Active ingredients of a person-centred intervention for people on HIV treatment: analysis of mixed methods trial data

Keira Lowther, Richard Harding, Victoria Simms, Aabid Ahmed, Zipporah Ali, Nancy Gikaara, Lorraine Sherr, Hellen Kariuki, Irene J Higginson, Lucy Ellen Selman, Keira Lowther, Richard Harding, Victoria Simms, Aabid Ahmed, Zipporah Ali, Nancy Gikaara, Lorraine Sherr, Hellen Kariuki, Irene J Higginson, Lucy Ellen Selman

Abstract

Background: A new model of care is required to meet the changing needs of people living with HIV (PLWH), particularly in low and middle-income countries, where prevalence is highest. We evaluated a palliative care intervention for PLWH in Mombasa, Kenya. Although we found no effect on pain (primary outcome), there was a positive effect on mental health (secondary outcome) in the intervention group. To inform replication and implementation, we have determined the active ingredients of the intervention and their mechanisms of action.

Methods: We conducted a randomised controlled trial (RCT) with qualitative exit interviews in HIV clinic attenders. The intervention was delivered over 5 months, with a minimum of 7 clinical contacts. Longitudinal quantitative data on components of care received were analysed using area under the curve and logistic regression. Qualitative data were analysed using inductive and deductive thematic analysis.

Results: Quantitative data analysis identified that intervention patients received more weak opioid, laxatives, discussion about spiritual worries, emotional support from staff for themselves and their families, time to talk about worries, discussion about future and planning ahead. Qualitative data analysis found that patients reported that having time to talk, appropriate pain medication and effective health education was of therapeutic value for their psychological well-being. Integration of mixed method findings suggest that positive effect in quantitative measures of mental health and well-being are attributable to the active ingredients of: appropriate medication, effective health education and counselling, and having time to talk in clinical encounters. Mechanisms of action include symptom relief, improved understanding of illness and treatment, and support focused on articulated concerns.

Conclusions: Routine care must provide opportunities and means for existing clinical staff to make routine appointments more person-centred. This approach enabled staff to identify and manage multidimensional problems and provide tailored health education and counselling.

Trial registration: ClinicalTrials.gov ( NCT01608802 ). Registered 12th May 2012.

Keywords: HIV; Mixed methods; Palliative care; Psychosocial; RCT.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been sought and secured from Kings College London Research Ethics Committee (BDM/10/11–31), and Kenyan Medical Research Institute (KEMRI/RES/7/3/1). All participants provided written informed consent to participate in the study, through a signature or thumbprint.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests. All authors were funded by their respective institutions for the manuscript preparation.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Comparison of components of care received by participants allocated to the intervention and control study arms

