INTRODUCTION
The human immunodeficiency virus (HIV)
infection has been a life-threatening phenomenon of great global public health
concern with about 36.7 million people living with HIV as at 2016 of
which, 52% resided in Sub-Saharan Africa.1 Earlier considered a
death sentence, the introduction of antiretroviral therapy (ART) has resulted
in HIV infection becoming a manageable chronic disease.1
As at 2018, Nigeria had the
second largest burden of HIV in Africa with an estimated 3.4 million HIV
positive persons with 1,090,233 of these receiving lifelong ART.2 By
2019, Nigeria had an estimated HIV burden of 1.9 million people, the fourth
largest in the world. Approximately 1.14 million of these people were on ART,
giving a 60% ART coverage.3 The South–
South zone of Nigeria (where Rivers State is located) has the highest
prevalence of the disease with statistical values of 5.5%. This means that
Rivers is one of the states in the country where the disease is endemic. 4
Adherence to medications is the process by which
patients take their medication as prescribed, further divided into three
quantifiable phases: ‘Initiation’, ‘Implementation’ and ‘Discontinuation’.5 It is a complex phenomenon that is susceptible
to several influences. These
variables can be separated into five categories: Social and economic variables,
treatment-related factors, disease-related factors, patient-related factors,
and factors associated with health care. 6
Adherence is assessed through common methods like
pill counts, self-reports, diary keeping, and electronic monitoring, each
having its own strengths and limitations. An objective measure of adherence is
typically defined as taking at least 95% of all prescribed doses, as this level
has been shown to effectively maintain viral load suppression and prevent
replication.5 Traditional
adherence measures, such as self-reported adherence, have played key roles in
ART implementation to date. 7 Self-reported adherence is the most
widely used method to assess adherence, particularly in real-world clinical
settings.8 However, it has multiple limitations including social desirability
and recall biases.8 Poor or non-adherence includes missing doses
completely, taking drug doses at the wrong time or not complying with dietary
requirements associated with a drug.7 This highlights a common
reason for treatment failure which causes poor viral suppression, hence posing
a potential risk of drug resistance. Researchers
and clinicians have tried to enhance the accuracy of adherence assessments by
combining self-reported adherence with pill counts and pharmacy refill data.
However, this method requires more time, staff, and resources, and doesn't
always result in greater accuracy. Pharmacologic measures, electronic adherence
monitors, and ingestible electronic pills aim to provide objective insights
into both overall adherence and adherence patterns, but these tools are costly
and often not easily accessible.8 With ART medication adherence in Africa estimated at 77% and Nigeria, the
third largest in the burden of HIV in sub-Saharan Africa, there is a challenge
in ensuring an optimal level of treatment adherence to prevent the development
and spread of resistant strains of HIV.6 A high level of adherence
is required to achieve the desired outcome of ART.8
In both the developed and developing world, the control of HIV infection using antiretroviral therapy (ART) has led
to a significant reduction in the transmission, morbidity, and mortality of the
infection.9 Treatment success requires both a sustainable supply of ART to clinics
and lifelong adherence to
treatment by patients.10 This emphasizes the need for efficient
delivery of care, especially regular ART to the patients.
Until recently, the clinic-based model of care was
the mainly promoted approach to disease control. The community-based
approach was introduced as a means of debunking the overwhelming patient load
of HIV-infected people. It started in the form of house-to-house testing.
In Nigeria, Community pharmacists have shown preparedness to provide HIV/AIDS
care.11
As more people are being placed on treatment, the more
the existing care facilities are getting over-crowded. Antiretroviral service
delivery at community pharmacy presently known as community pharmacy
antiretroviral refill programme (CPARP) was introduced to relieve the treatment
site. Community Pharmacy Antiretroviral Refill Programme is a new
community-based model. In this program, stable clients are devolved from
hospitals and clinics to some selected community pharmacies for medication
refill. 12 A stable HIV/AIDS patient, according to this program, is
one who has been on ART for not less than one year, has a viral load of less
than 1000 cells/mL and does not have a current opportunistic infection. In
addition, the client must be on first-line agents and willing to be so devolved
to the community pharmacy. After being devolved, the client receives medication
from the pharmacy every quarter; and returns to the clinic every six months for
clinical assessment.13 Laboratory evaluation (viral load
determination) is also carried out at the clinic every six months for the first
12 months then every year subsequently. The services provided at the community
pharmacies for the clients include chronic care screening, medication adherence
monitoring, antiretroviral (ARV) refill, counseling
and support, documentation, referral, and linkages.
The determination of factors affecting
adherence is one of the several issues that can provide valuable information on
which patients are at most risk of non-adherence and to develop strategies to
improve long term adherence. Various factors have been reported to affect
adherence to ART both locally and internationally and these include, absence/presence
of social support resources, disease duration, ART duration, continuous and
consistent information about ART regimen, forgetting, avoidance of side effect,
avoidance of being seen (stigma), financial constraints, change of daily routine.
Others are demographics like sex, age, marital status, occupation, residential
area and such like.5 Though a similar study has been done in Port
Harcourt, there has been no study on adherence among patients devolved to
community pharmacies for ART creating a great
need for information about adherence to
ART administered to these devolved clients in Rivers state of southern Nigeria.10
However a community based study of PLHIV on differentiated care in
various pharmacies in Akwa- Ibom
State of Nigeria showed a prevalence of
overall satisfaction and
adherence with the program of 92.16%.14
This study therefore aims to assess the level of medication adherence in PLHIV
in Rivers state devolved for treatment to community pharmacies and to determine
the factors associated with their adherence to monitor and improve their health
care management.
METHODOLOGY
Study area:
The study was conducted at
the antiretroviral clinic of the Family medicine department in RSUTH. RSUTH is one of the institutions that
provide comprehensive antiretroviral services to PLHIV in the State Rivers
State University Teaching Hospital, Port Harcourt a tertiary public health care
facility in the South-South region of Nigeria. The hospital has the following
departments; Internal Medicine, General Surgery, Obstetrics and Gynaecology,
Ear, Nose and Throat, Ophthalmology, Family medicine and the Accident and
Emergency department. It serves the people living in Rivers State and its
neighbouring States. The hospital offers comprehensive care services including
ART for HIV-infected patients. The adult
ART clinic runs daily from 8:00 am to 4:00 pm and medication adherence is
reinforced through adherence counselling and education.
Study Design
and Duration: It was a cross-sectional descriptive study that lasted
for 3 months.
Study
population:
The study sample consisted of stable adult PLHIV devolved from RSUTH to receive refills
at community pharmacies but returned to RSUTH for their six-month follow up
visit.
Selection
criteria
Inclusion criteria: Consenting
devolved HIV clients (18 years old and above) who had spent up to 6months
receiving refills at the community pharmacies.
Exclusion criteria: Those who
had not spent up to 6 months in receiving refill at the community pharmacy or too
ill to participate.
Sample size
determination
Using
the formula n = z2 (p)
(q)/d2
Where: n = sample size for large population,
standard normal deviate (z) usually set at 1.96 which corresponds to the 95%
confidence level and a p-value of ≤0.05, and p (prevalence) chosen from a
cross- sectional study of community pharmacies’ ART program in Akwa-Ibom state, south- south Nigeria16 a
minimum sample size of 113 was calculated and was approximated to 124 with 10%
attrition addition (to increase the power).
Sampling
method
The simple random sampling method (yes or no)
was used to recruit devolved clients (who were recieving
refills at various community pharmacies), during their follow-up visit at the
RSUTH into the study. Adherence in this study was considered within the
previous three months from the time of study and graded as poor adherence (had missed medications
within the last 3 months) and good adherence (last missed medication more than
3 months ago or had never missed medication signifying >95%.)
Data Collection
Instrument
The instrument for data collection was a
standardized, structured interviewer administered questionnaire. The
questionnaire has sections comprising patient socio-demographic characteristics;
adherence questions; client’s knowledge of ART information on correct dosing
and side effects as well as reasons for missed pills.
Data
collection technique
The questionnaire was prepared in English
language and administered by trained data collectors chosen from the volunteers
working at the HIV unit. The interviews took place at the ART clinic of
the Family medicine department. The
respondents were informed of the objectives of the study. They were assured of the utmost
confidentiality of their responses, and written consent was obtained before the
interview. The right of the respondents to refuse participation was respected,
with absolutely no negative consequences to them.
Data
Analysis
Data generated from the
questionnaire was sorted, coded, and analysed using Statistical Package for
Social Sciences (IBM SPSS) version 22. Descriptive
statistics were used in the presentation of results. Data were represented in percentages and
graphs and then analysed using the Chi-Square test. Statistical
significance was set at a 95% confidence interval with a p-value of
< 0.05.
