ABSTRACT
Background: Achieving and maintaining viral load suppression is a critical goal in the management of HIV infection. Understanding the prevalence of viral load suppression and identifying factors associated with unsuppressed viral load can inform targeted interventions and improve treatment outcomes.
Aim:This study aimed to determine the prevalence of viral load suppression and explore the factors independently associated with unsuppressed viral load among patients on antiretroviral therapy (ART) for at least six months.
Methods: A facility-based analytical cross-sectional study was conducted among patients aged 15 and above who were receiving ART. Systematic sampling was used to recruit a sample size of 359 participants. Data on sociodemographic, clinical and treatment characteristics were collected through interviews and medical record reviews. Blood samples were collected, processed, and tested for CD4 count and Viral Load using VISITEC CD4 Test kit and PCR methods respectively. Multivariate logistic regression analysis was performed to identify factors independently associated with unsuppressed viral load.
Results: The study found a viral suppression rate of 90.8% among the study population. Factors independently associated with unsuppressed viral load included CD4 count >350 cells/µl (AOR=0.42, 95% CI 0.2-0.9), poor adherence to treatment (AOR=5.2, 95% CI 2.3-12.0), TB-coinfection (AOR=5.1, 95% CI 1.3-19.2), and previous unsuppressed viral load (AOR=5.0, 95% CI 1.2-20.5).
Conclusion: The prevalence of viral load suppression among patients on long-term ART was high in the study population. However, certain factors were identified as independent risk factors for unsuppressed viral load, including low CD4 count, poor adherence, TB-coinfection, and previous unsuppressed viral load.
Recommendation: These findings emphasize the need for targeted interventions focusing on improving treatment adherence, managing TB-coinfection, and closely monitoring patients with a history of unsuppressed viral load to enhance viral suppression rates and improve overall treatment outcomes in HIV-infected individuals.
Keywords: HIV, viral load suppression, unsuppressed viral load, antiretroviral therapy, prevalence, associated factors, cross-sectional study.
TABLE OF CONTENT
DECLARATION i
CERTIFICATION ii
DEDICATION iii
ACKNOWLEDGEMENT iv
SUMMARY v
TABLE OF CONTENT vii
LIST OF TABLES x
LIST OF FIGURES xi
CHAPTER I
INTRODUCTION
1.1 BACKGROUND 1
1.1 Operational Definitions 3
1.2 Problem Statement 4
1.3 Study Justification 5
1.4 AIMS AND OBJECTIVES 7
1.41 General Objective 7
1.42 Specific objectives 7
CHAPTER II
LITERATURE REVIEW
2.1 INTRODUCTION 8
2.2 HIV Viral Load Suppression Rates 9
2.3 Socio- demographic Predictors for Unsuppressed Viral Load 10
2.4 Clinical Factors 11
2.4.1 CD4 Count 11
2.4.2 Adherence Level 12
2.4.3 HIV/TB coinfection 13
2.4.4 History of Previous Unsuppressed Viral Load 14
2.4.5 Duration on ART 15
2.4.6 WHO Clinical Staging 16
CHAPTER III
METHODS
3.1 Study Area 17
3.2 Study Design 17
3.3 Study Population 17
3.4 Inclusion Criteria 18
3.5 Exclusion criteria 18
3.6 Sample Size Determination 18
3.61 Finite Correction 19
3.7 Sampling Technique 20
3.8 Study instruments 21
3.9 Data collection methods 21
3.91 Venous blood sample collection, processing, testing, and transportation 21
3.92. Laboratory Procedure for the Estimation of CD4 count using VISITEC CD4 Test Kit 21
3.93 Viral Load Testing 22
3.10. Data Management 24
3.10.1 Data Quality 24
3.10.2 Measurement Variable 25
3.10.3 Data Analysis 25
3.10.4 Ethical Consideration 25
3.10.5 Study Limitations 26
CHAPTER IV
RESULTS
4.1 Socio-demographic Characteristics of Study Participants on ART at IDH 27
4.2 Clinical and Treatment Characteristics of Study Participants on ART at IDH 29
Table 2 continued 31
4.3 Proportion of Study participants with Viral Load Suppression on ART at IDH 31
4.4 Factors associated with unsuppressed viral load among patients on ART attending IDH Kano 34
Table 4 continued 36
4.5 Independent Predictors of Unsuppressed Viral load among adult ART patients Receiving Care at IDH kano. 36
CHAPTER V
DISCUSSION
CHAPTER VI
CONCLUSION AND RECOMMENDATION
6.1 Conclusion 43
6.2 Recommendations 43
REFERENCE 45
APPENDIX I 50
APPENDIX II 51
Appendix III: Data extraction tool 53
LIST OF TABLES
Page number
Table 1:
Sociodemographic Characteristics of Study Participants.............................................................30
Table 2: Clinical and Treatment Characteristics of Study Participants.......................................................32
Table 3: Proportion of Study Participants that are virally suppressed.........................................................35
Table 4: Bivariate Analysis of Factors Associated with Unsuppressed Viral load.....................................38
Table 5: Multivariate Logistic Regression Factors Associated with Unsuppressed Viral Load.................41
LIST OF FIGURES
Page Number
Figure 1: Overall HIV Viral load Status of Study Participants...........................................37
CHAPTER ONE
INTRODUCTION
1.1BACKGROUND
Human immunodeficiency virus (HIV) is a leading cause of global burden of disease. Globally in 2021, an estimated 84.2 million people had become infected with Human immunodeficiency virus (HIV) and 40.1 million people had died of Acquired Immunodeficiency Disease Syndrome (AIDS)-related illnesses since the start of the pandemic1,2. In 2021, an estimated 38.4 million people were living with HIV worldwide and 36.7 million of them were adults. An estimated 68% live in sub- Saharan Africa3.In 2020, there were 20.6 million people with HIV in eastern and southern Africa, and 5.0 million in western and central Africa4.Nigeria has the second largest HIV epidemic in the world and one of the highest rates of new infections in sub-Saharan Africa. Although HIV prevalence among adults is much less (1.4%) than other sub-Saharan African countries such as South Africa (19%) and Zambia (11.5%), the size of Nigeria's population means 1.9 million people were living with HIV in 2019.Six states in Nigeria accounts for 41% of people living with HIV, including Kaduna, Akwa Ibom, Benue, Lagos, Oyo, and Kano5.
In recent years, significant progress has been made in increasing access to antiretroviral therapy (ART) for people living with HIV6.Antiretroviral therapy is aimed to achieve and maintainviral suppression, thereby preventing disease progression and transmission. In 2014, the Joint United Nations Program on HIV/AIDS (UNAIDS) set the 90-90-90 global targets and for epidemic control of HIV, whereby the third 90 represents a target to achieve viral suppression in at least 90% of patients initiating ART by 20207.In December 2020, UNAIDS released a new set of ambitious targets calling for 95% of all people living with HIV to know their HIV status, 95% of all people with diagnosed HIV infection to receive sustained antiretroviral therapy, and 95% of all people receiving antiretroviral therapy to have viral suppression by 20308.HIV treatment outcomes among people living with HIV (PLWHIV) are dependent on monitoring of the response to antiretroviral therapy (ART). WHO clinical staging, immunological (CD4 T-cell count) and monitoring of routine viral load suppression are methods used to monitor treatment outcomes. Immunological and clinical monitoring has poor sensitivity and lower positive predictive value for identifying treatment failure compared to viral suppression5.
The World Health Organization (WHO) in July 2013 recommended the use of viral load testing as the gold standard to monitor patients response to ART6. Establishment of the virological suppression status among patients enrolled on ART is important for timely detection of treatment failures, identification of patients in need of more intensive adherence support and minimizes development of drug resistance and unnecessary switch to expensive and limited ART regimen options9. Maintaining VLS keeps HIV- positive patients healthy and reduces the risk of HIV transmission.A recent analysis of National HIV Surveillance System and National HIV Behavioural Surveillance data showed a rate of 0 per 100 person-years of HIV transmission for individuals on antiretroviral therapy (ART) with suppressed viral loads, but a rate of 6.1 per 100 person years for individuals in care who were not virally suppressed10. According to some studies, the median duration to suppress the viral load from the initiation of ART to suppression of the viral load below 1000 copies/ml is 1 month to 7 months4. The predictors of time to viral load suppression, identified by different studies, are: the choice of treatment regimen, initial viral load, baseline CD4 count and previous anti-retroviral (ARV) treatments used4.WHO defines viral load suppression as having a HIV-1 RNA 1000 copies/mL at least six months after initiation of ART, which indicates that viral replication is not well controlled11. WHO also recommends routine VL monitoring should be done after six months of ART initiation and then every 12 months thereafter10.
In 2015, more than 14.5 million of the 36.7 million (43%) people living with HIV did not know their status. About 54% of the people living with HIV had not yet started Antiretroviral treatment and only an estimated 38% of people living with HIV worldwide were virally suppressed4. In 2016, however, only 44% of the people living with HIV who were on treatment had viral suppression globally11.Recently, VL monitoring has been scaled up in resource-limited settings; however, in most sub-Saharan African countries, access remains limited. The proportion of patients who had received at least one VL test by mid-2016 was 19% in Malawi, 11% in Cote d’Ivoire, 49% in Kenya, 43% in Namibia, 9% in Tanzania and 22% in Uganda12.
Nigeria has shown steady progress on increasing access to treatment for people living with HIV, with the adoption of a test and treat policy in 201613. This measure has further accelerated referrals to treatment facilities for people who test positive for the virus. From 2010 to 2017, the country almost tripled the number of people living with HIV who had access to antiretroviral therapy, up from 360 000 people in 2010 to more than one million people in 201814. However, it is estimated that more than half of the people living with HIV still do not have suppressed viral loads.At the national level, viral suppression among people living with HIV aged 15–49 years stands at 42.3% (45.3% among women and 34.5% among men)14.This study aimed to determine the viral suppression rate and predictors of non-suppressed viral load among patients on ART in Kano state.
1.1 Operational Definitions
Adherence to medication: adherence to long-term therapy is defined as the extent to which a person’s behavior (taking medication, following a diet and/or executing lifestyle changes) corresponds with agreed upon recommendations from a health care provider. Adherence to medication can be categorizes as Good (equal to or greater than 95% or ≤ 3 doses missed per month), Fair (85-94% or 4-8 doses missed per month), or Poor (less than 85% or ≥ 9 doses missed per month).
Clinical failure: new or recurrent clinical event indicating severe immunodeficiency (WHO clinical stage 4 conditions) after 6 months of effective treatment.
Immunological failure: CD4 count at or below 200 cells/mm3 following clinical failure.
Viral load (VL): the amount of HIV in a sample of blood. Viral load (VL) is reported as the number of HIV RNA copies per milliliter of blood. An important goal of antiretroviral therapy (ART) is to suppress a person’s VL to an undetectable level—a level too low for the virus to be detected by a VL test.
Viral suppression: when antiretroviral therapy (ART) reduces a person’s viral load (HIV RNA) to<1000 copies /ml
Unsuppressed viral load: defined as plasma viral load above 1000 copies/mL after 6 months of ART initiation.
1.2 Problem Statement
Routine VL monitoring for HIV patients on ART is a standard practice in developed countries to monitor the rate of suppression and optimal treatment outcomes of patients on antiretroviral therapy (ART). Many studies have demonstrated that lower HIV viral load suppression appears with a wide range of factors in different settings, however, the level and the cause of the problem differs from country to country, for example, the suppression rate of VL in South Africa 15%, in Swaziland 16%, in Uganda 29%, in Cambodia 23.2%, in Zimbabwe 14% and in Nigeria 28%15. In these studies factors such as socio-demographic and psychological conditions, previous treatment failure, low baseline CD4, ARV regimens and long periods on ART, drug resistance, poor adherence to treatment, poor absorption of ARVs, co-morbidities, drug toxicity, substance abuse and weak social support networks, sexually transmitted infections (STI) and lack of knowledge or awareness about the benefits of viral suppression were associated with viral load non suppression6. Other studies revealed that people with non-nucleoside reverse-transcriptase inhibitor (NNRTI) drugs (Efavirenz or Nevirapine (EFV/NVP), resistance among people retained on ART ranged from 4% to 28%, while among people with unsuppressed viral load on first line NNRTI regimens; it ranged from 47% to 90%. Therefore, People with NNRTI resistance were less likely to achieve viral suppression16. This could result in the emergence and accumulation of drug resistance (DR) mutations or patients being prescribed more toxic and expensive regimens, further limiting drug options for the patients and increasing overall ART program cost17. Viral load suppression below the 90% target suggests that there are gaps in quality of HIV treatment service delivery, inadequate identification and switching of people failing first-line ART which was resulted in both human and financial consequences. In 2017 WHO tackling HIV drug resistance report, the mathematical modelling predicts that if NNRTIs continue to be included in first-line ART regimens, and the level of pre-treatment HIV drug resistance (PDR) to NNRTIs reaches above 10% in sub-Saharan Africa, the global targets to end AIDS as a public health threat by 2030 will not be attained16, moreover between 2016-2020 it is predicted that there will be 105 000 new HIV infections, 135 000 AIDS deaths, and 650 million USD additional costs needed for ARV drug, the World Health Organization (WHO) recommended that low and middle-income countries (LMIC) include in their HIV treatment regimens, highly potent ARVs with lower toxicity and resistance and proven efficacy within diverse populations. Subsequently, Dolutegravir-based regimens were recommended for adoption as the preferred first line regimen with over a million PLWH estimated to be currently on this regimen in LMICs, including Nigeria18.
In addition, from the HIV prevention and public health significance, sustained virological failure at the community level can substantially increase new drug resistance HIV transmission and increase new HIV infections. VL monitoring is therefore, critical for early detection of treatment failure and to maintain the long-term sustainability of ART19.
In Nigeria before 2016, according to the World Health Organization (WHO) criteria, treatment outcome of HIV patients was monitored clinically and immunologically (CD4 T-cell count) and this approaches are poor predictors of treatment failure and lead to delayed recognition of virological non-suppression and unnecessary switching to second line regimens13. The 2020 national HIV care and treatment guideline of Nigeria recommending routine and targeted viral load (VL) to monitor ART patients’ treatment outcome and to standardize the quality of HIV service. Based on this, the implementation of VL testing service had been applying since 201620. However, there were few studies done on the predictors of non-viral suppression to determine ART outcomes among patients on first-line antiretroviral therapy. Hence, there is limited data available on the proportion of viral suppression and associated factors for unsuppressed VL. In addition, there is no study conducted in the study area. Therefore, the purpose of this study is to assess the extent of viral suppression and factors independently related to unsuppressed viral load among adult patients initiated on ART at public health facility in Kano state Nigeria.
1.3 Study Justification
The quality of life for people living with HIV/AIDS has improved following the introduction of HAART hence has reduced the suffering and death, with the introduction of HIV Counselling and Testing (HCT) campaign by the Nigerian government, more people have come to know their status and were started on antiretroviral therapy. Access to HIV prevention, care and treatment increased with the UNAIDS 2011 -2015 strategy. However, core to the success of this program is the durability of antiretroviral therapy. Inability to sustain treatment may lead to treatment failure and hence defeat the purpose. First line therapy may fail if patients drug adherence patterns are not followed resulting to formation of resistant strains thus change in therapy to the second line.
A continuous and sustained suppression of viral replication is required for prolonged clinical benefit. Suboptimal viral suppression often leads to drug resistance and subsequently treatment failure and spread of resistance strains. Occurrence of treatment failure often has socio-economic implications because of the increased direct and indirect cost associated with starting expensive second line regimen. Improvement of patient outcome is dependent on putting the patients on successful regimens. Knowledge of factors that are predictive of treatment failure will aid in isolating patients that are at a higher risk of treatment failure. Furthermore, in absence of predictive factors, the scarce resources available may be wasted unnecessarily by using it for patients that are less likely to develop treatment failure.
The findings in this study will be useful to health care workers of HFs in anticipating unsuppressed viral load among ART patients and assist at promoting future management of People living with HIV with unsuppressed viral load. In addition, the findings will also be used bySMOH and FMOH in policy making and review guidelines of HIV management that would avert possible virologic failure. Kano state government, non-governmental organizations (NGOs), stakeholders and other partners working in HIV care and treatment found in kano state will benefit from the findings of this study.
1.4 AIMS AND OBJECTIVES
1.4. 1General Objective
To assess HIV viral load suppression rate and predictors of unsuppressed viral load among HIV clients aged 15 years and above receiving ART at a secondary health facility in Kano state.
1.4.2 Specific objectives
1. To describe the socio-demographic and clinical characteristics of HIV clients aged 15 years and above receiving ART in Kano state.
2. To determine the proportion of HIV clients on ART with suppressed viral load receiving care at IDH Kano state.
3. To determine factors that are associated with unsuppressed viral load among HIV clients on ART in Kano state.
4. To determine the independent predictors of unsuppressed viral load among HIV Clients on ART in Kano state using multivariate analysis
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