Professor van der Walt said in an
interview with me at the South African TB conference, there is a
push to get South Africa to provide continuous isoniazid preventive therapy
(IPT) to people with HIV without symptoms of TB.
In his plenary talk at the
conference, Professor Gavin Churchyard stressed the one silver lining in the Thibela
TB study of IPT in the mines: IPT reduced TB by two thirds in people known
to have HIV who qualified for it. But it only worked as long as they were
taking it. This was in line with the findings from the BOTUSA study comparing
six months to 36 months of IPT in people living with HIV. In that study, people
started developing TB again shortly after discontinuing treatment (roughly 6
months to a year afterwards).
Notably, final data from that study presented as
a late breaker at CROI this year, showed that the same thing happened to the
tuberculin skin test positive cases in the 36 month IPT arm: cumulative TB incidence increased by
90% after IPT was discontinued.
The implication seems clear, continuous IPT is
indicated for people at risk of active TB in settings with a high burden of HIV
if that is so, why was there not a single mention of isoniazid preventive
therapy (IPT) in the “Transforming the HIV/TB response: Defining the next 10
years” activist pre-meeting to the 3rd South African TB Conference
held last month in Durban? It suggests that, as TB interventions go, IPT
doesn’t rate very highly on the agenda of the South African HIV-TB activists
who organised the meeting in South Africa.
Africa revised its IPT strategy in 2010 closely matching the WHO’s ICF/IPT
guidelines. These guidelines emphasise the use of WHO’s 4 TB symptom screening
tool to rule out TB in PLHIV every single time a person with HIV had contact
with the health system, and recommend 6 or 36 months of IPT for everyone who
doesn’t have TB symptoms in settings with a high HIV prevalence (unless there
is some contraindication that would make IPT dangerous such as heavy alcohol
use) for either 6 months or 36 months (essentially continuously). Of course,
South Africa is just such a setting, but this detail wasn’t given much
attention at the time. Tuberculin skin testing was no longer required, making
implementation much easier. So South Africa moved ahead with rolling out the
well it has done is a matter of perspective. South Africa now has the largest
IPT programme anywhere in the world, having provided IPT to 124,049 people,
according to WHO data for 2011.1
But that’s out of roughly 5.6 million PLHIV in the country according to 2009
data, of which, a couple of million have had some contact with the country’s
HIV care and treatment programmes, and 1.5 million are on ART. Since over
213,006 were people living with HIV were being treated for active TB as well,
that would suggest that less than 10% of the people living with HIV who are
accessing services received IPT. So why so few? There are clearly opportunities
for screening that are being missed, but the data show that the HIV programme
screened 758,837 HIV-positive people for TB.
did only one in six get IPT? Surely the other five out of six weren’t all
of the problem could be the non-specific nature of the symptom screen, which
essentially screens out anyone who isn’t feeling well to make sure that they receive
diagnosis and treatment for whatever ails them. After that, they should qualify
for and be put on IPT according to the guidelines. But it sounds as though they
simply get lost to the IPT process.
to reports from some HIV clinics, at any point in time, half of the people with
HIV will screen positive on the TB symptom screen.
the figures weren’t so high in a study presented at the South African TB
conference by US CDC’s Dr Joel Chehab, who presented findings from a
cross-sectional study assessing levels of TB/HIV integration in 49 health
facilities in 9 provinces in South Africa.2
Out of 2512 people newly diagnosed in February 2011, about 76% received a TB
symptom screen. About 8% had TB, for 23% the data were missing or not recorded,
which ended the process (these could have been the remaining symptomatic
patients who tend to wander into black holes). 70% had no TB symptoms, which is
higher than what other clinics have reported, but these arepeople who have just
been diagnosed, and tend to be healthier than people attending an ART clinic.
But only 46% of the eligible patients started IPT.
part this was because 29% of the facilities were not providing IPT, though they
provided all the other key TB services. Having the 2010 guidelines on hand at
the clinic had an impact on whether or not patients received IPT: guidelines
were available in 84% of the facilities which offered IPT, but were avialble in
only29% of facilities which did not (p= 0.006), suggesting a fundamental lack
of information represents a primary barrier for IPT provision.
