HIV/AIDS patients’ knowledge, attitude, and practice toward anti-retroviral therapy medications’ adverse effects and associated factors in Tikur Anbessa Specialized Hospital

Abstract

Background:

Adverse effects (AEs) have been reported with all antiretroviral therapy (ART) medications, and it was among the most common cause for switching or terminating therapy and drug non-adherence. Even though AEs of ART medications are common and to be expected, little study has been conducted on the understanding of patients on the AEs. Therefore, this study aimed to assess patients’ knowledge, attitude, and practice (KAP) toward ART medications’ AEs and associated factors.

Methods:

A cross-sectional study design was applied using an interviewer-administered questionnaire from June to September 2021 on human immunodeficiency virus/acquired immunodeficiency syndrome patients on follow-up at Tikur Anbessa Specialized Hospital, Ethiopia. Data was gathered, cleaned, and analyzed using SPSS version 23. Logistic regression analysis was performed to assess the relationship between the independent variable and patients’ knowledge and attitude about the AEs of ART medication. A p-value of 0.05 was used to determine the statistical significance.

Results:

About 230 people were enrolled in this study, with 51.3% of them female. Study participants had a mean age of 36 years (standard deviation = 14.19). Of 230 participants, 67.8% had received advice on the AEs of ART medications. Poor knowledge and attitude were observed among 47.8 and 51.3% of respondents, respectively. Prior AEs experience, lack of experiencing opportunistic infection, and lack of counseling about ART medications’ AEs were associated with poor knowledge, whereas female gender and a lack of counseling regarding ART medications’ AEs were associated with a negative attitude (p < 0.05). Even though most patients (81.7%) report AEs of the medication to professionals, a significant number of patients involved in malpractices such as taking other drugs to treat AEs (24.3%), not prepared to do anything (27.1%), change the suspected drug (24.3%), reduce the dose (18.7%), and use local herbal medicines to treat suspected AEs (20.2%).

Conclusion:

Overall, the study participants had poor knowledge, lack of positive attitudes, and non-adherence to the actual recommended practice toward AEs of ART medications. Lack of comorbidity, having prior AEs experience, and lack of counseling regarding ART medication AEs were associated with poor knowledge. Female gender and a lack of counseling on the AEs of ART medications were associated with a negative attitude.

Plain language summary

HIV/AIDS patients’ knowledge, attitude, and practice toward anti-retroviral therapy medications’ adverse effects and associated factors in Tikur Anbessa Specialized Hospital

Patients are expected to be aware of the adverse effects (AEs) associated with their medication and its management. AEs are common with antiretroviral therapy (ART) medications. It is among the most common causes for patients to lose faith in the safety of medicines, resulting in poor adherence or complete discontinuation of life-prolonging medications. Understanding the level of awareness about AEs of ART medication among consumer is important to fill this knowledge gap and improve medication adherence and quality of life. The study evaluates human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients’ knowledge, attitude, and practice (KAP) toward AEs of ART medications and associated factors.

The authors used a cross-sectional study design using an interviewer-administered questionnaire to measure KAP toward AEs of ART medication among HIV/AIDS patients on follow-up at Tikur Anbessa Specialized Hospital (TASH), Ethiopia. TASH is the largest teaching and referral specialized hospital in Ethiopia. About 230 of 270 distributed questionnaires were completed, with the response rate of 85%.

Among the 230 participants, 68% had received advice on the AEs of ART medications, 82% knew that all medicines had some sort of AEs, 53% knew the AEs of their medications, and 60% knew what to do if they suspected AEs, which was primarily informing their healthcare provider (82%). About 48 and 51% of respondents had poor knowledge and attitudes about the AEs of ART medications, respectively. Previous AEs experience, lack of experiencing opportunistic infection, and lack of counseling about ART medications’ AEs were associated with poor knowledge, whereas female gender and lack of counseling were associated with negative attitude.

Our findings indicated that the study participants had low knowledge, negative attitudes and low adherence to recommended practice toward AEs of ART medications. Lack of counseling regarding the AEs of ART medications was associated with the poor knowledge and poor attitude toward ART medication AEs.

