title: Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial.
abstract: BACKGROUND
  People with HIV accessing antiretroviral therapy (ART) have persistent physical, psychological, social, and spiritual problems, which are associated with poor quality of life and treatment outcomes. We assessed the effectiveness of a nurse-led palliative care intervention on patient-reported outcomes.
  
  
  METHODS
  We did this randomised controlled trial at a clinic in Kenya for adults with HIV, established on ART, and reporting moderate-to-severe pain or symptoms. We randomly assigned participants (1:1) either to a palliative care intervention (including assessments of physical, emotional, and spiritual wellbeing and quality of life) given six times over 4 months, or to usual care. Participants and investigators were not masked to allocation. The primary outcome was pain (scored on the African Palliative Care Association's African Palliative Outcome Scale). This trial is registered with ClinicalTrials.gov, number NCT01608802.
  
  
  RESULTS
  We screened 2070 patients, of whom we enrolled 120: 60 allocated to each group. In the control group, median pain score improved from 1·0 (IQR 0·0-2·0) at baseline to 5·0 (3·0-5·0) at 4 months; in the intervention group, it improved from 1·0 (0·0-2·0) at baseline to 4·5 (3·0-5·0) at 4 months. Compared with standard care, the intervention had no significant effect on pain (coefficient -0·01, 95% CI -0·36 to 0·34, p=0·95).
  
  
  CONCLUSIONS
  A nurse-led palliative care intervention was not effective in reducing pain. However, person-centred assessment and care delivered by staff who have received additional training had positive effects on self-reported mental health related quality of life and psychosocial wellbeing.
  
  
  BACKGROUND
  Diana Princess of Wales Memorial Fund.
authors.affiliation: Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King's College London, London, UK.
authors.forename: Keira
authors.initials: K
authors.lastname: Lowther
authors.affiliation: Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King's College London, London, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Selman
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Simms
authors.affiliation: Kenyan Hospice Palliative Care Association, Nairobi, Kenya.
authors.forename: Nancy
authors.initials: N
authors.lastname: Gikaara
authors.affiliation: Bomu Hospital, Mombasa, Kenya.
authors.forename: Aabid
authors.initials: A
authors.lastname: Ahmed
authors.affiliation: Kenyan Hospice Palliative Care Association, Nairobi, Kenya.
authors.forename: Zipporah
authors.initials: Z
authors.lastname: Ali
authors.affiliation: Department of Medical Physiology, University of Nairobi, Nairobi, Kenya.
authors.forename: Hellen
authors.initials: H
authors.lastname: Kariuki
authors.affiliation: Department of Infection and Population Health, University College London, London, UK.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Sherr
authors.affiliation: Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King's College London, London, UK.
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.affiliation: Department of Palliative Care and Rehabilitation, Cicely Saunders Institute, King's College London, London, UK. Electronic address: ea-richardharding@kcl.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Harding
mesh_terms: D000328:Adult; D000554:Ambulatory Care Facilities; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000451:nursing* / Q000628:therapy; D006801:Humans; D007630:Kenya; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D059408:Pain Management / Q000379:methods / Q000451:nursing* / Q000706:statistics & numerical data; D010166:Palliative Care; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents