KHAYELITSHA 2001.html
REVIEW
KHAYELITSHA 2001 - 2011:
10 YEARS OF PRIMARY CARE HIV
AND TB PROGRAMMES
Daniela Belen Garone1,2, MD, PhD
Katherine Hilderbrand1,2, BSc, MSc
Andrew M Boulle2, MB ChB, MSc, FCPHM, PhD
David Coetzee2, MB ChB, MSc, FCPHM
Eric Goemaere1,2, MD, DSc
Gilles Van Cutsem,1,2 MD, DTM&H, MPH
Donela Besada1,2, BSc, MPH
1Médecins Sans Frontières, Khayelitsha, Cape Town, South Africa
2Centre
for Infectious Disease Epidemiology and Research, School of Public
Health and Family Medicine, Faculty of Health Sciences,
University of Cape Town
Tuberculosis (TB) and HIV care in Khayelitsha, and in South Africa
as a whole, has overcome numerous obstacles in the past three decades.
This article highlights what has been achieved in Khayelitsha,
describes the key clinical programme and policy changes that have
supported universal coverage for HIV and TB care over the last 10
years, and outlines the challenges for the next decade.
The evolution of tuberculosis (TB) and HIV care in Khayelitsha, and
in Africa as a whole, has overcome numerous obstacles in the past three
decades: poor leadership in acknowledging the HIV crisis, inadequate
provision of appropriate scientific interventions, and scepticism about
the feasibility of treatment programmes in settings challenged with
extreme resource constraints. Over the past 10 years in Khayelitsha,
HIV has been transformed from less than 500 people tested for HIV and
no one on antiretroviral therapy (ART) in 1998 to 50 000 tested and 20
000 on ART in 2011.1
Stakeholders in the Khayelitsha sub-district have reflected in the
course of the past year on the previous decade of service developments
as part of commemorating 10 years of public sector ART provision. This
article highlights what has been achieved collectively by several
service providers (the City of Cape Town, Médecins Sans
Frontières, the Western Cape province, academic institutions,
the Treatment Action Campaign (TAC), non-governmental and
community-based organisations), describes the key clinical programme
and policy changes that have supported universal coverage for HIV and
TB care over the past 10 years, and outlines the challenges for the
next decade.
HIV PREVENTION AND INCIDENCE REDUCTION
Dedicated efforts have been made to scale up a combination of
prevention interventions that has resulted in substantial changes in
health outcomes over the past decade.
PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV
The implementation of a prevention of mother-to-child transmission
(PMTCT) programme in 1999, with antenatal and perinatal antiretroviral
chemoprophylaxis and free exclusive formula feeding, marked the
beginning of public sector antiretroviral-based services in South
Africa. This programme, with progressive improvements and
intensification in line with the evolution of national guidelines, has
resulted in a reduction in documented mother-to-child transmission from
12.5% in 2002 to 2.5% in 2010 based on polymerase chain reaction (PCR)
testing at 6 weeks (Fig. 1). This success is mirrored in many other
sites in South Africa, and demonstrates that PMTCT to very low
proportions of infants infected is both feasible and scalable.
Box 1. Key elements of the programme
Khayelitsha
is a large township with approximately 500 000 inhabitants, located on
the outskirts of Cape Town. It has one of the highest burdens of both
HIV and toberculosis (TB) in South Africa. An estimated 16% of the
population is HIV infected; TB incidence is above 1 500/100 000 per
year and TB/HIV co-infection is close to 70%. The incidence of
drug-resistant TB is estimated at 50/100 000 per year.11
The
Khayelitsha programme, started in 1999, was the first in South Africa
to provide antiretroviral therapy (ART) at primary care level in the
public sector and one of two pilot projects in the country to provide
decentralised care for drug-resistant tuberculosis.12 Key strategies implemented include:
■prevention of mother to child transmission with ART and formula
■large-scale HIV counselling and testing, including out-of-facility testing, youth clinics,and male clinics
■mass community condom distribution
■decentralisation of ART to all clinics in the sub-district
■‘one-stop-shop’ integration of ART and TB services
■nurse management of HIV and TB care, including nurse-initiated ART and TB treatment
■doctor support and mentorship, with a strong secondary care referral system
■district level planning and co-ordination
■three-tier
monitoring and evaluation system (paper register, electronic
register,and electronic medical record in selected sites)
■ongoing training and mentoring at clinic and district level
Furthermore, the decentralisation of paediatric ART into primary
care clinics, which started in 2004, resulted in a steady increase in
children being initiated on ART each year, from 4 in 2001 to 145 in
2008. The numbers have decreased since then to 115 in 2010. The
successful decentralisation of paediatric care has led to positive
health outcomes; 87% of children started on ART in primary care
remained in care, and 98% remained alive after 5 years on ART.
