Clinical trial NCT04054466: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Alcohol Drinking
Keywords: HIV
Counseling
Antiretroviral Therapy
Alcohol Drinking
Nursing Care
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY
First posted: 2019-08-13
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Alcohol consumption
timeFrame: At the beginning of the study and then every month until the end of six months of follow-up
Secondary outcomes:
measure: HAART Adherence
timeFrame: One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.
Other outcomes:
measure: Cluster of cuadruple differentiation CD4 T lymphocyte count
timeFrame: Every control made for Hospital until the end of six months of follow-up
measure: Viral load
timeFrame: Every control made for Hospital until the end of six months of follow-up
Locations:
city: Lima
country: Peru
facility: Yesenia Musayón
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Flor Musayón, Dr
role: PRINCIPAL_INVESTIGATOR
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