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Characteristics and outcomes of individuals enrolled for HIV care in a rural clinic
in Coastal Kenya
Hassan, A.S.
Publication date
2014
Link to publication
Citation for published version (APA):
Hassan, A. S. (2014). Characteristics and outcomes of individuals enrolled for HIV care in a
rural clinic in Coastal Kenya.
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2
STUDY SITE
Kenya is one of the seven sub-Saharan countries with more than 1 million people living with HIV/AIDS by the end of 2011 [71], and has an average adult HIV prevalence of about 5.6% in 2012 [72]. Whilst the country reports a generalized epidemic, pockets of concentrated epidemics, especially among the high risk populations, are increasingly becoming evident [73]. Wide geographic variations in prevalence have also been observed, with Nyanza region having the highest prevalence of HIV infection among adults at 15.1%, whilst the North Eastern region reporting the lowest prevalence at 2.1%. An estimated prevalence of 4.3% was reported from the Coast province [72].
Kenya, like many other developing countries, has adopted a standardized public health ap-proach in the provision of ART. Free ART services became available in public health facilities in 2006. Since then, a rapid scale up has been experienced, with ART coverage among those eligible rising from 38% in 2007 to 72% by the end of 2011 [74]. As at the end of 2012, more than 500,000 individuals had been started ART in Kenya.
The current National ART eligibility guidelines [75], largely adopted from the 2010 WHO guidelines [76] recommend ART initiation in individuals with WHO clinical stage III and IV regardless of the CD4 T-cell count, and/or CD4 T-cell count of <350 cells/μL regardless of the WHO clinical staging [28]. First line therapy is mainly comprised of 2 NRTI’s and one NNRTI. Patients failing first line therapy are switched to a second line regimen, mainly comprising of 2 NRTI’s and a boosted PI.
The Comprehensive Care and Research Clinic
The studies described in this thesis were carried out at the Comprehensive Care and Research Clinic (CCRC) within Kilifi district hospital (KDH), a rural hospital in Coastal Kenya (figure 1). The District is one of the poorest in the country. Subsistence farming is the mainstay socioeconomic activity. The hospital serves a catchment population of more than 260,000 people from both within and outside the district. Even though a few public peripheral sites have been upgraded to offer comprehensive HIV care within the District, majority of the HIV infected individuals seek care from the CCRC.
The CCRC started registering individuals for HIV care in 2004. Standards of care are pro-vided according to the National AIDS and STI Control Programme (NASCOP) guidelines. Participants routinely undergo rapid HIV testing, voluntarily or provider initiated, at different settings within and outside the hospital setting. Whilst some of the confirmed HIV infected individuals are referred to peripheral health centers, majority are referred to the CCRC for enrolment into HIV care.
26 Chapter 2
In the CCRC, care is provided by counselors, nurses and clinical officers. Routine laboratory in-vestigations are undertaken at registration into care and every six months thereafter, or when clinically indicated. Newly registered patients are immediately prescribed daily cotrimoxazole and given a two-week appointment to assess for side effects and discuss laboratory results. Individuals are deemed ART-eligible if they meet the WHO criteria i.e. clinical stage III/IV or CD4 cell count of <350 cells/μl. Individuals not eligible for ART continue to receive a package of pre-ART care, including nutritional assesments and cotrimoxazole prophylaxis, and are monitored for ART eligibility. Individuals meeting the eligibility criteria are initiated ART and followed up monthly or two-monthly thereafter. Over time, the clinic had a consistent supply of the United States PEPFAR funded antiretrovirals offered to eligible patients at no cost. Recently, there is a transition towards government funded antiretroviral drugs in Kenya. Clients requesting to transfer their HIV care to other health facilities at any one point are issued with a standard referral note and their status updated on an electronic database. Data on deaths is also passively captured and dependant on reporting by health staff from in-patient wards, relatives, friends and/or acquaintances.
Electronic surveillance systems
When the clinic was started in 2004, an electronic data system (Filemaker, version 5.5) was implemented to capture sociodemographic characteristics of individuals registered for HIV Figure 1: A map showing the location of the Comprehensive Care & Research Clinic (CCRC) within the Kilifi District Hospital (KDH) and the main road linking the hospital to other parts of the district and neighboring districts to the north and the south
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care. At registration into care, sociodemographic data including gender, date of birth, marital status, highest level of education and religion were routinely collected at the time of registra-tion into HIV care on standardized forms by trained counselors and fieldworkers. A trained data clerk entered these into the data system.
For long term clinical surveillance, and in addition to sociodemographic data, sub-systems to routinely collect clinical and laboratory data were established and interlinked in 2007. Clinical data including anthropometry, WHO clinical staging, opportunistic infections, ART status, ART start date, ART regimen and appointment dates were routinely captured at every clinic visit on real time in standardized forms by trained clinicians. Laboratory data including full blood count, CD4 T-cell counts and biochemistry were routinely captured after reception of results from the lab. Lab requests were made by clinicians when clinically indicated and according to the national guidelines.
Because of the longitudinal nature of these sub-systems, and to enhance efficiency in the data collection, the electronic systems were migrated to the MySQL platform in 2007. By the end of 2013, the clinic had registered 8911 HIV-infected individuals and HIV exposed infants for care. Of these, 3794 individuals were initiated on ART (figure 2).
