Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial

John A Joska, Lena S Andersen, Rosana Smith-Alvarez, Jessica Magidson, Jasper S Lee, Conall O'Cleirigh, Steven A Safren, John A Joska, Lena S Andersen, Rosana Smith-Alvarez, Jessica Magidson, Jasper S Lee, Conall O'Cleirigh, Steven A Safren

Abstract

Background: There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC).

Objective: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa.

Methods: This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments).

Results: The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019.

Conclusions: Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals.

Trial registration: ClincialTrials.gov NCT02696824; https://ichgcp.net/clinical-trials-registry/NCT02696824.

International registered report identifier (irrid): DERR1-10.2196/14200.

Keywords: HIV; cognitive behavioral therapy; integrated treatment; major depressive disorder; medication adherence; task shifting.

Conflict of interest statement

Conflicts of Interest: SAS receives royalties from Oxford University Press on CBT manuals addressing adherence and depression in chronic illness. He also receives royalties from Oxford University Press, Guilford Publications, and Springer/Humana Press for books that address the delivery of CBT and related issues. The other authors declare that they have no conflicts of interest.

©John A Joska, Lena S Andersen, Rosana Smith-Alvarez, Jessica Magidson, Jasper S Lee, Conall O’Cleirigh, Steven A Safren. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.02.2020.

Figures

Figure 1
Figure 1
Consolidated standards of reporting trials diagram. CBT-AD: cognitive behavioral therapy for adherence and depression; ETAU: enhanced treatment as usual; SOC: standard of care; 4M: 4-month; 8M: 8-month; 12M: 12-month.

