|Year : 2012 | Volume
| Issue : 3 | Page : 95-101
Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs) in selected hospitals in Nigeria
Kenneth Anene Agu, Azuka Cyriacus Oparah, Uche M Ochei
Department of Clinical Pharmacy and Pharmacy Practice, University of Benin, Nigeria
|Date of Web Publication||5-Sep-2012|
Kenneth Anene Agu
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, University of Benin, Benin City (300001)
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Purpose: The study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following routine patient counseling and education in selected hospitals in Nigeria. Materials and Methods: From 36,459 HIV-infected patients on ART in the 36 selected hospitals, a study-specific instrument was administered to 3,650 patients in a cross-sectional study. Patients were provided counseling and education on ADRs before and after commencing ART. Factor analysis was performed using principal components extraction. Item score means above midpoint (3.7) on a 5-point scale were regarded as positive attitudes and below as negative attitudes. A chi-square test was used for inferential statistics; P<0.05 was used to determine statistical significance. Results: The mean questionnaire return rate was 47.5%. Data from 2329 (63.8%) participants were analyzed, 63.1% females and 34.4% aged 25-34 years old. A total of 80.1% participants accepted to have been counseled on ADRs; 65.8% knew that all medicines cause some kind of adverse effects; 55.1% knew the adverse effects of their medicines; 60.8% knew what to do when they suspect ADRs and it included mainly reporting to the healthcare provider (88.1%). However, only 31.9% had experienced ADRs previously. The knowledge of ADRs was associated with gender and educational and employment status of the patients (P<0.05). A total of 95.6% reported self-efficacy to ART. Majority of the rated attitude score means were >3.7 which denotes positive attitudes to ADRs. Three extracted factors accounted for 73.1% of cumulative variability. All attitude items had very significant loadings of ≥0.5. Conclusion: Overall, participants reported good knowledge and positive attitudes to adverse effects of their medicines compared to what was reported previously. The patient counseling and education on drug therapy provided to patients may have contributed to these findings and are highly recommended.
Keywords: ART, attitudes, adverse drug reactions, HIV, knowledge, Nigeria, patients
|How to cite this article:|
Agu KA, Oparah AC, Ochei UM. Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs) in selected hospitals in Nigeria. Perspect Clin Res 2012;3:95-101
|How to cite this URL:|
Agu KA, Oparah AC, Ochei UM. Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs) in selected hospitals in Nigeria. Perspect Clin Res [serial online] 2012 [cited 2020 Jan 19];3:95-101. Available from: http://www.picronline.org/text.asp?2012/3/3/95/100657
| Introduction|| |
Antiretroviral therapy (ART) has significantly reduced rates of morbidity and mortality in HIV-infected persons. , Nevertheless, patients also experience the adverse effects of antiretroviral drugs. ART regimens involve combination of at least three drugs and this implies combined toxicities from the individual drugs. Adverse drug reactions (ADRs) are an important cause of morbidity and mortality globally.  The treatment of ADRs imposes a high financial burden on health care. Some countries spend up to 15-20% of their hospital budget dealing with drug complications.  Studies have corroborated the association between adverse effects and non-adherence to medications. ,,, Non-adherence to ART increases the risk for development of drug-resistant virus and consequently treatment failure. 
Several studies have assessed the knowledge and attitudes of health workers regarding ADRs. ,, However, only few studies have evaluated patients' knowledge, attitudes and reporting practices about ADR. ,, The patients' knowledge of the adverse effects of their medication was reported to be very poor.  This was corroborated by other studies that reported significant deficits in patients' knowledge of their medications. , Patients' experience of serious ADR impact on their current lives both physically and psychologically to the extent that medicines were dreaded and even avoided altogether.  Patient reports of ADRs experienced were more detailed in the description of the reactions compared to those from health workers and often noted the impact of the ADR on their lives. 
Increased patient knowledge of drug therapy may improve adherence and reduce the morbidity and mortality related to ADRs especially those that are preventable. Bongard et al. reported that majority of patients desired to be informed of all possible adverse effects of their medications regardless of how rare the adverse effects were.  Patients do not favor physician discretion in the provision of information relating to their care. 
