INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial

Glenn J Wagner, Victoria Ngo, Peter Glick, Ekwaro A Obuku, Seggane Musisi, Dickens Akena, Glenn J Wagner, Victoria Ngo, Peter Glick, Ekwaro A Obuku, Seggane Musisi, Dickens Akena

Abstract

Background: Despite 10 to% of persons living with HIV in sub-Saharan Africa having clinical depression, and the consequences of depression for key public health outcomes (HIV treatment adherence and condom use), depression treatment is rarely integrated into HIV care programs. Task-shifting, protocolized approaches to depression care have been used to overcome severe shortages of mental health specialists in developing countries, but not in sub-Saharan Africa and not with HIV clients. The aims of this trial are to evaluate the implementation outcomes and cost-effectiveness of a task-shifting, protocolized model of antidepressant care for HIV clinics in Uganda.

Methods/design: INDEPTH-Uganda is a cluster randomized controlled trial that compares two task-shifting models of depression care--a protocolized model versus a model that relies on the clinical acumen of trained providers to provide depression care in ten public health HIV clinics in Uganda. In addition to data abstracted from routine data collection mechanisms and supervision logs, survey data will be collected from patient and provider longitudinal cohorts; at each site, a random sample of 150 medically stable patients who are depressed according to the PHQ-2 screening will be followed for 12 months, and providers involved in depression care implementation will be followed over 24 months. These data will be used to assess whether the two models differ on implementation outcomes (proportion screened, diagnosed, treated; provider fidelity to model of care), provider adoption of treatment care knowledge and practices, and depression alleviation. A cost-effectiveness analysis will be conducted to compare the relative use of resources by each model.

Discussion: If effective and resource-efficient, the task-shifting, protocolized model will provide an approach to building the capacity for sustainable integration of depression treatment in HIV care settings across sub-Saharan Africa and improving key public health outcomes.

Trial registration: INDEPTH-Uganda has been registered with the National Institutes of Health sponsored clinical trials registry (3 February 2013) and has been assigned the identifier NCT02056106.

Figures

Figure 1
Figure 1
Depression and treatment eligibility assessment protocol. PHQ = Patient Health Questionnaire. OI = opportunistic infections. Rx = treatment. Dx = diagnosis. ART = antiretroviral therapy.
Figure 2
Figure 2
Algorithm for dose or medication changes. PHQ = Patient Health Questionnaire.

