|Year : 2021 | Volume
| Issue : 2 | Page : 54-59
Medication adherence of antiretroviral drugs in HIV-positive children in Maharashtra
Tanishq N Gore, Neeraja Pasalkar, Rojin Mathew Daniel, Prasanna R Deshpande
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be) University, Pune, Maharashtra, India
|Date of Submission||15-Mar-2021|
|Date of Decision||15-May-2021|
|Date of Acceptance||16-Jun-2021|
|Date of Web Publication||1-Feb-2022|
Dr. Prasanna R Deshpande
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be) University, Pune, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Human immunodeficiency virus (HIV) is a viral infection that can lead to acquired immunodeficiency syndrome (AIDS). It is a virus that breaks down the CD4 cells in the immune system which weakens the immune system allowing it to be vulnerable for lethal opportunistic infections.
Aim and Objective: Medication adherence of antiretroviral drugs in HIV-positive children in Maharashtra.
Methodology: A prospective, observational, multi-centric study was conducted among HIV-inflicted paediatrics in Maharashtra. This study was conducted for a duration of 6 months, i.e., from October 19 to March 20 on patients under the inclusion criteria. Marathi and English versions of MARS (Medication Adherence Report Scale) questionnaire and demographic details were collected form the participants.
Results: A total of 75 questionnaires were distributed and procured, filled with vital information of the participants among the three study sites. The average age of the participants was found to be 14.1 years. Overall female predominance was there (55% girls. According to our scoring scale, an adherence of 90.66% was observed among the participants, whereas the other 9.33% were considered non-adherent or partially adherent.
Conclusions: The present study indicates that the HIV-inflicted paediatric patients have a good knowledge about their medical condition and were adherent to antiretroviral therapy.
Keywords: HIV, India, Maharashtra, Medication Adherence, Pediatrics
|How to cite this article:|
Gore TN, Pasalkar N, Daniel RM, Deshpande PR. Medication adherence of antiretroviral drugs in HIV-positive children in Maharashtra. J Patient Saf Infect Control 2021;9:54-9
|How to cite this URL:|
Gore TN, Pasalkar N, Daniel RM, Deshpande PR. Medication adherence of antiretroviral drugs in HIV-positive children in Maharashtra. J Patient Saf Infect Control [serial online] 2021 [cited 2022 May 29];9:54-9. Available from: https://www.jpsiconline.com/text.asp?2021/9/2/54/337094
| Introduction|| |
Human immunodeficiency virus (HIV) is a viral infection that can lead to acquired immunodeficiency syndrome (AIDS). The HIV infection is a significant global public health problem which claimed 770,000 lives in 2018. In India, it was estimated by National AIDS Control Organisation (NACO) that the number of people living with HIV is at 21,40,000 (1,590,000–2,839,000) in 2017. Out of these, the number of children (<15 years) account for 61,000 (43,000–85,000). According to the statistics from the World Health Organisation in 2018, the reported number of children (0–14 years) receiving highly active anti-retroviral therapy (HAART) was only 5,66,000. While the estimated number of children needing antiretroviral therapy was around ~1,990,000 resulting in a coverage of just 28% of HIV-infected children.
Adherence is defined as a patient's ability to follow a treatment plan, take medications at prescribed times and frequencies and follow restrictions regarding food and other medications. In India, very few studies are concerned with the adherence of the paediatric HIV-afflicted patients, especially as there as stigma associated with this disease. The national guidelines by NACO indicate a requirement for >95% adherence to antiretroviral treatment (ART) for optimal treatment. There are various methods that have been developed to measure adherence like (a) self-report questionnaires or structured interviews, (b) therapeutic drug monitoring, (c) electronic devices and (d) pharmacy pick-up/refill rates. The use of well-reviewed questionnaires like the Medication Adherence Rating Scale (MARS) and its derivatives can help assess adherence in a convenient and effective way.