None of the studies to our knowledge evaluated the knowledge and attitudes of patients about ADRs in Nigeria. This study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following patient education intervention in selected hospitals in Nigeria.
| Materials and Methods|| |
In a cross-sectional study, the knowledge and attitudes of HIV-infected patients receiving antiretroviral therapy (ART) regarding adverse reactions of antiretroviral drugs were evaluated after routine patient counseling and education in selected hospitals in Nigeria.
The study was carried out in 36 public hospitals providing comprehensive HIV treatment services in Nigeria.
The President Emergency Fund for AIDS Relief (PEPFAR) through United States Agency for International Development (USAID) supports free comprehensive HIV care and treatment to HIV-infected patients in many health facilities in Nigeria. The HIV-infected patients in the PEPFAR-supported health facilities selected for this study were provided three sessions of pretreatment adherence counseling and education that included information on adverse effects of antiretroviral drugs. This information was reinforced while on therapy at every medication refill visit at the ART outpatient pharmacy.
This intervention was aimed at improving the patient knowledge of antiretroviral therapy and consequently adherence.
All HIV-infected patients currently receiving ART, refilled their antiretroviral medications at the outpatient ART Pharmacy Department during the study period and consented to participate were eligible to be included in the study. All HIV-infected patients who did not meet the above criteria and those receiving ART for the first time were excluded.
Study population, sample and sampling methods
The study population included 36,459 HIV-infected patients currently receiving ART in the 36 purposively selected study sites. From this population, 3,650 HIV-infected patients on ART were selected using the simple random sampling technique. The sample size was determined based on the "rule of the thumb" proposed by Nunnaly, who suggested that the number of subjects should be at least 10 times the number of items. 
The 17-item data collection instrument was study specific and employed mainly a 5-point Likert-type scale. The study instrument had three sections namely socio-demographic (5-items), knowledge of adverse effects of HIV medicines (5-items), and attitude to the adverse effects of HIV medicines (7-items).
The initial draft of the instrument was made and circulated to technical experts and a biostatistician, objectively discussed, and modified based on their feedbacks for content validity. In addition, it was also pretested to assess the feasibility and reliability of the study instrument and modified accordingly. The characteristics of the site and participants used in the pretesting were similar to those of the study site and participants; and they were not included in the main study to avoid bias.
The administration of the instrument to study participants was done by the researcher and 10 trained research assistants.
The ethical approval for this study was obtained from National Health Research Ethics Committee (NHREC) Abuja, Nigeria. Informed consent of the patients was also obtained. They were assured of the confidentiality of the information.
Data analysis was done using PASW statistics-18 software. The responses were analyzed using descriptive statistics of the sample characteristics and questionnaire items. The Likert rating scale was anchored as follows: Strongly agree = 5, agree = 4, neutral = 3, disagree = 2, and strongly disagree = 1; negatively worded items were reverse coded so that higher scores represent higher knowledge and attitudes. A Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy was calculated to determine the extent to which the attitude variables belonged together and were appropriate for factor analysis. The sample is adequate if the value of KMO is greater than 0.5;  values greater than 0.90 are rated as "marvelous" for factor analysis.  Bartlett's test of sphericity was also performed; and a value less than 0.05 of the significance level indicate that a factor analysis may be useful with variables.
Factor analysis was performed using principal components extraction and varimax rotation with Kaiser normalization. Listwise deletion was used for missing values in the factor analysis. Factors selected for rotation had eigen-values greater than 1. Items with factor loadings greater than or equal to 0.40 were considered significant, and loadings of 0.50 or greater were considered "very significant."  Rated attitude scores were treated as interval data suited for quantitative analysis. Mean item scores were computed for the individual attitude items. A midpoint of 3.7 was used for the 5-point scale which was determined by adding all the scores and computing the average. Mean scale scores above the midpoint were regarded as positive attitudes while below the mid-point were considered as negative attitudes.