References

    1. UNAIDS. UNAIDS report on the global AIDS epidemic 2013
    1. Ferradini L, Jeannin A, Pinoges L, Izopet J, Odhiambo D, Mankhambo L, Karungi G, Szumilin E, Balandine S, Fedida G, Carrieri MP, Spire B, Ford N, Tassie JM, Guerin PJ, Brasher C. Scaling up of highly active antiretroviral therapy in a rural district of Malawi: an effectiveness assessment. Lancet. 2006;367:1335–42.
    1. Ivers LC, Kendrick D, Doucette K. Efficacy of antiretroviral therapy programs in resource-poor settings: a meta-analysis of the published literature. Clin Infect Dis. 2005;41:217–24.
    1. Levitt NS, Steyn K, Dave J, Bradshaw D. Chronic noncommunicable diseases and HIV-AIDS on a collision course: relevance for health care delivery, particularly in low-resource settings - insights from South Africa. J Clin Nutr. 2011;94:1690S–6.
    1. Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000;342:921–9.
    1. Donnell D, Kiarie J, Thomas K, Baeten J, Lingappa J, Cohen C, Celum C. Proceedings of the Seventeenth Conference on Retroviruses and Opportunistic Infections. San Francisco; 2010. ART and risk of heterosexual HIV-1 transmission in HIV-1 serodiscordant African couples: a multinational prospective study [abstract]
    1. Bunnell R, Ekwaru JP, Solberg P, Wamai N, Bikaako-Kajura W, Were W, Coutinho A, Liechty C, Madraa E, Rutherford G, Mermin J. Changes in sexual behavior and risk of HIV transmission after antiretroviral therapy and prevention interventions in rural Uganda. AIDS Behav. 2006;20:85–92.
    1. Eisele TP, Mathews C, Chopra M, Lurie MN, Brown L, Dewing S, Kendall C. Changes in risk behavior among HIV-positive patients during their first year of antiretroviral therapy in Cape Town South Africa. AIDS Behav. 2009;13:1097–105.
    1. Starace F, Ammassari A, Trotta MP, Murri R, De Longis P, Izzo C, Scalzini A, d'Arminio Monforte A, Wu AW, Antinori A. dICoNA Study Group. NeuroICoNA Study Group. Depression is a risk factor for suboptimal adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2002;31(Suppl):136–9.
    1. Wagner GJ, Goggin K, Remien RH, Rosen MI, Simoni J, Bangsberg DR, Liu H. A closer look at depression and its relationship to HIV antiretroviral adherence. Ann Behav Med. 2011;42:352–360.
    1. Ammassari A, Trotta MP, Murri R, Bartoli L, Monforte AD, Wu AW, Starace F. Depressive symptoms, neurocognitive impairment, and adherence to highly active antiretroviral therapy among HIV-infected persons. Psychosom. 2004;45:394–402.
    1. Wagner GJ, Ghosh-Dastidar B, Slaughter M, Akena D, Nakasujja N, Okello E, Musisi S. Changes in condom use during the first year of HIV treatment in Uganda and the relationship to depression. Ann of Behav Med. in press.
    1. Kelly JA, Murphy DA, Bahr GR, Koob JJ, Morgan MG, Kalichman SC, Stevenson LY, Brasfield TL, Bernstein BM, St Lawrence JS. Factors associated with severity of depression and high risk sexual behavior among persons diagnosed with human immunodeficiency virus (HIV) infection. Health Psychol. 1993;12:215–9.
    1. Kennedy CA, Skurnick J, Wan JY, Quattrone G, Sheffet A, Quinones M, Wang W, Louria DB. Psychological distress, drug and alcohol use as correlates of condom use in HIV-serodiscordant heterosexual couples. AIDS. 1993;7:1493–9.
    1. Mayne TJ, Vittinghoff E, Chesney MA, Barrett DC, Coates TJ. Depressive affect and survival among gay and bisexual men infected with HIV. Arch Intern Med. 1996;156:2233–8.
    1. Lima VD, Geller J, Bangsberg DR, Patterson TL, Daniel M, Kerr T, Montaner J, Hogg RS. The effect of adherence on the association between depressive symptoms and mortality among HIV-infected individuals first initiating HAART. AIDS. 2007;21:1175–83.
    1. Antelman G, Kaaya S, Ruilan W, Mbwambo J, Msamanga GI, Fawzi WW, Fawzi MC. Depressive symptoms increase risk of HIV disease progression and mortality among women in Tanzania. J Acquir Immune Defic Syndr. 2007;44:470–7.
    1. Hartzell JD, Spooner K, Howard R, Wegner S, Wortmann G. Race and mental health diagnosis are risk factors for highly antiretroviral therapy failure in a military cohort despite equal access to care. J Acquir Immune Defic Syndr. 2007;44:411–6.
    1. Anastos K, Schneider M, Gange S, Minkoff H, Greenblatt RM, Feldman J, Levine A, Delapenha R, Cohen M. Women’s Interagency HIV Study Collaborative Group. The association of race, sociodemographic, and behavioral characteristics with response to highly active antiretroviral therapy in women. J Acquir Immune Defic Syndr. 2005;39:537–44.