HIV TESTING
HIV testing has increased steadily since the advent of the
programme. The programme started with enzyme-linked immunosorbent assay
(ELISA) testing of 500 people in January 1999. The introduction of
rapid HIV testing kits, PCR testing for infants, employment of lay
counsellors to conduct HIV counselling and testing (HCT),
community-based testing sites, wide-scale HCT campaigns, and targeted
testing for TB patients/suspects, youth and males saw a dramatic
increase in the numbers of people being tested each year. By the end of
2010, 22 centres were providing HCT and approximately 57 000 people
were being tested annually. In a community survey conducted in 2004,
28% of men and 53% of women of reproductive age in Khayelitsha reported
having been tested for HIV.2
COMMUNITY CONDOM DISTRIBUTION
Male condom distribution has been a major priority in the programme.
The number of condoms distributed per year increased from 2 million in
2004 to more than 10 million in 2006; currently more than a million
condoms are distributed every month. This was made possible through the
combined efforts of the public sector, including the City of Cape Town,
and non-governmental organisations, especially TAC. TAC expanded condom
distribution from health care facilities to community distribution
points, such as taxi ranks, public libraries, toilets and shebeens.3 During
the same period, the number of adults reported to have been treated for
sexually transmitted infections (STIs) decreased fourfold, from 28 000
in 2004 to less than 5 000 in 2009.
OPENING OF A MALE-FRIENDLY CLINIC
Recognition of the need for a service dedicated to reaching men and
providing HCT and STI treatment resulted in the opening of a male
walk-in clinic at a taxi rank in 2007. This new service was widely
advertised in the community through the use of taxi ranks and the local
radio. This clinic has become the largest STI treatment site in the
Cape Metro area, with the number of STIs treated increasing from 843 in
2007 to 2 547 in 2010. In the first half of 2011 the clinic counselled
and tested as many men as were tested throughout 2010, and the number
tested during 2010 in the male clinic represented 27% of all men tested
in Khayelitsha. The clinic aims to promote and empower men to take
ownership of their sexual health and safety and that of their partners.
Its success demonstrates that men use health services that are adapted
to their needs: short waiting times, close to a usual gathering place
for men (taxi rank), and separate from public health services attended
mostly by women and children. Two new male clinics are planned for 2011
to continue to reach out to men, who remain a group with limited access
to care.
ANTIRETROVIRAL THERAPY
In May 2011 there were 20 000 patients on ART, which is estimated to
represent 63% coverage of those in need in Khayelitsha, according to
current World Health Organization (WHO) eligibility criteria. Retention
in care at one year on ART has remained consistently above 85% since
the beginning of the programme.4 In addition, virological suppression among patients in care also remained above 87% in those tested,4 thereby
decreasing the community viral load given the relatively high
proportion of infected adults who are on ART. It is therefore likely
that this is contributing to a reduction in the number of new HIV
infections.
EVOLUTION OF HIV PREVALENCE
HIV prevalence among women presenting for antenatal care has been
routinely measured by the programme since 1999, and since 2003 the
testing acceptance rate has been close to 100%. The antenatal HIV
prevalence among those who test in routine care has stabilised since
2006 and may now be declining (Fig. 2). This decline is not mirrored by
the annual anonymous antenatal survey, which might be explained by the
fact that in routine care women already on ART are often not retested
for HIV, whereas during the annual survey all pregnant women are
tested, regardless of whether they are on ART or not. Considering the
decreased mortality, the absence of an increase in antenatal prevalence
in recent years could be the result of the benefits of ART offsetting
reduced new infections.
Emerging data illustrate that treatment serves as a powerful prevention tool,5 and
to decrease HIV incidence there is a need to combine wide-scale access
to ART with available prevention tools, including HCT, PMTCT and condom
distribution. In parallel, there is the need to focus on innovative
tools to measure HIV incidence in order to adequately assess HIV
prevention efforts.
DECREASING MORBIDITY
Increasing access to ART, as a result of decentralisation, task
shifting and TB/HIV integration, has allowed patients to access and
initiate treatment earlier. This in turn has resulted in decreasing
HIV-related mortality and morbidity. Patients presenting to care
earlier are also typically less complex to manage clinically, which
facilitates increased nurse management of care.
EVIDENCE OF EARLIER ART ACCESS
Median CD4 counts of people starting ART increased from 43
cells/µl in 2001 to 162 cells/µl in 2010. In the same
period the proportion of patients presenting with a WHO stage IV
diagnosis decreased from 50% to 20%.