Ethical
Consideration: Ethical
approval was obtained for this study, from the ethical committee of the Rivers
State Hospital Management Board (RSUTH/REC/2021052).
Outcomes measured: The outcomes measured were socio-demographical data of
clients, reasons for missed pills, family/social data, and medical and pharmaceutical
data.
RESULTS
The table
above analyzes the relationship between patients’
adherence levels and other factors such as family/social support and medical
factors.
Family/Social
Support:
Of the
patients who received family or social support, 56 (48.7%) had poor adherence
(missed medications within the last 3 months), while 59 (51.3%) had good
adherence (missed medications more than 3 months ago or never missed).
Among
those without family/social support, 7 (77.8%) had poor adherence, while only 2
(22.2%) had good adherence. The Statistical Results of Chi-square (X˛) value:
2.815 with a p-value of 0.093, and Fischer’s exact test of 0.164, indicates no
statistically significant relationship between adherence levels and
family/social support.
Availability
of Pharmacists to Answer Questions:
Among
patients with access to pharmacists, 50 (45.0%) had poor adherence, and 61
(55.0%) had good adherence. All 13 patients without access to pharmacists
(100%) had poor adherence, with none achieving good adherence.
Statistical
Results of Chi-square (X˛) value: 14.06, with a p-value of 0.000, and Fischer’s
exact test of 0.000 indicates a statistically significant relationship between
adherence levels and the availability of pharmacists to answer questions.
Constantly
Receives Adherence Counselling
For
patients who consistently received adherence counselling, 60 (50.0%) had poor
adherence, and 60 (50.0%) had good adherence. For those who did not receive
consistent counselling, 3 (75.0%) had poor adherence, and only 1 (25.0%) had
good adherence.
Statistical
Results of Chi-square (X˛) value: 0.968, p-value of 0.325, and Fischer’s exact
test of 0.619
Interpretation:
The p-values are greater than 0.05, indicating no statistically significant
relationship between adherence levels and receiving adherence counselling.
Satisfaction
with the Service Provided:
Among
patients satisfied with the service provision, a higher proportion 61 (52.1%)
had good adherence, while 56 (47.9%) had poor adherence.
All seven
patients dissatisfied with the service had poor adherence (100%), with none
achieving good adherence. Statistical Results of Chi-square (X˛) value: 7.182, p-value
of 0.007, and Fischer’s exact test of 0.013 indicates a statistically
significant relationship between adherence levels and satisfaction with the
service provided.
DISCUSSION:
High
levels of adherence were seen among those with good social factors, older age
groups, and long-term ART intake as in consonant with several other reported
cross-sectional studies.6, 8 In this study, ‘hiding their
medications’ was the rarest reason. This suggests a reduced stigmatization level,
which may have been due to good social support and education on the nature of
the disease as well as the importance of taking medication correctly. Most of the respondents missed their pills
because of forgetfulness and depression. This was similar to reports from other
Nigerian studies. 18,19
The
prevalence of ART medication adherence in this study was 49.2%. This was lower
than the national figure of 77%, in a study in Benin, which reported a
prevalence of 83.3% and 79.5% in a Lagos study.17,18
This could be because of self-reported medication adherence which is also
affected by recall bias.
Statistically
significant factors affecting adherence include the availability of pharmacists
to answer questions (p = 0.000), which is strongly associated with better
adherence and satisfaction with the service provided (p = 0.007), where
satisfied patients show better adherence. This agrees with the studies in Akwa Ibom state, Nigeria by Olorunsola et al and in Kwazulu-
Natal by Chimbindu et al.16,17
Studies have shown that patients with access to pharmacists are more likely to
have better adherence, agreeing with the results of our study. 8,9,10
This shows
poor access to a health care provider to be a major health disparity.
RECOMMENDATIONS
·
Pill count should therefore be encouraged to
combat forgetfulness.
·
Community pharmacies, being the best
structures are to be maintained to bring about this differentiated care with
expectant better results of global ART coverage.
CONCLUSION
This
community pharmacy ART refill model of differentiated care needs proper
monitoring with regular adherence counselling, pill count, and encouraging
accessibility of health care providers and promoting family support for
improved medication adherence to produce optimal clinical outcomes among PLHIV.
ACKNOWLEDGEMENT
The
authors are thankful to all those who contributed to the success of this study.
Conflict of Interest
The
authors declare that there is no conflict of interest.
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