    1. Cook JA, Grey D, Burke J, Gurtman AC, Richardson JL, Wilson TE, Young MA, Hessol NA. Depressive symptoms and AIDS-related mortality among a multisite cohort of HIV-positive women. Am J Public Health. 2004;94:1133–40.
    1. Pence BW, Miller WC, Gaynes BN, Eron JJ Jr. Psychiatric illness and virologic response in patients initiating highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2007;44:159–66.
    1. Myer L, Smit J, Le Roux L, 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 Pat Care STDS. 2008;22:147–57.
    1. Brandt R. The mental health of people living with HIV/AIDS in Africa: a systematic review. Afr J AIDS Res. 2009;8:123–33.
    1. Nakimuli-Mpungu E, Bass JK, Alexandre P, Mills EJ, Musisi S, Ram M, Katabira E, Nachega JB. Depression, alcohol use and adherence to antiretroviral therapy in sub-Saharan Africa: A systematic review. AIDS Behav. 2012;16:2101–118.
    1. Bolton P, Wilk CM, Ndogoni L. Assessment of depression prevalence in rural Uganda using symptom and function criteria. Soc Psychiatry Psychiatr Epidemiol. 2004;39:442–7.
    1. Olleya BO, Seedat S, Stein DJ. Persistence of psychiatric disorders in a cohort of HIV/AIDS patients in South Africa: a 6-month follow-up study. J Psychosom Res. 2006;61:479–84.
    1. Sebit MB, Tombe M, Siziya S, Balus S, Nkomo SD, Maramba P. Prevalence of HIV/AIDS and psychiatric disorders and their related risk factors among adults in Epworth, Zimbabwe. East Afr Med J. 2003;80:503–12.
    1. Olatunji B, Mimisga MJ, O’Clerigh C, Safren SA. A review of treatment studies of depression in HIV. Top HIV Med. 2006;14:116–28.
    1. Ferrando SJ, Wapenyi K. Psychopharmacologic treatment of patients with HIV and AIDS. Psychiatr Q. 2002;73:33–49.
    1. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 3. Arlington, Virginia: American Psychiatric Association; 2000.
    1. Yun LW, Maravi MBS, Kobayashi JS, Barton PL, Davidson AJ. Antidepressant treatment improves adherence to antiretroviral therapy among depressed HIV-infected patients. J Acquir Immune Defic Syndr. 2005;38:432–438.
    1. Akincigil A, Wilson IB, Walkup JT, Siegel MJ, Huang C, Crystal S. Antidepressant treatment and adherence to antiretroviral medications among privately insured persons with HIV/AIDS. AIDS Behav. 2011;15:1819–28.
    1. Cook J, Cohen MH, Grey D, Anastos K, Kirstein L, Palacio H, Richardson J, Wilson T, Young M. Effects of depressive symptoms and mental health quality of life on use of highly active antiretroviral therapy among HIV-serodiscordant women. J Acquir Immune Defic Syndr. 2002;30:401–9.
    1. Turner BJ, Laine C, Cosler L, Hauck WW. Relationship of gender, depression, and health care delivery with antiretroviral adherence in HIV-infected drug users. J Gen Intern Med. 2003;18:248–57.
    1. Collins PY, Homan AR, Freeman MC, Patel V. What is the relevance of mental health to HIV/AIDS care and treatment programs in developing countries? A systematic review. AIDS. 2006;20:1571–82.
    1. Okello E, Neema S. Explanatory models and help seeking behavior: pathways to psychiatric care among patients admitted for depression in Mulago hospital, Kampala, Uganda. Qual Health Res. 2007;17:14–25.
    1. Zachariah R, Ford N, Philips M, Lynch S, Massaquoi M, Janssens V, Harries AD. Task shifting in HIV/AIDS: opportunities, challenges and proposed actions for sub-Saharan Africa. Trans R Soc Trop Med Hyg. 2009;103:549–58.
    1. WHO UNAIDS. Task shifting: Rational Redistribution of Tasks Among Health Workforce Teams, Global Recommendations and Guidelines. 2011. [ ], accessed June 3, 2012.
    1. Sanne I, Orrell C, Fox MP, Conradie F, Ive P, Zeinecker J, Cornell M, Heiberg C, Ingram C, Panchia R, Rassool M, Gonin R, Stevens W, Truter H, Dehlinger M, van der Horst C, McIntyre J, Wood R. CIPRA-SAStudy Team. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomized non-inferiority trial. Lancet. 2010;376:33–40.
    1. Callaghan M, Ford N, Schneider H. A systematic review of task-shifting for HIV treatment and care in Africa. Hum Resour Health. 2010;8:8.
    1. Gaynes BN, Rush AJ, Trivedi MH, Wisniewski SR, Balasubramani GK, McGrath PJ, Thase ME, Klinkman M, Nierenberg AA, Yates WR, Fava M. Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. J Gen Intern Med. 2008;23:551–60.
    1. Wells K, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unützer J, Miranda J, Carney MF, Rubenstein LV. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled study. JAMA. 2000;283:212–20.
