | 306 (58.8) | 94 (18.1) | 94 (23.5) |
3 | 412 | 346 (84.0) | 236 (57.3) | 110 (26.7) | 110 (31.8) |
4 | 850 | 572 (67.3) | 492 (57.9) | 80 (9.4) | 80 (14.0) |
5 | 425 | 338 (79.5) | 228 (53.6) | 110 (25.9) | 110 (32.5) |
6 | 249 | 215 (86.3) | 177 (71.1) | 38 (15.3) | 38 (17.7) |
7 | 146 | 92 (63.0) | 57 (39.0) | 35 (24.0) | 35 (38.0) |
Total*
|
3,053
|
2,326 (76.8)
|
1,752 (56.4)
|
574 (20.4)
|
574 (26.7)
|
Control clinic
| |||||
8 | 421 | 87 (20.7) | 86 (20.4) | 1 (0.2) | 1 (1.1) |
9 | 174 | 119 (68.4) | 105 (60.3) | 14 (8.0) | 14 (11.8) |
10 | 388 | 129 (33.2) | 120 (30.9) | 9 (2.3) | 9 (7.0) |
11 | 166 | 51 (30.7) | 47 (28.3) | 4 (2.4%) | 4 (7.8) |
12 | 593 | 197 (33.2) | 165 (27.8) | 32 (5.4) | 32 (16.2) |
13 | 789 | 669 (84.8) | 636 (80.6) | 33 (4.2) | 33 (4.9) |
14 | 837 | 684 (81.7) | 534 (63.8) | 150 (17.9) | 150 (21.9) |
15 | 626 | 333 (53.2) | 221 (35.3) | 112 (17.9) | 112 (33.6) |
16 | 320 | 25 (7.8) | 24 (7.5) | 1 (0.3) | 1 (4.0) |
17 | 373 | 135 (36.2) | 103 (27.6) | 32 (8.6) | 32 (23.7) |
18 | 164 | 27 (16.5) | 27 (16.5) | 0 (0.0) | 0 (0) |
19 | 285 | 211 (74.0) | 182 (63.9) | 29 (10.2) | 29 (13.7) |
20 | 576 | 449 (78.0) | 327 (56.8) | 122 (21.2) | 122 (27.2) |
21 | 315 | 290 (92.1) | 244 (77.5) | 46 (14.6) | 46 (15.9) |
Total*
|
6,027
|
3,406 (50.7)
|
2,821
(42.6)
|
585 (8.10)
|
585 (13.5)
|
The normalisation process model
Constructs | Dimensions |
---|---|
Interactional workability The interactional workability construct seeks to examine whether the complex intervention promotes ease and efficiency of interaction between people and practice. The model proposes that the new intervention is more likely to be normalised if the intervention maintains or enhances existing norms and social relations. |
Congruence Congruence requires shared expectations of normal conduct and purpose of the clinical encounter. |
Disposal of work This requires an investigation into the level of agreement about the meaning and consequences of the work and of expectations about its goals. | |
Relational integration The relational workability construct investigates the extent to which the complex intervention can be integrated with existing knowledge, practices and relationships. The model proposes that normalisation is more likely if the intervention maintains or improves accountability and confidence within existing professional networks. |
Accountability Accountability requires agreement about the validity and expertise of knowledge and role divisions underpinning the work. |
Confidence Confidence requires agreement on the credibility and utility of the knowledge and expertise, and the criteria by which it is evaluated. | |
Skills-set workability Skills-set workability is concerned with how the current division of labour is affected by the intervention, the capacity of participants to deploy the required tasks and how the quality of the work is monitored. The model proposes that normalisation is more likely if the intervention has a good fit with an actual or realisable division of labour. |
Allocation Allocation requires agreement on the formal and informal rules about the assignment of tasks, beliefs about ownership and appraisal of skills, rewards linked to roles and how work is monitored. |
Performance Performance involves the ability of the organisation and people to deploy the intervention as planned and includes agreement about the tasks, boundaries, responsibility and autonomy of participants. | |
Contextual integration Contextual integration focuses on how the organisation uses its capacity and resources in the normalisation of the complex intervention. The model proposes that the complex intervention is more likely to be normalised if the organisation is able to be responsive and flexible in executing the work. |
Execution Refers to the organisational factors influencing practical implementation and monitoring of the intervention. This includes decisions about distributing responsibility, power and resources and linkages to organisational structures. |
Realisation Realisation is made possible by agreement about the value of the intervention, policies about procurement, delivery of personnel and equipment and mechanisms for modifying organisational objectives. |
Methodology
Study setting
The PITC intervention
Voluntary counselling and testing | Provider–initiated testing and counselling for STI patients | |
---|---|---|
Patient access
| • Client-initiated: patients come on their own initiative or are medically referred for HIV testing. | • Provider-initiated: patients come to the clinic because they are seeking treatment for STI-related symptoms. |
• Patients anticipate being tested for HIV at their clinic visit. | • The STI nurse offers all STI patients an HIV test, irrespective of their presenting complaint. | |
Providers
| • Usually provided by trained lay counsellors. | • Professional healthcare providers (STI nurses) trained to provide PITC. |
• Basic counselling training can be lengthy (10 to 20 days). | • Training is short (2 days) and is focused on how to offer the test and how to get informed consent from patients. | |
Primary purpose of the intervention
