Validation of a counseling guide for adherence to antiretroviral therapy using implementation science*

Objective: to determine the contents that must be included in the usual counseling to improve the adherence to antiretroviral therapy (ART) of HIV patients, according to their different levels of alcohol consumption, and to determine the validity of the Counseling Guide in improving the adherence to ART in patients who consume alcohol using Implementation Science. Method: this is an observational study with formative and validation phases. The formative phase defined the content, approach and structure of the counseling. Validation included focus groups with patients and nurses, trial process by an expert and a pilot test. The criteria evaluated based on Implementation Science were: intervention source, evidence strength and quality, relative advantage, and complexity. The following criteria were also evaluated: usefulness, practicality, acceptability, sustainability, effectiveness; content consistency and congruence; procedural compliance and difficulties, and time spent in counseling. Results: the strength of evidence of the counseling is High-IIA, with strong level of recommendation and presenting usefulness, practicality, acceptability, sustainability and effectiveness. Eight in 11 experts argued that the Guide is clear, consistent and congruent. Initial counseling takes around 24 minutes; and follow-up counseling, 21. The instruments of the Guide present reliability levels between good and high (0.65 ≥ alpha ≤ 0.92). Conclusion: the Counseling Guide is valid to improve the adherence to antiretroviral therapy in patients who consume alcohol.


Introduction
Proposing, developing and implementing effective health intervention programs aimed at specific population groups in different contexts and with defined purposes requires an evidence-based and stipulated operational milestone (1) .
Around 2009, some scientists began to study the processes, domains and structures linked to the successful outcome of implementation, consolidating the reference framework of implementation science (2)(3)(4) .
Implementation science facilitates the integral analysis required to implement effective interventions in a health service (2) , registering five fundamental domains for such: the intervention, the internal front (e.g.: organization), the external front (e.g.: regulations), the individuals involved and the processes (2)(3)(4) . implementation science present promising results (5)(6) ; even more if a strict effort between research, service and public policies is established, including evidence patterns, participation of health providers, local government and some educational components (7) . However, no studies on the use of Implementation Science as a strategy to develop new health approach interventions and models in the country where this study was conducted were found.
Adherence to antiretroviral therapy (ART) is a crucial conduct when one wants to achieve some level of success in the effectiveness of treatment; however, access is not the sole requirement to incorporate ART, knowledge (12) and determination are also required.
However, it is often difficult to maintain an adherent behavior for a long time. Counseling is a strategy applied in different contexts and environments to empower the patient into making decisions that contribute to improve, maintain and help him care for his health (13)(14) ; to create alternatives and suggest strategies to achieve results (15) , and in this case, to maintain the adherence to treatment.
Counseling is offered to every patient before and after the HIV diagnosis, before the onset of ART and throughout life. Several initiatives and proposals exist to provide counseling, considering different approaches and even different methods (16)(17)(18)(19)(20) ; however, a scientifically validated counseling guide is unavailable in this field, as well as one that allows stating -with some level of certainty -that such counseling is effective for its application intent.
Hazardous alcohol consumption is associated with reduced adherence and reduced viral suppression (21)(22) , it is thus necessary that these types of interventions include strategies that allow patients to have healthy behaviors and reduce alcohol consumption to improve adherence and quality of life (23) . According to the current technical standard of the selected health service, alcohol consumption patterns must be explored during the nursing interview protocol to "define nursing diagnoses or lead patients to propose their own solutions" (24) .

Method
The process was developed in two phases.  The seven nurses worked at the service, and none were on leave or vacation. The patients were older than 18 years, of both sexes, and invited to participate voluntarily in a focus group. Two focus groups of discussion were formed with 15 participants each. To participate in the focus group, patients needed to receive ART in the service, not be in the AIDS phase, not be hospitalized, not suffer mental illness that would limit their will or that would cause dependence on a third individual for taking medications. In each focus group, three relatives or support agents of these patients were also voluntarily involved.
Two guides were designed for the focus groups, one for nurses and the other for patients, using the "interview guide tool" as the basis -available at the CFIR website (2) : http://www.cfirguide.org/guide/app/ index.html#/guide_select. The following indicators Rev. Latino-Am. Enfermagem 2020;28:e3228.
were evaluated: "perception of key actors on the intervention: whether the perception develops internally or externally"; the "relative advantage", understood as the "perception of the actors about the advantage of implementing the intervention in the face of an alternative solution"; "adaptability", as the "degree to which an intervention can be adapted, refined or reinvented to meet local needs"; "reliability", as the "ability to test small-scale intervention in the organization, and be able to reverse the course (undo the intervention), if necessary"; and "complexity", defined as the "perceived difficulty of execution, which is reflected in the duration, After the application of the pilot test the researchers talked to each of the nurses to identify any difficulties or inconvenience that were not recorded in the instrument.
Considering the results of the pilot phase, the Guide was again improved to its final version.
For data analysis, the evaluation forms delivered by each specialist were tabulated and the Agreement Index (AI) (28) was evaluated, the binomial test and Aiken's V coefficient (29) were calculated for each segment of the Guide by evaluated criterion. Validity was considered for agreement index equal to or greater than 80% (28) , and p<0.05 significance value for both the binomial test and Aiken's V coefficient (29) .
Information obtained from the focus groups were individually analyzed for each, considering the evaluated constructs. Following, consensus, agreements and disagreements were identified in the patients' groups.
The records obtained from the pilot test were
i.e., High evidence: evidence with randomized and controlled trial with important limitations, solid evidence from observational studies, and a strong level of recommendation: "Almost all patients should receive the recommended course of action" (30) .
They following aspects were identified as "relative advantages" of the intervention: the current counseling practice performed in the service but without a formally defined structure; the experience of nursing professionals in counseling; the acceptability of the procedure by patients; the patients' need for educational and emotional support from the health professionals for adherence; and the recognition of counseling as an intervention performed by nursing professionals. Table 1 presents the responses of 8 judges -out of 11 who were invited -, who corroborated in considering that the Guide has a clear, consistent and congruent content. Although the maximum score attributed was two, only in three items up to two specialists attributed the score of one, for this reason, an absolute agreement was not achieved in these segments of the Guide, but rather of majority. In these cases, the content was revised for improvement and suitability. Similarly, the nurses considered that, although it is possible to apply it, this will take an additional time, but it will ensure the offer of complete counseling for patients to improve their lifestyle and adherence to ART. However, the nurses suggested replacing some technical terms by more common synonyms (Figure 1).
The suggested content and recommendations were included in the guide.
According to the pilot test, that is, in the application of the counseling guide with patients, we found that the nurse employs 24 minutes, on average, for initial counseling and 21 minutes for the follow-up counseling, with a minimum of 13 minutes. The nurses who participated in the pilot test recognized the benefit of using the guide as to the accuracy, order and complete approach of the content; however, they also identified that the difficulties inherent to the system and the current structure of the service hinder its application, such as the scarce space available to offer counseling, lack of privacy, among others ( Figure 2).

All instruments that are part of the Counseling
Guide have a good and high level of reliability ( Table 2).

Constructs Nurses Patients and family members
General assessment Good strategy, useful and important to the patient. Of great help to improve counseling parameters. It allows them to follow steps or procedures regarding the treatment and care that may be offered to the patient. It allows them addressing issues related to reality such as alcohol problems.
It will be of great help to know what to do.

Complexity
The language is adequate. There could be difficulty with drug names. Counseling was very well designed.
Some words are unclear, such as adhesion, so they need to be replaced by more common synonyms.

Utility
It will help patients and their supporters improve or change their lifestyles and improve adherence to antiretroviral therapy.
To improve and expand knowledge and quality of life.
To detect consumption problems in time and act in a timely manner.

Practicality
There could be difficulty to find the time for listening. Nurses could offer counseling. Preparation is recommended.
It could be the time, but if it is important for health, it should be given the necessary time.

Acceptability
Nurses would accept it. It is not considered a waste of time.
It is not considered a waste of time.

Sustainability
It is not a waste of money or resources, it will probably take longer, but it will be helpful. Yes, it should apply.

Effectiveness
Yes, because it will help improve their knowledge and empowerment. It will help them analyze the situation of those who drink alcohol.
To include what was mentioned. improve the adherence to ART;

Initial counseling Follow-up counseling
Counselor profile The participating nurse meets the profile for the counseling process or is in the process for it.
The participating nurse meets the profile for the counseling process or is in the process for it.