Reliability analysis was performed to determine the internal consistency of the instrument using Cronbach's alpha. The intraclass correlation coefficient (ICC) with a two-way mixed model (where people effects are random and measures effects are fixed) were also determined. The chi-square test was used for inferential statistics to explore associations between socio-demographics and groups of questionnaire items. All reported P values were two-tailed and P < 0.05 used to determine statistical significance.
| Results|| |
Characteristics of study participants
The mean questionnaire return rate was 47.5% (95% CI, 37.1-57.9). Completed and returned questionnaires from 2329 (63.8%) of the targeted 3650 participants for this study were valid for analysis. Of the participants, 63.1% of them were females; 34.4% were between 25 and 34 years old; 33.7% had secondary education; 37.9% were self-employed and 59.3% were married [Table 1].
|Table 1: Frequency distribution of the participants' socio-demographic characteristics (N= 2329)|
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Knowledge of adverse effects of HIV medicines
Of the participants, 80.1% of them accepted that they were counseled about the unpleasant effects of their medicines before starting the medications; 11.8% reported that there were not counseled while 8.1% were not sure if they were counseled about the unpleasant effects of their medicines.
However, only 65.8% of the participants reported knowing that all medicines no matter how good cause some kind of unpleasant (adverse) effects; 14.9% reported lack of knowledge of this fact while 19.4% were not sure about this fact. The participants' knowledge that all medicines cause some kind of adverse effects had a significant association with participants' sex ( P = 0.013), educational ( P = 0.000), and employment status ( P = 0.004), unlike the age group ( P = 0.360) and marital status ( P = 0.616).
Only 55.1% of the participants reported knowing the unpleasant (adverse) effects of their medicines; 27.6% reported lack of this knowledge and 17.3% were not sure if they know the adverse effects of their medicines.
Of the participants, 60.8% reported knowing what to do when they experience unpleasant effects suspected to be caused by their medications; 24.4% reported lack of this knowledge and 14.8% were not sure if they know what to do when they experience unpleasant effects. The participants' knowledge of adverse effects of their medications and what to do when they experience adverse effects was statistically associated with sex ( P = 0.000), age group ( P = 0.000), educational status ( P = 0.000), and employment status ( P = 0.000) unlike the marital status ( P = 0.286).
When the participants were asked to indicate the specific action(s) to be taken when they experience unpleasant effects suspected to be caused by their medicines, 88.1% indicated that they will report to healthcare provider at the clinic/hospital [Table 2].
|Table 2: Frequency distribution of the actions reported to be taken by the participants when they experience unpleasant effects suspected to be caused by their medicines, N = 1349 |
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Of the participants, 31.9% participants reported having experienced adverse effects of their medicines in the last 30 days, 55.3% have not experienced adverse effects, and 12.7% were not sure if they had experienced adverse effects in the last 30 days.
Sex ( P = 0.597), marital status ( P = 0.172), and educational status ( P = 0.202) of the participants had no statistical association with the participants' experience of adverse effects in the last 30 days unlike age ( P =0.000) and employment status ( P =0.000).
Attitudes toward adverse effects of HIV medicines
Of the participants, 95.6% agreed that they benefit from their medications and get better when they take them; 51.3% agreed that medicines sometimes have adverse effects and can make ones health condition worse; and 75.5% disagreed that it is of no use to ask doctor or pharmacist about any adverse effects of medications because it is not preventable and will still occur anyway [Table 3].
|Table 3: Frequency distribution of the participants' responses to the attitude items |
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With respect to factor analysis of attitude items, after the listwise deletion of missing values, 2229 cases remained. The Kaiser-Meyer-Olkin measure of sampling adequacy for the factor analysis was 0.80. Bartlett's Test of sphericity was statistically significant ( P = 0.000) indicating that factor analysis was useful for the attitude data. The internal consistency of the 7-item attitude scale based on standardized items as measured by Cronbach's alpha was 0.563. The average intraclass correlation coefficient for consistency was 0.448 (95%CI, 0.413-0.483).
Using the criterion of an eigenvalue greater than 1.0, three factors were extracted which accounted for 73.1% of variability in the original variables. A large first factor accounted for 43.9% of the variance. The second and third factors accounted for 14.9% and 14.4% of the variance, respectively. All the communalities were 0.50 or greater (of which 85.7% of them were 0.70 or greater). The scree plot indicated a break after the third factor (eigenvalue = 0.824). All the items on the attitude scale had one factor loading of 0.62 or greater [Table 4].
| Discussion|| |
The study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following patient counseling and education intervention in selected hospitals in Nigeria. Majority of the participants accepted that they were counseled about adverse effects of their medicines. This corroborated the information that patient counseling and education on drug therapy were provided to the patients at these hospitals.