| • The primary purpose is to promote uptake of HIV testing and to link people to HIV care and prevention services. | • The primary purpose is, similarly, to promote uptake of HIV testing and increase the number of people who know their HIV status. |
• The emphasis is on assessing patient readiness to test, and the counsellor is supposed to remain neutral about the choice (and not to promote taking the HIV test as the preferred option). | • The intervention also aims to integrate HIV testing efficiently into a regular STI consultation, while still respecting the need for patient informed consent. | |
• The provider can promote HIV testing as the medically recommended option (rather than remaining neutral about the preferred choice). | ||
Pre-test encounter
| • Patient-centred counselling techniques focus on promoting an informed decision and include basic HIV information, risk assessment, test-readiness assessment, and risk reduction messages. | • Offer of HIV testing is introduced using regular clinical communication as part of the STI consultation. |
• Written informed consent for testing is obtained. | • This involves a brief explanation of why an HIV test is recommended in the context of an STI consultation, a brief assessment of the patient’s readiness to test for HIV, offering the HIV test and opportunity for the patient to ask questions. Risk assessment and risk reduction are dealt with as part of the regular STI consultation. | |
• Can take up to 25 minutes. | • Written informed consent for testing is obtained. | |
• Intervention is meant to add maximum 5 to 10 minutes to the STI consultation when efficiently integrated. | ||
The HIV test
| • Due to limits to their scope of practice, lay counsellors cannot perform the rapid HIV test themselves. | • The nurse does the HIV rapid test along with other blood tests during the STI consultation, which reduces waiting time for patients. |
• The rapid test is performed by a nurse, which may involve some waiting time. | ||
Post-test and follow-up care
| • The nurse communicates the result of the rapid HIV test to the lay counsellor. | • The nurse refers the patient to a lay counsellor in the facility, to receive the HIV test result and post-test counselling. |
• The lay counsellor then informs the patient and provides post-test counselling. | • The patient may need to wait for a lay counsellor to be available. | |
• The primary focus is on providing emotional support for HIV-positive patients and linking them to care, as well as providing risk reduction messages for HIV-positive and HIV-negative patients. | • The primary focus is similarly on emotional support for HIV-positive patients, but with stronger linkage to HIV care (e.g., the nurse does the CD4 blood test on the same day, and the patient is encouraged to attend follow-up sessions with the lay counsellor). | |
• Lay counsellors are encouraged to provide up to three follow-up counselling sessions with HIV-positive patients. | • There is less focus on HIV-negative patients. |
Study design
Methods | Number of participants |
---|---|
Focus groups with staff, five months into the trial: | |
• HIV Lay counsellors (one group) | 8 |
• STI nurses (one group) | 8 |
Focus groups with staff, 17 months into the trial: | |
• HIV lay counsellors (one group) | 5 |
• STI nurses (one group) | 7 |
• Facility managers (one group) | 11 |
• Project leaders (one group) | 3 |
Participant observation during the 2006 to 2007 period. This included reviewing associated documents such as official minutes and researchers’ notes. | The researcher attended multiple meetings (planning, preparation, supervision monitoring, and evaluation) |
Participant observation of training: the researcher observed the first round of training for both STI nurses and lay counsellors and selected follow-up training. | 10 STI nurses (and their clinical supervisors) and 12 lay counsellors |
Interviews with patients. | 20 |
Observation of nurse clinical consultations. | 13 |
Population and sampling
Data collection
Data analysis
Stages of the PITC implementation process | Key factors shaping the deployment of the PITC intervention |
---|---|
Stage 1 (August to October 2005)
| |
Project initiation and preparation
|
Credibility, ownership and framing the project by top management
|
• The HIV manager of the municipal health department identified a gap in HIV testing uptake for STI patients. She rallied managerial colleagues to motivate for the implementing of the PITC intervention in a demonstration project. | • The project was initiated by the health department itself and not by an external research organisation. |
• The person who initiated the project was a senior manager (the HIV/TB manager) with a track record of achieving quality improvements in the TB/HIV and STI programmes. | |
• The project aim was to assess the feasibility, effectiveness and efficiency of the PITC intervention in an operational setting. | • The PITC intervention was based on recommendations made in the WHO draft guideline for PITC in 2006. |
