NCT04054466

Brief Summary

The success of treatment in patients with HIV depends not just on the therapeutic regimen used, but also on the adherence or level of compliance with the treatment achieved by the patient. Patients who consume alcohol are at risk of not complying with antiretroviral treatment, because of the effects caused by alcohol consumption or the interaction that alcohol may have with medications. Differentiated counseling according to consumption levels could help improve the adherence of patients who receive HAART and who also consume alcohol. The objective of the study is to determine the effectiveness of nursing counseling in improving behavior of alcohol consumption in patients with HIV. An experimental study will be developed with three phases, and the sampling used in each of the phases will be random. The first will identify the level of alcohol consumption and adherence to HAART of patients of the Health Strategy of the Hospital Nacional Cayetano Heredia and will develop two focus groups, one with patients and another with nurses to analyze the feasibility, utility, adaptability and Possible effectiveness of the counseling proposed in the improvement of adherence to HAART. In a second phase the intervention will proceed in two groups, one of them is the experimental group where the differentiated counseling will be applied and the second group the control where the habitual counseling will be applied. In the third phase, the counseling undergoing experimentation to evaluate its possible scalability will be subjected again to analysis through focus groups with patients and nurses. For the evaluation of the variables, different validated instruments will be used: AUDIT for the evaluation of consumption, Simplified Medication Adherence Questionnaire (SMAQ) to assess adherence to HAART, some data will be taken from the patient's clinical history, guides for focus groups will be used. Descriptive statistics will be used to estimate the level of alcohol consumption and adherence to HAART by patients. The comparability of the study groups in the experimental phase will be evaluated and the effectiveness of the counseling will be demonstrated by comparing means of adherence to HAART before after the intervention. The project respects the bioethical principles of Charity, Justice and autonomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

March 31, 2019

Last Update Submit

July 24, 2024

Conditions

HIVAlcohol Drinking

Keywords

HIVCounselingAntiretroviral TherapyAlcohol DrinkingNursing Care

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption

    Intake of any beverage with alcoholic content reported by the subject throughout his life, last year, last six months, last months and last seven days from an interview, additionally we evaluate Alcohol Disorders through Alcohol Disorders Identification Test (AUDIT).

    At the beginning of the study and then every month until the end of six months of follow-up

Secondary Outcomes (1)

  • HAART Adherence

    One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.

Other Outcomes (2)

  • Cluster of cuadruple differentiation CD4 T lymphocyte count

    Every control made for Hospital until the end of six months of follow-up

  • Viral load

    Every control made for Hospital until the end of six months of follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

Intervention with counselling designed

Behavioral: Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART

Control group

OTHER

Intervention with habitual counselling

Behavioral: Habitual Counseling

Interventions

Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAARTBEHAVIORAL

It is a health intervention, performed by the nurse with the purpose of providing support or support to the patient's health care. The main objective of counseling is to improve adherence to treatment in patients who receive HAART but also consume alcoholic beverages. The components of the differentiated counseling according to the levels of consumption are consolidated according to the recommendations given by the World Health Organization (WHO) after the application of the AUDIT: Social consumption (sometime in life, in the last year or in the last month) = mainly education about consumer risks, its application will be bi-monthly.

Also known as: New Counseling
Experimental group
Habitual CounselingBEHAVIORAL

Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment

Also known as: Old Counseling
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing to participate in the study.
  • Have an assessment of the level of consumption and adherence to HAART.

You may not qualify if:

  • Have been identified with a level of dependence on alcohol consumption, given that this group of patients requires specialized attention (50).
  • Do not consume alcohol.
  • Being hospitalized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yesenia Musayón

Lima, Lima 41, Peru

Location

Related Publications (22)

  • Thangavel S, Mulet CT, Atluri VSR, Agudelo M, Rosenberg R, Devieux JG, Nair MPN. Oxidative Stress in HIV Infection and Alcohol Use: Role of Redox Signals in Modulation of Lipid Rafts and ATP-Binding Cassette Transporters. Antioxid Redox Signal. 2018 Feb 1;28(4):324-337. doi: 10.1089/ars.2016.6830.

    PMID: 29132227BACKGROUND

  • Dey A, Cederbaum AI. Alcohol and oxidative liver injury. Hepatology. 2006 Feb;43(2 Suppl 1):S63-74. doi: 10.1002/hep.20957.

    PMID: 16447273BACKGROUND

  • Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

    PMID: 16079372BACKGROUND

  • Fishbein M. The role of theory in HIV prevention. AIDS Care. 2000 Jun;12(3):273-8. doi: 10.1080/09540120050042918.

    PMID: 10928203BACKGROUND

  • Hankins CA, de Zalduondo BO. Combination prevention: a deeper understanding of effective HIV prevention. AIDS. 2010 Oct;24 Suppl 4:S70-80. doi: 10.1097/01.aids.0000390709.04255.fd.

    PMID: 21042055BACKGROUND

  • Baum MK, Rafie C, Lai S, Sales S, Page JB, Campa A. Alcohol use accelerates HIV disease progression. AIDS Res Hum Retroviruses. 2010 May;26(5):511-8. doi: 10.1089/aid.2009.0211.

    PMID: 20455765BACKGROUND

  • Room R, Babor T, Rehm J. Alcohol and public health. Lancet. 2005 Feb 5-11;365(9458):519-30. doi: 10.1016/S0140-6736(05)17870-2.

    PMID: 15705462BACKGROUND

  • Cook RL, Zhou Z, Kelso-Chichetto NE, Janelle J, Morano JP, Somboonwit C, Carter W, Ibanez GE, Ennis N, Cook CL, Cohen RA, Brumback B, Bryant K. Alcohol consumption patterns and HIV viral suppression among persons receiving HIV care in Florida: an observational study. Addict Sci Clin Pract. 2017 Sep 27;12(1):22. doi: 10.1186/s13722-017-0090-0.

    PMID: 28950912RESULT

  • Pokhrel KN, Gaulee Pokhrel K, Neupane SR, Sharma VD. Harmful alcohol drinking among HIV-positive people in Nepal: an overlooked threat to anti-retroviral therapy adherence and health-related quality of life. Glob Health Action. 2018;11(1):1441783. doi: 10.1080/16549716.2018.1441783.

    PMID: 29495948RESULT

  • Shuper PA, Neuman M, Kanteres F, Baliunas D, Joharchi N, Rehm J. Causal considerations on alcohol and HIV/AIDS--a systematic review. Alcohol Alcohol. 2010 Mar-Apr;45(2):159-66. doi: 10.1093/alcalc/agp091. Epub 2010 Jan 8.

    PMID: 20061510RESULT

  • Chander G, Lau B, Moore RD. Hazardous alcohol use: a risk factor for non-adherence and lack of suppression in HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 1;43(4):411-7. doi: 10.1097/01.qai.0000243121.44659.a4.

    PMID: 17099312RESULT

  • Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2010 Dec 1;112(3):178-93. doi: 10.1016/j.drugalcdep.2010.06.014. Epub 2010 Aug 11.

    PMID: 20705402RESULT

  • Samet JH, Horton NJ, Meli S, Freedberg KA, Palepu A. Alcohol consumption and antiretroviral adherence among HIV-infected persons with alcohol problems. Alcohol Clin Exp Res. 2004 Apr;28(4):572-7. doi: 10.1097/01.alc.0000122103.74491.78.

    PMID: 15100608RESULT

  • Cebeci F, Celik SS. Discharge training and counselling increase self-care ability and reduce postdischarge problems in CABG patients. J Clin Nurs. 2008 Feb;17(3):412-20. doi: 10.1111/j.1365-2702.2007.01952.x. Epub 2007 Nov 30.

    PMID: 18047578RESULT

  • Kamb ML, Fishbein M, Douglas JM Jr, Rhodes F, Rogers J, Bolan G, Zenilman J, Hoxworth T, Malotte CK, Iatesta M, Kent C, Lentz A, Graziano S, Byers RH, Peterman TA. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group. JAMA. 1998 Oct 7;280(13):1161-7. doi: 10.1001/jama.280.13.1161.

    PMID: 9777816RESULT

  • Braithwaite RS, McGinnis KA, Conigliaro J, Maisto SA, Crystal S, Day N, Cook RL, Gordon A, Bridges MW, Seiler JF, Justice AC. A temporal and dose-response association between alcohol consumption and medication adherence among veterans in care. Alcohol Clin Exp Res. 2005 Jul;29(7):1190-7. doi: 10.1097/01.alc.0000171937.87731.28.

    PMID: 16046874RESULT

  • Bertholet N, Daeppen JB, Wietlisbach V, Fleming M, Burnand B. Reduction of alcohol consumption by brief alcohol intervention in primary care: systematic review and meta-analysis. Arch Intern Med. 2005 May 9;165(9):986-95. doi: 10.1001/archinte.165.9.986.

    PMID: 15883236RESULT

  • Tanner-Smith EE, Lipsey MW. Brief alcohol interventions for adolescents and young adults: a systematic review and meta-analysis. J Subst Abuse Treat. 2015 Apr;51:1-18. doi: 10.1016/j.jsat.2014.09.001. Epub 2014 Sep 16.

    PMID: 25300577RESULT

  • Wandera B, Tumwesigye NM, Nankabirwa JI, Mafigiri DK, Parkes-Ratanshi RM, Kapiga S, Hahn J, Sethi AK. 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. J Int Assoc Provid AIDS Care. 2017 May/Jun;16(3):276-285. doi: 10.1177/2325957416649669. Epub 2016 May 23.

    PMID: 27215561RESULT

  • Noyes ET, Levine JA, Schlauch RC, Crane CA, Connors GJ, Maisto SA, Dearing RL. Impact of Pretreatment Change on Mechanism of Behavior Change Research: An Applied Example Using Alcohol Abstinence Self-Efficacy. J Stud Alcohol Drugs. 2018 Mar;79(2):223-228. doi: 10.15288/jsad.2018.79.223.

    PMID: 29553349RESULT

  • Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.

    PMID: 21390262RESULT

  • Kalichman SC, Grebler T, Amaral CM, McNerey M, White D, Kalichman MO, Cherry C, Eaton L. Intentional non-adherence to medications among HIV positive alcohol drinkers: prospective study of interactive toxicity beliefs. J Gen Intern Med. 2013 Mar;28(3):399-405. doi: 10.1007/s11606-012-2231-1. Epub 2012 Oct 12.

    PMID: 23065532RESULT

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Flor Musayón, Dr

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimentation period will be carried out with a randomized trial type design with concurrent control. The experimental group will receive the counseling and the control group will be constituted by a group of patients randomly selected from the population of patients who started HAART in the last three months in the Strategy who will receive the usual counseling. Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 31, 2019

First Posted

August 13, 2019

Study Start

September 15, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

According to the registry of the ethics committee, the study data will only be used for the present investigation.

Locations

PE(1)