Therefore, this study was designed to identify the levels of adherence and the factors influencing adherence to ART among HIV-positive children in Maharashtra.
| Methodology|| |
This was a prospective, observational, multi-centric study.
This study was conducted for a duration of 6 months dated from October 2019 to March 2020 on patients under the inclusion criteria.
The three selected study sites were Non-Governmental Organisations (NGOs) located in the state of Maharashtra.
- Patients receiving HAART (age <18 years)
- Caregiver or guardian of the patient incompetent to respond.
- Patients not receiving HAART
- Patients being reviewed under medico legal cases.
Number of subjects
A convenient sample size of 75 patients inclusive of all genders.
- Institutional Review Committee approval was obtained
- Approval from the NGOs mentioned in the study sites.
- Questionnaire Form (English and Marathi, Medication Adherence Rating Scale; MARS)[Figure 1] and [Figure 2].
Translation of the questionnaire
The questionnaire was translated into Marathi (regional language) for the study to facilitate better comprehension of the questions and objectives to the patient.
Validation of the questionnaire
The draft of the questionnaire was shown to colleagues, linguists and other professionals for determining errors on pilot basis (n = 5), and they were asked to check the context, conciseness, grammar and course of the questions.
Launching of questionnaire
The selection of participants was comprehensive to the inclusion criteria.
Detailed information entailing the study objectives were explained to the participants and consent was received thereby ascertaining their willingness to participate in the study.
The questionnaires were issued to the participants.
The questionnaires were procured for demographic details, methods of data collection whether self-responded or interview based and to analyse medication adherence.
Data entry and analysis
The collected data were entered into Microsoft Excel, and the assessment of medication adherence was done according to the acknowledgement received with respect to the given set of questions.
Analysis of the data was carried out using various statistical methods such as Chi-square test, margin of error, confidence level and response rate.
Raosoft calculator (raosoft.com) and mathisfun.com were the sites used for the statistical analysis.
| Results|| |
In this study, a total of 75 questionnaires were distributed at the three sites, of which all 75 were collected back with filled in information. This gave us a response rate of 100%. For the sample size of 75, the margin of error was found to be 11.29% according to Raosoft sample size calculator, considering parameters such as confidence level, response distribution as 95% and 50%, respectively. The number of filled questionnaires obtained from sites 1, 2 and 3 were 11, 38 and 26, respectively.
Demographics of the patients in our study are shown in [Table 1].
[Table 2] portrays the patient's responses with respect to the questions from [Figure 1].
Interpretation of results
The questions that show significance respective to the demographic categories can be determined using the Chi-square test [Table 3].
|Table 3: Question-wise P values of patient's responses based on the respective demographic categories|
Click here to view
Age showed statistical significance only when the patients were asked whether they only take medications when they fell sick.
No significance of gender was seen related to adherence.
When patients responded by themselves, they mentioned that medication does not make them feel tired or sluggish while patients who were interviewed mentioned they do sometimes feel tired or sluggish on medication.
Based on education level, questions 1 and 2 related to forgetfulness and carelessness, respectively, showed statistical significance.
The MARS-10 contains 10 items that a patient who is fully adherent to their prescribed medication (and so would be expected to have a 'positive' subjective response to medication) would answer as 'True', and vice-a-versa 10 items such a patient who is partially adherent would answer as 'False'. To calculate the score from a set of answers, each 'positive' answer was given a score of plus one, and each 'negative' answer was given a score of zero. In the following [Table 4], the 'positive' answers (score = +1 [plus one]) are shown in the bold text. In question one, for example, an answer of 'False' would score plus one and an answer of 'True' would score minus one. The total score for each patient was calculated as the sum of the positive scores. A positive total score indicates a positive subjective response (adherent) and a below average total score indicates a negative subjective response (non-adherent) [Table 4].
Adherence based on the scoring system
Based on the scoring system, the adherence of the patients was analysed from the data obtained by the means of a questionnaire. The rate of adherence obtained is displayed in [Table 5].
As observed, the rate of adherence was found to be 90.66% based on the limited data obtained from the questionnaire.
Based on the data collected, the Cronbach's alpha value was low at 0.52 which falls in the 'Poor' category for internal consistency.
| Discussion|| |
To the best of our knowledge, this is one of its kind study to be well researched and documented in the country that assesses the medication adherence in HIV-inflicted paediatric patients.
A convenience sample size of '75' was incorporated in our study. The sample size included in White et al. (n = 63) was comparatively lower and that of Smith et al. was almost the same, i.e., n = 79. Seth et al. (n = 106), Nsheha et al. (n = 183), Mehta et al. (n = 164), Eticha and Berhane (n = 193), Nichols et al. (n = 440), Mghamba et al. (n = 300), Vreeman et al. (n = 191) comprised of a greater sample size in contrast to our study of a sample size of n = 75.
Our study was highly inclusive of only paediatric population receiving HAART. The mean age group of patients in our study was 14.1 years. Nshena et al. (n = 17) years had a greater mean age group in comparison to our study. Seth et al. (n = 8.6) years, K Mehta et al. (n = 10.2) years, Eticha et al. (n = 7.8) years, Nichols et al. (n = 9.8) years, Mghamba et al. (n = 8) years, White et al. (n = 7.9), Smith et al. (n = 7.1) and Vreeman et al. (n = 8.2) years manifested a lower mean age group of the patients as compared to our study having mean age group of n = 14.1 years.
Our study was inclusive of both the genders specified. The percentage of males in our study was 45%, whereas that of females was 55%. Vreeman et al. had similar percentage of males (45%) and females (55%) as that of our study. Smith et al. (55.7%), Nshena et al. (51%), K Mehta et al. (58%), Eticha et al. (62.2%), Nichols et al. (52%), Mghamba et al. (49.3%), White et al. (57%) and Seth et al. had a percentage greater than the males in our study, i.e. 45%. Moreover, comparatively percentage of females were lower in the above studies in comparison to our study of 55% females.
The duration of our study was 6 months. The duration of Eticha et al. (2 months) was lesser than our study, whereas Nshena et al., Mghamba et al., White et al. and Vreeman et al. were conducted over a period of 6 months that is equivalent to our study duration. Mehta et al. (17 months), Nichols et al. (41 months) and Smith et al. (63 months) were conducted for a greater span of time on comparison.
In our study, the method of data collection was a validated MARS questionnaire. A set of 10 questions were presented to the participants in English as well as Marathi. Nshena et al. (structure questionnaire), K Mehta et al., Eticha et al. and Mghamba et al. presented with the method of data collection as questionnaire as well. Seth et al. was an interview-based method of archival. White et al. was interview based as well as a questionnaire type. Micro electro mechanical system (MEMS), i.e., MEMS method was used for the collection of data in Vreeman et al.
Based on the scoring system, the adherence of the patients in our study was analysed from the data obtained by the means of a questionnaire. The rate of adherence was found to be 90.66% based on the limited data obtained from the questionnaire. The adherence noted in Eticha et al. (86.90%), Nshena et al. (24.60%), Mghamba et al. (85%) and Smith et al. (85%) was found out to be less when compared to the adherence level in our study. Whereas K Mehta et al. (90.9%), Seth et al. (95.3%–99%), Nichols et al. (93.20%) and Vreeman et al. (96.30%) showed more adherence level as compared to our adherence level of 90.66.