References

    1. Shisana O, Rehle T, Simbayi L, Zuma K, Jooste S, Zungu N, Labadarios D, Onoya D. Human Sciences Research Council Press. 2014. [2019-03-07]. South African National HIV Prevalence, Incidence and Behaviour Survey, 2012 Internet .
    1. Abdool Karim SS, Churchyard GJ, Karim QA, Lawn SD. HIV infection and tuberculosis in South Africa: an urgent need to escalate the public health response. Lancet. 2009 Sep 12;374(9693):921–33. doi: 10.1016/S0140-6736(09)60916-8.
    1. Takuva S, Brown AE, Pillay Y, Delpech V, Puren AJ. The continuum of HIV care in South Africa: implications for achieving the second and third UNAIDS 90-90-90 targets. AIDS. 2017 Feb 20;31(4):545–552. doi: 10.1097/QAD.0000000000001340.
    1. Peltzer K, Szrek H, Ramlagan S, Leite R, Chao L. Depression and social functioning among HIV-infected and uninfected persons in South Africa. AIDS Care. 2015;27(1):41–6. doi: 10.1080/09540121.2014.946383.
    1. Freeman M, Nkomo N, Kafaar Z, Kelly K. Factors associated with prevalence of mental disorder in people living with HIV/AIDS in South Africa. AIDS Care. 2007 Nov;19(10):1201–9. doi: 10.1080/09540120701426482.
    1. Seedat S, Williams D, Herman A, Moomal H, Williams S, Jackson P, Myer L, Stein D. South African Medical Journal. 2009. [2019-03-07]. Mental health service use among South Africans for mood, anxiety and substance use disorders .
    1. Bhana A, Petersen I, Baillie KL, Flisher AJ, The Mhapp Research Programme Consortium Implementing the World Health Report 2001 recommendations for integrating mental health into primary health care: a situation analysis of three African countries: Ghana, South Africa and Uganda. Int Rev Psychiatry. 2010;22(6):599–10. doi: 10.3109/09540261.2010.536152.
    1. Mall S, Sorsdahl K, Swartz L, Joska J. "I understand just a little…" Perspectives of HIV/AIDS service providers in South Africa of providing mental health care for people living with HIV/AIDS. AIDS Care. 2012;24(3):319–23. doi: 10.1080/09540121.2011.608790.
    1. Myers B, Carney T, Wechsberg WM. "Not on the agenda": a qualitative study of influences on health services use among poor young women who use drugs in Cape Town, South Africa. Int J Drug Policy. 2016 Apr;30:52–8. doi: 10.1016/j.drugpo.2015.12.019.
    1. Lund C, Kleintjes S, Kakuma R, Flisher AJ, MHaPP Research Programme Consortium Public sector mental health systems in South Africa: inter-provincial comparisons and policy implications. Soc Psychiatry Psychiatr Epidemiol. 2010 Mar;45(3):393–404. doi: 10.1007/s00127-009-0078-5.
    1. Petersen I, Lund C. Mental health service delivery in South Africa from 2000 to 2010: one step forward, one step back. S Afr Med J. 2011 Sep 28;101(10):751–7.
    1. Pence BW. The impact of mental health and traumatic life experiences on antiretroviral treatment outcomes for people living with HIV/AIDS. J Antimicrob Chemother. 2009 Apr;63(4):636–40. doi: 10.1093/jac/dkp006.
    1. Sherbourne CD, Hays RD, Fleishman JA, Vitiello B, Magruder KM, Bing EG, McCaffrey D, Burnam A, Longshore D, Eggan F, Bozzette SA, Shapiro MF. Impact of psychiatric conditions on health-related quality of life in persons with HIV infection. Am J Psychiatry. 2000 Feb;157(2):248–54. doi: 10.1176/appi.ajp.157.2.248.
    1. Layard R, Clark DM. Thrive: How Better Mental Health Care Transforms Lives and Saves Money. London: Princeton University Press; 2015. pp. 978–1.
    1. Grenard JL, Munjas BA, Adams JL, Suttorp M, Maglione M, McGlynn EA, Gellad WF. Depression and medication adherence in the treatment of chronic diseases in the United States: a meta-analysis. J Gen Intern Med. 2011 Oct;26(10):1175–82. doi: 10.1007/s11606-011-1704-y.
    1. Patel V, Chisholm D, Parikh R, Charlson FJ, Degenhardt L, Dua T, Ferrari AJ, Hyman S, Laxminarayan R, Levin C, Lund C, Medina Mora ME, Petersen I, Scott J, Shidhaye R, Vijayakumar L, Thornicroft G, Whiteford H. Addressing the burden of mental, neurological, and substance use disorders: key messages from Disease Control Priorities , 3rd edition. Lancet. 2016 Apr;387(10028):1672–85. doi: 10.1016/S0140-6736(15)00390-6.
    1. Ammassari A, Trotta MP, Murri R, Castelli F, Narciso P, Noto P, Vecchiet J, D'Arminio Monforte A, Wu AW, Antinori A, AdICoNA Study Group Correlates and predictors of adherence to highly active antiretroviral therapy: overview of published literature. J Acquir Immune Defic Syndr. 2002 Dec 15;31 Suppl 3:S123–7. doi: 10.1097/00126334-200212153-00007.