• The PITC intervention was promoted as being necessary to enhance comprehensive STI care and in response to real human resource constraints. | |
Governance accountability structure established
|
Governance, leadership and accountability mechanisms were in place
|
• A project governance structure, the Project Steering Committee (PSC), provided oversight of the planning, implementation, monitoring and evaluation of the PITC project. | • The PSC provided a structured governance mechanism for the participation, collaboration and accountability of relevant stakeholders, including managing conflicting views. |
• The PSC was chaired by HIV manager, who was the initiator, project leader, and who acted as the champion for the project. | |
• The PSC comprised frontline clinical staff (nurses and lay counsellors), clinical supervisors, clinic management, HIV counselling trainers, project management and the project leader. | • The PSC met at quarterly intervals and provided meetings of the PSC, provided opportunity for continuous monitoring and evaluation, regular feedback and motivation. |
Stage 2 (October 2005 to March 2006)
| |
Planning and project management mechanisms
|
Detailed planning, flexibility and management support provided
|
• There was a lengthy planning process spanning nearly nine months prior to implementation as well a detailed operational planning. | • Planning was a ‘start and stop’ process due to disagreements among stakeholders about the acceptability and relevance of the PITC intervention. |
• Facility managers and frontline staff had the flexibility to re-design patient flows in their clinics that would best accommodate the integration of the HIV offer into the STI consultation. | |
• Staff requested the support of a project manager to ensure effective implementation and monitoring and evaluation. Management responded positively (contextual integration). | |
• To strengthen the project management, a project manager was allocated on a part-time basis to be responsible for coordinating the operational level implementation and monitoring. | |
Stage 3 (January to April 2006)
| |
Design of the PITC intervention
|
Local adaptation, contestation and compromise enhancing the acceptability and feasibility of the PITC intervention
|
• The WHO version of the PITC intervention had to be adapted on several levels to fit with the local requirements. | • The adaptation of the PITC in intervention was done on several levels geared towards improving the feasibility and acceptability of the intervention. (Upwards task shifting and task sharing). |
• The intervention involved re-allocation of roles between clinical staff and lay health workers. | |
• There were several areas of disagreement amongst stakeholders in the PSC regarding the design of the intervention, task re-allocation, and training. The clinical guideline was lengthened to accommodate concerns among HIV trainers regarding ethical implementation of PITC. | |
• A clinical guideline for nurses was developed to guide their practice in the consultation. | • The above conflicts threatened the feasibility of implementing the project. |
• The conflict resolution and leadership skills shown by the project leader were largely responsible for the successful resolution of conflicts: using compromise and executive decision-making. | |
Training
|
Training coverage and feasibility
|
• The frontline STI nurses and lay counsellors, as well as a few clinical supervisors, were trained on the PITC intervention by trainers from an HIV counselling training unit within the health department. | • Training was well attended not only by the STI nurses responsible for implementation, but also by their immediate clinical supervisors (district HIV/TB coordinators). |
• Training course for nurses was 2.5 days (reduced from 5 days initially suggested by trainers). | |
• Lay counsellors received training to provide more in-depth post-test counselling over two to three counselling sessions per patient. | |
Stage 4 (April 2006 to December 2007)
| |
• Health facility-based implementation and monitoring and evaluation
|
Early and continuous monitoring, feedback and support provided
|
• Implementation started April 2006 in seven health facilities | • Monitoring and evaluation mechanisms were in place from the start and were continuous throughout the duration of the intervention. |
• The monitoring and evaluation systems were planned from the start, including the outcome indicators and the data sources. | • Project support was provided through quarterly ‘cluster’ monitoring meetings that were conducted by staff from two or three clinics at time. |
• A quarterly review meeting of the PSC was conducted where all facilities were provided with feedback on progress. | • In cluster meetings and in quarterly PSC meetings, nurses and facility managers reviewed progress (based on routine health information), shared best practices, and addressed practical problems (e.g., ensuring supplies of test-kits, testing registers and clinical guideline sheets). |
Evaluation of staff and patient experiences
|
Evaluation of multiple dimensions provided information on perspectives and experiences of important stakeholders.