There were also a few limitations to the study like the fact that the study was conducted over a period of 6 months which was only enough to procure a convenient sample size of 75. Had the study been conducted for a longer duration the sample size could have excelled. Furthermore, there weren't as many research articles related to the project from India so it was arduous to get articles as a standard reference for the parameters of the study. This could be a really distinctive study as compared to previous studies conducted in India. The range of the study was restricted to some extent due to the ethical and regulatory protections in place for paediatric patients. We tried approaching private practitioners to obtain more patients in our inclusion criteria, but they were reluctant to disclose their information. To add to it only a finite number of NGOs were actually approachable as the amount of institutions available were low already. We tried to approach government officials for their support, but they were unavailable. Furthermore, the research outcome might encounter transition in the near future as children are accountable to enumerable developmental changes including their opinion about certain things in our case adherence to the medications. Stigma and discrimination are known barriers to adherence and caregivers are therefore reluctant to disclose a child's HIV status to anyone resulting them being less than approachable and thus fewer patients are available for studies. Due to the small sample size and nature of the data, the findings cannot be generalised, but may be used to inform future research. Adherence measurement in children is more complicated than measurement in adults because primarily the behaviour and lifestyle changes are more radical or varied as compared to adults.
| Conclusions|| |
To the best of our knowledge, this is one of the rarer studies assessing the medication adherence of HIV-positive paediatric patients in Maharashtra. Our study concluded that the HIV-positive paediatric patients had good knowledge about their medical condition and were adherent to antiretroviral therapy. Awareness and knowledge regarding the disease condition, treatments and statistics is one of the ways to reduce non-adherence among patients.
A huge thank you to one and all for their guidance and succor in accomplishment of our project. Your encouragement means the absolute world to us!
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Sahay S, Reddy KS, Dhayarkar S. Optimizing adherence to antiretroviral therapy. Indian J Med Res 2011;134:835-49.
] [Full text]
Lam WY, Fresco P. Medication adherence measures: An overview. Biomed Res Int 2015;2015:217047.
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res 2000;42:241-7.
Wessa P. Cronbach alpha (v1.0.5) in Free Statistics Software (v1.2.1), Office for Research Development and Education; 2017. Available from: https://www.wessa.net/rwasp_cronbach.wasp/]
. [Last accessed on 2020 March 30].
White YR, Pierre RB, Steel-Duncan J, Palmer P, Evans-Gilbert T, Moore J, et al. Adherence to antiretroviral drug therapy in children with HIV/AIDS in Jamaica. West Indian Med J 2008;57:231-7.
Smith C, Gengiah TN, Yende-Zuma N, Upfold M, Naidoo K. Assessing adherence to antiretroviral therapy in a rural paediatric cohort in KwaZulu-Natal, South Africa. AIDS Behav 2016;20:2729-38.
Seth A, Gupta R, Chandra J, Maheshwari A, Kumar P, Aneja S. Adherence to antiretroviral therapy and its determinants in children with HIV infection - Experience from Paediatric Centre of Excellence in HIV Care in North India. AIDS Care 2014;26:865-71.
Nsheha AH, Dow DE, Kapanda GE, Hamel BC, Msuya LJ. Adherence to antiretroviral therapy among HIV-infected children receiving care at Kilimanjaro Christian Medical Centre (KCMC), Northern Tanzania: A cross- sectional analytical study. Pan Afr Med J 2014;17:238.
Mehta K, Ekstrand ML, Heylen E, Sanjeeva GN, Shet A. Adherence to Antiretroviral Therapy Among Children Living with HIV in South India. AIDS Behav 2016;20:1076-83.
Eticha T, Berhane L. Caregiver-reported adherence to antiretroviral therapy among HIV infected children in Mekelle, Ethiopia. BMC Pediatr 2014;14:114.
Nichols JS, Kyriakides TC, Antwi S, Renner L, Lartey M, Seaneke OA, et al. High prevalence of non-adherence to antiretroviral therapy among undisclosed HIV-infected children in Ghana. AIDS Care 2019;31:25-34.
Mghamba FW, Minzi OM, Massawe A, Sasi P. Adherence to antiretroviral therapy among HIV infected children measured by caretaker report, medication return, and drug level in Dar Es Salaam, Tanzania. BMC Pediatr 2013;13:95.
Vreeman RC, Nyandiko WM, Liu H, Tu W, Scanlon ML, Slaven JE, et al.
Measuring adherence to antiretroviral therapy in children and adolescents in western Kenya. J Int AIDS Soc 2014;17:19227.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]