Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial

Jeremy C Kane, Anjali Sharma, Laura K Murray, Geetanjali Chander, Tukiya Kanguya, Molly E Lasater, Stephanie Skavenski, Ravi Paul, John Mayeya, Carla Kmett Danielson, Jenala Chipungu, Chipo Chitambi, Michael J Vinikoor, Jeremy C Kane, Anjali Sharma, Laura K Murray, Geetanjali Chander, Tukiya Kanguya, Molly E Lasater, Stephanie Skavenski, Ravi Paul, John Mayeya, Carla Kmett Danielson, Jenala Chipungu, Chipo Chitambi, Michael J Vinikoor

Abstract

Aims: Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia.

Methods: The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use.

Conclusions: The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.

Keywords: Brief intervention; HIV; Randomized controlled trial; Substance use; Transdiagnostic therapy; Unhealthy alcohol use; Zambia.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2020 The Authors.

Figures

Fig. 1
Fig. 1
Flow diagram.

References

    1. Aharonovich E., Hatzenbuehler M.L., Johnston B. A low-cost, sustainable intervention for drinking reduction in the HIV primary care setting. AIDS Care. 2006;18(6):561–568. doi: 10.1080/09540120500264134.
    1. Babor T.F., Higgins-Biddle J.C., Saunders J.B., Monteiro M. The alcohol use disorders identification test: Guidelines for use in primary care. Geneva. 2001
    1. Bedoya C.A., Mimiaga M.J., Beauchamp G., Donnell D., Mayer K.H., Safren S.A. Predictors of HIV transmission risk behavior and seroconversion among Latino men who have sex with men in Project EXPLORE. AIDS and Behavior. 2012;16(3):608–617. doi: 10.1007/s10461-011-9911-4.
    1. Bolton, P., Lee, C., Haroz, E. E., et al. (2014). A Transdiagnostic community-based mental health treatment for comorbid disorders: Development and outcomes of a randomized controlled trial among burmese refugees in Thailand. PLoS Medicine 11(11). doi:10.1371/journal.pmed.1001757.
    1. Chan A.-W., Tetzlaff J.M., Altman D.G. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annals of Internal Medicine. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Chander G., Hutton H.E., Lau B., Xu X., McCaul M.E. Brief intervention decreases drinking frequency in HIV-infected, heavy drinking women. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2015;70(2):137–145. doi: 10.1097/QAI.0000000000000679.
    1. Chishinga N., Kinyanda E., Weiss H.A., Patel V., Ayles H., Seedat S. Validation of brief screening tools for depressive and alcohol use disorders among TB and HIV patients in primary care in Zambia. BMC Psychiatry. 2011;11:75. doi: 10.1186/1471-244X-11-75.
    1. Chorpita B.F., Daleiden E.L., Weisz J.R. Identifying and selecting the common elements of evidence based interventions: A distillation and matching model. Mental Health Services Research. 2005;7(1):5–20. doi: 10.1007/s11020-005-1962-6.
    1. Chorpita B.F., Weisz J.R. Practicewise; Satellite Beach, FL: 2009. Match-Adtc: Modular approach to therapy for children with anxiety, depression, trauma, or conduct problems.
    1. Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement. 1960;20:37–46.
    1. Curran G.M., Bauer M., Mittman B., Pyne J.M., Stetler C. Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical Care. 2012;50(3):217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Farchione T.J., Fairholme C.P., Ellard K.K. Unified protocol for transdiagnostic treatment of emotional disorders: A randomized controlled trial. Behavior Therapy. 2012;43(3):666–678. doi: 10.1016/j.beth.2012.01.001.
    1. Fawzi W., Msamanga G., Spiegelman D., Hunter D.J. Studies of vitamins and minerals and HIV transmission and disease progression. Journal of Nutrition. 2005;135(4):938–944. . Accessed December 11, 2017.
    1. Gerbi G.B., Habtemariam T., Tameru B., Nganwa D., Robnett V. The correlation between alcohol consumption and risky sexual behaviors among people living with HIV/AIDS. Journal of Substance Use. 2009;14(2):90–100. doi: 10.1080/14659890802624261.
    1. Gilbert P., Ciccarone D., Gansky S.A. Interactive “video doctor” counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings. Myer L, ed. PLoS ONE. 2008;3(4): doi: 10.1371/journal.pone.0001988.
    1. Hahn J.A., Dobkin L.M., Mayanja B. Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa. Alcoholism, Clinical and Experimental Research. 2012;36(5):854–862. doi: 10.1111/j.1530-0277.2011.01669.x.
    1. Hahn J.A., Samet J.H. Alcohol and HIV disease progression: Weighing the evidence. Current HIV/AIDS Reports. 2010;7(4):226–233. doi: 10.1007/s11904-010-0060-6.