    1. Katon W, von Korff M, Lin E, Walker E, Simon GE, Bush T, Robinson P, Russo J. Collaborative management to achieve treatment guidelines: impact on depression in primary care. JAMA. 1995;273:1026–31.
    1. Rush A, Fava M, Wisniewski S, Lavori PW, Trivedi MH, Sackeim HA, Thase ME, Nierenberg AA, Quitkin FM, Kashner TM, Kupfer DJ, Rosenbaum JF, Alpert J, Stewart JW, McGrath PJ, Biggs MM, Shores-Wilson K, Lebowitz BD, Ritz L, Niederehe G. STAR*D Investigators Group. Sequenced Treatment Alternatives to Relieve Depression (STAR*D): rationale and design. Control Clin Trials. 2004;25:119–42.
    1. Lancet Global Mental Health Group. Scale up services for mental disorders: a call for action. Lancet. 2007;370:1241–52.
    1. Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, De Silva MJ, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Effectiveness of an intervention led by lay health counselors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomized controlled trial. Lancet. 2010;376:2086–95.
    1. Patel V, Araya R, Bolton P. Treating depression in the developing world. Trop Med Intl Health. 2004;9:539–41.
    1. Trivedi MH, Rush AJ, Crismon ML, Kashner TM, Toprac MG, Carmody TJ, Key T, Biggs MM, Shores-Wilson K, Witte B, Suppes T, Miller AL, Altshuler KZ, Shon SP. Clinical results for patients with major depressive disorder in the Texas Medication Algorithm Project. Arch Gen Psychiatry. 2004;61:669–80.
    1. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M. STAR*D Study Team: Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163:28–40.
    1. Wells K, Sherbourne C, Schoenbaum M, Ettner S, Duan N, Miranda J, Unutzer J, Rubenstein L. Five-year impact of quality improvement for depression: results of a group-level randomized controlled trial. Arch Gen Psychiatry. 2004;61:378–86.
    1. Wells KB, Tang L, Miranda J, Benjamin B, Duan N, Sherbourne CD. The effects of quality improvement for depression in primary care at nine years: results from a randomized, controlled group-level trial. Health Serv Res. 2008;43:1952–74.
    1. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS. National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R) JAMA. 2003;289:3095–105.
    1. Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001;44:119–27.
    1. Glasgow RE, Askew S, Purcell P, Levine E, Warner ET, Stange KC, Colditz GA, Bennett GG. Use of RE-AIM to address health inequities: application in a low-income community health center based weight loss and hypertension self-management program. Transl Behav Med. 2013;3:200–10.
    1. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–13.
    1. Sheehan D, Lecrubier Y, Sheehan K, Janavs J, Weiller E, Keskiner A, Schinka J, Knapp E, Sheehan MK, Dunbar GC. The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. Eur Psychiatr. 1997;12:232–41.
    1. Yanofski J, Croarkin P. Choosing antidepressants for HIV and AIDS patients: insights on safety and side effects. Psychiatry. 2008;5:61–6.
    1. WHO. mhGAP Mental Health Gap Action Programme: scaling up care for mental, neurological, and substance use disorders. 2008.
    1. Taljaard M, Donner A, Villar J, Wojdyla D, Velazco A, Bataglia V, Faundes A, Langer A, Narváez A, Valladares E, Carroli G, Zavaleta N, Shah A, Campodónico L, Romero M, Reynoso S, de Pádua KS, Giordano D, Kublickas M, Acosta A, Organization WH. Global Survey on Maternal and Perinatal Health Research Group. Intracluster correlation coefficients from the 2005 WHO Global Survey on Maternal and Perinatal Health: implications for implementation research. Paediatr Perinat Epidemiol. 2005;2008(22):117–25.
    1. Donner A, Klar N. Methods for comparing event rates in intervention studies when the unit of allocation is a cluster. Am J Epidemiol. 1994;140:279–89.
    1. Klar N, Gyorkos T, Donner A. Cluster randomization trials in tropical medicine: a case study. Trop Med Hyg. 1995;89:454–9.
    1. Tan Torres T, Baltussen RM, Adam T, Hutubessy R, Acharya A, Evans DB, Murray CJL. Making Choices in Health: WHO Guide to Cost-Effectiveness Analysis. Geneva: World Health Organization; 2003. [ ]
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMC Med. 2013;11:80.
    1. Mast TC, Kigozi G, Wabwire-Mangen F, Black R, Sewankambo N, Serwadda D, Gray R, Wawer M, Wu AW. Measuring quality of life among HIV-infected women using a culturally adapted questionnaire in Rakai district, Uganda. AIDS Care. 2004;16:81–94.

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