    1. Kagee A. Psychological distress among persons living with HIV, hypertension, and diabetes. AIDS Care. 2010;22(12):1517–21. doi: 10.1080/09540121.2010.484458.
    1. Davies T, Lund C. Integrating mental health care into primary care systems in low- and middle-income countries: lessons from PRIME and AFFIRM. Glob Ment Health (Camb) 2017;4:e7. doi: 10.1017/gmh.2017.3.
    1. Petersen I, Marais D, Abdulmalik J, Ahuja S, Alem A, Chisholm D, Egbe C, Gureje O, Hanlon C, Lund C, Shidhaye R, Jordans M, Kigozi F, Mugisha J, Upadhaya N, Thornicroft G. Strengthening mental health system governance in six low- and middle-income countries in Africa and South Asia: challenges, needs and potential strategies. Health Policy Plan. 2017 Jun 01;32(5):699–709. doi: 10.1093/heapol/czx014.
    1. Hoeft TJ, Fortney JC, Patel V, Unützer J. Task-sharing approaches to improve mental health care in rural and other low-resource settings: a systematic review. J Rural Health. 2018 Dec;34(1):48–62. doi: 10.1111/jrh.12229.
    1. van Ginneken N, Tharyan P, Lewin S, Rao G, Meera S, Pian J, Chandrashekar S, Patel V. Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database Syst Rev. 2013 Nov 19;(11):CD009149. doi: 10.1002/14651858.CD009149.pub2.
    1. Nel A, Kagee A. The relationship between depression, anxiety and medication adherence among patients receiving antiretroviral treatment in South Africa. AIDS Care. 2013 Aug;25(8):948–55. doi: 10.1080/09540121.2012.748867.
    1. Craighead E, Sheets E, Brosse A, Ilardi S. Psychosocial treatments for major depressive disorder. In: Nathan PE, Gorman JM, editors. A Guide to Treatments That Work. New York, NY, US: Oxford University Press; 2007.
    1. Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1–10. doi: 10.1037/a0012715.
    1. Safren S, Bedoya C, O'Cleirigh C, Biello K, Pinkston M, Stein M, Traeger L, Kojic E, Robbins G, Lerner J, Herman D, Mimiaga M, Mayer K. Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Lancet HIV. 2016 Nov;3(11):e529–38. doi: 10.1016/S2352-3018(16)30053-4.
    1. Safren SA, O'Cleirigh CM, Bullis JR, Otto MW, Stein MD, Pollack MH. Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):404–15. doi: 10.1037/a0028208.
    1. Andersen LS. ProQuest Dissertations Publishing. United States -- New York: Hofstra University; 2009. Effectiveness of cognitive-behavioral therapy on the reduction of depression in people infected with HIV/AIDS in South Africa.
    1. Andersen LS, Magidson JF, O'Cleirigh C, Remmert JE, Kagee A, Leaver M, Stein DJ, Safren SA, Joska J. A pilot study of a nurse-delivered cognitive behavioral therapy intervention (Ziphamandla) for adherence and depression in HIV in South Africa. J Health Psychol. 2018 May;23(6):776–787. doi: 10.1177/1359105316643375.
    1. Sheehan D. Medical Outcomes Systems. 2014. Oct 14, [2019-10-14]. The Mini-International Neuropsychiatric Interview, Version 7.0 for DSM-5 (MINI 7.0) .
    1. Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Safren SA, Otto MW, Worth JL, Salomon E, Johnson W, Mayer K, Boswell S. Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring. Behav Res Ther. 2001 Oct;39(10):1151–62. doi: 10.1016/s0005-7967(00)00091-7.
    1. Safren SA, Otto MW, Worth JL. Life-steps: applying cognitive behavioral therapy to HIV medication adherence. Cogn Behav Pract. 1999 Sep;6(4):332–41. doi: 10.1016/S1077-7229(99)80052-2.
    1. Traeger L, O'Cleirigh C, Perry N, Bedoya A, Safren S. Does substance use interfere with acquisition and maintenance of HIV medication adherence skills?. 6th International Conference on HIV Treatment and Prevention Adherence; 2011; Miami Beach, FL. 2011.
    1. Hayes S, Tormino D. If behavioral principles are generally applicable, why is it necessary to understand cultural diversity? Behav Ther (N Y N Y) 1995;18:23.
    1. Hatch M, Friedman S, Paradis C. Behavioral treatment of obsessive-compulsive disorder in African Americans. Cogn Behav Pract. 1996 Dec;3(2):303–15. doi: 10.1016/S1077-7229(96)80020-4.
    1. Tanaka-Matsumi J, Seiden D, Lam K. The culturally informed functional assessment (CIFA) interview: a strategy for cross-cultural behavioral practice. Cogn Behav Pract. 1996;3(2):215–33. doi: 10.1016/S1077-7229(96)80015-0.
