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

Abstract

Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which should be taken into account when designing research in similar populations. Researchers should be aware of the effects of financial reimbursement and contact with researchers in isolated and impoverished communities.

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

“…good quality of life for people living with HIV (Lazarus et al, 2016), then careful assessment of pain and symptoms must be a priority. This requires the replication of simple interventions to deliver person-centred HIV outpatient care (Logie and Harding, 2005b, Lowther et al, 2018a, Lowther et al, 2018b, Lowther et al, 2016, Lowther et al, 2015a), strategies to ensure pain relieving drugs are available in pharmacies and are prescribed (Logie and Harding, 2005a), and that low cost, effective interventions such as pain self-management for people living with HIV are delivered (Nkhoma et al, 2018, Nkhoma et al, 2015. Importantly, our data highlight the important of self-reported outcomes from diagnosis until the end of life.…”

Non-specialist psychosocial support interventions for women living with HIV: A systematic review

“…Living with HIV impacts physical, social and psychological aspects of a person's health and life (Lingen-Stallard, Furber, & Lavender, 2016;WHO, 2016b). A higher proportion of people living with HIV experience depression and anxiety than the general population: some studies reported higher prevalence in females than males, and a negative impact of psychological distress on quality of life (Lowther et al, 2016;Niu, Luo, Liu, Silenzio, & Xiao, 2016;Vo et al, 2016). A large global survey led by, and for, women living with HIV on their sexual and reproductive health and rights found that 82% of women reported depressive symptoms and 78% reported experiencing rejection (Orza et al, 2015).…”

Management of nursing care in HIV/AIDS from a palliative and hospital perspective

“…There is an increasing number of PLWHA with multidimensional problems that include physical symptoms, psychic, spiritual suffering and social problems (9) . A shift in care focus is needed to address such needs by ensuring access to HAART, particularly in the light of the evidence that non-targeting to psycho-emotional suffering is associated with non-adherence to therapy (8) . However, although HAART has made HIV/AIDS a manageable chronic condition, it has paradoxically also separated the disease-centered curative treatment from the palliative approach focused on its specific symptoms, since in traditional PLWHA care, symptoms related to HAART experienced by patients were constantly neglected due to the focus on curative treatment (17) .…”

“…There is evidence of the need to link efforts with support networks and levels of health care, such as Primary Care, in order to facilitate the implementation of care models to fully meet the needs of these people (8) . For many, the community support needed for a death at home is not accessible (21) .…”

“…The implementation of palliative care for PLWHA is permeated with complexities inherent in their experiences, often being affected by multiple comorbidities and submitted to polypharmacy, which results in an important functional decline (7)(8) . In the final phase of life, the implementation of palliative care can prevent therapeutic futility and contribute to beneficence, among other principles of bioethics; since the planning of their actions reflects a significant reduction in the use of blood products, antibiotics, prophylaxis against opportunistic diseases and HAART for patients already diagnosed at this stage, as well as the non-use of measures for prolonging life with artificial supports (4) .…”