Introduction

The human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) is a major global public health concern, which took the lives of an average 40.1 million people to date.^1,2 At the end of 2021, there were an estimated 38.4 million people with HIV, more than two-thirds of whom resided in the World Health Organization (WHO) African Region.^1,2 In 2021, 1.5 million individuals became newly infected with HIV, and 650,000 individuals passed away from HIV-related causes. ² By 2015, Sub-Saharan Africa accounted for three-quarters of all HIV-positive people and nearly the same number of AIDS-related deaths. ³ According to 2021 United Nations Programme on HIV/AIDS (UNAIDS) Ethiopia Spectrum national estimates, Ethiopia had an estimated 616,105 HIV-positive people, with 425,699 adults (>25 years), 36,364 adolescent (15–24 years), and 17,550 children under the age of 15 on antiretroviral therapy (ART). ⁴

When ART is started early, it can significantly reduce HIV-related morbidity, lower the risk of premature death, and improve the quality of life for long periods of time. The viral suppressive effect of ART leads to reductions in infectivity and a lower likelihood of disease transmission among sexual partners.^5,6 AIDS-related illness has decreased in recent decades, owing primarily to the continuous scaling-up of highly active ART. ⁷ The same is true in Ethiopia, where AIDS-related deaths have decreased dramatically from 83,000 in 2000 to 15,600 in 2017 because of ART implementation. ⁸

Despite its highest potential for HIV infection management, ART can also cause mild to severe adverse effect (AE). ⁹ ART-related AEs are among the most prevalent reasons for switching or terminating therapy, extended hospital stays, high costs, medication non-adherence, and even death. In Ethiopia, according to a pharmacovigilance center report from 2009 to 2011, antiretroviral drugs are responsible for more than three-quarters of adverse drug events, followed by antituberculosis drugs. ¹⁰ ART-related adverse events are frequently linked to lower levels of medication adherence, leading to the discontinuation of drug therapy. ¹¹

In Ethiopia, there are few studies carried out to assess patients’ knowledge, attitudes, and practices regarding ART-related adverse events. ¹² Studies which are conducted revealed that drug toxicity is the primary reason for changing the first-line regimen among HIV patients on ART, limiting our treatment options. It’s also one of the most important predictors of poor compliance. ¹³ The purpose of this study is therefore aimed at assessing the knowledge, attitude, and practice (KAP) of HIV/AIDS patients toward their antiretroviral medications’ AEs. The study also examines factors associated with HIV/AIDS patients’ KAP toward their antiretroviral medications’ AEs in Tikur Anbessa Specialized Hospital (TASH). This study will help professionals to determine patients’ general KAP toward their antiretroviral medications’ AEs and help them to improve medication adherence and quality of life.

Methods

Study design and population

A cross-sectional study was conducted by using an interviewer-administered questionnaire on HIV/AIDS patients on follow-up at the HIV clinic of TASH in Addis Ababa, Ethiopia. TASH is the largest specialized hospital in Ethiopia, with over 700 beds, and serves as a training center for undergraduate and postgraduate health science students. The HIV clinic in TASH provides free comprehensive HIV care services, including ART, treatment of opportunistic infections, HIV counseling and testing; care for HIV-exposed infants and family planning services, adolescent psychosocial support, and adult adherence support. The study was conducted from June 2021 to September 2021. All adult patients with HIV/AIDS on follow-up at the ART clinic of TASH were the source population, while those patients who visited TASH and were on anti-retroviral medication during the study period and fulfilled inclusion criteria were the study population. All registered HIV/AIDS patients of age 15 years and above accessing treatment and care at TASH during the study period were included in the study. Patients with HIV who were not taking antiretroviral medication, children under the age of 15, patients who refused to participate in the study, patients with psychiatric illnesses or cognitive impairment, and pregnant women were all excluded from the study.

Sample size and sampling technique

The sample size for the study was determined using the following formula

$$n=\frac{Z2p\left(1-p\right)}{d2}=\frac{\left(1.96\right)2x\left(0.5\right)\left(0.5\right)}{\left(0.05\right)2}=384$$

Where:

• ➢ n – The initial sample size required

• ➢ p – Prevalence of KAP (50%)

• ➢ d – The margin of sampling error tolerated (5%)

• ➢ Percentage confidence level (1.96) – Z is Z-statistic for a level of confidence.

In the proportional formula, since there is no estimate of the prevalence rate on this topic, we used a prevalence of 50%, a 5% margin of error, and a 95% confidence level. Using the above formula the sample size is calculated to be 384.

Since the total population is <10,000, which is 910. The final sample size (reduction formulas) can be given as:

$$nf=\frac{n}{1+n/N}=\frac{384}{1+384/910}=270$$

Where

• ➢ nf – final sample size

• ➢ n – total study population, which is 384

• ➢ N – the source of population during 1 month data collection was 910

Therefore, a final sample size of 270 participants was targeted for the current study. People who attend the follow-up ART clinic waiting in queue who participated in the study were sampled using systematic random sampling. The first person was selected by default and then the next person was chosen by constant interval (k) considering daily sample size (k = N/n; where N = 18–20 average number of patients per day; n = 6–7 sample to be taken per day). An average of 18–20 patients per day attend the follow-up ART clinic, which is open 3 days a week, and an average of six patients per day were sampled using a systematic random sampling technique to meet the required number of sample size during the study period.

Data collection and management

The data was collected manually via paper based and online Google forms using a pre-tested interviewer-administered questionnaire. The data collectors gather information face to face from participants who sit in row every three interval (k = N/n; where N = 18–20 average number of patients per day; n = 6–7 sample to be taken per day) by guiding with either of the two tools (paper-based or online Google forms). During data collection period two data collectors were involved: one data collector used paper-based data collection tool while the other used online google form. The questionnaire was prepared in English and translated into the Amharic language. It was developed after a critical literature evaluation. The questionnaire was designed to capture crucial information needed to address the study’s objective. The data collection tool was enriched by external experts’ comment. The variables collected from the study participants included socio-demographic factors (age, gender, occupation, educational level, religion, monthly income, marital status, place of residence) and clinical characteristics of the study participants (duration of HIV infection, comorbid disease, opportunistic infections, WHO HIV clinical stage, type of regimen, etc.). The questionnaire also included four-item questions to evaluate knowledge of ART medications’ AEs, seven-item questions to measure attitudes toward ART medication AEs, and six-item questions to assess practice for dealing with ART medications’ AEs. After the responses were collected, the Amharic responses were translated into English to be analyzed. Prior to questionnaire being administered it was tested on 5% of the sample size and, based on the finding, an amendment was made to the final questionnaire to ensure the quality of data. The data collectors were trained on how to conduct data collection and resolve any problems that may occur during the data collection process.

Assessment of KAPs toward ART medications’ AEs

The knowledge scale was based on an instrument developed by literature review and adapting published instrument containing statements about ART medications’ AEs knowledge and scored as ‘True’, ‘False’, or ‘Don’t Know’. Correct responses were summed on a four-point rating scale with scores above mean indicating higher/good knowledge levels and below mean scores indicating lower/poor knowledge. The attitude scale was also based on a question developed by adapting different literature about attitude toward AEs of ART medication. The scale was scored on a five-point Likert-type scale, which rated as Strongly agree (1), Agree (2), Neutral (3), Disagree (4), and Strongly disagree (5) with score above mean indicating good attitude. The practice scale contained items that were scored as ‘yes’, ‘no’, or ‘not applicable’ (https://www.sciencedirect.com/science/article/pii/S2214139119300344).^12,14–16

Data analysis

The data that was collected manually via paper-based method were entered into Google form to add up to the others filled directly on the Google form. Then all the collected data were exported to Excel and cleaned to ensure accuracy, consistency, and completeness. This data was exported to the SPSS version 23 (Chicago, Illinois, United States) and analysis was performed. The descriptive statistics of categorical and continuous data were summarized using frequency, percentage median, mean, and standard deviation (SD). Logistic regression analysis was performed to assess the relationship between socio-demographic and clinical characteristics, and patients’ knowledge about the AEs of ART medication. Those variables with statistical significance in binary logistic regression were further analyzed using multivariable logistic regression to overcome the effect of the confounding variables. A p-value of <0.05 was considered statistically significant for all data analysis.

Results

Socio-demographic characteristics

Out of the 230 participants in this study, 118 (51.3%) were females. The mean (SD) age of study participants was 36 years (SD = 14.19), in which most were in the age range of 15–35 years. About 30% were self-employed, 27% were working in government organizations, and 28.7% had secondary education. Of the study participants, about 46.1% were married, 32.2% had a monthly family income of between 3000 and 5000 Ethiopian birr (ETB), and the majority of the participants (96.5%) lived in urban areas (Table 1).

Table 1.

Socio-demographic characteristics of adult HIV/AIDS patients on follow up at TASH, Addis Ababa, Ethiopia (N = 230).

Variables/item descriptions		N (%)
Age in years	Mean (SD)	36 ± 14.19
	15–35	102 (44.3)
	36–45	59 (25.7)
	46–55	44 (19.1)
	56–65	22 (9.6)
	>65	3 (1.3)
Sex	Female	118 (51.3)
	Male	112 (48.7)
Employment status	Employed	69 (30)
	Self-employed	56 (24.3)
	Unemployed	42 (18.3)
	Student	58 (25.2)
	Retired	5 (2.2)
Place of work	Government organization	62 (27)
	Private organization	56 (24.3)
	Non-government organization	7 (3)
	Currently not working	105 (45.7)
Education status	Unable to read and write	20 (8.7)
	Able to read and write	11 (4.8)
	Primary school (grades 1–8)	16 (7)
	Secondary school (grades 9–12)	66 (28.7)
	Certificate/diploma	63 (27.4)
	Degree/above	54 (23.5)
Religion	Orthodox	156 (67.8)
	Muslim	31 (13.5)
	Protestant	37 (16.1)
	Jehovah witness	5 (2.2)
Monthly family income (ETB)	<1000	38 (16.7)
	1000–3000	48 (21.1)
	3000–5000	73 (32.2)
	5000–7000	42 (18.5)
	7000–10,000	17 (7.5)
	>10,000	9 (4.0)
Marital status	Single	83 (36.1)
	Married	106 (46.1)
	Divorced	13 (5.7)
	Widowed	23 (10)
	Separated	5 (2.2)
Place of resident	Urban	222 (96.5)
	Rural	8 (3.5)

AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus; SD, standard deviation; TASH, Tikur Anbessa Specialized Hospital.

