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

2 novembre 2020 mis à jour par: 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

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Lima, Pérou, Lima 41
        • Recrutement
        • Yesenia Musayón
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Alcohol consumption
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
HAART Adherence
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Cluster of cuadruple differentiation CD4 T lymphocyte count
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 septembre 2018

Achèvement primaire (Anticipé)

30 novembre 2020

Achèvement de l'étude (Anticipé)

31 décembre 2020

Dates d'inscription aux études

Première soumission

31 mars 2019

Première soumission répondant aux critères de contrôle qualité

10 août 2019

Première publication (Réel)

13 août 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2020

Dernière vérification

1 novembre 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 066991
  • D43TW009763 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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