Benefits
Allows them to obtain the available information.
There is more organization, and counseling is more complete.
Patients leave happier.
It allows them to deepen the content. It forces them to complete counseling Difficulties of the process They must know how to apply and what instruments should be applied. Lack of privacy during counseling. Confidentiality is needed, space is scarce to offer it properly.
There is no comfort, there is overload.
They must know the Guide beforehand; training and simulation are needed. The procedure should be well known. It takes longer, requires deepening. It requires more space and more trained nurses.  In the guide, counseling is defined as "a health intervention strategy performed by trained professionals to generate, in a trust environment, a professional relationship that helps patients identify their health situation, risk factors to which they are exposed, empowers them as to their health management, allows them to develop basic skills to solve problems, and enables them to make decisions and acquire practices that contribute to the adherence to antiretroviral therapy."

Average time taken in minutes ± SD
And counseling in alcohol-consuming patients is defined as "an oriented counseling for non-dependent alcoholconsuming patients, in order to recognize the risks and consequences of alcohol consumption, develop strategies to avoid, control or reduce consumption at a risk-free level and incorporate healthy behaviors that contribute to improving adherence to antiretroviral therapy." In the guide, we propose the counselor profile, which can be easily recognized by the acronym SUCCESS: *STI = Sexually Transmitted Infections; † HIV/AIDS = Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome; ‡ ART = Antiretroviral Therapy Rev. Latino-Am. Enfermagem 2020;28:e3228.
The counseling proposal is based on two theories and one model: humanistic T., cognitive-behavioral T. and transtheoretical model.
The humanist approach is applied through the empowerment of the patient for their health care and relationship of trust (31)(32) . The cognitive-behavioral approach, on the other hand, applies through the learning of favoring conduits, the reinforcement of positive conducts, behavioral activation, among others (33-34) .
The transtheoretical model establishes that the change in health goes through six stages: precontemplation, contemplation, preparation, action, maintenance and termination (35) . This model applies after identifying the level of alcohol consumption.
Counseling to improve adherence to ART is still organized in two types of counseling: initial counseling and follow-up counseling. Each of them has three moments: initial stage, central stage, final or closing stage, the Guide includes steps to follow and suggested discourses ( Figure 3).
The guide identifies the developing phase, establishes a suggested discourse, and guides the action that the counselor must follow at each moment.
Initial counseling takes approximately 25 minutes, while follow-up counseling takes 15 minutes, the duration includes the assessment of patient adherence and alcohol consumption.

Central stage
1. To introduce yourself to the patient and explain the purpose of the session.
Good morning, Mr. Pérez, I am nurse counselor Margarita Ortiz (indicate the name) And I want to welcome you to the counseling sessions available, which aim to offer you the support needed to care for your health.
2. To express that the information provided during the conversation is strictly confidential, except those occasions when it is necessary to link a third party. What will be done with the patient's consent or to preserve their safety or that of others.
It is important to consider, Mr. Pérez, that the information provided in each counseling session are strictly confidential, so you can talk with all...

1.
To inquire the patient's concerns, anxieties, needs or health situation regarding the Antiretroviral Therapy (ART).
Do you have any specific concerns about what comes from now on? I am referring to initiating the Antiretroviral Therapy (ART).
-Listen carefully to each question and take notes. -Listen carefully to the patient's answers for each question and take notes.
-When repeating the questions, for each appropriate answer the patient gives, Take advantage to reinforce your conduct and reinforce your knowledge and actions.
However, the pilot test, the application of mild counseling for approximately 20 minutes, estimated that after acquiring a certain ability in its use, one can be

Conclusion
The Counseling Guide to improve adherence to ART in HIV-infected patients who drink alcohol has content validity, and its application is considered useful, acceptable, adaptable, sustainable, and potentially effective to improve adherence to the treatment of HIV patients according to their alcohol consumption levels.
The validated guide is potentially scalable to other realities in which the profile of patients is compatible: Hispanic adult patients who receive ART and who are not in the AIDS phase; and also, nurses whose training profile and similar language can facilitate the comprehension of its application. Moreover, the method adopted for the validation of nursing interventions, such as counseling in this particular case, has been described in such a way that it can be replicated and adapted to other nursing interventions.