Feasibility and Acceptability of a Task-Shifted Intervention to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe, a Low Income Country in Sub-Saharan Africa

Melanie Abas, Primrose Nyamayaro, Tarisai Bere, Emily Saruchera, Nomvuyo Mothobi, Victoria Simms, Walter Mangezi, Kirsty Macpherson, Natasha Croome, Jessica Magidson, Azure Makadzange, Steven Safren, Dixon Chibanda, Conall O'Cleirigh, Melanie Abas, Primrose Nyamayaro, Tarisai Bere, Emily Saruchera, Nomvuyo Mothobi, Victoria Simms, Walter Mangezi, Kirsty Macpherson, Natasha Croome, Jessica Magidson, Azure Makadzange, Steven Safren, Dixon Chibanda, Conall O'Cleirigh

Abstract

Using a pilot trial design in an HIV care clinic in Zimbabwe, we randomised 32 adults with poor adherence to antiretroviral therapy and at least mild depression to either six sessions of Problem-Solving Therapy for adherence and depression (PST-AD) delivered by an adherence counsellor, or to Enhanced Usual Care (Control). Acceptability of PST-AD was high, as indicated by frequency of session attendance and through qualitative analyses of exit interviews. Fidelity was >80% for the first two sessions of PST-AD but fidelity to the adherence component of PST-AD dropped by session 4. Contamination occurred, in that seven patients in the control arm received one or two PST-AD sessions before follow-up assessment. Routine health records proved unreliable for measuring HIV viral load at follow-up. Barriers to measuring adherence electronically included device failure and participant perception of being helped by the research device. The study was not powered to detect clinical differences, however, promising change at 6-months follow-up was seen in electronic adherence, viral load suppression (PST-AD arm 9/12 suppressed; control arm 4/8 suppressed) and depression (Patient Health Questionnaire-4.7 points in PST-AD arm vs. control, adjusted p value = 0.01). Results inform and justify a future randomised controlled trial of task-shifted PST-AD.

Keywords: Adherence; Depression; Intervention; Problem solving; Sub-Saharan Africa.

Conflict of interest statement

Conflict of interest

Dr. Steven Safren receives royalties from Oxford University Press and Guilford Publications for books on cognitive-behavioral treatments for various psychological difficulties, including coping with chronic illness and depression. All remaining author, Abas, Nyamayaro, Bere, Saruchera, Mothobi, Simms, Mangezi, Macpherson Croome, Magidson, Makadzange, Chibanda, O’Cleirigh declares that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors. The study was approved by, the Medical Research Council of Zimbabwe and the Research Council of Zimbabwe (MRCZ/A/1736), Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics Committee (JREC 18/13) and King’s College London College Research Ethics Committee (PNM/13/14-158). The trial was also registered with the Pan African Clinical Trials Registry (PACTR201511001150307).

Informed consent

Informed consent was obtained from all individual participants included in the study. Participants were compensated with USD3 per visit for public transport costs and were provided with refreshments.

Figures

Fig. 1
Fig. 1
Flow-chart showing the experimental and enhanced usual care interventions
Fig. 2
Fig. 2
Flow-chart showing the progress of participants from screening to follow-up

