Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART

HIV Clinical Trial

Official title:

Effectiveness of the Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients Receiving HAART

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054466
• Other study ID #: 066991
• Secondary ID: D43TW009763
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Universidad Peruana Cayetano Heredia
• Contact: Flor Musayón, Dr.
• Phone: 995006662
• Email: yesenia.musayon[@]upch.pe
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Goals:

1. Determine the necessary contents to include the usual counseling to improve the adherence to HAART of patients with HIV according to their different levels of alcohol consumption.

2. To compare the prevalence of alcohol consumption in the last month and last six months between patients who receive and do not receive differentiated nursing counseling according to the level of alcohol consumption.

3. Determine if the intervention is sustainable and scalable.

Material and methods:

Type of study and research design It is an experimental study with three phases, which are detailed below.

First phase The study will start with a formative research to define the content of the intervention strategy, the extension of it, the duration of each session and the approach to be used for each subgroup.

To do this, the level of alcohol consumption of HIV patients receiving HAART and their levels of adherence will first be identified.

Alcohol consumption will be evaluated through the measurement of the prevalence of consumption and the application of the AUDIT (see annex 2) that identifies, alcohol risk consumption, harmful alcohol consumption and dependence. Adherence to HAART will be identified mainly through the SMAQ instrument recommended by the Ministry of Health (see annex 3) for the patients of the strategy and the consistency of this measurement will be sought with the record of the delivery of medications, the treatment card.

Subsequently, the design of the differentiated counseling protocol for the levels of consumption presented by the patients will be concluded. For each component, contents with scientific evidence will be refined. The contrast with the scientific evidence, the available theory and the reality of consumption will consolidate the proposal of counseling.

The elaborated protocol will be submitted to the opinion of focal groups with patients and nurses (see annexes 4 and 5) to validate the proposed counseling and evaluate its usefulness, acceptability, adaptability, feasibility (cost / time), sustainability and possible effectiveness of the proposal. Differentiated counseling for alcohol users according to their consumption levels. Focus groups will be recorded with the prior authorization of the participants.

Finally, the counseling proposal with the feedback received from the focus group will be submitted to the opinion of experts on the subject of HIV, alcohol consumption and nursing counseling. With these tools we will have a counseling protocol (including initial session and follow-up sessions) that will be applied in a pilot test to 10 volunteer patients in order to complete its validation and identify difficulties in its application: 05 patients (for the initial session ) and 05 patients (follow-up session).

Finally, a training program for nurses will be designed in order to have the required profile in the professionals for the application of the counseling.

Second stage Subsequently, the experimentation period will start 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.

Third phase This final phase will be the analysis of the opinion of patients and nurses on the sustainability (cost / time) scalability of the proposal of differentiated counseling for patients consuming alcohol according to their levels of consumption post experimental evaluation. This phase will be carried out using focus groups: of patients and nurses.

In this phase, the economic evaluation of the intervention will also be carried out. For this purpose, the costs at the market value of all the resources, services or supplies required to carry out the counseling will have been recorded. The cost for each counseling session provided to each patient will also be calculated to then obtain the simple average cost per session for each subgroup according to consumption levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be willing to participate in the study.

• Have an assessment of the level of consumption and adherence to HAART.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alcohol Drinking
• HIV

Intervention

Behavioral:
• Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART
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.
• Habitual Counseling
Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment

Locations

Country	Name	City	State
Peru	Yesenia Musayón	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia	CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY, Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Peru, 

References & Publications (22)

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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 Cli — View Citation

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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 — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cluster of cuadruple differentiation CD4 T lymphocyte count	Number of CD4 lymphocytes recorded in the laboratory test performed based on the blood test of the patient receiving HAART, and filed in his Medical Record with the signature of the responsible professional.	Every control made for Hospital until the end of six months of follow-up
Other	Viral load	Number of replicated copies of the human immunodeficiency virus found per milliliter of blood plasma of the patient receiving HAART and which is recorded in the laboratory result filed in his Medical Record. Said result must be signed by the responsible professional.	Every control made for Hospital until the end of six months of follow-up
Primary	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	HAART Adherence	Adherence to pharmacological therapy with antiretrovirals is the degree of compliance of the pharmacological treatment according to medical indication and evaluated by the application of the SMAQ. , the record of attendance to the pick up of the medicines and the treatment card.	One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.

External Links

•   Análisis de la Situación Epidemiológica del VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA) en el Perú
•   Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the US Preventive Services Task Force
•   Boletín VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA)
•   Cuestionario de Identificación de los Transtornos debidos al Consumo de Alcohol
•   El Alcohol: Un producto de consumo no ordinario: Investigación y Políticas Públicas
•   I Estudio sobre prevención y consumo de drogas en la población general de Lima Metropolitana y el Callao - 2013
•   Incidence and associated factors to adverse reactions of the initial antiretroviral treatment in patients with HIV
•   Información sobre la medicación y adherencia al tratamiento antirretroviral de gran actividad en pacientes con VIH/SIDA de un hospital de Lima
•   Integrating mindfulness as self-care into counselling and psychotherapy training
•   La Dependencia alcohólica como factor de riesgo de tuberculosis multidrogo-resistente
•   Modelo de Consejería Orientada a Jóvenes
•   Narrative career counselling: Theory and exemplars of practice
•   Norma Técnica de Salud de Atención Integral del Adulto con Infección por el Virus de la Inmunodeficiencia Humana (VIH)
•   Nutrición y alcoholismo crónico
•   Principles of Drug Addiction Treatment: A Research-Based Guide
•   Test Audit y CAGE
•   Treatment for Alcohol Problems: Finding and Getting Help