    1. Nezu AM, D'Zurilla TJ. Social problem solving and negative affective conditions. In: Kendall PC, Watson D, editors. Personality, Psychopathology, and Psychotherapy. Anxiety and Depression: Distinctive and Overlapping Features. San Diego, CA, US: Academic Press; 1989. pp. 285–315.
    1. Andersen L, Kagee A, Safren S, O'Cleirigh C, Stein D, Joska J. Understanding depression and its impact on adherence to HAART in people living with HIV/AIDS in South Africa. 6th International Conference on HIV Treatment and Prevention Adherence; 2011; Miami, FL. 2011.
    1. Turner JA, Chapman RC. Psychological interventions for chronic pain: a critical review. I. Relaxation training and biofeedback. Pain. 1982 Jan;12(1):1–21. doi: 10.1016/0304-3959(82)90167-1.
    1. Waltz J, Addis M, Koerner K, Jacobson N. Testing the integrity of a psychotherapy protocol: assessment of adherence and competence. J Consult Clin Psychol. 1993 Aug;61(4):620–30. doi: 10.1037//0022-006x.61.4.620.
    1. Myer L, Smit J, Roux LL, Parker S, Stein DJ, Seedat S. Common mental disorders among HIV-infected individuals in South Africa: prevalence, predictors, and validation of brief psychiatric rating scales. AIDS Patient Care STDS. 2008 Feb;22(2):147–58. doi: 10.1089/apc.2007.0102.
    1. Freeman M, Nkomo N, Kafaar Z, Kelly K. Mental disorder in people living with HIV/Aids in South Africa. S Afr J Psychol. 2008 Sep;38(3):489–500. doi: 10.1177/008124630803800304.
    1. Breuer E, Stoloff K, Myer L, Seedat S, Stein DJ, Joska J. Reliability of the lay adherence counsellor administered substance abuse and mental illness symptoms screener (SAMISS) and the International HIV Dementia Scale (IHDS) in a primary care HIV clinic in Cape Town, South Africa. AIDS Behav. 2012 Aug;16(6):1464–71. doi: 10.1007/s10461-011-0067-z.
    1. Kennedy SH, Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol. 2006 Feb;16(2):93–100. doi: 10.1016/j.euroneuro.2005.09.002.
    1. Hamilton M. The Hamilton Rating Scale for Depression. In: Sartorius N, Ban TA, editors. Assessment of Depression. Berlin, Heidelberg: Springer; 1986.
    1. Gagiano CA, Müller FG, de Kock RF, Schall R. Moclobemide in continuation treatment of major depressive episodes: an open follow-up study over six months. J Clin Psychopharmacol. 1995 Aug;15(4 Suppl 2):46S–50S. doi: 10.1097/00004714-199508001-00009.
    1. Gagiano CA, Müller FG, Berk M, Joubert PM, Brown RG, Schall R. Moclobemide twice daily in the treatment of major depressive episode: a double-blind, multicenter comparison with different three times daily dosage schedules. J Clin Psychopharmacol. 1995 Aug;15(4 Suppl 2):4S–9S. doi: 10.1097/00004714-199508001-00002.
    1. Radloff LS. The CES-D Scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977 Jun 01;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Damond F, Roquebert B, Bénard A, Collin G, Miceli M, Yéni P, Brun-Vezinet F, Descamps D. Human immunodeficiency virus type 1 (HIV-1) plasma load discrepancies between the Roche COBAS AMPLICOR HIV-1 MONITOR Version 1.5 and the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 assays. J Clin Microbiol. 2007 Oct;45(10):3436–8. doi: 10.1128/JCM.00973-07.
    1. WHO ASSIST Working Group The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002;97(9):1183–94. doi: 10.1046/j.1360-0443.2002.00185.x.
    1. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791–804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
    1. Wells KB, Stewart A, Hays RD, Burnam MA, Rogers W, Daniels M, Berry S, Greenfield S, Ware J. The functioning and well-being of depressed patients. Results from the Medical Outcomes Study. J Am Med Assoc. 1989 Aug 18;262(7):914–9.
    1. Linden M, Schermuly-Haupt M. Definition, assessment and rate of psychotherapy side effects. World Psychiatry. 2014 Oct;13(3):306–9. doi: 10.1002/wps.20153. doi: 10.1002/wps.20153.
    1. Georgeu D, Colvin CJ, Lewin S, Fairall L, Bachmann MO, Uebel K, Zwarenstein M, Draper B, Bateman ED. Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial. Implement Sci. 2012 Jul 16;7:66. doi: 10.1186/1748-5908-7-66.
    1. Dewing S, Mathews C, Cloete A, Schaay N, Shah M, Simbayi L, Louw J. From research to practice: lay adherence counsellors' fidelity to an evidence-based intervention for promoting adherence to antiretroviral treatment in the Western cape, South Africa. AIDS Behav. 2013 Nov;17(9):2935–45. doi: 10.1007/s10461-013-0509-x.

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