South African National Adherence Guidelines: need for revision?

Abstract

Dear Sirs, Fox et. al. recently reported a cluster-randomized evaluation of two interventions forming part of the South African National Adherence Guidelines (AGL) at 24 facilities in four South African provinces 1. As the authors note, South Africa has the greatest number of people living with HIV and the largest HIV care and treatment programme globally. However, suboptimal patient retention and viral suppression put patients receiving antiretroviral treatment (ART) at risk of poor health outcomes, development of viral resistance, and heightened risk of transmitting HIV, besides threatening the country's achievement of UNAIDS 2nd and 3rd 90-90-90 HIV treatment targets 2. Thus, an important national and international health priority is to improve patient retention and viral suppression amongst this large number of ART patients, and the AGL have been implemented to attempt to improve both. However, in the most rigorous evaluation of the AGL to date, enhanced adherence counselling (EAC) for patients with elevated viral loads and early tracing and retention in care (TRIC) for those who missed a facility visit showed no benefit over control after 12 months. In an unplanned secondary analysis using a difference-in-differences approach, which included people excluded according to the protocol, the authors document higher viral resuppression at EAC intervention facilities after three months. It is notable that amongst patients eligible for EAC who received viral load testing at three months, the proportion who achieved viral suppression did not increase during the intervention period at intervention sites (compared to the pre-intervention period) but rather decreased (from 31% to 28%). The treatment effect thus found was due to the fact that resuppression worsened to a lesser degree during the intervention period in the intervention sites, whereas at control sites resuppression dropped to a greater extent (from 35% pre-intervention period to 25% during the intervention period). Also, for the primary analysis of EAC, it is noteworthy that in the EAC study population the proportion of participants with suppressed viral loads after three months (amongst those with available viral load results) was 15.5% vs. 35.3% in the control group, being statistically significantly worse in the intervention group. These data, together with the absence of any effect at 12 months, suggest that a single (or possibly two) in-facility counselling session as implemented under the AGL has no effect in improving viral resuppression amongst those with elevated viral loads. The authors postulate that some form of counselling for those with elevated viral loads in the control arm may have masked any benefit of EAC; that EAC is not effective, at least as implemented; and that the lack of benefit of EAC may be due to delays in administering the intervention rather than to the intervention itself. To take this further, it is plausible that one or two in-facility counselling sessions with a clinic counsellor in routine settings are insufficient to affect the adherence behaviour of those with elevated viral loads, and more intensive or aptly designed interventions may be required to have a measurably beneficial effect. The TRIC model also showed no benefit over the standard of care tracing procedures for returning patients to care, and the authors state that it has been a difficult intervention to roll out and monitor. In view of this randomized evaluation which fails to show any benefit of EAC and TRIC as part of the AGL, the AGL would benefit from a re-examination to include evidence-based and cost-effective interventions that improve retention and viral suppression amongst ART patients. One or two in-clinic counselling sessions for patients receiving ART as implemented under EAC seem unable to provide the tools for fundamental and long-lasting behaviour changes that are required for ART patients who have become unstable to develop the adherence skills necessary to successfully empower them to adhere to ART, in order to translate to long-term health benefits. A more intensive intervention that has shown promise in improving both retention and viral suppression in large-scale implementation (albeit in non-randomized studies that included both unstable and stable participants) is home-based adherence support, which utilizes lay health workers who perform regular visits at the patients home to support ART adherence and retention 3-6. Amongst ART patients with elevated viral loads, home-based visits and adherence counselling provided by lay counsellors also resulted in a high proportion who achieved virological resuppression 7. Longer-term community-based support enables ART patients to develop relationships and build trust with community health workers who provide a link between the facility and the community, who are able to identify and assist in addressing household and psychosocial barriers to adherence, and who are better able to respond to the emerging needs of patients during long-term treatment. Implementation of interventions according to whether ART patients are either stable or unstable may benefit the health system to relatively easily classify a large body of patients. However, this may not necessarily benefit the individual patient who passes through both stable and unstable periods during long-term ART. The patient may benefit more from a continuum of care based on support and a longer-term relationship with a CHW who provides ongoing psychosocial support, enables greater self-management skills regarding ART adherence and HIV/AIDS, and who can use social capital and widen the community safety net, all of which may contribute to reducing treatment fatigue and improving retention and ART outcomes 8-10. Adherence and retention in ART care in sub-Saharan Africa are a community effort rather than merely individual activities. The results of this evaluation of the AGL have important implications for adherence and retention-enhancing programmes in South Africa. High-quality studies from resource-poor settings on interventions that improve adherence to ART are rare, particularly amongst unstable patients and regarding the cost-effectiveness of interventions 11. Further research that allows large-scale implementation in this critical area is required. Adapting the AGL to promote long-term ART adherence and retention support, bearing in mind the changing needs of individual patients during lifelong treatment, and addressing the complex interplay of psychosocial and community factors that enhance adherence and retention in high-burden settings will likely have value for the region in its quest to achieve the ambitious UNAIDS HIV treatment goals by 2030 12. There is increasing global support for the community-based care components of primary healthcare services (PHC), including household services and ART adherence support 13, 14. There is vast scope to effectively expand PHC services at the community level while maintaining quality of care and simultaneously reaping the benefits of closer collaboration between health services and communities when delivering PHC.