BETTER ART REGIMENS
The programme has also seen a gradual evolution towards improved
first-line regimens. Documentation of high rates of adverse events with
the use of stavudine (d4T) contributed to the growing evidence base
that led to the WHO recommendation to replace d4T with better-tolerated
alternatives.6
A tenofovir-based regimen was introduced in 2005 in Khayelitsha for
patients experiencing d4T toxicity, and was included in the national
first-line regimen for all patients in 2010.
INTEGRATION OF TB AND HIV SERVICES
The ‘one-stop-shop’ integration of TB and HIV services
began in 2004, and allowed co-infected patients to access TB and HIV
services in the same clinic and from the same health staff.7
In 2010, 99% of TB patients in TB/HIV integrated clinics were offered
HCT, and 95% of them were being tested. Furthermore, 99% of co-infected
patients had a CD4 count result recorded and over 95% were started on
co-trimoxazole preventive therapy. The successful integration of the
services has led to improvements in the detection rates of
smear-negative pulmonary TB and extrapulmonary TB, as nurses’
clinical skills in managing both diseases improved. In addition,
integration has resulted in a decrease in the median time from the
start of TB treatment to ART initiation.7
Improved TB diagnostic methods, including smear-negative algorithms,
systematic TB culture, line-probe assays, and the piloting of
GeneXpert, as well as the systematic screening of HIV patients for TB,
are all expected to contribute to increased TB diagnosis. The
integration of HIV/TB care has been accompanied by improved TB cure
rates (from 44% in 2005 to 81% in 2010), despite the increased
caseload.
Box 2. Community-based model of care for drug-resistant tuberculosis
■Drug-resistant
tuberculosis (DR-TB) refers to TB that has become resistant to
first-line treatment and requires longer and more difficult treatment
with second-line anti-TB drugs.
■Instead
of attempting to hospitalise all DR-TB patients, the Khayelitsha model
of care uses a patient-centred approach with community-based treatment
through existing primary care services.
■Using
lessons learned from the decentralisation of HIV care, diagnosis and
treatment of DR-TB has been integrated into the routine TB and HIV
programmes in Khayelitsha since early 2008.
COMMUNITY-BASED MANAGEMENT OF DRUG-RESISTANT TB
Before 2007, all patients with drug-resistant tuberculosis
(DR-TB) in Khayelitsha had to be admitted to a central TB hospital to
receive their treatment. Khayelitsha has piloted a community-based
DR-TB programme in which drug- resistant TB is diagnosed and treated in
primary care clinics as opposed to a centralised facility. The number
of cases of DR-TB diagnosed increased from 14 in 2003 to 200 in 2010.
Over 80% of patients diagnosed with DR-TB in 2009 and 2010 started
treatment. The decentralisation of care was able to ensure that 71% of
cases started treatment through the local clinic, while only 14% were
admitted to the centralised specialist DR-TB hospital. In addition, the
median time to treatment initiation decreased from 71 days in 2007 to
33 days in 2010.
DECREASING MORTALITY
DECENTRALISED, TB/HIV INTEGRATED, NURSE-MANAGED ART
Recorded mortality of adults at 3 months on ART decreased from 10%
in 2002 to 2.2% in 2010, in part due to patients accessing ART earlier.
While mortality ascertainment is less complete in recent years, there
remains a year-on-year decline in mortality even after linkage to the
national death registry to correct for mortality under-ascertainment.4 Recorded mortality of adults at one year on ART decreased from under 15% to 8% between 2002 and 2007.4
This decline in early mortality and earlier access to ART has occurred
alongside a dramatic increase from 100 people initiated on ART in 2001
to approximately 20 000 by mid-2011 (Fig. 3). The sharp rise in
treatment enrolment was made possible due to decentralisation of ART to
every clinic, TB/HIV integration, and nurse-managed ART and TB care.
Decentralised care began in 2006 and new clinics were accredited as ART
sites each year thereafter. National guidelines allowed for
nurse-initiated TB/HIV integrated ART in April 2010, and all 11 clinics
in Khayelitsha were providing ART by the end of 2010. In terms of
longer-term outcomes, previous data based on death registry linkage
have also confirmed that 4 out of 5 patients who started treatment were
alive 5 years after starting treatment.4
PATIENTS TREATED FOR DRUG-RESISTANT TUBERCULOSIS
While there has been an increase in the detection of DR-TB, the
Khayelitsha programme has seen an improvement in the survival of people
with DR-TB. Of those diagnosed with DR-TB in 2008, 62.4% remained alive
after 18 months, reflecting an overall mortality of 38%. While
mortality levels remain high, given that 76% of all DR-TB patients are
HIV infected, this represents significant improvements in health
outcomes among people with DR-TB compared with other settings.8
CHALLENGES
RETENTION IN CARE
While the programme has achieved many successes, several challenges
remain in ensuring universal access to ART. With the advent of improved
drug regimens and models of care, HIV has become a manageable chronic
disease. Approximately 85% of patients are retained in care after 12
months, while only 65% of patients are still in care at 5 years on
treatment; this highlights the need for further innovations to improve
long-term retention. With increased enrolment came increased losses to
follow-up, probably due to saturation of services, patient mobility and
death. This trend in patient losses to follow-up stabilised and even
began to decrease in the later years as a result of the adoption of
measures to adapt to the high numbers of patients on treatment.