Patients’ clinical characteristics

The mean (SD) duration of HIV infection among study participants was 11.4 years (SD = 4.8), with most in the range of 6–20 years of disease duration. Out of the 230 participants, 81.7% (n = 188) were educated about their clinical condition and 67.8% (n = 156) were reported to have been counseled on the AEs of their medicines. Among the participants, 25.7% had an AE to one or more of the ARTs they were prescribed, and 55.7% of the participants’ ART regimens were tenofovir disoproxil fumarate + lamivudine + dolutegravir. About 27% of participants reported having an opportunistic infection. Of the 27%, about two-thirds (66.1%) of them reported having tuberculosis as their opportunistic infection, while 19.4% had pneumonia (Table 2). The percentage of participants that switched from their initial regimen was 70.4%. The rationale for the switch was indicated to be mainly because of therapeutic failure (45.3%). The other participants mentioned that AEs (18.6%), unavailability of the regimen (18%), and the introduction of new updated ART guidelines (18%) were the common reasons for switching from the initial regimen.

Table 2.

Clinical characteristics of adult HIV/AIDS patients on follow-up at TASH, Addis Ababa, Ethiopia (N = 230).

Variables/item descriptions		N (%)
Duration of HIV infection in years	Mean (SD)	11.4 ± 4.8
	⩽5	31 (13.5)
	6–10	73 (31.9)
	11–15	71 (31.0)
	16–20	50 (21.8)
	>20	4 (1.7)
Education given about their clinical condition	Yes	188 (81.7)
	No	22 (9.6)
	Not sure	20 (8.7)
Counselled about unpleasant effect of ART medicine	Yes	156 (67.8)
	No	54 (23.5)
	Not sure	20 (8.7)
Prior AEs experience	Yes	59 (25.7)
	No	171 (77.4)
Type of current ART regimen	TDF + 3TC + DTG	128 (55.7)
	TDF + 3TC + ATV/r	46 (20.0)
	TDF + 3TC + EFV	20 (8.7)
	ABC + TDF + DTG	6 (2.6)
	ZDV + 3TC + NVP	5 (2.2)
	TDF + 3TC + NVP	3 (1.3)
	Others	22 (9.5)
Preventive therapy taken	Yes	130 (56.5)
	No	92 (40.0)
	Not sure	8 (3.5)
Initial ART switched	Yes	162 (70.4)
	No	66 (28.7)
	Not sure	2 (9.0)
Comorbidity	Yes	70 (30.6)
	No	159 (69.4)
Type of comorbidity	HTN	25(35.7)
	Diabetes	19 (27.1)
	Cardiac	14 (20.0)
	Asthma	8 (11.4)
	Other	4 (5.7)
Opportunistic infections	Yes	62 (27.0)
	No	168 (73.0)
Type of opportunistic infections	TB	41 (66.1)
	Pneumonia	12 (19.4)
	Herpes zoster	4 (6.5)
	Herpes simplex	2 (3.2)
	Oesophageal candidiasis	1 (1.6)

ABC, abacavir; AE, adverse effect; AIDS, acquired immunodeficiency syndrome; ART, antiretroviral therapy; ATV/r, atazanavir; DTG, dolutegravir; EFV, efavirenz; HIV, human immunodeficiency virus; HTN, hypertension; NVP, nevirapine; SD, standard deviation; TASH, Tikur Anbessa Specialized Hospital; TB, tuberculosis; 3TC, lamivudine; TDF, tenofovir disoproxil fumarate; ZDV, zidovudine.

Participants’ knowledge of ART AEs

Out of the four knowledge questions, with a score ranging from 0 to 2 for each, the respondents’ mean knowledge score was 4.01 (SD = 2.30). A knowledge score greater than or equal to the mean was achieved by 120 (52.2%) of the respondents. Accordingly, about half of the respondents had poor knowledge of the AEs of ART medications. As described in Table 3, about 81.7% of the study participants knew that all medicines, no matter how good, can cause some kind of unpleasant (adverse) effects. In addition, only about 53.0% of the participants know about the unpleasant (adverse) effects of their medicines. Of 230 participants, about 40% did not know or were not sure what to do when they experienced unpleasant effects suspected to be caused by their medications. Among the participants who knew the AEs of their medications, 42.2% believed that their regimen could cause gastrointestinal problems, 28.3% believed that it could cause psychiatric effects, 16.7% believed that it could cause metabolic effects, 13.3% believed that it could cause neurological effects, and 3.3% believed that it could cause cardiovascular effects.