|
• Evaluations of patient and staff perspective and experience were conducted through various qualitative research methods. | • Patient satisfaction surveys and patient exit interviews were done midway to explore the acceptability of the PITC intervention. |
• Evaluation of staff perspective was conducted via focus groups, to explore the acceptability of and the barriers and facilitators to implementation. | |
• STI clinical consultations of nurses were observed to examine the delivery of the intervention in terms of efficiency of integration and the quality of informed consent processes. |
Promoting factors | Potential threats and how these were addressed | |
---|---|---|
Interactional workability
| ||
Congruence
| • The design of the intervention was congruent with both operational needs (too few lay counsellors) and STI clinical practice. | • It is difficult to justify upwards task shifting (from lay counsellors to nurses) in a low resource setting, so the PITC intervention was adapted to minimise the increased workload on nurses. |
Disposal
| • Nurses saw this as an opportunity to enhance the standard of STI care. | • It was critical that nurses accepted the paradigm shift toward normalising HIV testing. The project champion achieved this by convincing nurses of the benefits and the feasibility of a shift in practice towards integrating HIV testing. |
Relational integration
| ||
Accountability
| • There was a governance structure responsible for stakeholder involvement, planning and oversight. | • The downside of this accountability structure and consultative planning was that it resulted in a long, protracted and fragmented planning phase that delayed the implementation date. |
• Leadership by senior management promoted ownership. | • There was a range of disagreements among stakeholders. The conflicts threatened the viability of the project. Conflict resolution involved a compromise: to extend the clinical guideline and shorten the training. Removal of these stumbling blocks was largely due to the conflict resolution skills of the project champion and because she had the seniority to make executive decisions. | |
• The project was provided with a dedicated project manager to support implementation and monitoring. | ||
Confidence
| • Nurses were convinced of the utility and feasibility of new intervention, even though they were concerned about the additional workload. | • Lay counsellors and trainers were less confident about the new PITC intervention (see ‘Skill-set workability’ below). |
Skills-set workability
| ||
Allocation
| • The new tasks for nurses were in line with standard STI practice. | • Lay counsellors were concerned about their reduced role in pre-test counselling and their job security. This concern was allayed because they were allocated an increased role in the post-test counselling of HIV-positive patients. |
• All the parties agreed that the intervention required training. • Training was well attended by nurses and their clinical supervisors. | ||
• Lay counsellors and HIV trainers were concerned about the acceptability, ethics and feasibility of PITC intervention. They agreed to support the intervention only when the clinical guideline was adapted to focus more on assessing the patient’s test readiness. The adapted clinical guideline meant nurses had to include more questions and tasks, making the intervention longer and more difficult to integrate efficiently into the STI consultation. | ||
• Training focused on counselling skills and did not address the operational challenges of integrating the new HIV tasks within the clinical consultation. | ||
Performance
| • The HIV offer was delivered to the majority of new STI patients in an ethical manner. | • The HIV test was not offered to all new STI patients as intended, reducing the size of the impact. |
• Levels of confidence and efficiency of delivering the intervention varied with gaps in clinical communication skills evident. | • There was variation in the how efficiently individual nurses delivered the intervention and in how long it took. Although positive about the intervention, nurses remained concerned about the added time. | |
• Nurses persisted with intervention despite the challenges around how to balance the new tasks. | ||
Contextual integration
| ||
Execution
| • Receptive environment for a paradigm shift toward normalising HIV testing. | • The feasibility of this intervention depended on management identifying extra capacity in terms of nurse time, which may be difficult to do in many similar PHC settings. |
• Operational conditions promoted shift toward expanding HIV testing. | ||
• Not all the variation in the HIV testing outcomes across intervention clinics could be fully explained, and some may be due to organisational factors. | ||
Realisation
| • Organisational leadership and accountability in place. | • Dedicated project management support may not be a sustainable component to up-scaling. |
• Responsive resourcing of the intervention through dedicated project management. | • No cost-effectiveness evaluation was conducted. | |
• Facility managers reinforced line management accountability. |