Chehab also pointed out that in some provinces, IPT provision was very low, due
to problems in the health sector in Mpumulanga and Limpopo. Meanwhile the
Western Cape Province had not yet accepted the IPT policy (it has since with
some caveats described below).
there are other problems implementing the IPT policy within the health system.
some sites, healthcare worker perception of IPT also continues to be a barrier
to implementation. One poster described
health worker attitudes towards IPT at 8 facilities in and around the city of
Potchefstroom in the Northwest Province from April 2009-March 2011. During that
period, only about 9% of eligible patients received IPT during the study
period. In a survey to find out why, only 41.1% of the nurses had received
HIV/AIDS training within 12 months of the survey. Notably, this was the same
percentage who said they felt competent initiating IPT treatment. 17% of them
felt that IPT initiation was “a waste of time.”
there hasn’t been adequate training support for the IPT rollout. Other critical
support was lacking, according to another presentation.
“IPT has been implemented without monitoring
tools being provided and that created a challenge to follow up clients and to
evaluate the outcomes,” said Tumi Mbengo of the University Research Corp (URC).
Consequently, the USAID TB Project developed and implemented an IPT follow-up
register in some districts supported by URC in October 2010. She presented an
analysis of the data recorded in these registers from the 17 health facilities
in the Sedibeng district during 2011. Use of the registers led to improved
rates of IPT initiation and improved follow-up.
They show that breakthrough TB became much rarer over time, due to
improved symptom screening. They also showed dips in IPT initiation due to
isoniazid stock outs in the district in the third and forth quarters.
But she stressed that “the most significant
finding was the high and stable level of unknown outcomes due either to early
treatment interruptions or to weak data recording by the health staff.
“Advocacy at all levels needs to be addressed
so as to improve adherence,” she said, including patient and community
education about IPT and development of community based mechanisms to track down
people who default on IPT treatment.
But getting community buy-in and support may be
difficult, given the low interest that many of the leading activists in the
country have in the IPT programme as it is currently structured. The reasons
are quite clearly illustrated by the following excerpt from the first edition
of the NSP Review: Engaging with South
Africa’s National Strategic Plan for HIV, STIs and TB, which is
being produced by the Treatment Action Campaign and Section 27 to monitor the
progress of the country achieving the targets set out in the strategic plan.
“Isoniazid preventative therapy (IPT) is now
available in public health facilities for people living with HIV. IPT can reduce
a person’s risk of developing active TB. However, concerns were raised that IPT
is being implemented in South Africa without the condition that
it only be offered to patients who are tuberculin skin test-positive
(TST-positive). There is abundant evidence that IPT only benefits such
patients. Moreover, it is potentially harmful to give IPT to TST-negative
patients. As there are conflicting views on the use of IPT, there
needs to be further consultation involving clinicians and people living with
HIV on its use and roll-out,” the unnamed author writes.
are of course right. The data pretty consistently show that only TS- positive
people get any significant benefit from IPT, and for them that benefit is
profound. IPT doesn’t seem to do much for people without signs of an immune
response to TB however.
data were considered during the ICF/IPT guideline policy setting consultations
convened by WHO, which included leading experts and community representatives.
Nevertheless, they concluded that the “Tuberculin Skin Test (TST) is not a
requirement for initiating IPT for people living with HIV. However, in some
settings where it is feasible, it can help to identify those who would most
benefit from IPT.”
Their chief concern about requiring TST was that the operational challenges
to providing IPT in resource-constrained settings represented a barrier to IPT
access. “The challenges include staff training in the administration and
accurate reading of the test, the need for the patient to attend the clinic at
least twice over 48-72 hours with associated inconvenience and cost. Additionally,
there is a limited supply of tuberculin world wide, it is costly to ship and
requires an adequate cold chain to ensure test performance.”
A number of studies have shown that large
numbers of people don’t come back in to get their TST’s read — but strategies
such as doing home visits to read the TST could address that problem. Community-based
methods of providing TST have not been adequately considered. Problems with tuberculin supply and providing
cold chain storage may be more intractable.
And yet, now, as leading TB experts are calling
for people to be put on continuous IPT, the community may insist that these
challenges be dealt with before they endorse such a strategy.
Notably in the Western Cape, the decision to
provide IPT to PLHIV has finally been reached — even continuous IPT — however,
they will be providing TST for people so that they can know whether IPT will
offer them benefit, before they go on it.
 Uwimana J. TB/HIV Integration
Conference. 3rd South African TB Conference, Durban, South Africa,
 Chehab JC. Vilakazi-Nhlapo K, Peters A et al.
Integration of TB and HIV Services in South Africa, 2011. 3rd South
African TB Conference, Durban, South Africa, 2012