CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 233 enrolled
Drug / intervention
Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT04054466
NCT04054466N/ACompleted

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

Universidad Peruana Cayetano Heredia·interventional·Posted Aug 13, 2019·Updated Jul 26, 2024

In Brief

A clinical study evaluating Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART and Habitual Counseling for HIV and Alcohol Drinking. Completed, enrolled 233 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2019
Enrollment StartSep 15, 2018
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.9 years ago

Interventions

Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAARTbehavioral

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 Counselingbehavioral

Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment