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BMC Psychiatry
Published in: BMC Psychiatry 1/2017

Open Access 01-12-2017 | Study protocol

A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART

Authors: Munyaradzi Madhombiro, Bazondlile Dube-Marimbe, Michelle Dube, Dixon Chibanda, Moleen Zunza, Simbarashe Rusakaniko, David Stewart, Soraya Seedat

Published in: BMC Psychiatry | Issue 1/2017

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Abstract

Background

Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA).

Methods

This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8 HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes. Booster sessions will be administered to both groups at 3 and 6 months respectively.
The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV, viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline, 3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants. The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the treatment arms allocated to the participants. However, the principal investigator, participants and intervention staff will be unblinded.
Data will be analysed using STATA Version 14. Primary and secondary outcomes will be measured at four time points that is; at baseline, 3, 6, and 12 months respectively. All participants will be included in the analysis of primary and secondary outcome measures. The mean AUDIT scores will be compared between groups using student t-tests. Multilevel logistic regression analysis will be performed for binominal variables and multilevel linear regression for continuous variables. Descriptive statistics will be computed for baseline and follow-up assessments.

Discussion

The study will be the first to address problematic alcohol use in PLWHA in Zimbabwe. It seeks to use local resources in delivering a modified, brief, evidence-based, and culturally contextualised intervention. The study results will determine the effectiveness of adapting psychological interventions for AUDs in HIV infected adults using a task-sharing framework.

Trial registration

Pan African Clinical Trial Registry, PACTR20150900121​1149. Registered 22 July 2015.
Literature
1.
Organization WH. International guide for monitoring alcohol consumption and related harm. 2000.
2.
3.
Organization WH. Global status report on alcohol 2004. 2004.
4.
Braithwaite RS, Conigliaro J, Roberts MS, Shechter S, Schaefer A, McGinnis K, et al. Estimating the impact of alcohol consumption on survival for HIV+ individuals. AIDS Care. 2007;19(4):459–66.CrossRefPubMedPubMedCentral
5.
Samet JH, Freedberg KA, Savetsky JB, Sullivan LM, Stein MD. Understanding delay to medical care for HIV infection: the long-term non-presenter. AIDS. 2001;15(1):77–85.CrossRefPubMed
6.
Mayston R, Lazarus A, Patel V, Abas M, Korgaonkar P, Paranjape R, et al. Pathways to HIV testing and care in Goa, India: exploring psychosocial barriers and facilitators using mixed methods. BMC Public Health. 2016;16(1):765.CrossRefPubMedPubMedCentral
7.
Justice AC, McGinnis KA, Tate JP, Braithwaite RS, Bryant KJ, Cook RL, et al. Risk of mortality and physiologic injury evident with lower alcohol exposure among HIV infected compared with uninfected men. Drug Alcohol Depend. 2016;161:95–103.CrossRefPubMed
8.
Hahn JA, Woolf-King SE, Muyindike W. Adding fuel to the fire: alcohol’s effect on the HIV epidemic in Sub-Saharan Africa. Curr HIV/AIDS Rep. 2011;8(3):172–80.CrossRefPubMed
9.
Kalichman SC, Simbayi LC, Jooste S, Cain D. Frequency, quantity, and contextual use of alcohol among sexually transmitted infection clinic patients in Cape Town, South Africa. Am J Drug Alcohol Abuse. 2007;33(5):687–98.CrossRefPubMed
10.
Starace F, Ammassari A, Trotta MP, Murri R, De Longis P, Izzo C, et al. Depression is a risk factor for suboptimal adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2002;31(Suppl 3):S136–9.CrossRefPubMed
11.
Willie TC, Overstreet NM, Sullivan TP, Sikkema KJ, Hansen NB. Barriers to HIV medication adherence: examining distinct anxiety and depression symptoms among women living with HIV who experienced childhood sexual abuse. Behav Med. 2015;42(2):120–7.
12.
Stevens VM, Neel JL, Baker DL. Psychosis and nonadherence in an HIV-seropositive patient. AIDS Read. 2000;10(10):596–601.PubMed
13.
14.
Molina PE, Happel KI, Zhang P, Kolls JK, Nelson S. Focus on: Alcohol and the immune system. Alcohol Res Health. 2010;33(1–2):97–108.PubMedPubMedCentral
15.
Pandrea I, Happel KI, Amedee AM, Bagby GJ, Nelson S. Alcohol’s role in HIV transmission and disease progression. Alcohol Res Health. 2010;33(3):203–18.PubMedPubMedCentral
16.
Theall KP, Amedee A, Clark RA, Dumestre J, Kissinger P. Alcohol consumption and HIV-1 vaginal RNA shedding among women. J Stud Alcohol Drugs. 2008;69(3):454–8.CrossRefPubMed
17.
Tran BX, Nguyen LT, Do CD, Nguyen QL, Maher RM. Associations between alcohol use disorders and adherence to antiretroviral treatment and quality of life amongst people living with HIV/AIDS. BMC Public Health. 2014;14:27.CrossRefPubMedPubMedCentral
18.
Morojele NK, Kekwaletswe CT, Nkosi S. Associations between alcohol use, other psychosocial factors, structural factors and antiretroviral therapy (ART) adherence among South African ART recipients. AIDS Behav. 2014;18(3):519–24.CrossRefPubMed
19.
Valenti WM. HAART is cost-effective and improves outcomes. AIDS Read. 2001;11(5):260–2.PubMed
20.
Holmes WC, Bilker WB, Wang H, Chapman J, Gross R. HIV/AIDS-specific quality of life and adherence to antiretroviral therapy over time. J Acquir Immune Defic Syndr. 2007;46(3):323–7.CrossRefPubMed
21.
Neuman MG, Cohen L, Zakhari S, Nanau RM, Mueller S, Schneider M, et al. Alcoholic liver disease: a synopsis of the Charles Lieber’s Memorial Symposia 2009–2012. Alcohol Alcohol. 2014;49(4):373–80.CrossRefPubMedPubMedCentral
22.
Schneider M, Chersich M, Temmerman M, Degomme O, Parry CD. The impact of alcohol on HIV prevention and treatment for South Africans in primary healthcare. Curationis. 2014;37(1):1137.CrossRefPubMed
23.
Morojele NK, Kachieng’a MA, Mokoko E, Nkoko MA, Parry CD, Nkowane AM, et al. Alcohol use and sexual behaviour among risky drinkers and bar and shebeen patrons in Gauteng province, South Africa. Soc Sci Med. 2006;62(1):217–27.CrossRefPubMed
24.
Baker A, Lee NK, Claire M, Lewin TJ, Grant T, Pohlman S, et al. Brief cognitive behavioural interventions for regular amphetamine users: a step in the right direction. Addiction. 2005;100(3):367–78.CrossRefPubMed
25.
Naicker S, Eastwood JB, Plange-Rhule J, Tutt RC. Shortage of healthcare workers in sub-Saharan Africa: a nephrological perspective. Clin Nephrol. 2010;74(Suppl 1):S129–33.PubMed
26.
Sander LD, Holtzman D, Pauly M, Cohn J. Time savings--realized and potential--and fair compensation for community health workers in Kenyan health facilities: a mixed-methods approach. Hum Resour Health. 2015;13:6.CrossRefPubMedPubMedCentral
27.
Deller B, Tripathi V, Stender S, Otolorin E, Johnson P, Carr C. Task shifting in maternal and newborn health care: key components from policy to implementation. Int J Gynaecol Obstet. 2015;130(Suppl 2):S25–31.CrossRefPubMed
28.
29.
Adams JL, Almond ML, Ringo EJ, Shangali WH, Sikkema KJ. Feasibility of nurse-led antidepressant medication management of depression in an HIV clinic in Tanzania. Int J Psychiatry Med. 2012;43(2):105–17.CrossRefPubMedPubMedCentral
30.
Wagner GJ, Ngo V, Glick P, Obuku EA, Musisi S, Akena D. INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial. Trials. 2014;15:248.CrossRefPubMedPubMedCentral
31.
Mental health: WHO minds the GAP. Lancet. 2010;376(9749):1274.
32.
Babor TF, De la Fuente JR, Saunders JB, Grant M. AUDIT—the alcohol use disorders identification test: guidelines for use in primary health care. Geneva: World Health Organization; 1989b.
33.