References

    1. Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013;382:1525–1533. doi: 10.1016/S0140-6736(13)61809-7.
    1. Atun R, Bataringaya J. Building a durable response to HIV/AIDS: implications for health systems. J Acquir Immune Defic Syndr. 2011;57:S91–S95. doi: 10.1097/QAI.0b013e3182218441.
    1. Unge C, Södergård B, Ekström AM, Carter J, Waweru M, Ilako F, et al. Challenges for scaling up ART in a resource-limited setting: a retrospective study in Kibera, Kenya. J Acquir Immune Defic Syndr. 2009;50:397–402. doi: 10.1097/QAI.0b013e318194618e.
    1. UNAIDS . 90–90-90 an ambitious treatment target to help end the AIDS epidemic. Geneva: UNAIDS; 2014.
    1. Harding R, Simms V, Penfold S, Downing J, Namisango E, Powell RA, et al. Quality of life and wellbeing among HIV outpatients in East Africa: a multicentre observational study. BMC Infect Dis. 2014;14:613. doi: 10.1186/s12879-014-0613-1.
    1. Simms V, Gikaara N, Munene G, Atieno M, Kataike J, Nsubuga C, et al. Multidimensional patient-reported problems within two weeks of HIV diagnosis in East Africa: a multicentre observational study. PLoS One. 2013;8:e57203. doi: 10.1371/journal.pone.0057203.
    1. Lowther K, Harding R, Selman L, Higginson IJ. Experience of persistent psychological symptoms and perceived stigma among people with HIV on antiretroviral therapy (ART)? A systematic review. Int J Nurs Stud. 2014;51:1171–1189. doi: 10.1016/j.ijnurstu.2014.01.015.
    1. Nachega JB, Mutamba B, Basangwa D, Nguyen H, Dowdy DW, Mills EJ, et al. Severe mental illness at ART initiation is associated with worse retention in care among HIV-infected Ugandan adults. Tropical Med Int Health. 2013;18:53–57. doi: 10.1111/tmi.12019.
    1. Harding R, Karus D, Easterbrook P, Raveis V, Higginson I, Marconi K. Does palliative care improve outcomes for patients with HIV/AIDS? A systematic review of the evidence. Sex Transm Infect. 2005;81:5–14. doi: 10.1136/sti.2004.010132.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi: 10.1136/bmj.h1258.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337. .
    1. Lowther K, Higginson IJ, Simms V, Gikaara N, Ahmed A, Ali Z, et al. 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;7:600. doi: 10.1186/1756-0500-7-600.
    1. Lowther K, Selman L, Simms V, Gikaara N, Ahmed A, Ali Z, et al. Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial. Lancet HIV. 2015;2:e328–e334. doi: 10.1016/S2352-3018(15)00111-3.
    1. Lowther K, Simms V, Selman L, Sherr L, Gwyther L, Kariuki H, et al. 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;12:288. doi: 10.1186/1471-2334-12-288.
    1. Harding R, Selman L, Agupio G, Dinat N, Downing J, Gwyther L, et al. Validation of a core outcome measure for palliative care in Africa: the APCA African palliative outcome scale. Health Qual Life Outcomes. 2010;8:10. doi: 10.1186/1477-7525-8-10.
    1. Powell RA, Downing J, Harding R, Mwangi-Powell F, Connor S. Development of the APCA African palliative outcome scale. J Pain Symptom Manag. 2007;33:229–232. doi: 10.1016/j.jpainsymman.2006.10.008.
    1. Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995;18:179–183. doi: 10.1002/nur.4770180211.
    1. Wu AW. MOS-HIV health survey. Users manual. Baltimore: Johns Hopkins University; 1999.
    1. McCrone P, Dhanasiri S, Patel A, Knapp M, Lawton-Smith S. Paying the price. London: King’s Fund; 2008.
    1. Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client socio-demographic and service receipt inventory–European version: development of an instrument for international research. EPSILON study 5. European psychiatric services: inputs linked to outcome domains and needs. Br J Psychiatry Suppl. 2000;(39):s28–33.
    1. Mast TC, Kigozi G, Wabwire-Mangen F, Black R, Sewankambo N, Serwadda D, et al. Measuring quality of life among HIV-infected women using a culturally adapted questionnaire in Rakai district, Uganda. AIDS Care. 2004;16:81–94. doi: 10.1080/09540120310001633994.
    1. Stangl AL, Bunnell R, Wamai N, Masaba H, Mermin J. Measuring quality of life in rural Uganda: reliability and validity of summary scores from the medical outcomes study HIV health survey (MOS-HIV) Qual Life Res. 2012;21:1655–1663. doi: 10.1007/s11136-011-0075-5.
    1. Taylor TN, Dolezal C, Tross S, Holmes WC. Reliability and validity of two HIV/AIDS-specific quality of life instruments adapted for use in HIV-positive Zimbabweans. AIDS Care. 2009;21:598–607. doi: 10.1080/09540120802302574.
    1. Agency EM. Guideline on missing data in confirmatory clinical trials. European medicines agency. 2010.
    1. Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ. 1995;310:170. doi: 10.1136/bmj.310.6973.170.
    1. Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15:1277–1288. doi: 10.1177/1049732305276687.
    1. WHO . Consolidated guidelines on general HIV care and the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2013.
    1. Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011;11:828. doi: 10.1186/1471-2458-11-828.
    1. Petersen I, Hanass Hancock J, Bhana A, Govender K. A group-based counselling intervention for depression comorbid with HIV/AIDS using a task shifting approach in South Africa: a randomized controlled pilot study. J Affect Disord. 2014;158:78–84. doi: 10.1016/j.jad.2014.02.013.
    1. Lowther K, Harding R, Ahmed A, Gikaara N, Ali Z, Kariuki H, et al. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya. AIDS Care. 2016;28:60–63. doi: 10.1080/09540121.2016.1146214.
    1. Lowther K, Harding R, Ahmed A, Gikaara N, Ali Z, Kariuki H, et al. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya. AIDS Care. 2016;0:1–4.
    1. Moore G, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions. UK Medical Research Council (MRC) guidance. London: MRC Population Health Science Research Network; 2014.
    1. Holtzman CW, Brady KA, Yehia BR. Retention in care and medication adherence: current challenges to antiretroviral therapy success. Drugs. 2015;75:445–454. doi: 10.1007/s40265-015-0373-2.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner