Compliance With Management Indicators In A Program For The Management Of Patients Living With Hiv/Aids

HIV / AIDS infection is a public health problem for which multiple control strategies have been developed. Colombia seeks to standardize care in specialized centers, under the recommendations of the current Clinical Practice Guide and with a multidisciplinary intervention.

Objective. To determine compliance with management indicators in a program for the management of patients living with HIV / AIDS, in a specialized IPS in Cali Colombia. Materials and methods. An observational, descriptive, longitudinal andretrospective study was conducted in a cohort of patients over 18 years of age who enteredthe program and started antiretroviral therapy (ART), between January and December 2016.

Results. Information from 173 clinical records and data reported in the High-Cost Account of patients diagnosed with HIV / AIDS was analyzed. 13 clinical are indicators were evaluated, all of them process three initial evaluations, two monitoring, six therapies and two specific preventions. 23.07% of the indicators met the goal established by the CAC consensus; 100% compliance with the recommendations was identified in 11% of the population and in termsof optimal virological response, 72.83% achieved undetectable viral load results between week 9 and week 117 after the start of ART; 69.3% reported viral suppression before week 48 and 1.15% of the population was evaluated for viral load within 48 weeks of treatment with a result <50 copies. Conclusion. This study determined compliance with management indicators in a population of patients infected with HIV / AIDS, by measuring evidence-based consensus indicators, to evaluate management and clinical outcomes and management and evaluation indicators. the implementation of the recommendations proposed in the clinical practice guide (CPG)

Despite multiple efforts by countries to control the HIV/AIDS pandemic, the disease continues to be one of the main public health problems worldwide (1). It is estimated that since the 1980s, more than 70 million peoplehave been infectedwith the HIV virus, and at least 35 million have died from it. By 2018, the number of people living with HIV/AIDS in the world was 37 million, and of these,only 59% of those over 15 years of age received antiretroviral treatment (ART) (1-3); however, advances in early diagnosis techniques, access to highly effective ARV (antiretroviral) treatment, and control of mother-to-child transmission are strategies promoted by international organizations in order to reverse and contain the HIV/AIDS epidemic (3); its implementation depends on the

resources of each country, therefore, in low-income countries, such as in the sub-Saharan Africa region, the epidemic continuesto rise

(4). With regard to vertical transmission, in the absence of any intervention the transmission rate is 15-45%;Effective interventions reduce these numbers to levels below 5% (5,6). The Joint United Nations Programme on HIV/AIDS (UNAIDS) in partnership with the World Health Organization/Pan American Health Organization (WHO/PAHO) sets regional goals in Latin America and the Caribbean by 2020 to increase the proportion of people with HIV/AIDS who know their diagnosis to 90%, increase to 90% the proportion of people diagnosed receiving ARV treatment,and increasing the proportion of people on HIV treatment with an undetectable viral load to 90 per cent, through the 90-90-90 strategy. Complementary to these goals,the fourth goal is to reduce late

1

diagnosis; This is in order to control new infections, diagnose early stages of the disease, related death, as well as improve patients' quality of life (7).

The effectiveness of ART in suppressing serum viral load to undetectable values (< 50>

In Colombia, according to the Ministry of Health and Social Protection, an estimated

150,116 peopleliving with HIV in 2016,by 2018 108,648(72%) had been diagnosed, which represents a decrease of 28% comparedto the 2016 estimate. However, 25% of these patients do not have access to health services or have dropped out of care programs (14-16). Santiago de Cali, with a reported incidence rate of 42.97/100,000 inhabitants (ASIS 2018), is considered one of the four Colombian cities with the highest number of cases. In the cityof Cali, there are 31 institutions authorized to care for patients living with HIV, of which 14 are Benefit Plan Administrative Companies (EAPB), 12 are Health Provider Institutions (IPS) and five are State Social Enterprises (ESE) (17).

Faced with this public health situation, the Ministry of Health and Social Protection of Colombia, Resolution No. 3186 of 2003, through the Policy on Comprehensive Care for Pathologies Classified as High Cost (Agreement 245 of 2003),seeks to guarantee equity, sustainability and strategies for the prevention and control of HIV/AIDS (18). Since 2014, the implementation of the practice guide has been promoted.This is a clinical approach based on scientific evidence, as well as the creation of a pathway that favors early diagnosis, initial assessment, clinical management, pharmacological treatment, and viral load monitoring periodically after the start of ART, with the aim of detecting virological failure in a timely manner (19). Since these recommendations are still in the process of being implemented, both the consensus of the high-cost account and the clinical practice guideline recommend that institutions that care for people living with HIV/AIDS evaluate annually the quality and effectiveness of institutional programs through indicators of initial evaluation, monitoring, specifictherapy and prevention. The objective of this research was to determine the compliance with management indicators in a program for the management of patients livingwith HIV/AIDS, in a specialized IPS in Cali, Colombia.

Population And Study Area

An operational research was carried out through an observational, descriptive, longitudinal study with retrospective data collection.

Source of information

As sources of information, clinical records and data from the High Cost Account were used, from a cohort of patients who entered an institutional program for the comprehensive management of HIV/AIDS, between January 1 and December 31, 2016.

Reference population:

Patients with a confirmed diagnosis of HIV/AIDS, seen in the outpatient clinic in a specialized IPS, with follow-up for at least 48 continuous weeks, from the start of their ART.

Selection criteria

Inclusion: We included the records of adult patients over 18 years of age, of both sexes, with a confirmed de novo diagnosis of HIV/AIDS, enrolled in the Specialized IPS program, who started an ARV treatment scheme during 2016.

Exclusion: Records of patients who died of causes unrelated to HIV/AIDS infection during follow-up were excluded.

As adherenceis an indirect response to compliance, it was measured according to the WHO (2004) definition, which corresponds to the degree to whicha patient's behavior,in relation to taking medication, monitoring of a diet or the modification of lifestyle habits, corresponds to the recommendations agreed with the health professional (WHO) (20,21).

For viral load adoptedaccording to the recommendations of the 2014 Clinical Practice Guideline (CPG), the amount of HIV virus quantified in a blood sample,is reported as the numberof viral RNA copies per millimeter of blood. It is usefulfor determining prognosis, assessing responseto treatment, and monitoring viralsuppression; It should be performed on patients infectedwith HIV/AIDS at the start of ARV treatment, two months after initiation of the drug or when the drug regimen is modified, every 6 months as a follow-up after the start of ARV treatment whenever an undetectable viral load (< 50>

Of the three categories of indicators (structure, process, and outcome) proposedby Donabedian, et al. (22,23)and recommended by the CAC and the GPC for the evaluation of specialized programs in the care of patients with HIV/AIDS (18,19),this research focused on the measurement of process indicators.

Sample Size

This research included all records of patients who entered the program during 2016 and started ART, 173 records were analyzed. No sampling technique was required

Data analysis

Regarding the variables analyzed in the study were; 7 Demographic and Clinical at the time of Diagnosis, 16 Clinics at the beginning of ART and 16 Clinics at cut-off (December 31, 2016).Using the Stata14® software (StataCorp, College Station, Texas, USA), univariate analysis was performed, applying descriptive statistics; The distribution of the data was evaluated for all numericalvariables, through the statistical test Shapiro Wilk Normality Test, the quantitative variables were summarized through the median with their interquartile ranges. Nominal variables were summarized through proportions, statistically significant differences with p- values equal to or less than 0.05 were considered.This research used as a reference of compliance two groups of indicators, recommended by the evidence-based consensus to evaluate management and clinical results in care institutions for people living with HIV in Colombia, as well as the recommendations of the Clinical PracticeGuideline (CPG) basedon scientific evidence for the care of HIV/AIDS infection in adolescents (13 years of age or older) and adults (19). published in 2014. It was calculated as a proportion with their respective 95% confidence intervals, taking as numerator those subjectswith HIV/AIDS who complied with 100% of the recommendations and as denominator the entire population with ART enrolled in the program during 2016. With respect to compliance with the indicators proposed by the CAC, 13 clinical area indicators were evaluated, all of them process-related; three for initial evaluation, two for monitoring, six for therapy and two for specific prevention.

The optimalvirologic response frequency, defined as a viral load of less than 50 viral RNA copies per mL, was calculated as a proportion with their respective 95% confidence intervals, taking the numberof patients as the numerator with HIV/AIDS who obtaineda viral load of less than 50 copies of viral RNA per milliliter at week 48 and the denominator was taken the entire ART population included in the program during2016. With a compliance standardof 80% according to the ColombianFund for High-Cost Diseases, a result > 80%, a medium of 80% to 70% and a low range < 70>

Through bivariate analysis, the factors related to non-compliance with the indicators were identified, the OR with their respective confidence intervals was used as measures of association, the statistical association was carried out through the Chi2 statistical test and significant values of p were assumed to be equal to or less than

0.05. A multivariate analysis was performed through binomial logistic regression to adjust for possible confounders and determine the weight that each variable contributed to the non-compliance with the recommendations of the clinical practice guideline. The rate of viral suppression was assessed through survival analysis with the Kaplan-Meier curves; To determine the statistical differences between the curves by sex, the Log Rank Test was used.

Ethical Considerations

This research was approved as a risk-free investigation by the ethics committees of the specialized IPS and the Free University, according to minutes 007-2019, CD- 002714-S010010105 of 2019. This

research is covered by international agreements on biomedical research according to the Helsinki Agreement, and the level of risk is declared according to Resolution 8430 of 1993 of the Ministry of Social Protection of Colombia. The authors declare no conflict of interest.

The selection criteriaof 271 clinical records of patients who entered the HIV program during January 1 and December 31, 2019 were evaluated.

2016; A total of 98 recordswere excluded becausethey did not meet the selection criteria, and information from 173 records was analyzed, Figure 1.

Regarding compliance with the indicators proposed by the CCS, to measure the quality of the process,an overall compliance of 23.07% (3/13), Annex 1, was obtained.

Figure 1. Diagramfor the identification of patient registries with compliance with the recommendations of the CPG and with

optimal virological response at week 48 in a Specialized IPS Cali 2016.

The study population was mainly made up of men with 86.7% (150/173), the median age was 32 years (IQR 25 - 44), 75.7% (131/173), reported having residence in Cali, the entire population belonged to the contributory regime, of the 23 women registered in the program, 17.3% (4/23) were pregnant. According to the stage of infection at the time of diagnosis, 63.5% (113/173) of patients were in stages.

In the early stages of A1-A2 and B1-B2 (25), the most frequently reported method of family planning was the barrier method (94.2% (163/173), Table 1.

Table 1: Demographic and Clinical Characteristics of the Population at the Time of Diagnosis

With respect to compliance with the initial assessment indications, proposed by the indicators of the clinical practice guideline and the evidence-based consensus of minimum indicators, to evaluate management and clinical outcomes in institutions for the care of people living with HIV in Colombia, 92.48%(160/173) of the people diagnosed with HIV infection receivedcare from an expert physician and during follow-up had a medianof 6 ( IQR 4-7) medical care per year. 

Regarding the measurement of the initial viral load (CV), this was performed in all diagnosed patients, of whom 98.8% (171/173) reportedviral load of one thousandor more copies at the start of ART and one patient with an undetectable viral load at the time of diagnosis. CD4 count was measured at diagnosis at 93.06% (161/173) with a median CD4 cell/mm3 (IQR 157-380), of which 31.8% (55/173) of the subjects had CD4 ≤ 200 and 16.1% (28/173) CD4 ≤ 100 patients; whilethe CD4 lymphocyte control count during follow-up was performed in 87.8% (152/173) of the patients. According to the CAC recommendation, 100% of patients should have a CD4 lymphocyte control count throughout the 48 weeks of follow-up from program entry, Table 2.

Table 2: Clinical characteristics of the population at the time of initiation of ART

Of the patients

who reported CD4 count ≤ 200 at the time of diagnosis, 23.6% (13/55) had opportunistic infections, the most frequent being generalized histoplasmosis and meningeal cryptococcosis, followed by Pneumocystis jirovecii pneumonia, multifocal leukoencephalopathy and toxoplasmosis. Prophylaxis for these germs was documented in three registry patients, one patient received trimethoprim sulfa and fluconazole and two patients received trimethoprim sulfa alone.

The 173 patients includedwere initiated ART and 95.3% (165/173) received counseling before initiating treatment for ECT. (TEC = Compliance AdvisoryWorker). The most frequently reported cause for the initiation of ART was related to the viral load value at diagnosis in 50.8% (88/173), followed by CD4 lymphocyte count value (42.2% (73/173), Table 1, 2, Annex 1.

Regarding the monitoring indicators, proportion of PLHIV with annual screening for syphilis or STIs, 29.5% (51/173) were diagnosed with a sexually transmitted infection in the following 12 months of follow-up, with screening of 100% of the study population. with a 100% compliance standard according to the Colombian Fund for High Cost Diseases;A result > 95% is

considered an appropriate range, medium from 95% to 90% and as low range < 90>

Regarding the indicator of the proportion of PLHIV with annual PPD, 47.4% (82/173)were evaluated for latent TB infection through the PPD (purified proteinderivative) skin test,of which 6.1% (5/82) of those evaluated reported a positive test 10 mm and of these,two received isoniazid prophylaxis. In the CCS, a measurement standard of 90% is considered as a goal in Colombia, with an adequate range

> 80%, a mediumrange of 80% to 50%, and a low range < 50% (24).

Regarding compliance with the therapy indicators, all pregnant women (4/23) received ART, a standard of 100% is considered in the CAC as a goal in

Colombia. No active TB was diagnosedduring the periodevaluated, so none of them received anti-TB treatment. A 90% target is considered in the CCS in Colombia. Regarding the resultsrelated to the optimalvirological response, it was foundthat 72.83% (126/173) achieved undetectable viral load results between week 9 and week 117 after initiation of ART. Regarding the indicator; proportion of PLHIV with undetectable viral load (CV) at 48 weeks or more of 48, with a standard of 80?cording to the Colombian Fund for High-Cost Diseases. IPS that care for PLHIV are expected to meet the standard, with an adequate range being considered a result > 80%, a mean range of 80% to 70%, and a low range < 70% (24). The remaining patients suppressed throughout follow-up with viral suppression data achieved up to week 117 after initiation oftreatment. Of the patients with undetectable viral load, 95.2% (120/126) obtained results in ≥ 48 weeks, 3.9% (5/126) viral load < 48>

50% of patients had their viral load assessed between week 68-92 after the start of ART. Continuing with the indicators of therapies; proportion of PLHIV with genotyping study in virologic failure as reported in clinical records, 100% (1/1), were studied with the viral genotyping test; it is considered a 90% standard in the CAC according to the Colombian Fund for High Cost Diseases. IPS that care for PLHIV is expected to meet the standard, with an adequate range being considered a result > 90%, a mean range of 90% to 70%, and a low range < 70>

Regarding the change of therapeutic scheme; In the indicator, proportion of PLHIV with a change in ART, 31.2% (54/173) of the subjects presented some change in the ART regimen; is considered a standard < 30> 40% (24); and the change associated with intolerance, adverse effect and drug interactions was 28.9% (50/173).

Regarding the prescription of patients who start ART within the reporting period, with any of the guidelines for choosing first-line treatment; the indicator, the proportion of PLHIV with initial ART prescription according to the choice guidelines defined in the Colombian Clinical Practice Guideline (CPG); for the Tenofovir/Emtricitabine/Efavirenz regimen, it was 19.6% (34/173), for the Tenofovir/Emtricitabine/Atazanavir/Ritonavir regimen 26.5%    (46/173),    for          the Tenofovir/Emtricitabine/Darunavir/Ritonavir regimen 7.5% (13/173), for the Tenofovir/Emtricitabine/Raltegravir regimen8.1% (14/173), for the Abacavir/Lamivudine/Efavirenz regimen815/173)

and likewise for the Abacavir/Lamivudine/Atazanavir/Ritonavir regimen (15/173). With respect to the level of compliance recommended by the CCS standards (adequate > 95%; medium 90- 95%; and under < 90>

In relation to compliance with specific prevention indications, the proportion of patients with prophylaxis for Pneumocystis jirovecii pneumonia did not meet the goal established for patients with CD4<200>200/ml lymphocyte count at the time of diagnosis, 72.9% had a complete HBV vaccine regimen (78/107). A 100% standard is considered a target in Colombia in the CCS, Table 3.

In this evaluation, an overall adherence to the recommendations of the CPG and CAC was found to be 11% (19/173) (Table 3). Viral load measurement at 48 weeks was performed in two 1.15% patients, who had an undetectable viral load (< to>

Figure 2. Viral Load Suppression SurvivalAnalysis by Sex

Table 3: Current clinicalcharacteristics at cut-off(December 31, 2016) of patients enrolled in the institutional program

To explore the possible clinical factors related to non-compliance with the Clinical and Management Results indicators proposed by the2014 High Cost Account Consensusand the recommendations of the Clinical PracticeGuideline (GPC); the bivariate analysisshowed a statistically significant association with havinga psychiatric illness at the beginning of ART, which behaved as a protective factor with an OR of 0.05 (95% CI 0.004-0.645) and a value of p = 0.0199;And this is a residual confounder; It could be associated with the samplesize and the clinical variables that did not reach non- compliance in the subjects. It was also found that consultation with

an infectious disease physician favored compliance with the recommendations of the clinicalpractice guidelines in 80% (OR 0.2, 95% CI 0.06-0.8: p=0.041). Some clinically significant variables, such as male sex, CD4 lymphocyte count at the start of ART, and pregnancy status, did not show a significant association for non- compliance with the indicators, Table 4.

Table 4: Factors related to non-compliance with the recommendations of the clinical practice guidelines in an IPS specialized in the management of HIV/AIDS

According to the multivariate analysis, it was found that the factors that independently explaincompliance with the recommendations of the clinical practice guideline were interconsultation with an infectious disease specialist, the result of last CV and pregnant woman, and the variable opportunistic infections and psychiatric illness at the start of ART was excluded, which shows that this behaved as a confounder. Non-compliance is not related to the clinical variables of the subjects, since they do not explain the non- compliance with the indicators; Non-compliance may be related to

program administrative variables that were not evaluated during the study; Therefore, it is important for programmes to assess administrative barriers(process indicators); Hence the importance of the epidemiology of health services, Table 5.

Table 5: Adjusted model of factors related to non-compliance with the management indicators and evaluation of the resultsof the implementation of the proposed recommendations of the clinical practice guideline (CPG) in an IPS specialized in the management of HIV/AIDS

Factors related to optimal virological response were also explored, and the following variables were found to be statistically significant: CD4 lymphocyte count, which behaved as a protective factor with an OR = 0.18 (95% CI 0.07-0.46) and a p≤0.001value. A statistically significant association was also found between optimal viral load and non-performance of PPD (OR = 2.42, 95% CI 1.19-4.9 with a value of p = 0.014). Other variables of clinical significance, according to the theoretical framework of the research, such as age, sex, and change of ART medications, among others, were not statistically significant in this study, Table 6.

Table 6: Factors related to the non-optimal virological response of the management indicators and evaluation of the resultsof the implementation of the proposedrecommendations of the clinical practice guideline (CPG) in an IPS specialized in the management of HIV/AIDS.

According to the multivariate analysis, the associated factors that independently explain the increased risk for optimal virologic response according to the recommendations of the clinical practice guideline were the CD4 lymphocyte count and not performing the PPD, it is possible that it is an indicator variable of administrative barriers that were not evaluated; The reading was not recordedin all subjects to whom the PPD was applied, Table7.

Table 7: Adjusted model of factors related to the non-optimal virological response of the management indicators and evaluation of the results of the implementation of the proposed recommendations of the clinicalpractice guideline (CPG) in an IPS specialized in the management of HIV/AIDS

According to the survival analysis to estimate the rate of viral suppression takingweek 117 as an outcome, where 72.83% (126) of the subjects evaluated managed to suppress viral load (viral load RNA < 50 copies/mm3) at 79 weeks of follow-up, the probability of viral non-suppression was 0.8323. (0.7570- 0.8861). At week 48 after the initiation of ART, only 3.66% of the population had achieved virologic suppression 0.9634(0.9203-0.9834). Significant differences were found in the survival curve on the speed of viral suppression according to sex. However, curves discriminated by

ART were not compared. It was observed that females suppressed viral load more rapidly than males. However, over time during follow-up (week 109), the lines cross, showing similar behavior for both sexes. According to the value of p and Log Rank

<0>

Table 8: Main studiescited

This researchevaluated the clinicaland demographic characteristics of patients diagnosed with HIV/AIDS infection, enrolled in a specialized IPS in Cali, Colombia, during 2016, and determined compliance with management indicators in a program for the management of patientsliving with HIV/AIDS, in a specialized IPS in Cali, Colombia. virologic response and determinants of optimal virologic response at week 48. The main reason for patients not having a viral load at week 48 after starting ART was the lack of timely follow-up by the program's multidisciplinary group. It was found that 11% of the population studied by the specialized IPS complied with the guidelines of the CPG and the indicators of the CAC; in contrastto data provided by the Ministry of Health and Social Protection, in Colombia in 2018, 75% of the diagnosed population had access to pharmacological treatment and remained adhered to care programs (14). Since no information about drug adherence was obtained through surveysin the registries of the study population, it was not possible to measure it or obtain information about it to compare it with the studies reviewed in the literature.

Regarding the analysis of demographic factors, the present study reported that 86.7% of the population corresponds to the male sex, whichis in agreement with what has been reviewed in the literature; regarding pregnant women, a study carried out in South America reportedthat 75% of pregnant women started ART after 26.6 weeks of gestation until 11.7 weeks after delivery.as a strategy for the prevention of mother-to-child transmission, this prophylaxis resulted in CVP (Plasma viral load) < 400>

gestation to achievea CVP < 400copies/ml at delivery (26-28).The study found that all pregnantwomen (4/23) receivedART; 2 of them had started ART before pregnancy and the other 2 pregnant women started ART between the 17th and 27th week of gestation, since they entered the specialized HIV/AIDS program. The viral load after the first four weeks of starting ART reported more than one thousand copies/ml for all pregnant women, however, viral suppression was achieved at the end of gestation in 75% (3/4) only one pregnant womanreported detectable viral load but less than a thousandcopies at the end of pregnancy. It is considered late entry; A pregnant woman who presents after 28 weeks with a diagnosisof HIV and has never received ART should begin treatment with HAART (a combination of three or more antiretroviral drugs). without delay (29).

On the other hand, the study reported that 1.7% (3/173) of patients at the start of ART had chronic kidney disease, however, the stage of the disease or the need for dialysis replacement therapy is not specified. However, the expert panel of the clinical practice guideline (CPG) recommends management with antiretrovirals in all HIV-infected persons with nephropathy, taking into account analytical descriptive studies suggesting a relationship between virologicalcontrol, preservation of renal functionand survival; since HIV-associated nephropathy is the main cause of end-stage renal disease in this group of patients and is characterized by HIV- associated renal disease. due to involvement of glomerular capillaries, tubular microcystic dilation and tubulo-reticular inclusions. Therefore, if this condition is left untreated, it usually progresses to end-stage renal failurein a matter of weeks tomonths

(19). It was found in the literature through the consensus on the management of renal pathology in patients with HIV infection Expert Panel of the AIDS Study Group (GESIDA) of the Spanish Society of Infectious Diseases and ClinicalMicrobiology (SEIMC), the SpanishSociety of Nephrology (S.E.N.) and the Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC). whereas renal function should be monitored in all HIV-infected patients on a regular basis, as well as, those on renal replacement therapy or pre-dialysis (GFR < 20 ml/min/1.73 m2) should be placed on the kidney transplant waitinglist as long as they meet the general criteria after evaluation for kidney transplantation and the specific criteria  for  HIV  infection.  (Quality  of  evidence:  High.

Recommendation Rating: Strong (30). Several studies have shown cost-effectiveness for the health system of kidney transplantation; Data reported in Argentina and Colombia show that kidney transplantation is the best treatment alternative for patientswith end- stage chronic kidney disease and provides better results in terms of survival, quality of life, and cost-effectiveness than dialysis replacement therapy, improving the sustainability of healthsystems (31-33).

In relation to the analysis of the factors related to non-compliance with the Clinical and Management Results indicators proposed by the2014 High Cost Account consensus and the recommendations of the Clinical PracticeGuideline (CPG), none of the clinical variables analyzed in this study could independently explain,after adjustment, non-compliance with the recommendations of the clinical practice guideline could be explained by the limitations in the samplesize, as well as by possibleconfounding variables such as psychiatric illness, interconsultation with an infectious disease specialist, which in the multivariate analysis lost the significance presented in the bivariate. In contrast, studies conducted in India found a relationship between clinical variables and compliance or adherence, where 96.8% of patients had optimal adherence (> 95%), with the TCD4 count (p= 0.05) and the effect of education to patients by programs on the importance of compliance and adherence to recommendations (p=0.04). While the main variables related to non-compliance were alterations in mental health (p=0.001), this could explain that in the face of serious mental illnesses that require a companion or caregiver, their assistance could favor adherenceor compliance with therecommendations of the clinical practiceguidelines (34-36). The impossibility of this study to find factors

The clinical differences related to compliance and adherence could be explained by the size of the sample or the fact that in this cohort the administrative variables have a greater strength of association than the clinical ones, however, these administrative variables were not available in the information sources consulted. In this study, demographic variables related to non-compliance were also not found, as demonstrated in countries with a high burden of HIV/AIDS such as sub-Saharan Africa and Asian countries, it was found that non-compliance was related to age under 30 years and female sex (37)

The review of the literature made it possible to compare the results found with those found in other studies such as the one conductedin the Bahamas in 2014, which determined optimal adherence or compliance if there were medical prescriptions in 11 monthsor more for each patient and viral suppression with a viral load was considered < 1000>

According to studies carriedout in the population of the city of Cali, Colombia, compliance or adherence rangesbetween 40% and 80%, andthe analysis of related sociodemographic factors showed that the lower opportunity to achieve optimal adherence or compliance (>95%) was related to age under 40 years (OR = 3.9; p=0.01), low socioeconomic stratum (OR= 4.7; p= 0.018), polypharmacy (more than 4 pills per day) (OR=3.6; p=0.062) and women with a partner or children diagnosed with HIV/AIDS (OR=2.43; p=0.083) (39-41). In contrast to the study conducted, compliance was 11% and the analysis of sociodemographic factors did not show statistical significance.

The proportion of patients who achieved viral suppression at the sixth month (week 24) of treatment was less than 1%, while at the first year (week 48) it was 1.15%. Survival analysis at week 117 (2.25 years), the last follow-up of the cohort, showed that 73% of followed patients achieved optimal viral suppression at more than twice the time recommended by the GPC. In studiesin the European population, it was reported that 42% of patients had viral loads of less than 200 copies/ml in the first month of ART, while in the third month this percentage reached 53% and at week 48, 48.1% achieved viral suppression (viral load <50>

North America reportedthrough its observational and experimental studies that about 70% of patients achieved rapid and successful immune and virological response to ART; Factorsthat predicted this response included early initiation of ART and age over 50 years,

85% had an undetectable viral load for 12 months (44-50). In relation to age, in the present study, virological suppression cannot be explained, because the risks are not proportional over time. It seems that in the group around 60 years of age, the rate of viral suppression is fastercompared to the other two groups. However,the population of patients included in this age group is too small to be compared. Nationwide, 70% of patients with ART managed to suppress their viral load and about 29.5% of patients on antiretroviral therapy (ART) were considered to be in Therapeutic Failure(TF), of which virological failure was the most frequent with 20.9%. In patients who showedlack of adherence to treatment, the chances of presenting a TF and virological were higher, 6.67 and 12.19 times, respectively, comparedto patients who showed good adherence and in terms of early vs. late genotyping, it was found that the most frequent type of resistance in patients under ART was to non- nucleoside inhibitors in 76% and the late study group had a higher risk of resistance to nucleoside inhibitors and protease inhibitors. The most frequently found association was non-adherence to treatment (51,52).This is very similar to the presentresearch, given that 84.21% of patients who complied with 100% of the program's benefits achieved undetectable viral load.

In relation to virological response, the determinants found in the literature that were not evaluated in the presentstudy were associated with the health care system, lifestyle, drug abuse, low income, and low level of education (young adults) (50) (53-63).

Regarding the indicator of CD4 count and prophylaxis of opportunistic infections, this study found that 97% of the population had CD4 counts, of which 48% (83/173) of patients had CD4

≤ 200 cells per cubic millimeter and of these, 8.09% received prophylaxis. Of the 55 patients with CD4 counts ≤ 200, 23.6% (13/55) were diagnosed

opportunistic infections. These indicatorsare considered below the U.S. PublicHealth Service and the USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus.MMWR 2002; 51(No.RR-8) (64). These low percentages in compliance with this indicator may be due to the limited time established by the program to provide the comprehensive care required by this population and consequently affects the quality of care and the information contained in medical records.

