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

2 de noviembre de 2020 actualizado por: Yesenia Musayon, Universidad Peruana Cayetano Heredia

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

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

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

240

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Lima, Perú, Lima 41
        • Reclutamiento
        • Yesenia Musayón
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental group
Intervention with counselling designed

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.

Otros nombres:
  • New Counseling
Otro: Control group
Intervention with habitual counselling
Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
Otros nombres:
  • Old Counseling

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Alcohol consumption
Periodo de tiempo: At the beginning of the study and then every month until the end of six months of follow-up
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HAART Adherence
Periodo de tiempo: One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.
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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cluster of cuadruple differentiation CD4 T lymphocyte count
Periodo de tiempo: Every control made for Hospital until the end of six months of follow-up
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
Viral load
Periodo de tiempo: Every control made for Hospital until the end of six months of follow-up
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Flor Musayón, Dr, Universidad Peruana Cayetano Heredia

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de septiembre de 2018

Finalización primaria (Anticipado)

30 de noviembre de 2020

Finalización del estudio (Anticipado)

31 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

31 de marzo de 2019

Primero enviado que cumplió con los criterios de control de calidad

10 de agosto de 2019

Publicado por primera vez (Actual)

13 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 066991
  • D43TW009763 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Consumo de alcohol

3
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