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Open Access Study protocol

Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy

Keira Lowther1*, Victoria Simms2, Lucy Selman1, Lorraine Sherr3, Liz Gwyther4, Hellen Kariuki5, Aabid Ahmed6, Zipporah Ali7, Rachel Jenkins8, Irene J Higginson1 and Richard Harding1

Author affiliations

1 Cicely Saunders Institute, Department of Palliative Care and Rehabilitation, Kings College London, London, UK

2 London School of Hygiene and Tropical Medicine, London, UK

3 University College London, London, UK

4 Department of Family Medicine, University of Cape Town, Cape Town, South Africa

5 Department of Medical Physiology, University of Nairobi, Nairobi, Kenya

6 Bomu Medical Centre, Mombasa, Kenya

7 Kenyan Hospice Palliative Care Association, Nairobi, Kenya

8 Institute of Psychiatry, Kings College London, London, UK

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Citation and License

BMC Infectious Diseases 2012, 12:288  doi:10.1186/1471-2334-12-288

Published: 6 November 2012

Abstract

Background

Patients with HIV/AIDS on Antiretroviral Therapy (ART) suffer from physical, psychological and spiritual problems. Despite international policy explicitly stating that a multidimensional approach such as palliative care should be delivered throughout the disease trajectory and alongside treatment, the effectiveness of this approach has not been tested in ART-experienced populations.

Methods/design

This mixed methods study uses a Randomised Controlled Trial (RCT) to test the null hypothesis that receipt of palliative care in addition to standard HIV care does not affect pain compared to standard care alone. An additional qualitative component will explore the mechanism of action and participant experience. The sample size is designed to detect a statistically significant decrease in reported pain, determined by a two tailed test and a p value of ≤0.05. Recruited patients will be adults on ART for more than one month, who report significant pain or symptoms which have lasted for more than two weeks (as measured by the African Palliative Care Association (APCA) African Palliative Outcome Scale (POS)). The intervention under trial is palliative care delivered by an existing HIV facility nurse trained to a set standard. Following an initial pilot the study will be delivered in two African countries, using two parallel independent Phase III clinical RCTs. Qualitative data will be collected from semi structured interviews and documentation from clinical encounters, to explore the experience of receiving palliative care in this context.

Discussion

The data provided by this study will provide evidence to inform the improvement of outcomes for people living with HIV and on ART in Africa.

ClinicalTrials.gov Identifier: NCT01608802

Keywords:
HIV; ART; Palliative care; Africa; Evaluation