Over one-half of the participants acknowledged the fact that all medicines no matter how good cause some kind of adverse effects; and reported knowledge of both adverse effects of their medicines and what to do when they experience these adverse effects. Majority of the participants indicated that they will go back to the hospital and report to healthcare provider when they experience adverse effects. This is good compared to significant deficits in patients' knowledge of their medications reported previously, ,, although there is still room for improvement. The patients' knowledge of adverse effects of their medications and what to do when they experience these adverse effects was significantly associated with gender, educational, and employment status of the patients. Female gender, post secondary education, students, and unemployed participants reported better knowledge compared to others.
Less than one-third of the participants have experienced adverse effects of their medicines in the previous 30 days. Marital status, gender, and educational status of the participants had no significant association with the occurrence of adverse effects in these participants. A further study is needed to accurately document the incidence or/and prevalence of adverse effects of ART and associated risk factors in these patients.
The belief that prescribed medications are efficacious and taking them will be of benefit to the consumer is fundamental to good adherence. Almost all the participants reported self-efficacy of their antiretroviral therapy, a positive attitude to drug therapy. Using a midpoint of 3.7, all participants had rated mean scores across majority of the attitude items that denotes positive attitudes to adverse effects of their current medications. Conversely, participants had rated scores mean for the attitude item "medicines sometimes have adverse effects and can make ones health condition worse" that denotes negative attitudes. In addition, participants' rated scores mean to the statement that "adverse effects of medicines are their problem for which they should worry about and take responsibility" denotes negative attitudes. Overall, the participants reported positive attitudes to adverse effects of their medicines. A good understanding of these adverse effects is imperative in developing positive attitudes to them. Patients' experience of serious ADR may impact negatively on their current lives.  However, if patients understand the adverse effects of their medicines and what to do when they occur, the physical and psychological impact on their lives may be minimal as they may begin to develop positive attitudes and coping strategies to them. The study findings may corroborate the linkage between good knowledge and positive attitudes.
The patient counseling and education on drug therapy provided at the study sites may have contributed to the better knowledge and positive attitudes reported among the participants and are highly recommended in all hospitals. This is particularly important as studies have shown that patients desired to be informed of all possible adverse effects of their medications and do not favor physician discretion in the provision of information relating to their care. ,
The KMO value was greater than 0.5 indicating that the sample was adequate for factor analysis.  This was corroborated by Bartlett's test of sphericity which was also significant. The internal consistency of the 7-iems attitude scale as measured by Cronbach's alpha was poor.  This was corroborated by ICC value that indicated a fair agreement of items in the attitude scale.  However, it is important to note that increasing the value of alpha is partially dependent upon the number of items in the scale. All items in the attitude scale had very significant loadings of 0.50 or greater which may indicate that the extracted factors represented the variables well.  The extracted factors reduced the complexity of the dataset with a 26.9% loss of information.
There were limitations to this study. Unstable HIV-infected patients such as those with advanced HIV infection that could not refill their medications at the outpatient pharmacy or were hospitalized during the study period may have been omitted. Some participants may falsely report good knowledge and positive attitudes to adverse effects of their medicines to impress the researcher (response bias). Both factors may overestimate the effects been measured in this study. There may be recall bias when responding to the questionnaire items in the instrument. This has the potential to either overestimate or underestimate the effects been measured.
Majority of the participants were counseled about adverse effects of their medicines. Overall, the participants reported good knowledge and positive attitudes to adverse effects of their medicines following the intervention compared to what was reported previously. Almost all participants reported self-efficacy of their antiretroviral therapy. The knowledge of adverse effects of drugs was associated with gender, educational, and employment status of the patients. A good understanding of these adverse effects is imperative in developing positive attitudes to them. The patient counseling and education on drug therapy provided at the study sites may have contributed to the better knowledge and positive attitudes reported among the participants and are highly recommended in all hospitals.
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[Table 1], [Table 2], [Table 3], [Table 4]