References

    1. UNAIDS. Fact Sheet 2016. 2016.
    1. (UNAIDS) JUNPoHA. HIV and AIDS estimates (2015) 2015 .
    1. ICAP. Zimbabwe Population-Based HIV Impact Assessment (2015–2016). 2016.
    1. UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. 2014.
    1. Kobin AB, Sheth NU. Levels of adherence required for virologic suppression among newer antiretroviral medications. Ann Pharmacother. 2011;45(3):372–379.
    1. Chaiyachati KH, Ogbuoji O, Price M, Suthar AB, Negussie EK, Barnighausen T. Interventions to improve adherence to antiretroviral therapy: a rapid systematic review. AIDS. 2014;28(Suppl 2):S187–S204.
    1. Gross R, Bellamy SL, Chapman J, Han X, O’Duor J, Palmer SC, et al. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013;173(4):300–306.
    1. CDC. Compendium of evidence-based interventions and best practices for HIV prevention: Medication Adherence Chapter United States2015 [updated April 2015. .
    1. Kidia K, Machando D, Bere T, Macpherson K, Nyamayaro P, Potter L, et al. ‘I was thinking too much’: experiences of HIV-positive adults with common mental disorders and poor adherence to antiretroviral therapy in Zimbabwe. Trop Med Int Health. 2015;20:903.
    1. Safren SA, Otto MW, Worth JL, Salomon E, Johnson W, Mayer K, et al. Two strategies to increase adherence to HIV antiretroviral medication: life-Steps and medication monitoring. Behav Res Ther. 2001;39(10):1151–1162.
    1. Bere T, Nyamayaro P, Magidson J, Chibanda D, Chingono A, O’Cleirgh C, et al. Cultural adaptation of a cognitive-behavioural intervention to improve adherence to antiretroviral therapy among people living with HIV/AIDS in Zimbabwe: Nzira Itsva. J Health Psychol. 2016:1–12.
    1. Nakimuli-Mpungu E, Bass J, Alexandre P, Mills E, Musisi S, Ram M, et al. Depression, alcohol use and adherence to antiretroviral therapy in sub-Saharan Africa: a systematic review. AIDS Behav. 2012;16(2):2101–2118.
    1. Uthman OA, Magidson JF, Safren SA, Nachega JB. Depression and adherence to antiretroviral therapy in low-, middle- and high-income countries: a systematic review and meta-analysis. Curr HIV/AIDS Rep. 2014;11(3):291–307.
    1. Chibanda D, Benjamin L, Weiss H, Abas M. Mental, neurological and substance use disorders in people living with HIV/AIDS in low and middle income countries. JAIDS. 2014;67(Suppl 1):S54–S67.
    1. Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008;5(4):193–203.
    1. Martin LR, DiMatteo . The Oxford handbook of health communication, behavior change, and treatment adherence. Oxford: Oxford University Press; 2013.
    1. Papakostas GI. Cognitive symptoms in patients with major depressive disorder and their implications for clinical practice. J Clin Psychiatry. 2014;75(1):8–14.
    1. Watkins E, Baracaia S. Rumination and social problem-solving in depression. Behav Res Ther. 2002;40(10):1179–1189.
    1. Levens SM, Muhtadie L, Gotlib IH. Rumination and impaired resource allocation in depression. J Abnorm Psychol. 2009;118(4):757–766.
    1. Leserman J. Role of depression, stress, and trauma in HIV disease progression. Psychosom Med. 2008;70(5):539–545.
    1. Antoni MH. Stress management effects on psychological, endocrinological, and immune functioning in men with HIV infection: empirical support for a psychoneuroimmunological model. Stress. 2003;6(3):173–188.
    1. WHO. Mental health Atlas. 2011 (Geneva).
    1. World Health Organization. Atlas: psychiatric education and training across the world 2005: World Health Organization; 2005.
    1. Safren SA, O’Cleirigh C, Judy T, Raminani S, Reilly LC, Otto MW, et al. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009;28:1–10.
    1. Simoni J, Wiebe J, Sauceda J, Huh D, Sanchez G, Longoria V, et al. A preliminary RCT of CBT-AD for adherence and depression among HIV positive Latinos on the U.S.-Mexico Border: The Nuevo Día Study. AIDS Behav. 2013;17(8):2816–2829.
    1. Safren SA, O’Cleirigh C, 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;80:404–415.
    1. Safren S, Andres Bedoya C, C OC, Biello KB, Pinkston M, Stein MD, et al. Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Lancet HIV. 2016.
    1. Sin NL, DiMatteo MR. Depression treatment enhances adherence to antiretroviral therapy: a meta-analysis. Ann Behav Med. 2014;47(3):259–269.
    1. Pence BW, Gaynes BN, Adams JL, Thielman NM, Heine AD, Mugavero MJ, et al. The effect of antidepressant treatment on HIV and depression outcomes: the SLAM DUNC randomized trial. AIDS. 2015;29(15):1975–1986.
