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

Primary Purpose

HIV, Alcohol Drinking

Status
Unknown status
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART
Habitual Counseling
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Counseling, Antiretroviral Therapy, Alcohol Drinking, Nursing Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yesenia MusayónRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

Intervention with counselling designed

Intervention with habitual counselling

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
March 31, 2019
Last Updated
November 2, 2020
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health, CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY
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1. Study Identification

Unique Protocol Identification Number
NCT04054466
Brief Title
Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART
Official Title
Effectiveness of the Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients Receiving HAART
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health, CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Goals: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol Drinking
Keywords
HIV, Counseling, Antiretroviral Therapy, Alcohol Drinking, Nursing Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Intervention with counselling designed
Arm Title
Control group
Arm Type
Other
Arm Description
Intervention with habitual counselling
Intervention Type
Behavioral
Intervention Name(s)
Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART
Other Intervention Name(s)
New Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Habitual Counseling
Other Intervention Name(s)
Old Counseling
Intervention Description
Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
Primary Outcome Measure Information:
Title
Alcohol consumption
Description
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).
Time Frame
At the beginning of the study and then every month until the end of six months of follow-up
Secondary Outcome Measure Information:
Title
HAART Adherence
Description
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.
Time Frame
One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.
Other Pre-specified Outcome Measures:
Title
Cluster of cuadruple differentiation CD4 T lymphocyte count
Description
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.
Time Frame
Every control made for Hospital until the end of six months of follow-up
Title
Viral load
Description
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.
Time Frame
Every control made for Hospital until the end of six months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flor Musayón, Dr.
Phone
995006662
Email
yesenia.musayon@upch.pe
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Cárcamo, Dr.
Phone
997350773
Email
cesar.carcamo@upch.pe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flor Musayón, Dr
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yesenia Musayón
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yesenia Musayón, Dr.
Phone
995006662
Email
yesenia.musayon@upch.pe

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
According to the registry of the ethics committee, the study data will only be used for the present investigation.
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Análisis de la Situación Epidemiológica del VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA) en el Perú
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Nutrición y alcoholismo crónico

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

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