    1. Huber, P. J. (1967). The behavior of maximum likelihood estimates under nonstandard conditions. In: Vol. 1 of the proceedings of the fifth Berkeley symposium on mathematical statistics and probability. Berkeley, CA: University of California Press, pp. 221–233.
    1. Humeniuk R., Ali R., Babor T.F. Validation of the alcohol, smoking and substance involvement screening test (ASSIST) Addiction. 2008;103(6):1039–1047. doi: 10.1111/j.1360-0443.2007.02114.x.
    1. Humeniuk, R. E., Henry-Edwards, S., Ali, R. L., Poznyak, V., & Monteiro, M. (2010). The alcohol, smoking and substance involvement screening test (ASSIST): Manual for use in primary care.
    1. Jonas D.E., Garbutt J.C., Amick H.R. Behavioral counseling after screening for alcohol misuse in primary care: A systematic review and meta-analysis for the U.S. preventive services task force. Annals of Internal Medicine. 2012 doi: 10.7326/0003-4819-157-9-201211060-00544.
    1. Kalichman S.C., Simbayi L.C., Vermaak R. Randomized trial of a community-based alcohol-related HIV risk-reduction intervention for men and women in Cape Town South Africa. Annals of Behavioral Medicine. 2008;36(3):270–279. doi: 10.1007/s12160-008-9067-2.
    1. Kane J.C., Bolton P., Murray S.M., Bass J.K., Lakin D., Whetten K., Skavenski van Wyk S., Murray L.K. Psychometric evaluation of HIV risk behavior assessments using Audio Computer Assisted Self-Interviewing (ACASI) among orphans and vulnerable children in Zambia. AIDS Care. 2018;30(2):160–167.
    1. Kane J.C., Murray L.K., Bass J.K., Johnson R.M., Bolton P. Validation of a substance and alcohol use assessment instrument among orphans and vulnerable children in Zambia using Audio Computer Assisted Self-Interviewing (ACASI) Drug and Alcohol Dependence. 2016;166:85–92. doi: 10.1016/j.drugalcdep.2016.06.026.
    1. Kane J.C., Murray L.K., Sughrue S. Process and implementation of Audio Computer Assisted Self-Interviewing (ACASI) assessments in low resource settings: A case example from Zambia. Glob Mental Health. 2016;3 doi: 10.1017/gmh.2016.19.
    1. Kane J.C., Skavenski Van Wyk S., Murray S.M. Testing the effectiveness of a transdiagnostic treatment approach in reducing violence and alcohol abuse among families in Zambia: Study protocol of the Violence and Alcohol Treatment (VATU) trial. Global Mental Health. 2017;4 doi: 10.1017/gmh.2017.10.
    1. Kane J.C., Vinikoor M.J., Haroz E.E., Al-Yasiri M., Bogdanov S., Mayeya J.…Murray L.K. Mental health comorbidity in low-income and middle-income countries: A call for improved measurement and treatment. Lancet Psychiatry. 2018;5(11):864–888. doi: 10.1016/S2215-0366(18)30301-8.
    1. Kaner E.F.S., Brown N., Jackson K. A systematic review of the impact of brief interventions on substance use and co-morbid physical and mental health conditions. Ment Heal Subst Use Dual Diagnosis. 2011 doi: 10.1080/17523281.2011.533449.
    1. Kaner EFS, Dickinson HO, & Beyer FR, et al. (2007) Effectiveness of brief alcohol interventions in primary care populations. In: Kaner EFS, ed. Cochrane database of systematic reviews. Chichester, UK: John Wiley & Sons, Ltd; 2007:CD004148. doi:10.1002/14651858.CD004148.pub3.
    1. Leserman J. Role of depression, stress, and trauma in HIV disease progression. Psychosomatic Medicine. 2008;70(5):539–545. doi: 10.1097/PSY.0b013e3181777a5f.
    1. Mollica, R. F., Caspi-Yavin, Y., Bollini, P., Truong, T., Tor, S., & Lavelle, J. (1992). The harvard trauma questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. The Journal of Nervous and Mental Disease. 1992;180(2):111–116. . Accessed December 11, 2011.
    1. Murray S.M., Bolton P.A., Kane J.C., Lakin D., Bass Judith K., Murray L.K. Measuring symptoms of psychopathology in Zambian orphans and vulnerable children: Scale validation and psychometric evaluation. Assessment. 2018;epub doi: 10.1177/1073191118780455.
    1. Murray L.K., Dorsey S., Bolton P. Building capacity in mental health interventions in low resource countries: An apprenticeship model for training local providers. International Journal of Mental Health Systems. 2011;5(1):30. doi: 10.1186/1752-4458-5-30.
    1. Murray L.K., Dorsey S., Haroz E., Lee C., Alsiary M.M., Haydary A.…Bolton P. A common elements treatment approach for adult mental health problems in low- and middle-income countries. Cognitive Behavioral Practice. 2014;21:111–123. doi: 10.1016/j.cbpra.2013.06.005.
    1. NIAAA. (2005). Helping patients who drink too much. .
    1. NIAAA. (2005). Brief interventions. . Accessed December 11, 2017.
    1. NIH. (2017). Behavioral & integrative treatment development program (R34). .
