HIV Care Research on the impact of palliative care
services offered in ART clinics Richard Harding describes the ‘TOPCare’ randomised controlled trials in two sub-Saharan African countries
Rationale for study
Despite the undoubted successes in antiretroviral therapy (ART) reducing HIV mortality, people on ART continue to experience a high burden of physical and psychological problems.1–5 lent from diagnosis,6
Such problems are preva- and arguably the required skills of
palliative care have been lost in the advent of treat- ment options. Uncontrolled symptoms are linked to poor adherence and sexual risk taking,7,8 rebound.5
and with viral
A systematic review of the literature found that the majority of evidence for HIV palliative care was generated prior to ART, and not in low–middle- income countries.9
Systematic appraisal of the outcome
evidence found a wealth of experience in HIV palliative care in Africa, yet a dearth of evidence.10 Our previous research in Tanzania showed that around half of HIV outpatients would benefit from pal- liative care irrespective of their treatment status,11
South Africa demonstrated that hospices can successful- ly initiate and maintain patients on ART,13
and in Ugan-
da and South Africa that psychological problems persist irrespective of treatment.12
Furthermore, longitudinal
studies we have conducted in East Africa have identified the palliative care-related needs among 1200 patients accessing outpatient care in the presence of ART,14
and
found that palliative care can improve outcomes under targeted quality improvement audit.13
Therefore, our
previous work has identified the following: the barriers to HIV palliative care in the era of treatment; the lack of evidence of efffectiveness; the appropriateness of palliative care throughout the HIV disease trajectory and alongside ART; and the feasibility and effectiveness of palliative care in non-randomised studies. However, it is clear that very little HIV research activity is being con- ducted globally to test palliative care interventions.14–17 As described by Kim Green’s overview of the integra- tion literature in this issue, there are strong reasons why palliative care delivery from within existing HIV care is the preferred mechanism in terms of access, costs, outcomes. In this paper we describe two ongoing HIV palliative care trials (‘TOPCare’).
Study aim and objectives We aim to evaluate the efficacy of HIV palliative care training and a simple palliative care assessment tool provided to nurses of patients on ART, and to evalu- ate this in terms of patient outcomes under clinical
Dr Richard Harding, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King’s College London School of Medicine, UK.
July 2012
experimental conditions in two African countries using randomised controlled trial (RCT) designs. The TOPCare objectives are: • to investigate whether self-report pain and symptoms significantly improve under palliative care compared with those of patients in standard care;
• to compare self-report adherence with ART in the treatment and control groups;
• to compare self-report health-related quality of life under palliative care with standard care;
• to compare additional multidimensional palliative care outcomes (psychological, social, and spiritual wellbeing) in line with the WHO definition of pallia- tive care in the treatment and control groups.
and in
Design and setting Each Phase III clinical trial (i.e. one trial in each of two countries) is powered and conducted in parallel with a common research design protocol, thus permitting evidence of outcomes that reflects two different ART providers, providing evidence of palliative care ef- ficacy relevant to different HIV care settings. Each of the two HIV care facilities (one in each of Kenya and South Africa) is a highly experienced HIV and ART care provider, with proven longevity. TOPCare in Kenya will evaluate palliative care delivery in BOMU, a large Mis- sion Hospital. In South Africa, the evaluation is being conducted in a Government Community Health Clinic (the Ivan Toms Clinic) in a township outside Cape Town. The TOPCare trial has been registered on the global clinical trials register,
www.clinicaltrials.gov. We did not aim to power a trial of pooled data across countries, as we recognise that clinical, cultural, and socioeco- nomic differences preclude an approach that assumes homogeneity of palliative care sites, and HIV care sites, between countries. Our experience of previous mul- ticentred research in East Africa has demonstrated the heterogeneity of sites.
The intervention Within each well-established HIV ART clinic, patients are randomly allocated to either continue receiving standard care (control group) or to receive standard care plus appointments with a clinic nurse trained in basic palliative care (intervention group). The intervention nurse receives weekly supervision from a local pallia- tive care service and uses a simple assessment form at each patient appointment. This manualised assessment and care planning approach routinely addresses the physical, psychological, social, and spiritual problems of patients.
Africa Health 31
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