Multicenter Study

. 2019 Jul 8;19(1):905.

doi: 10.1186/s12889-019-6893-z.

Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV

R Horne¹, E Glendinning², K King², T Chalder³, C Sabin⁴, A S Walker⁵, L J Campbell⁶, I Mosweu⁷, J Anderson⁸, S Collins⁹, R Jopling², P McCrone⁷, H Leake Date¹⁰, S Michie¹¹, M Nelson¹², N Perry¹³, J A Smith¹⁴, W Sseruma¹⁵, V Cooper²; SUPA Group

Affiliations

¹ Department of Practice and Policy, Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Entrance A, BMA House, Tavistock Square, London, WC1H 9JP, UK. r.horne@ucl.ac.uk.
² Department of Practice and Policy, Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Entrance A, BMA House, Tavistock Square, London, WC1H 9JP, UK.
³ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16, De Crespigny Park, London, SE5 8AF, UK.
⁴ Centre for Clinical Research, Epidemiology, Modelling and Evaluation, Institute for Global Health, UCL, Royal Free Campus, Rowland Hill Street, London, NW3 2PF, UK.
⁵ MRC Clinical Trials Unit at UCL, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.
⁶ HIV Research Centre, King's College London, London, SE5 9RJ, UK.
⁷ Institute of Psychiatry at King's College London, Denmark Hill, London, SE5 8AF, UK.
⁸ Centre for the Study of Sexual Health and HIV, Homerton University Hospital, E9 6RS, London, UK.
⁹ HIV i-Base, 107 The Maltings, 169 Tower Bridge Road, London, SE1 3LJ, UK.
¹⁰ Departments of of Pharmacy and HIV Medicine, Brighton & Sussex University Hospitals NHS Trust, Brighton, BN2 5B, UK.
¹¹ Department of Clinical, Educational and Health Psychology, UCL, 1-19 Torrington Place, London, WC1E 7HB, UK.
¹² Kobler Clinic, Chelsea and Westminster Hospital NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK.
¹³ Brighton and Sussex University Hospitals NHS Trust, Brighton, BN2 5BE, UK.
¹⁴ Department of Psychological Sciences, Birkbeck, University of London, London, UK.
¹⁵ UK-CAB, 107 The Maltings, 169 Tower Bridge Road, London, SE1 3LJ, UK.

PMID: 31286908
PMCID: PMC6615195
DOI: 10.1186/s12889-019-6893-z

Multicenter Study

Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV

R Horne et al. BMC Public Health. 2019.

. 2019 Jul 8;19(1):905.

doi: 10.1186/s12889-019-6893-z.

Authors

Affiliations

¹ Department of Practice and Policy, Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Entrance A, BMA House, Tavistock Square, London, WC1H 9JP, UK. r.horne@ucl.ac.uk.
² Department of Practice and Policy, Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Entrance A, BMA House, Tavistock Square, London, WC1H 9JP, UK.
³ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16, De Crespigny Park, London, SE5 8AF, UK.
⁴ Centre for Clinical Research, Epidemiology, Modelling and Evaluation, Institute for Global Health, UCL, Royal Free Campus, Rowland Hill Street, London, NW3 2PF, UK.
⁵ MRC Clinical Trials Unit at UCL, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.
⁶ HIV Research Centre, King's College London, London, SE5 9RJ, UK.
⁷ Institute of Psychiatry at King's College London, Denmark Hill, London, SE5 8AF, UK.
⁸ Centre for the Study of Sexual Health and HIV, Homerton University Hospital, E9 6RS, London, UK.
⁹ HIV i-Base, 107 The Maltings, 169 Tower Bridge Road, London, SE1 3LJ, UK.
¹⁰ Departments of of Pharmacy and HIV Medicine, Brighton & Sussex University Hospitals NHS Trust, Brighton, BN2 5B, UK.
¹¹ Department of Clinical, Educational and Health Psychology, UCL, 1-19 Torrington Place, London, WC1E 7HB, UK.
¹² Kobler Clinic, Chelsea and Westminster Hospital NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK.
¹³ Brighton and Sussex University Hospitals NHS Trust, Brighton, BN2 5BE, UK.
¹⁴ Department of Psychological Sciences, Birkbeck, University of London, London, UK.
¹⁵ UK-CAB, 107 The Maltings, 169 Tower Bridge Road, London, SE1 3LJ, UK.