Figure 2: Graph showing cumulative number of individuals enrolled for HIV care (N= 8911) and initiated antiretroviral therapy (N=3794) at the Comprehensive Care and Research Clinic in Kilifi District Hospital
Figure 2: Graph showing cumulative number of individuals enrolled for HIV care (N= 8911) and initiated antiretroviral therapy (N=3794) at the Comprehensive Care and Research Clinic in Kilifi District Hospital
0 2000 4000 6000 8000 Fr eq ue nc y 2005 2003 2004 2006 2007 2008 2009 2010 2011 2012 2013 Year
28 Chapter 2
Figure 3: Distribution of individuals enrolled for HIV Care in the Comprehensive Care and Research Clinic between 2004 and 2013 by age and gender (N=8911).
Figure 4: Distribution of individuals registering for HIV care at the Comprehensive Care and Research Clinic by age and gender (N=6,482)
2
Of all the individuals enrolled for HIV care between 2004 and 2013, three quarters (n=6518 [73.2%]) were adults (≥15 years). Of these, more than two thirds (n=4583 [70.3%]) were female (figure 3).
Whilst most of the females registering for HIV care were aged 25 – 29 years, most of the males were aged 35 – 39 years old. Overall, the mean age at registration into care was 34.9 (95% CI: 34.7 – 35.2) years. Male clients were older at registration into care, compared to their female counterparts (38.4 [38.0 – 38.8] vs. 33.5 [33.2 – 33.8] years). Indeed, this was evident and consistent over the years (figure 4).
Only about a quarter (n=2393 [26.8%]) of registered individuals were children (<15 years). In fact, almost two-thirds of the children enrolled (n=1503 [62.8%]) were infants (<18 months) born to HIV infected mothers.
According to the Kenyan national guidelines, all infants born to HIV-infected mothers should be enrolled for care, started on cotrimoxazole prophylaxis, receive prevention of mother to child transmission (PMTCT) interventions and followed up until they are 18 months old. During follow up, and according to the national HIV early Infant diagnosis (EID) algorithm, a dried blood spot (DBS) sample should be taken for polymerase chain reaction (PCR) at six weeks. Nationally, PCR for EID are done centrally from a handful of government designated laboratories located in different parts of the country. An antibody test is also recommended at 9 months, with another confirmatory antibody test at 18 months. If an infant tests PCR or antibody positive at any point, the current algorithm recommends immediate initiation of antiretroviral therapy. In 2012, national guidelines were revised to recommend follow-up of mother-infant pairs in Maternal and Child Health clinics.
In the CCRC, EID was started in 2006. By 2012, 1503 exposed infants registered for EID and HIV care. Of these, 917 (61.0%) had a DBS taken for PCR. The remaining infants did not have a PCR done because they were either registered at an older age (>6 months, n=346 [23.0%]) or were lost to follow up before the test could be done. The median age at PCR was 1.4 months (range, 0.4 – 6.0) months. Overall, our data suggest that PCR positivity has halved over time, from an estimated 19.3% in 2006 to 10.3% in 2012 (figure 5). Our data therefore suggests that despite the roll out of PMTCT interventions, overall mother to child transmission remains more than 10% in this population.
I have provided herewith a brief description of the basic demographic characteristics of indi-viduals registered for HIV care in the CCRC to put studies in this thesis in context. Detailed clinical and molecular characteristics and outcomes are provided forthwith in the main body of the thesis.
30 Chapter 2
OUTLINE OF THE THESIS
As an introduction to the thesis, I start by giving a brief background on the biology of the human immunodeficiency virus (HIV), the status of the HIV epidemic and a description of the available antiretrovirals used in the management of HIV and AIDS (Chapter 1). The chapter ends with an outline of the objectives of this thesis.
To put the findings of the studies in this thesis in context, we describes the setting under which all the studies were carried out (Chapter 2). This chapter also briefly describes the surveillance systems and the distribution of individuals registered for HIV care in the clinic, where studies for this thesis were done. The chapter ends with a brief outline of the three core parts of the thesis: Characteristics, Pre-ART and On-ART outcomes of Individuals enroll-ing for HIV care.
Part 1 of this thesis describes the characteristics of individuals enrolling for care in a rural HIV clinic at a district hospital in Coastal Kenya. I carried out a study to describe the patient population, distribution and subtype diversity of HIV-1 infections among individuals enrolling for HIV care in setting (Chapter 3). In addition, I also analyzed samples from ART naïve HIV infected adults enrolling for HIV care to determine the prevalence of HIV-1 transmitted drug resistance in this population (Chapter 4).
Figure 5: Distribution of PCR positivity among infants enrolled for Early Infant Diagnosis and HIV Care at the Comprehensive Care and Research Clinic (N=917).
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Part 2 of the thesis describes outcomes of Individuals enrolled for HIV care prior to ART Initiation. I followed up individuals enrolled for HIV care in a cohort study to assess for incidence and predictors of early drop out from routine pre-ART care in our clinic (Chapter 5). I also followed up infants born to HIV-infected mothers in a mixed methods design to determine uptake and constraints of the early infant diagnosis (EID) process for detection of HIV infection and to describe loss to follow up of these infants from HIV care (Chapter 6). Part 3 of the thesis describes outcomes of individuals enrolled for HIV care after ART initia-tion. I followed up individuals initiated on ART in a cohort design to describe the incidence and predictors of attrition (loss to follow up and death) from care (Chapter 7). I also cross sectionally sampled individuals on ART to deteremine the prevalence and correlates of viro-logic treatment failure and acquired drug resistance (Chapter 8).
In the last chapter of the thesis, I summarize and discuss the main findings (Chapter 9) and their implications on future perspectives. The chapter ends with concluding remarks on the characteristics and outcomes of HIV-infected Individuals enrolled for HIV care in our rural HIV Clinic in Coastal Kenya.
32 Chapter 2
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