    1. Nouaman M.N., Vinikoor M., Seydi M. High prevalence of binge drinking among people living with HIV in four African countries. Journal of the International AIDS Society. 2018 doi: 10.1002/jia2.25202.
    1. Peltzer K., Naidoo P., Louw J. Screening and brief interventions for hazardous and harmful alcohol use among patients with active tuberculosis attending primary public care clinics in South Africa: Results from a cluster randomized controlled trial. BMC Public Health. 2013;13(1):699. doi: 10.1186/1471-2458-13-699.
    1. Petry N.M. Alcohol use in HIV patients: What we don’t know may hurt us. International Journal of STD and AIDS. 1999;10(9):561–570. doi: 10.1258/0956462991914654.
    1. Pithey A., Parry C. Descriptive systematic review of sub-Saharan African studies on the association between alcohol use and HIV infection. Sahara Journal. 2009 doi: 10.1080/17290376.2009.9724944.
    1. Platt L., Melendez-Torres G.J., O’Donnell A. How effective are brief interventions in reducing alcohol consumption: Do the setting, practitioner group and content matter? Findings from a systematic review and metaregression analysis. BMJ Open. 2016;6(8) doi: 10.1136/bmjopen-2016-011473. e011473.
    1. Radloff L.S. The CES-D scale: A self report depression scale for research in the general. Applied Psychological Measurement. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Rehm J., Samokhvalov A.V., Neuman M.G. The association between alcohol use, alcohol use disorders and tuberculosis (TB). A systematic review. BMC Public Health. 2009;9(1):450. doi: 10.1186/1471-2458-9-450.
    1. Saitz R. Unhealthy alcohol use. New England Journal of Medicine. 2005;352(6):596–607. doi: 10.1056/NEJMcp042262.
    1. SAMHSA (2017). Screening, brief intervention, and referral to treatment (SBIRT). Rockville, MD. .
    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;88(6):791-804. . Accessed January 6, 2017.
    1. StataCorp. (2017). Stata statistical software: Release 15. College Station, TX.
    1. Vagenas P., Azar M.M., Copenhaver M.M., Springer S.A., Molina P.E., Altice F.L. The impact of alcohol use and related disorders on the HIV continuum of care: A systematic review: Alcohol and the HIV continuum of care. Current HIV/AIDS Reports. 2015;12(4):421–436. doi: 10.1007/s11904-015-0285-5.
    1. Vilagut G., Forero C.G., Barbaglia G., Alonso J. Screening for depression in the general population with the center for epidemiologic studies depression (CES-D): A systematic review with meta-analysis. van der Feltz-Cornelis C, ed. PLoS ONE. 2016;11(5) doi: 10.1371/journal.pone.0155431. e0155431.
    1. Vinikoor M., Masaninga M., Bolton Moore C., Munamunungu V., Siyunda A., Mulenga L.…Wandeler G. Clinical correlates of alcohol use disorders among HIV-infected adults in Zambia. Conference on Retroviruses and Opportunistic Infections. 2015
    1. Vinikoor M.J., Zyambo Z., Muyoyeta M., Chander G., Saag M.S., Cropsey K. Point-of-care urine ethyl glucuronide testing to detect alcohol use among HIV-hepatitis B virus coinfected adults in Zambia. AIDS and Behavior. January 2018 doi: 10.1007/s10461-018-2030-8.
    1. Wandera B., Tumwesigye N.M., Nankabirwa J.I. Efficacy of a single, brief alcohol reduction intervention among men and women living with HIV/AIDS and using alcohol in Kampala, Uganda: A randomized trial. Journal of the International Association of Providers of AIDS Care. 2017;16(3):276–285. doi: 10.1177/2325957416649669.
    1. Watzl B., Watson R.R. Role of alcohol abuse in nutritional immunosuppression. Journal of Nutrition. 1992;122(3 Suppl):733–737. . Accessed December 11, 2017.
    1. Weiss W.M., Murray L.K., Zangana G.A.S. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: A randomized control trial. BMC Psychiatry. 2015;15(1):249. doi: 10.1186/s12888-015-0622-7.
    1. Weisz J.R., Chorpita B.F., Palinkas L.A. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: A randomized effectiveness trial. Archives of General Psychiatry. 2012;69(3):274–282. doi: 10.1001/archgenpsychiatry.2011.147.
    1. White H. A heteroskedasticity-consistent covariance matrix estimator and a direct test for heteroskedasticity. Econometrica. 1980 doi: 10.2307/1912934.
    1. World Health Organization. (2012). Screening and brief intervention for alcohol problems in primary health care. World Health Organization. . Accessed December 11, 2017.
    1. Wutzke S.E., Shiell A., Gomel M.K., Conigrave K.M. Cost effectiveness of brief interventions for reducing alcohol consumption. Social Science Medicine. 2001;52(6):863–870. . Accessed December 11, 2017.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir