Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.

Abstract Objective: to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV). Method: randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analysis of variance was used. Results: alcohol involvement decreased in the intervention group (F (1.119) = 50.28; p < 0.001; η2 p = 0.297), while HIV knowledge (F (1.130) = 34.34; p < 0.001; η2 p = 0.209) and condom use self-efficacy increased (F (1.129) = 27.20; p < 0.001; η2 p = 0.174). In addition, less participants consumed alcohol in the past week compared to the control group (χ2 = 15.95; p < 0.001). Conclusion: the nursing intervention had positive effects, which could help young women stay away from alcohol use and the risk of sexually transmitted infections. NCT: 02405481.


this entails.
In this sense, the causal relationship between alcohol consumption and the incidence of serious diseases, such as human immunodeficiency virus (HIV) infection (8)(9) have been elucidated, which represents another serious public health challenge (10) .
For example, it is known that alcohol consumption predicts sexual decision-making (11) , in addition to the fact that it could have negative effects on the cerebral prefrontal region (12) -area associated with risk assessment during decision taking. That increases the likelihood of an individual having risky sexual behaviors, such as having impulsive sex behavior, having sex with multiple partners, and having sex without a condom. Such behaviors are associated with an increased chance to become infected with HIV (13) .
As proof of the complex but close relationship between alcohol use and the risks of HIV transmission, some Latin American studies present revealing data. For example, a study (14) found that of those participants (young people from Northern Mexico) who reported having had sex, 41% had sex while under the influence of alcohol, and 61.2% without protection. They also highlighted that a higher alcohol consumption is associated with a higher prevalence of unprotected sex (r = 0.278, p < 0.01). Other researchers (15) estimated that 30.3% of women in their study had sex while under the influence of alcohol, of which 47.4% had sexual contact with someone they just met. In addition, those who reported having had sexual contact while under the influence of alcohol had more than twice as many sexual partners (Mean = 4.3), compared to those who did not report having sex after taking any type of drug (Mean = 2.0; t = 6.37, p < 0.001). Findings such as those reported above deserve attention from the nursing staff, especially with regard to the development and implementation of interventions aimed at preventing alcohol use and HIV transmission in vulnerable groups such as women (13,16) .

Preventive interventions on this issue have
shown variable efficacy, mainly because some have not demonstrated to have an impact on risk behaviors and they have only been limited to build knowledge (17) .
In fact, nurses have developed few interventions by for the Mexican population. An example of evidencebased intervention is the program Take care! Promote your health, which was adapted and implemented in northern Mexico (18) in order to delay the age of sexual onset and promote condom use. However, although it is effective, it does not include content on the use of alcohol and drugs and is addressed to parents and teenage children of both sexes -segment of the population different from the population at risk.
Considering the above, it is worth mentioning the work of a group of research nurses, who developed an intervention called Health, Education, Prevention and Self-Care (SEPA). It is an HIV prevention program developed for Latina women (including Mexican), initially residents in Chicago, United States of America (19) , but it has also been implemented in Hispanic women resident in Florida, United States of America (17,19) . SEPA effectively reduces the biological, behavioral and social risks that explain the transmission of HIV, including alcohol use. In fact, because of these attributes, it is listed by the Centers for Disease Prevention and Control as one of the few evidence-based nursing interventions recommended to be replicated (20) .
Because of its versatility, theoretical foundation and scientific evidence, SEPA is considered to have the characteristics of a program feasible to be implemented in Mexico. In addition, because it has been applied to young women, who are in the early stages of their sexual activity -within a context of personal, social and economic changes (21) that could facilitate their involvement with alcohol -SEPA is an attractive opportunity for nursing practice. Especially in light of the insufficient scientific production, the demand for preventive strategies, as well as the wide distribution of nursing staff in primary health care. For this reason, an experimental study was proposed in collaboration with the SEPA group, the objective was to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV). The following hypotheses were tested: H 1 : women in the intervention group will be less likely to show involvement with alcohol compared to those in the control group. H 3 : women in the intervention group will have an increased condom use self-efficacy than women in the control group.

Method
The study was a randomized, single-blinded clinical trial with a control group, developed from January to July 2018 (NCT02405481). The participants were from two public universities in Tamaulipas, Mexico.
Only women of Mexican nationality, aged between 18 and 30 years, with sexual activity in the past three months, availability to attend the intervention, and who signed an informed consent form were included.
Two research assistants conducted the recruitment two months before the intervention (by means of brochures and in person). In total, 543 applicants were received and examined. Of the applicants, 132 met the inclusion criteria and were randomly assigned to one of the two arms of the study: those who received SEPA were named as intervention group (IG; n = 66), while the control group (CG; n = 66) was composed of those who received a conventional preventive strategy. The sample size was sufficient to detect intra-subject and inter-subject differences, with a power greater than 80.0% and a medium effect size (ƒ = 0.25) (22) .
Given that SEPA was not developed to be administered to large groups, 12 blocks were created with a maximum number of 11 participants each, six corresponding to the intervention group and six to the control group. The random assignment to the experimental and control groups was performed using an electronic spreadsheet with SAP function. The principal investigator, who did not know the identity of the participants, performed these procedures. This was a single-blinded masking study, since the participants did not know the group to which they were assigned. It also encourages them to increase their knowledge through the interaction with their colleagues. According to these guidelines, the facilitator does not play the role of a teacher or try to impose her knowledge, but rather guides the dialogues and topics to be addressed. This encourages participants to discuss among themselves and carry out the activities of each meeting.
To maintain the reliability, prior training for facilitators was provided. This training lasted two months and was conducted by the principal investigator, who was trained by members of the research team of SEPA.
Intervention manuals and presentations were used that helped to understand the contents and activities of each session. It is worth mentioning that one year before the intervention, manuals and contents were adapted to the local context by experts. For example, the epidemiological information on the Latino population in the United States of America was replaced by that of the Mexican population, as well as the language.
Shortly after, a pilot study was conducted to examine the reliability of the instruments and identify areas for improvement. Based on the pilot study, it was concluded that the instruments showed acceptable reliability and no further adjustments were required.
The facilitators were nurses, with a level of education that ranged between bachelor's degree and doctorate degree. Their responsibilities were a) to carry out SEPA sessions; b) to provide educational material, c) as well as to carry out strategies to retain participants during the intervention.
The research assistants carried out the recruitment two months before the beggining of the intervention.
Dates for carrying out the interview were suggested to assess the inclusion criteria, which was conducted in private classrooms. Those who met the inclusion criteria were referred to the pre-test measurement and attended the intervention sessions. Conversely, those who did not meet the inclusion criteria were offered an educational lecture on a date other than the period in which SEPA was developed.
The study was carried out through five meetings: the pre-test and post-test measurements were performed in the meetings 1 and 5, respectively, while the meetings    (19) .
The Condom Use Self-efficacy Scale (

Results
The average age of participants was 20.02 years (standard deviation = 1.64) and they were aged between 18 and 29 years. Most of them were in a relationship, but were not married (53.8%), although a Rev. Latino-Am. Enfermagem 2020;28:e3262.
significant proportion was single (43.2%); few reported being married (3.0%). Tables 1 and 2 show some sociodemographic and alcohol use characteristics, segmented into control and intervention groups. It is noted that both groups started on equal terms because there were no significant differences neither in the continuous variables (Table 1) nor in the categorical variables ( Table 2).
Regarding the involvement with alcohol, the first hypothesis proposed that, at the end of the intervention, women in the IG would have a reduction in the involvement with alcoholic beverages compared to those in the CG. When analyzing the AUDIT score using ANOVA tests, a significant main effect of the time of measurement was identified (F (1.119) = 61.48; p < 0.001; η 2 p = 0.341), which means that there was a trend towards a reduction in the scores at the time of posttest. In addition, Table 3 shows a significant interaction between the group of belonging × time of measurement (F (1.119) = 50.28; p < 0.001; η 2 p = 0.297), which suggests differences between the IG and CG scores, according to the time of measurement.

Discussion
The findings of this experimental study revelead that the preventive intervention SEPA had positive effects in reducing alcohol consumption and preventing some risk factors for HIV transmission among young Mexican women. This provides scientific evidence on the effectiveness of SEPA intervention, which has been applied to Latino women from different contexts (17,19) , and no similar intervention had been applied within Mexico. It also shows that nurses can improve their actions (in this case, primary health care nurses) by their own means in order to improve population health.
Regarding the first study hypothesis, it was found that compared to the control group, women who attended the SEPA had a significant decrease in AUDIT questionnaire scores, as well as in alcohol consumption in the last seven days (from 25,8% in the pre-test to 7.6% in the post-test). These results are in line with those reported in a study of 548 Hispanic women living in the US, which has shown that after attending the SEPA, the frequency in which participants reported having been alcoholized decreased (17) . In comparison, our results also show an improvement in terms of AUDIT score.
The use of AUDIT can be an advantage, as it is a reliable instrument, whose scoring not only gives an idea of the amount and frequency of alcohol consumption, but also represents an approach on the possible consequences of alcohol consumption, as well as the symptoms of alcohol abuse and alcohol dependence (25) .
It has also been reported that the scores are associated with the attitudes and reasons why the individual drinks (30) , so that it represents the relationship that the individual has with alcohol in a more comprehensive way.
In this sense, the use of screening instruments such as AUDIT constitutes an advantage for the nursing practice: they allow prioritizing care and resources, specifically for the most vulnerable individuals. Therefore, such actions could also have benefits -economic and social -for  Since this study is one of the first approaches carried out in Mexico, its implementation was developed in an educational environment, and participants were young women with higher education and wide availability to attend the intervention during the study period. It is possible that in the general population the efficacy and understanding of the intervention will vary. In particular, some aspects could be adapted to a real context.
For example, carrying out an intensive recruitment, as it was performed here (to maintain several intervention groups simultaneously), could be a challenge in everyday conditions. Alternatively, a sequential recruitment could be carried out and, thus to form intervention groups throughout the year. This could also contribute to include part of the eligible population that was excluded due to lack of time. In future research, it will be necessary to consider these aspects when applying SEPA in a community context that faithfully represents other vulnerable segments of the Mexican population.

Conclusion
Based on the post-test measurements, it can be concluded that SEPA has the potential to reduce the involvement with alcoholic beverages and certain risk fators for HIV transmission in Mexican women. It has also proved to be understandable to the participants and to the nursing staff who administered it. It is noteworthy that it showed better results than a conventional strategy used by the nursing staff in a community context. Due to its methodological characteristics and results, it is considered as a strategy that could be incorporated into the preventive actions performed by the nursing staff with young women. This could benefit primary health care nurses, because in the future SEPA could represent a preventive strategy based on evidence with a positive impact on the public health of the region.
However, further studies should be conducted to confirm its usefulness in people of different educational levels.