NCT01608802

Brief Summary

Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a systematic appraisal of the literature found almost no outcome or evaluative evidence. Aim: The investigators aim to evaluate the efficacy of HIV palliative care training and a simple palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy (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). 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. 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; psychological morbidity. Inclusion: Patients will be screened and invited into the trial if they are on ART, score 3-5 on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give informed consent to trial entry and data collection. Analysis: An intention-to-treat analysis will be conducted to determine treatment response differences between the two conditions. In order to maximise the efficiency of longitudinal data, multi-level modelling will be applied as appropriate.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started May 2011

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

May 28, 2012

Last Update Submit

June 9, 2014

Conditions

HIV

Keywords

HIVAntiretroviral therapyPalliative carePain

Outcome Measures

Primary Outcomes (1)

  • Self-report pain using the APCA African POS

    Our primary outcome is the pain item of the African Palliative Care Association Palliative care Outcome Scale

    Period of 4 months

Secondary Outcomes (2)

  • Psychological morbidity

    Period of 4 months

  • Quality of Life

    4 month period

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Standard care will be provided to the control group, i.e. existing HIV outpatient multiprofessional care, ART monitoring and adherence support.

Other: Standard care

Palliative care

EXPERIMENTAL

Palliative care delivered by an existing nurse who has been provided with palliative care training, palliative care patient management planning records, and clinical supervision

Other: Palliative care

Interventions

Palliative careOTHER

Regular appointments with an existing clinic nurse who has been trained in palliative care, the patient is asked about their physical, psychological, social and spiritual problems, and a care management plan devised with referral as necessary.

Palliative care
Standard careOTHER

Patients attend monthly for their ART monitoring and prescription filling, and a multiprofessional team is available as necessary.

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (18 years or older),
  • with an HIV diagnosis known to the patient,
  • currently on ART for at least one month, and
  • scoring 3-5 (out of a range of 0-5) on pain or symptoms,
  • with sufficient capacity to consent to trial entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BOMU Hospital

Mombasa, Kenya

Location

Ivan Toms Clinic

Cape Town, Western Cape, South Africa

Location

Related Publications (4)

  • Lowther K, Harding R, Simms V, Ahmed A, Ali Z, Gikaara N, Sherr L, Kariuki H, Higginson IJ, Selman LE. Active ingredients of a person-centred intervention for people on HIV treatment: analysis of mixed methods trial data. BMC Infect Dis. 2018 Jan 10;18(1):27. doi: 10.1186/s12879-017-2900-0.

    PMID: 29316883DERIVED

  • Lowther K, Selman L, Simms V, Gikaara N, Ahmed A, Ali Z, Kariuki H, Sherr L, Higginson IJ, Harding R. Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial. Lancet HIV. 2015 Aug;2(8):e328-34. doi: 10.1016/S2352-3018(15)00111-3. Epub 2015 Jun 15.

    PMID: 26423375DERIVED

  • Lowther K, Higginson IJ, Simms V, Gikaara N, Ahmed A, Ali Z, Afuande G, Kariuki H, Sherr L, Jenkins R, Selman L, Harding R. A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data. BMC Res Notes. 2014 Sep 3;7:600. doi: 10.1186/1756-0500-7-600.

    PMID: 25187211DERIVED

  • Lowther K, Simms V, Selman L, Sherr L, Gwyther L, Kariuki H, Ahmed A, Ali Z, Jenkins R, Higginson IJ, Harding R. 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. BMC Infect Dis. 2012 Nov 6;12:288. doi: 10.1186/1471-2334-12-288.

    PMID: 23130740DERIVED

Related Links

MeSH Terms

Conditions

Pain

Interventions

Palliative CareStandard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Richard Harding, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Palliative Care

Study Record Dates

First Submitted

May 28, 2012

First Posted

May 31, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

ZA(1)KE(1)