PMID: 31286908
PMCID: PMC6615195
DOI: 10.1186/s12889-019-6893-z

Abstract

Background: Delay to start antiretroviral therapy (ART) and nonadherence compromise the health and wellbeing of people living with HIV (PLWH), raise the cost of care and increase risk of transmission to sexual partners. To date, interventions to improve adherence to ART have had limited success, perhaps because they have failed to systematically elicit and address both perceptual and practical barriers to adherence. The primary aim of this study is to determine the efficacy of the Supporting UPtake and Adherence (SUPA) intervention.

Methods: This study comprises 2 phases. Phase 1 is an observational cohort study, in which PLWH who are ART naïve and recommended to take ART by their clinician complete a questionnaire assessing their beliefs about ART over 12 months. Phase 2 is a randomised controlled trial (RCT) nested within the observational cohort study to investigate the effectiveness of the SUPA intervention on adherence to ART. PLWH at risk of nonadherence (based on their beliefs about ART) will be recruited and randomised 1:1 to the intervention (SUPA intervention + usual care) and control (usual care) arms. The SUPA intervention involves 4 tailored treatment support sessions delivered by a Research Nurse utilising a collaborative Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) approach. Sessions are tailored to individual needs and preferences based on the individual patient's perceptions and practical barriers to ART. An animation series and intervention manual have been developed to communicate a rationale for the personal necessity for ART and illustrate concerns and potential solutions. The primary outcome is adherence to ART measured using Medication Event Monitoring System (MEMS). Three hundred seventy-two patients will be sufficient to detect a 15% difference in adherence with 80% power and an alpha of 0.05. Costs will be compared between intervention and control groups. Costs will be combined with the primary outcome in cost-effectiveness analyses. Quality adjusted life-years (QALYs) will also be estimated over the follow-up period and used in the analyses.

Discussion: The findings will enable patients, healthcare providers and policy makers to make informed decisions about the value of the SUPA intervention.

Trial registration: The trial was retrospectively registered 21/02/2014, ISRCTN35514212 .

Keywords: Adherence; Antiretroviral therapy; Beliefs about medicines; Cognitive behavioural therapy; Engagement; HIV; Motivational interviewing; Perceptions; Randomised controlled trial.

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Conflict of interest statement

Lucy J Campbell, Simon Collins, Vanessa Cooper, Elizabeth Glendinning, Rebecca Jopling, Kathryn King, Heather Leake Date, Paul McCrone, Mark Nelson, Susan Michie, Iris Mosweu, Jonathan A Smith, Winnie Sseruma, Nicky Perry and Sarah Walker declare that they have no competing interests.

Jane Anderson receives grants, personal fees and non-financial support from Gilead Sciences; MSD, Janssen and BMS, and non-financial support from ViiV.

Trudie Chalder acknowledges the financial support from the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.

Rob Horne has undertaken speaker engagements with honoraria with the following companies: Abbvie, Amgen, Biogen Idec, Gilead Sciences, GlaxoSmithKline, Janssen, Pfizer, Roche, Shire Pharmaceuticals, MSD, Astellas, Astrazeneca, DRSU, Erasmus and Novartis and TEVA. Professor Rob Horne is founder and shareholder of a UCL-business spin out company (Spoonful of Sugar) providing consultancy on medication-related behaviours to healthcare policy makers, providers and industry.

Caroline Sabin has previously received funding for the membership of Data Safety and Monitoring Committees, Advisory Boards, speaker panels and for preparation of educational materials from Gilead Sciences, ViiV Healthcare and Janssen-Cilag.

Figures

**Fig. 1**
Adapted CONSORT diagram of the study

See this image and copyright information in PMC

References

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Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV

Affiliations

Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV

Authors

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Abstract

Conflict of interest statement

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