Table 3.

Knowledge about AEs of HIV medicines of adult HIV/AIDS patients on follow-up at TASH, Addis Ababa, Ethiopia (N = 230).

Type	Yes	No	Not sure
	n (%)	n (%)	n (%)
Do you know that all medicines irrespective of how good they are can cause some unpleasant effects?	188 (81.7)	20 (8.7)	22 (9.6)
Do you know the unpleasant effects of the particular medicines you are taking for your condition?	122 (53.0)	78 (33.9)	30 (13.0)
Do you know what to do when you experience some of these unpleasant effects suspected to be caused by your Medicines?	139 (60.4)	54 (23.5)	36 (15.7)

AE, adverse effect; AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus; TASH, Tikur Anbessa Specialized Hospital.

Attitudes toward AEs of HIV medicines

Out of the seven attitude questions asked, each with a possible score ranging from 1 to 5, the respondents’ overall mean attitude was 18.93 (SD = 3.32). Attitude scores greater than or equal to the mean were achieved by 118 (51.3%) of the respondents, which were categorized as having a good attitude. Of the participants, 64.2% strongly agreed that they benefit from their medications and get better when they take them, while 37.1 and 17.5% disagreed and strongly disagreed that medicines sometimes have AEs and can make one’s health condition worse, respectively. Furthermore, 50.9% disagreed and 32.2% strongly disagreed that it is of no use to ask their doctor or pharmacist about any unpleasant effects of their medications because knowing will scare them from taking them as instructed (Table 4).

Table 4.

Attitude toward AEs of HIV medicines of adult HIV/AIDS patients on follow-up at TASH, Addis Ababa, Ethiopia (N = 230).

Statement	Response n (%)
	Strongly agree (5)	Agree (4)	Neutral (3)	Disagree (2)	Strongly disagree (1)	Mean (±SD)
I benefit from my ART medicines and I get better when I take them.	147 (64.2)	72 (31.4)	5 (2.2)	2 (9.0)	3 (1.3)	4.56 (0.71)
ART Medicines sometimes have adverse effects and can make one’s health condition worse.	23 (10.0)	53 (23.1)	28 (12.2)	85 (37.1)	40 (17.5)	2.7 (1.28)
It is of no use to ask my doctor or pharmacist about any adverse effects of my ART medications because it is not preventable and will still occur anyway.	15 (6.5)	33 (14.3)	32 (13.9)	89 (38.7)	61 (26.5)	3.6 (1.2)
It is of no use to ask my doctor or pharmacist about any unpleasant effects of my medications because knowing will scare me from taking them as instructed.	8 (3.4)	15 (6.5)	16 (7.0)	117 (50.9)	74 (32.2)	4.70 (0.55)
It is of no use to tell my doctor or pharmacist about my unpleasant experience (adverse effects) with my ART medications because I will end up getting more additional medicines.	10 (4.4)	17 (7.5)	20 (8.8)	109 (47.8)	72 (31.6)	3.94 (1.04)
Adverse effects of my ART medicines are my problem for which I should worry about and take responsibility.	39 (17.0)	91 (39.6)	25 (10.9)	47 (20.4)	28 (12.2)	3.28 (1.3)
I will stop or feel scared to continue my ART medications if I know that my medicines can cause undesirable/horrible effects when I take them.	9 (4.0)	22 (11.7)	10 (4.3)	90 (39.1)	94 (40.9)	4.01 (1.13)

AE, adverse effect; AIDS, acquired immunodeficiency syndrome; ART, antiretroviral therapy; HIV, human immunodeficiency virus; SD, standard deviation; TASH, Tikur Anbessa Specialized Hospital.

Practice toward AEs of HIV medicine

The majority of participants (81.7%) (n = 188) stated that they will report suspected AEs to their healthcare provider, while about a quarter (24.3%) (n = 56) stated that they will choose other drugs to take on their own. Among the study participants, 27.1% (n = 62) were not prepared to do anything but relax and wait, 61.3% (n = 141) were unwilling to change the drug(s) suspected of causing their medicines’ AEs on their own, 70.9% (n = 163) were unwilling to reduce the dose of the drug(s) suspected of causing the AEs, while 20.2 (n = 46) were willing to treat AEs with herbal medicines (Table 5).

Table 5.

Actions reported to be taken by adult HIV/AIDS patients on follow-up at TASH, Addis Ababa, Ethiopia (N = 230).