Chandiwana SK, Sebit MB, Latif AS, Gomo E, Acuda SW, Makoni F, et al. Alcohol consumption in HIV-I infected persons: a study of immunological markers, Harare, Zimbabwe. Cent Afr J Med. 1999;45(11):303–8.PubMed
34.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Arch Intern Med. 1998;158(16):1789–95.CrossRefPubMed
35.
Üstün TB, Chatterji S, Villanueva M, Bendib L, Celik C, Sadana R, et al. WHO Multi-country Survey Study on Health and Responsiveness 2000–2001. In: Murray CJL, Evans DB, eds. Health systems performance assessment: debates, methods and empiricism. Geneva: World Health Organization; 2003. p. 761–96.
36.
Hanass-Hancock J, Myezwa H, Carpenter B. Disability and living with HIV: baseline from a cohort of people on long term ART in South Africa. PLoS One. 2015;10(12):e0143936.CrossRefPubMedPubMedCentral
37.
WHOQOL Group. The development of the World Health Organization Quality of Life Assessment Instrument (the WHOQOL). In: Orley J, Kuyken W, editors. Quality of life assessment: international perspectives. New York:Springer-Verlag; 1994.
38.
Peltzer K, Phaswana-Mafuya N. Health-related quality of life in a sample of HIV-infected South Africans. Afr J AIDS Res. 2008;7(2):209–18.CrossRefPubMed
39.
The WHOQOL Group. Developmentof the World Health Organization WHOQOL-BEFquality of life assessment. Psychol Med. 1998;28:551–8.
40.
Berman AH, Bergman H, Palmstierna T, Schlyter F. DUDIT − The drug use disorders identification test, MANUAL Version 1.0. Stockholm: Karolinska Institutet, Department of Clinical Neuroscience, Section for Alcohol and Drug Dependence Research; 2003.
41.
Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22–31.CrossRefPubMed
42.
Durbeej N, Berman AH, Gumpert CH, Palmstierna T, Kristiansson M, Alm C. Validation of the alcohol use disorders identification test and the drug use disorders identification test in a Swedish sample of suspected offenders with signs of mental health problems: results from the Mental Disorder, Substance Abuse and Crime study. J Subst Abuse Treat. 2010;39(4):364–77.CrossRefPubMed
43.
Voluse AC, Gioia CJ, Sobell LC, Dum M, Sobell MB, Simco ER. Psychometric properties of the Drug Use Disorders Identification Test (DUDIT) with substance abusers in outpatient and residential treatment. Addict Behav. 2012;37(1):36–41.CrossRefPubMed
44.
Whetten K, Reif S, Swartz M, Stevens R, Osterman J, Hanisch L, Eron JJ. A brief mental health and substance abuse screener for persons with HIV. AIDS Patient Care STDs. 2005;19(2):89–99.CrossRefPubMed
45.
Breuer E, Stoloff K, Myer L, Seedat S, Stein DJ, Joska JA. The validity of the Substance Abuse and Mental Illness Symptom Screener (SAMISS) in people living with HIV/AIDS in primary HIV care in Cape Town, South Africa. AIDS Behav. 2014;18(6):1133–41.CrossRefPubMed
46.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33. quiz 4–57.PubMed
47.
American Psychiatric Association. The diagnostic and statistical manual of mental disorders, Fifth Edition. Arlington: American Psychiatric Association; 2013.
48.
Pinninti NR, Madison H, Musser E, Rissmiller D. MINI International Neuropsychiatric Schedule: clinical utility and patient acceptance. Eur Psychiatry. 2003;18(7):361–4.CrossRefPubMed
49.
50.
Sacktor NC, Wong M, Nakasujja N, Skolasky RL, Selnes OA, Musisi S, McArthur JC, Ronald A, Katabira E. The international HIVDementia Scale: a new rapid screening test for HIV Dementia. AIDS. 2005;19(13):1367–74.
51.
Davidson JR, Book SW, Colket JT, Tupler LA, Roth S, David D, et al. Assessment of a new self-rating scale for post-traumatic stress disorder. Psychol Med. 1997;27(1):153–60.CrossRefPubMed
52.
Davidson JR, Tharwani HM, Connor KM. Davidson Trauma Scale(DTS) : normative scores in the general population and effect sizes in a placebo-controlled SSRI trials. Depress Anxiety. 2002;15(2):75–8.CrossRefPubMed
53.
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989;56(2):267–83.CrossRefPubMed
54.
Valvano ASL. Critical synthesis package: brief COPEQ uestionnaire. MedEdPORTAL. 2013;9:9453.
55.
Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the multidimensional scale of perceived social support. J Pers Assess. 1990;55(3–4):610–7.CrossRefPubMed
56.
Backs-Dermott BJ, Dobson KS, Jones SL. An evaluation of an integrated model of relapse in depression. J Affect Disord. 2010;124(1–2):60–7.CrossRefPubMed
57.
Gache P, Michaud P, Landry U, Accietto C, Arfaoui S, Wenger O, et al. The Alcohol Use Disorders Identification Test (AUDIT) as a screening tool for excessive drinking in primary care: reliability and validity of a French version. Alcohol Clin Exp Res. 2005;29(11):2001–7.CrossRefPubMed
58.
Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011;31(1):79–88.CrossRefPubMed
59.
Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for alcohol problems: a meta-analytic review of controlled investigations in treatment-seeking and non-treatment-seeking populations. Addiction. 2002;97(3):279–92.CrossRefPubMed
60.
Killip S, Mahfoud Z, Pearce K. What is an intracluter correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004;2(3):204–8.CrossRefPubMedPubMedCentral
61.
Bajunirwe F, Tisch DJ, King CH, Arts EJ, Debanne SM, Sethi AK. Quality of life and social support among patients receiving antiretroviral therapy in Western Uganda. AIDS Care. 2009;21(3):271–9.CrossRefPubMed
62.
Liu C, Johnson L, Ostrow D, Silvestre A, Visscher B, Jacobson LP. Predictors for lower quality of life in the HAART era among HIV-infected men. J Acquir Immune Defic Syndr. 2006;42(4):470–7.CrossRefPubMed
Metadata
Title
A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART
Authors
Munyaradzi Madhombiro
Bazondlile Dube-Marimbe
Michelle Dube
Dixon Chibanda
Moleen Zunza
Simbarashe Rusakaniko
David Stewart
Soraya Seedat
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2017
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-017-1208-3

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