Innovative models of care included the introduction of adherence clubs
and nurse management of patients.
MEN
The proportion of men among adults starting ART remains lower than
expected. Although the male walk-in clinic has driven an increase in
men testing for HIV and seeking treatment for STIs, men still represent
only 30% of adults in care after 10 years of ART treatment in
Khayelitsha. There is a need to develop programmes that cater to
men’s needs in order to improve their access to health services.
Furthermore, given that men rarely accompany their partners to
antenatal services, innovative mechanisms will be required to identify
serodiscordant couples in light of emerging guidelines that will
recommend the use of ART to reduce the risk of HIV transmission to the
negative partner.5
YOUTH
Pre-ART loss to follow up is particularly high among youth. In 2010,
up to 70% of eligible young people in the youth clinics were lost to
care before starting ART; 60% of these losses occurred immediately
after HIV testing. Youth on ART were also more likely than older adults
to be lost to follow-up.9
Recognition of the need to focus specific interventions targeted at
this high-risk group led to the establishment in 2005 of two youth
clinics that provide adapted and targeted services. Although pre-ART
loss to follow-up declined in 2010 – from 70% and 60% in the
first quarter to 45% and 29% in the last quarter for the two youth
clinics, respectively – early loss to care remains high and is
indicative of the need to continue to adapt services and interventions
that cater appropriately to the needs of youth.
TREATMENT FAILURE
At 5 years on ART, approximately 14% of patients had confirmed virological failure and 12% were on second-line ART.4
Mortality and treatment failure are found to be high in patients on
second-line treatment. Out of the 32% of patients who failed
second-line ART, 60% had poor adherence, and 30% returned to
undetectable viral loads after enhanced adherence support; the
remainder were switched to a third-line regimen. This highlights the
need for early detection of poor adherence in order to provide targeted
enhanced adherence support. A recent study in Khayelitsha demonstrated
that a viral load performed at 3 months resulted in better virological
outcomes than one performed at 6 months,10
demonstrating the usefulness of the viral load for early detection of
poor adherence and virological failure. Third-line drugs are currently
not available in the public sector due to their high costs. As access
to and time on ART increases, the number of patients requiring second-
and third-line regimens is rising, and prices for these drugs will need
to be driven down.
THE FUTURE
The key clinical challenges for the next decade will be to achieve
universal coverage of patients in need of ART, retain patients in care,
and decrease the number of new infections. This will necessitate
innovative models of care to decrease the burden of patients on chronic
treatment on health facilities – thereby allowing the facilities
to increase enrolment on ART – and improve long-term adherence
and retention, as well as the implementation of combination prevention
strategies.
Box 3. Strategies for the future – innovation and wide implementation
■Further out-of-facility community-based testing (in schools, taxi ranks, community halls)
■Initiation
of antiretroviral therapy at higher CD4 thresholds, potentially up to
CD4s of 500 cells/µl and/or high viral load thresholds, to further
reduce viral circulation and infectiousness at community level
(treatment as prevention, TASP)
■Community-based delivery of ART by community health workers and/or chronic dispensing units
■Increased investment in pre-ART (e.g. by creating pre-ART adherence clubs)
■New
pre-exposure prophylaxis strategies targeting young female adolescents
combined with development of new long-acting antiretroviral
formulations and other biomedical preventive interventions.
These strategies will have to be supported by new drug formulations and technologies, including:
■fixed-dose combinations for first- and second-line regimens
■semi-quantitative point of care viral load dipstick to monitor adherence and identify early treatment failures
■POC CD4 devices to reduce pre-ART loss to follow-up, mostly among adolescents
■more
robust regimens with a better safety profile, including drugs like
darunavir, which maintains a low toxicity in the long term once the
viral load has become undetectable
■ensure
appropriate access to reproductive health services, including Pap
smears for all women including those living with HIV and medical
termination of pregnancy at the primary health level.