Statement	Response n (%)
	Yes	No	Not sure
1. Report to healthcare provider (doctor, pharmacist, etc.) at the hospital	188 (81.7)	24 (10.4)	18 (7.8)
2. Take another drug (s) to treat the suspected AEs	56 (24.3)	154 (67.0)	20 (8.7)
3. Relax and do nothing as the AEs will resolve as my body gets used to the medicines	62 (27.1)	120 (52.4)	47 (20.5)
4. Change the drug (s) suspected to cause the AEs of my medicines	56 (24.3)	141 (61.3)	33 (14.3)
5. Reduce the dose of the drug (s) suspected to cause the AEs	43 (18.7)	163 (70.9)	24 (10.4)
6. Use local herbal medicines to treat suspected AEs	46 (20.2)	142 (62.3)	40 (17.5)

AE, adverse effect; AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus; TASH, Tikur Anbessa Specialized Hospital.

Factors associated with knowledge and attitude of patients toward ART’s AEs

The logistic regression results revealed that patients’ AEs experiences [odds ratio (OR) [95% confidence interval (CI)]; 4.63 (1.31, 16.39)] and lack of experiencing opportunistic infections [OR (95% CI); 2.0 (1.10, 3.65)] were strongly associated with poor knowledge about the AEs of ART medication. The study found that females had a more than three times poor overall attitude toward the AEs of ART medications than males (p < 0.05). In this study, a lack of counseling regarding the AEs of ART medication was significantly associated with having poor knowledge [OR (95% CI); 1.94 (1.04, 3.63)] and a poor attitude [OR (95% CI); 5.65 (1.38, 23.10)] toward ART medication AEs (Table 6).

Table 6.

Socio-demographic and clinical characteristics associated with knowledge and attitude of patients toward AEs of HIV medicines of adult HIV/AIDS patients on follow-up at TASH, Addis Ababa, Ethiopia (N = 230).

