Phase 3 Trial of Palliative Care for HIV Patients on Antiretroviral Therapy

Background / rationale Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa (as evidenced by the epidemiology of primarily HIV and cancer), a systematic appraisal of the literature found almost no outcome or evaluative evidence. Further systematic reviews of palliative care and HIV palliative care effectiveness have found the evidence to have been generated mainly in high income countries, before the advent of antiretroviral therapy (ART) and the evidence from Africa to be of generally lower quality (i.e. non-trial data) with limited potential for inclusion in evidence-based health care planning and delivery. In order to influence clinical practice, policy and guidelines, it is essential to provide high quality trial evidence of the effectiveness of palliative care for people on ART. In order to achieve the goal of maximum coverage, the capacity building of existing HIV care services to provide palliative care to their patients seems the most feasible. Further, the evidence demonstrates that the pain and symptom burden of those on ART is not different to those not on ART, therefore a key role for palliative care may be in the support of those accessing treatment. Our proposed study will develop a model of care that extends palliative care delivery into existing HIV/ART delivery sites, offering a mechanism of greater coverage and feasibility than alternative approaches such as referral of all palliative care-related problems out to specialist external providers.

• Aim 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 evaluate this in terms of patient outcomes under clinical experimental conditions in 2 African countries using randomised controlled trial (RCT) designs.
• Intervention being tested Within each well-established HIV ART clinic, patients will be 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 will receive weekly supervision from a local palliative care service and will use a simple assessment form at each patient appointment.
• Methods Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be powered and conducted in parallel to a common research design protocol, thus permitting evidence of outcomes that reflects 2 different ART providers, providing evidence of palliative care efficacy relevant to different HIV care settings. Each of the 2 HIV care facilities (one in each of Kenya and South Africa) is a highly experienced HIV and ART care provider, with proven longevity. The providers of the palliative care training are longstanding experts in the delivery of both palliative care training and palliative care.

Primary outcome: Each trial has been powered to a primary endpoint of pain control.

Secondary outcomes: The secondary outcomes are the core domains of palliative care as defined by the WHO (i.e. physical, including symptoms, psychological, social and spiritual) and measured by the APCA African POS. Further secondary outcomes measured will be: adherence to treatment; risk behaviours; health-related quality of life; and an additional measure of psychological morbidity.

The primary and secondary outcomes are the same for each country's trial.