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Individualised Motivational Counselling to Enhance Adherence to Antiretroviral Therapy is not Superior to Didactic Counselling in South African Patients: Findings of the CAPRISA 058 Randomised Controlled Trial

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Abstract

Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n = 150), or an intensive motivational adherence intervention after initiating ART (n = 147). Study arms were similar for age (mean 35.8 years), sex (43.1 % male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119,000 copies/ml). Virologic suppression at 9 months was achieved in 89.8 % of didactic and 87.9 % of motivational counselling participants (risk ratio [RR] 0.98, 95 % confidence interval [CI] 0.90–1.07, p = 0.62). 82.9 % of didactic and 79.5 % of motivational counselling participants achieved >95 % adherence by pill count at 6 months (RR 0.96, 95 % CI 0.85–1.09, p = 0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting.

Resumen

La inquietud de que la terapia didáctica de adherencia estándar pudiera ser inadecuada para maximizar la adherencia al tratamiento antiretroviral (ART), nos llevó a evaluar la terapia motivacional individualizada. Aleatorizamos 297 pacientes HIV-positivos sin ART previo en Durban, Sudáfrica, para recibir, ya sea terapia didáctica antes del inicio del ART (n = 150), o terapia motivacional intensiva después de iniciado el ART (n = 147). Los brazos del estudio fueron similares en edad (promedio 35.8 años), sexo (43.1 % hombres), recuento de células CD4+ (mediana 121.5 células/μl) y carga viral (mediana 119,000 copias/ml). La supresión virológica a los nueves meses se logró en el 89.8 % de los participantes que recibieron terapia didáctica y en 87.9 % de aquellos en terapia motivacional (riesgo relativo [RR] 0.98, 95 % intervalo de confianza [CI] 0.90–1.07, p = 0.62). 82.9 % de los participantes bajo terapia didáctica y 79.5 % de los tratados con terapia motivacional alcanzaron >95 % de adherencia por cuenta de píldoras a los seis meses (RR 0.96, 95 % CI 0.85–1.09, p = 0.51). Los participantes que recibieron terapia motivacional intensiva no mostraron una mayor adherencia al tratamiento o supresión virológica que aquellos bajo terapia didáctica rutinaria. Estos resultados son tranquilizadores ya que muestran que la menos costosa terapia didáctica es adecuada en este escenario.

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Notes

  1. We refer to patients in the treatment programme, and to participants when enrolled onto this study.

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Acknowledgements

This research was supported by the Doris Duke Charitable Foundation-funded Operations Research on AIDS Care and Treatment in Africa (ORACTA) Programme (Grant # 2005058). The Association of Commonwealth Universities funded PhD study for Francois van Loggerenberg at London School of Hygiene and Tropical Medicine. He was also supported by the Columbia University-Southern African Fogarty AIDS International Training and Research Programme (AITRP) funded by the Fogarty International Center, National Institutes of Health (Grant #D43TW00231). The National Institute of Allergy and infectious Disease (NIAID), National Institutes of Health (NIH) (Grant# AI51794) funded the infrastructure for this research. Alison Grant was supported by a Public Health Career Scientist award from the UK Department of Health. We would like to thank the clinic research support staff who provided the data collection, nursing services, as well as the administrative and counselling support for CAPRISA 058 study, Senzo Hlathi, Goodness Gumede, and Thandi Shezi. Dr Leila Mansoor provided advice and assisted with the training of the clinic counselling staff. Lise Werner, Anneke Grobler and Nonhlanhla Yende provided additional statistical guidance and support. Jayraj Ramota was the data manager, and data were entered and validated by Mfanafuthi Mthambela. Clive Govender provided data quality control. Members of the Center for Health, Intervention, and Prevention (CHIP), University of Connecticut, who developed the IMB model, were very helpful in the conceptualisation, conduct and analysis of this trial. Specifically, Paul Shuper and K. Rivet Amico provided on-going support and guidance. Katherine Fielding and Simon Lewin provided support as members of the PhD advisory committee. The intervention was based on one developed by Gerald Friedland (Yale University, USA), Marita Murrman, Patricia Torro, and Wafaa El-Sadr (all Columbia University, USA) in earlier work, and was generously shared; their support and guidance during the conceptualisation of this study conducted is acknowledged. We would like to especially acknowledge the participants who took part in this study.

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Authors and Affiliations

  1. CAPRISA, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa

    Francois van Loggerenberg, Kogieleum Naidoo, Santhanalakshmi Gengiah, Tanuja N. Gengiah & Salim S. Abdool Karim

  2. Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK

    Francois van Loggerenberg & Alison D. Grant

  3. The Global Health Network, Centre for Tropical Medicine, University of Oxford, NDM Research Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK

    Francois van Loggerenberg

  4. Mailman School of Public Health, Columbia University, New York, NY, USA

    Marita Murrman & Salim S. Abdool Karim

  5. Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK

    Katherine Fielding

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  1. Francois van Loggerenberg
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Correspondence to Francois van Loggerenberg.

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van Loggerenberg, F., Grant, A.D., Naidoo, K. et al. Individualised Motivational Counselling to Enhance Adherence to Antiretroviral Therapy is not Superior to Didactic Counselling in South African Patients: Findings of the CAPRISA 058 Randomised Controlled Trial. AIDS Behav 19, 145–156 (2015). https://doi.org/10.1007/s10461-014-0763-6

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