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

Abstract

BackgroundPatients 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/designThis 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.DiscussionThe 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

Is symptom prevalence and burden associated with HIV treatment status and disease stage among adult HIV outpatients in Kenya? A cross-sectional self-report study

“…A payment of $5 was made for patient expenses in relation to participation in the study, and a drink/fruit snack was offered. The researcher is a highly experienced Kenyan researcher who has worked in this setting with this population on several previous studies of people living with HIV (Lowther et al, 2012, Lowther et al, 2015b, and is fluent in local languages.…”

“…We used factor analysis with principal component analysis to create a continuous variable which was then converted into quintile. DHS has previously been used in HIV research in sub-Saharan Africa (Lowther et al, 2012).…”

Effect of participation in a randomised controlled trial of an integrated palliative care intervention on HIV-associated stigma

“…The trial had an embedded qualitative component with a sequential, explanatory design (Ivankova, Creswell, & Stick, 2006). Study methodology is reported elsewhere (Lowther et al, 2012), as are details of recruitment, follow up and missing data (Lowther et al, 2014), and results of the trial (Lowther et al, 2015). We found the intervention had significant positive effect in terms of mental health and well-being, but no effect on pain or physical outcomes (Lowther et al, 2015).…”

“…We conducted a randomised controlled trial (RCT) of a nurse-led palliative care intervention for PLWH established on ART in Mombasa, Kenya (Lowther et al, 2012(Lowther et al, , 2014(Lowther et al, , 2015. In qualitative exit interviews, the themes of stigma, resistance to stigma, and the effects of participation in the research, emerged inductively as highly salient to participants.…”

Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya

“…The Treatment Outcomes in Palliative Care trial (TOPCare) trial was designed to evaluate the effectiveness of a nurse-led palliative care intervention for people living with HIV (PLWH) (Lowther et al, 2012 ). To contextualise the trial findings and contribute towards trial methodology in low- and middle-income countries (LMIC), we aimed to explore the consequences of TOPCare trial participation.…”