Study variables		Knowledge status		p-Value	OR (95% CI)	Attitude status		p-Value	OR (95% CI)
		Poor knowledge	Good knowledge			Poor attitude	Good attitude
Gender	Male	50 (21.7)	62 (27.0)	Ref.		57 (24.8)	55 (23.9)	Ref.
	Female	60 (26.1)	58 (25.2)	0.35	1.64 (0.57, 4.74)	55 (23.9)	63 (27.4)	0.03	3.48 (1.16, 10.45)
Age (year)	>56	18 (7.8)	7 (3.0)	Ref.		11 (4.8)	14 (6.1)	Ref.
	15–25	43 (18.7)	28 (12.2)	0.53	0.33 (0.01, 10.52)	29 (12.6)	42 (18.3)	0.80	0.61 (0.01, 26.56)
	26–35	14 (6.1)	17 (7.4)	0.83	1.37 (0.84, 22.16)	16 (7)	15 (6.5)	0.76	0.65 (0.04, 9.85)
	36–45	20 (8.7)	39 (17.0)	0.57	1.83 (0.23, 14.52)	35 (15.2)	24 (10.4)	0.72	0.66 (0.07, 6.64)
	46–55	15 (6.5)	29 (12.6)	0.99	1.02 (0.13, 7.97)	21 (9.1)	23 (10)	0.87	1.21 (0.13, 11.45)
Education status	Degree/above	21 (10)	33 (15.7)	Ref.		26 (12.4)	28 (13.3)	Ref.
	Able to read and write	8 (3.8)	3 (1.4)	0.73	0.62 (0.04, 9.28)	7 (3.3)	4 (1.9)	0.33	0.11 (0.001, 9.86)
	Primary school	15 (7.1)	1 (0.5)	0.05	0.08 (0.004, 1.04)	9 (4.3)	7 (3.3)	0.90	1.17 (0.10, 13.44)
	Secondary school	29 (13.8)	37 (17.6)	0.14	0.33 (0.08, 1.43)	32 (15.2)	34 (16.2)	0.70	0.71 (0.13, 4.07)
	Certificate/diploma	22 (10.5)	41 (19.5)	0.69	0.73 (0.15, 3.41)	33 (15.7)	30 (14.3)	0.24	2.52 (0.54, 11.68)
Duration of HIV infection (years)	>20	3 (1.3)	1 (0.4)	Ref.		2 (0.9)	2 (0.9)	Ref.
	⩽5	20 (8.7)	11 (4.8)	0.91	0.88 (0.11, 7.02)	14 (6.1)	17 (7.4)	0.86	1.21 (0.15, 9.76)
	6–10	42 (18.3)	31 (13.5)	0.41	2.42 (0.30, 19.84)	33 (14.4)	40 (17.5)	0.85	1.21 (0.16, 9.08)
	11–15	21 (9.2)	50 (21.8)	0.74	1.44 (0.16, 12.98)	41 (17.9)	30 (13.1)	0.76	0.73 (0.10, 5.49)
	16–20	24 (10.5)	26 (11.4)	0.53	0.17 (0.001, 39.13)	21 (9.2)	29 (12.7)	0.76	1.38 (0.18, 10.61)
Education given about their clinical condition	Yes	84 (36.5)	104 (45.2)	Ref.		94 (40.9)	94 (40.9)	Ref.
	No	14 (6.1)	8 (3.5)	0.26	2.88 (0.46, 17.85)	7 (3)	15 (6.5)	0.36	0.43 (0.07, 2.63)
	Not sure	12 (5.2)	8 (3.5)	0.45	0.48 (0.07, 3.21)	11 (4.8)	9 (3.9)	0.46	0.46 (0.06, 3.63)
Counselling about AEs due to ART drug	Yes	64 (27.8)	92 (40)	Ref.		80 (34.8)	76 (33)	Ref.
	No	31 (13.5)	23 (10)	0.04	1.94 (1.04, 3.63)	19 (8.3)	35 (15.2)	0.02	5.65 (1.38, 23.10)
	Not sure	15 (6.5)	5 (2.2)	0.17	0.45 (0.14, 1.41)	13 (5.7)	7 (3)	0.43	2.67 (0.23, 30.75)
Drug AEs experience	Yes	17 (7.4)	42 (18.3)	0.02	4.63 (1.31, 16.39)	33 (14.3)	26 (11.3)	0.20	0.68 (0.37, 1.23)
	No	93 (40.4)	78 (33.9)	Ref.		79 (34.4)	92 (40.0)	Ref.
Reason for changing	ADRs	8 (5.0)	22 (13.7)	Ref.		20 (12.4)	10 (6.2)	Ref.
	Availability issue	13 (8.1)	16 (9.9)	0.58	1.57 (0.33, 7.36)	14 (8.7)	15 (9.3)	0.99	0.99 (0.18, 5.38)
	Because of current ART guidelines	16 (9.9)	13 (8.1)	0.74	1.29 (0.29, 5.82)	12 (7.5)	17 (10.6)	0.34	2.69 (0.36, 20.07)
	Therapeutic failure	36 (22.4)	37 (23.0)	0.39	1.86 (0.46, 7.52)	27 (16.8)	46 (28.6)	0.06	4.0 (0.96, 16.75)
Comorbidity	Yes	35 (15.3)	35 (15.3)	Ref.		30 (13.1)	40 (17.5)	Ref.
	No	74 (32.3)	85 (37.1)	0.63	0.87 (0.50, 1.53)	82 (35.8)	77 (33.6)	0.08	0.34 (0.10, 1.13)
Opportunistic infections	Yes	22 (9.6)	40 (17.4)	Ref.		33 (14.3)	29 (12.6)	Ref.
	No	88 (38.3)	80 (34.8)	0.02	2.0 (1.10, 3.65)	79 (34.3)	89 (38.7)	0.36	0.58 (0.18, 1.85)

ADRs, adverse drug reactions; AE, adverse effect; ART, antiretroviral therapy; CI, confidence interval; HIV, human immunodeficiency virus; OR, odds ratio; TASH, Tikur Anbessa Specialized Hospital.

Discussion

Despite its high effectiveness for managing HIV infection, ART can produce mild to severe medication AEs, which affect the patient’s perception of their disease management. ¹⁷ Therefore, assessing the knowledge, attitudes, and practice of HIV‑infected patients on ART regarding AEs is very important. In the current study, half of the participants had poor overall knowledge about the AEs of their ART medications. The majority of participants agreed that they were informed about the AEs of their medications and educated about their clinical condition. Similarly, a study conducted in South Africa ¹² and Ghana ¹⁵ found that people were well-informed about ART, but this contrasted with findings from other researchers who found that people were not well-informed about ART. ¹⁸ Even though most of the study participants know that all medicines, irrespective of how good they are, can cause some AEs, nearly 50 and 40% of participants did not know or were not sure about the AEs of particular medicines they were taking and what to do if it occurred, respectively. This finding is consistent with a study conducted in Nigeria among 36 selected hospitals. ¹⁹ Therefore, it is crucial to educate patients about the AEs of their specific drug and the steps that must be followed if it actually happens to them. This issue has an impact on their medication adherence and quality of life. ²⁰

In this study, of the participants who were aware of the AEs of their medications, 42.2% feel that their regimen can induce gastrointestinal effects, which is lower than a report from Pernambuco, Brazil, which indicated that around 69.1% reported gastrointestinal concerns. ²¹ Underreporting from the current study might be caused by study participants’ inadequate awareness of the potential AEs of their drug. This study also revealed that more than eighty percent of study participants were willing to report their AEs to their hospital healthcare provider. These findings are almost consonant with the study conducted in 36 public hospitals in Nigeria. ¹⁹ These are signs of good practice that prevented them from doing things in their own, which might hurt the disease condition management. However, in this study a significant number of study participants also took another drug on their own to treat suspected AEs, willing to use herbal medicine to alleviate AEs from their medications, and preferred to reduce the dose prescribed to them personally. The prevalence of this poor practice is substantially higher in the current study than it was in the Nigerian ¹⁹ and Ghana ¹⁵ studies. The difference might be related to the participant’s level of knowledge and the healthcare facility’s dedication to educating patients about how to handle the AEs they experience.

In the current study, the overall attitude assessment revealed that nearly half of the patients had a poor attitude toward the AEs of ART medications during utilization. In contrast to these findings, studies conducted in Nigeria ¹⁹ and Ghana ¹⁵ showed that more patients had a positive attitude toward AEs of ART medications in reporting it appropriately. This discrepancy could be attributed to differences in the level of awareness of enrolled patients as well as methodological differences such as sample size and methods of categorizing attitude status. Across some attitude questions, participants had a good mean score, which indicated positive attitudes to AEs of their current medications in taking it. The majority of respondents thought that taking their medications made them feel better, reflecting a favorable attitude toward medication. On the other hand, negative attitudes were indicated by the participants rated scores to the statement that ‘adverse effects of medicine are their problem for which they should be concerned and take responsibility’ and ‘medicines sometimes have adverse effects and can make one’s health condition worse’, which shows a poor attitude. The question denotes negative attitudes. ¹⁹ This suggests that there is low awareness of the possibility of AEs as a result of their medications, which is not seen as a ‘bad thing’, but rather as an unavoidable AE of medicine use to which they must adjust. When patients first start ART, they may experience severe AEs as a result of lower CD4 counts and immune reconstitution syndrome effects, ²² which can influence their negative attitudes. When the impact of ART is evaluated, AEs are frequently cited as lowering the quality of life, according to previous studies. ²³ Patients who can stick to their ART despite the discomfort quickly improve their quality of life and develop a positive attitude toward their medication. ²⁴

The logistic regression analysis showed that study participants who had AEs experience showed about five times poorer knowledge about AEs of ART medications. Patients who did not get counseling had poor knowledge about the AEs of ART medication and a poor attitude toward it. The findings of this study corroborate the Agu et al. ¹⁹ study, which found that HIV patients who were well informed about the AEs of their medications had positive attitudes toward reporting AEs to their healthcare providers. It also refutes previous research that claims patients do not want to know about the AEs of their medications. ²⁵ Continuous education and counseling about their disease and drug therapy are important to improve patients’ knowledge, positive attitudes, and good practice, which helps to achieve maximum outcomes. ²⁶ In this study, lack of experiencing opportunistic infections was also strongly associated with poor knowledge about the AEs of ART medication while other studies do not show any relations with opportunistic infections.^15,19 Patients who have comorbid conditions may have a chance to communicate with multiple healthcare providers, giving them the opportunity to learn more about the AEs of their medications from various experts. Providing patients with information about the AEs of their medication is frequently believed to significantly improve their knowledge. ²⁷ Females showed a more than three times negative overall attitude regarding the AEs of ART medications, which is similar to Eric et al. study, which found that while female attitudes about ART medication have improved, the negative attitude toward the AEs of ART medication has persisted. ²⁸ This could be attributed to socioeconomic issues that influence the focus of counseling and education about AEs of ART medications. ²⁹

Limitation

Even though the study brings actual data that was retrieved from patients’ personal reports about KAP of AEs of ART medications, it has some limitations. Some of these are short study duration, use of self-report questionnaires, single center study, and small sample size, which limits generalization for the whole population. The study identifies important points about HIV/AIDS Patients’ KAP toward ART medications’ AEs and associated factors that have to be addressed through intervention. As such, we suggest that the Ethiopia ministry of health and federal food and medicine authority should create an awareness about the AEs of ART medication and its management through different communication channels. The healthcare professionals such as physician, nurses, and pharmacist should also investigate patients’ perception during usual care and properly counsel the patients about the AE of the medication.

Conclusion

Even though the majority of HIV/AIDS patients on ART drugs who participated in this study got counseling on their disease and the AEs of their ART medications, the knowledge and positive attitude toward the medications’ AEs is low. The knowledge of AEs of ART medications were affected by previous ADR experience, a lack of experiencing opportunistic infection, and a lack of counseling about ART medications’ side effects, whereas a lack of counseling about ART medications’ AEs and female gender were associated with a negative attitude. In addition, a significant number of study patients involved in malpractice not recommended in actual practice toward AEs of ART medications.