Given the complexity of the management and the deficiencies for the problematic management of people living with HIV/AIDS, the Ministry of Health of Colombia guarantees integrityin care through resolutions 3202 and 429 of 2016, in addition to promoting responsible sexual and reproductive health, in order to reduce the incidence of patients with HIV/AIDS; Offer testing in friendly service programs(rapid testing), to ensure earlydiagnosis and timely treatment in positive cases. In the care of patients diagnosed with HIV/AIDS, ensure comprehensive care, with expert personnel in management, and comply with the criteria established by the GPC; Actively integrate the intervention of the psychosocial group, provide follow-up and continuity in pharmacological and non- pharmacological treatment, reduce accessibility barriers for the population of dispersed areas, administrative barriers, promote responsible sexual health, construction, review and periodic measurement of clinicaland administrative indicators of process and result. It also recommends the evaluation of management and clinical results in institutions for the care of people living with HIV in Colombia and, at the same time, the generation of improvement plans in thosethat are not being met according to the established goal (65-67). However, in additionto compliance with these regulations, the success of PLHIVmanagement programs also depends on patient adherence, which in turn dependson the humanization of the service, the elimination of administrative barriers, the quality of care, and safety of patients. All of the above should be monitored through administrative and clinical outcome indicators.

The HIV epidemic continues to be a challenge for the world'spublic health systems, and its control must take into account not only clinical indicators, but also administrative ones.

The demographic characteristics of PLHIV in this program are consistent with those reportedin the literature and mainlyaffect men aged 32 years.

The diagnosis, treatment and follow-up of PLHIV is complex and requires participatory care from both the patient and the program.

Another weakness of the information system is the quality of the clinical records to extract real data that reflect the current situation of the population.

Program evaluation should be ongoing, focused on quality of care and clinical outcomes.

Limitations And Strengths

Due to the factthat this researchwas retrospective, the information on the exposure and the quality of the data in the clinical recordswas limited (information bias); a margin of error was found in the completion of the medical record and in the typing of the data recorded in the high-cost account. An attempt was made to control the error by corroborating the information recordedin the CAC with the clinical, laboratory and administrative records of the IPS; variables such as socioeconomic status, marital status, occupation, educational level,physical activity, and consumption of psychotoxic substances, were not measured since they were not recorded in the medical record and are not part of the CCS variables. No record was found of any self-reported survey to measure pharmacological adherence in the population enrolledin the program, as this tool was not available, only records of the months that the medications were formulated were obtained. The information found is similar to that of the national population, given that it has similar sociocultural, economic and health characteristics; In addition, specialized programs must be aligned with the CPG, with which the study population was evaluated. However, it is important to evaluate other determinants, which were not included in this research, but are of utmost importance, in order to analyze the population in a comprehensive way.

In relation to the measurement of evidence-based consensus indicators, it was not possible to measure monitoring indicators such as the proportion of PLHIV with CD4 follow-upand viral load in the

last six months and the proportion of PLHIV with annual cardiovascular risk assessment (CVR), since these data were not recorded in the reported registries.

Recommendations

Encourage further studies that allow for follow-up over a longer period of time, including tools to assess adherence to ART and according to social determinants, adverse effects related to medication use and barriers to access to medications in care facilities, the use of psychoactive substances, the transferfrom rural areas, the educational level, the economic income, the family or social support given that there is a knowledge gap.

Program evaluation processes through operational research should be included in order to adjust HIV/AIDS prevention and control strategies and improve the safety and quality of HIV/AIDS care population, as well as strengthening sexual and reproductive health services. In addition, at the institutional level, each IPS or specialized program must evaluate the efficiency of its HIV/AIDS strategies, evaluating adherence to antiretroviral treatment, virological response to pharmacological treatment on a regular basis according to the recommendations of national and international guidelines based on the best evidence, as well as comprehensive and multidisciplinary care with quality. that positively impact this specific population.

All authors declarethat they have no conflicts of interest that could influence the resuls or conclusions of the article.