    1. Abas M, Bowers T, Manda E, Cooper S, Machando D, Verhey R, et al. ‘Opening up the mind’: problem-solving therapy delivered by female lay health workers to improve access to evidence-based care for depression and other common mental disorders through the Friendship Bench Project in Zimbabwe. Int J Ment Health Syst. 2016;10(1):1–8.
    1. Chibanda D, Cowan F, Verhey R, Machando D, Abas M, Lund C. Lay health workers’ experience of delivering a problem solving therapy intervention for common mental disorders among people living with HIV: a qualitative study from Zimbabwe. Commun Ment Health J. 2016:1–11.
    1. D’Zurilla T, Nezu A. Problem-solving therapy: a positive approach to clinical intervention. 3. New York: Spring Publishing Company; 2007.
    1. Mynors-Wallis L. Problem-solving treatment for anxiety and depression: a practical guide. Oxford: Oxford University Press; 2005.
    1. Haaga DA. Introduction to the special section on stepped care models in psychotherapy. J Consult Clin Psychol. 2000;68(4):547–548.
    1. Sobell MB, Sobell LC. Stepped care as a heuristic approach to the treatment of alcohol problems. J Consult Clin Psychol. 2000;68(4):573.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613.
    1. Chibanda D, Gibson L, Weiss HA, Munjoma R, Araya R, Abas M. Validation of screening tools for depression and anxiety disorders in a primary care population with high HIV prevalence in Zimbabwe. J Affect Disord. 2016;198:50–55.
    1. Sacktor NC, Wong M, Nakasujja N, Skolasky RL, Selnes OA, Musisi S, et al. The International HIV Dementia Scale: a new rapid screening test for HIV dementia. AIDS. 2005;19(13):1367–1374.
    1. Dube P, Kroenke K, Bair M, Theobald D, Williams L. The P4 screener: a brief measure for assessing potential suicidal risk. J Clin Psychiatry Prim Care Companion. 2010;12:12.
    1. Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. AIDS Care. 2000;12(3):255–266.
    1. Haberer JE, Kahane J, Kigozi I, Emenyonu N, Hunt P, Martin J, et al. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav. 2010;14(6):1340–1346.
    1. Safren SA, Otto MW, Worth JL. Life-steps: applying cognitive behavioral therapy to HIV medication adherence. Cogn. Behav Pract. 1999;6(4):332–341.
    1. Nezu AM, Nezu CM, Perri MG. Problem-solving therapy for depression: theory, research, and clinical guidelines. New York: Wiley; 1989.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
    1. Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109.
    1. Fergusson D, Aaron SD, Guyatt G, Hébert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325(7365):652–654.
    1. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine Publishing Company; 1967.
    1. Miles M, Huberman M. Qualitative data analysis: an expanded sourcebook. 2. London: Sage Publications Inc; 1994.
    1. Strauss A, Corbin J. Basics of qualitative research: selective coding techniques and procedures for developing grounded theory. Newbury Park: Sage; 1998.
    1. Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376(9755):1838–1845.
    1. Paintsil E. Monitoring antiretroviral therapy in HIV-infected children in resource-limited countries: a tale of two epidemics. AIDS Res Treat. 2011;2011:9.
    1. Bell AC, D’Zurilla TJ. Problem-solving therapy for depression: a meta-analysis. Clin Psychol Rev. 2009;29(4):348–353.
    1. Nezu AM. Problem solving and behavior therapy revisited. Behav Ther. 2004;35(1):1–33.
    1. Ware NC, Pisarski EE, Tam M, Wyatt MA, Atukunda E, Musiimenta A, et al. The Meanings in the messages: how SMS reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016;30(8):1287–1294.
    1. Wagner G, Ghosh-Dastidar B. Electronic monitoring: adherence assessment or intervention? HIV Clin Trials. 2002;3(1):45–51.
    1. van der Aa HP, van Rens GH, Comijs HC, Margrain TH, Gallindo-Garre F, Twisk JW, et al. Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial. BMJ. 2015;351:h6127.
    1. Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013;16:18586.
    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;16(6):1464–1471.
    1. Patel V, Simunyu E, Gwanzura F, Lewis G, Mann A. The Shona Symptom Questionnaire: the development of an indigenous measure of common mental disorders in Harare. Acta Psychiatr Scand. 1997;95:457.
    1. Ortego C, Huedo-Medina TB, Llorca J, Sevilla L, Santos P, Rodriguez E, et al. Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011;15(7):1381–1396.

Source: PubMed

3
Sottoscrivi