ADHERENCE CLUBS
Adherence clubs were established to improve clinic efficiency
(decongest clinics and allow clinicians time for initiating patients),
sustain high enrolment targets, and improve long-term adherence. The
adherence clubs are group clinic visits for stable patients that are
run by lay health workers and meet every 2 months. On club days
patients receive their medication and are screened for opportunistic
infections and adverse events, and are referred to a clinician if
necessary. In addition, patients receive an educational talk on the day
of their visit.
By the end of 2010, a total of 30 clubs were created, 23 of them
situated in the community and 7 in the Ubuntu Clinic in Khayelitsha.
More than 750 people were enrolled in total. An early evaluation
revealed that after 1 year of enrolment in the clubs, 99.2% of the
patients were alive; at 2 years this figure stood at 97.5%. After the
first year of enrolment, loss to follow-up was 1.1% and mortality 0.7%.
This model is currently being expanded to other clinics in order to
increase coverage. With the adoption of new national regulations,
community health care workers will now be able to manage these clubs
effectively. There is still a need to adapt the drug distribution
system further in order to allow for regulated and quality-assured
chronic drug dispensing units that are able to provide medications more
conveniently to patients in the community, thereby ensuring that there
is increased access to treatment closer to patient’s homes.
REDUCING HIV AND TB INCIDENCE
Despite some early positive signs, the national target of a 50%
reduction in HIV incidence is not close to being achieved. An exception
to this is in the area of PMTCT, where transmission has been reduced by
80% since the beginning of the programme. There is a need to continue
to focus on sustained behavioural interventions, including widespread
condom distribution, out-of-facility community-based testing, and
biomedical interventions to reduce HIV incidence. New targeted
pre-exposure prophylaxis strategies (particularly for women wishing to
have children), initiation of ART at a CD4 count of 500 cells/µl,
new drug formulations and technologies including fixed-dose
combinations, point-of-care viral load and CD4 testing, and robust
low-toxicity regimens must be explored.
Furthermore, there is a need to continue to focus on the early
diagnosis and treatment of TB and DR-TB, both to improve individual
patient outcomes and to reduce transmission. Despite dramatic
improvements in case detection for DR-TB, only half of all estimated
DR-TB cases are diagnosed in Khayelitsha, and there is a need to
increase case detection to curb HIV transmission. Access to molecular
diagnostics, including GeneXpert, shows promising results in increasing
detection of TB and DR-TB. This could also provide a sensitive
screening tool for the provision of INH prophylaxis in TB-negative
patients.
Discussion
The success in scaling up HIV/TB service provision in Khayelitsha is
attributed to the collaborative efforts of service providers, policy
makers, academics, civil society and the community at large. The
Khayelitsha programme was successful in achieving community buy-in
because it offered a reliable service within the community, was
supported through partnerships, and was complemented by widespread
treatment literacy.
While the district is best known for its role in demonstrating the
feasibility of ART in resource-constrained settings, some of the most
important lessons have come in more recent years, where the latent
capacity of South Africa’s public health system has been
demonstrated when subjected to energy, innovation and meaningful
collaboration. In spite of the numerous partnerships, Khayelitsha
remains a difficult environment in which to deliver services, but it
has nevertheless been possible to achieve coverage and scale for a
number of activities beyond the most optimistic outlooks of a decade
ago. In the areas of PMTCT and ART provision this is being demonstrated
in South Africa as a whole, where expectations have been exceeded in
recent years.
Increased funding for antiretrovirals and the resulting increase in
access to care helped to strengthen the overall health system, and the
implementation of a large-scale TB/HIV programme resulted in decreased
rates of both illness and death among people living with HIV as well as
a likely reduction in the number of new HIV infections. This unique
clinical programme contributed to national policy changes that have had
a tangible impact on the lives of thousands of people living with HIV
and TB in South Africa, and has demonstrated the possibility of
achieving universal coverage of ART and positive patient outcomes in
resource constrained settings.
Challenges ahead include the need to reduce HIV transmission in the
community. The Khayelitsha programme has paved the way for innovative
approaches to treatment provision that have allowed an increasing
number of people to access quality treatment closer to their
communities. The future of HIV and TB treatment and care will require a
focus on combination prevention and treatment interventions, in
addition to the adoption of new innovations that can have a tangible
impact on the spread of the dual epidemics.
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Fig. 1. Rate of mother-to-child HIV transmission, 2002 - 2010.
Fig. 2. Khayelitsha antenatal prevalence, 1999 - 2010.CHC = community health centre; City Clinic = City of Cape Town Clinic.
Fig. 3. Monthly patient ART enrollment, 2001 - 2010.