Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART
NCT ID: NCT04054466
Last Updated: 2024-07-26
Study Results
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Basic Information
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COMPLETED
NA
233 participants
INTERVENTIONAL
2018-09-15
2020-03-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
TREATMENT
TRIPLE
Study Groups
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Experimental group
Intervention with counselling designed
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.
Control group
Intervention with habitual counselling
Habitual Counseling
Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an assessment of the level of consumption and adherence to HAART.
Exclusion Criteria
* Do not consume alcohol.
* Being hospitalized.
18 Years
ALL
No
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY
UNKNOWN
Universidad Peruana Cayetano Heredia
OTHER
Responsible Party
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Yesenia Musayon
PhD
Principal Investigators
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Flor Musayón, Dr
Role: PRINCIPAL_INVESTIGATOR
Universidad Peruana Cayetano Heredia
Locations
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Yesenia Musayón
Lima, , Peru
Countries
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References
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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.
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Related Links
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Información sobre la medicación y adherencia al tratamiento antirretroviral de gran actividad en pacientes con VIH/SIDA de un hospital de Lima
Incidence and associated factors to adverse reactions of the initial antiretroviral treatment in patients with HIV
Análisis de la Situación Epidemiológica del VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA) en el Perú
La Dependencia alcohólica como factor de riesgo de tuberculosis multidrogo-resistente
Boletín VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA)
Norma Técnica de Salud de Atención Integral del Adulto con Infección por el Virus de la Inmunodeficiencia Humana (VIH)
Principles of Drug Addiction Treatment: A Research-Based Guide
Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the US Preventive Services Task Force
Treatment for Alcohol Problems: Finding and Getting Help
Nutrición y alcoholismo crónico
Other Identifiers
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066991
Identifier Type: -
Identifier Source: org_study_id
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