It’s time to integrate TB/HIV care on a national scale (part 1)

Several good reasons for TB/HIV service integration

The case for improving collaboration between TB and HIV programmes was made in several presentations, starting with a plenary speech made at the South African AIDS Conference by Dr Kevin de Cock, Director of WHO’s Department of AIDS.

“What patients need is to be treated in a manner that is effective and convenient for them for both diseases. And that is the non-negotiable bottom line,” he said.

Better patient care

“Before we offered TB services and HIV services separately and this posed a lot of challenges for both the patients and the health workers,” said Hellen Muttai, a clinical care manager who shared data from Kenya’s Kericho District Hospital at the Implementers' Meeting. Before integration, patients had double queues, drug prescriptions, sets of labs, and had to attend two separate clinics on different days. Unsurprisingly, the uptake of TB/HIV services before integration was extremely low. “If patients with TB had HIV, the clinician just made a referral, they didn’t follow-up to see whether that patient had accessed services later on. And patients had to move from one clinic to another so they spent a lot of time in the hospital to receive TB and HIV services separately,” she said.

In the case of Kericho District Hospital, TB/HIV integration meant bringing HIV services into an existing TB clinic, including offering people with TB HIV-related services including provider-initiated HIV testing and counselling (PITC), and if HIV-positive, providing subsequent services such as cotrimoxazole and ART (as long as they continued to be on TB treatment). After integration, 94.2% of the TB patients were tested for HIV; 45.4% were indeed coinfected; they all received cotrimoxazole and other HIV care and treatment services; 78% were deemed eligible for ART and they all received it, most before they had completed TB treatment.

There is no question that this intervention saves lives.

Likewise, TB/HIV services have been integrated into Mulago Hospital in Uganda since August 2005, when it began offering both provider-initiated HIV testing to all TB inpatients and outpatients, enhanced TB screening in the HIV clinic, and concurrent TB and HIV screening of all medical inpatients. 96% accepted HIV testing and 33% of the people with TB were coinfected.

“We had a very large number of patients that we identified who had both TB and HIV disease and because of this we found it necessary to introduce a clinic where we were able to provide both TB and HIV services concurrently,” said Dr Rhoda Wanyenze.  So a combined TB/HIV clinic was set up operating on one day of the week within the TB unit offering the basic package of HIV care and ART and CD4 monitoring during the course of TB treatment. 327 out of 706 coinfected people who have so far received services from the integrated TB/HIV clinic have started ART while there.

Even TB treatment and non-ART HIV care alone improved the immunological status of people with HIV and TB according to an analysis of 792 patients enrolled between July 2005 and December 2006 at Kericho District Hospital.

“We noticed that the patients who were not eligible for ART, or who were not treated for ART, even if you just treated the TB without offering them ART, their CD4 cell count still improved,” said Muttai. Those given just HIV care and TB treatment had a mean increase of 78 CD4 cells six months after enrolment, while those who received ART as well had an increase of 139 CD4 cells (p <0.001).

“Clinicians treating patients with TB/HIV should be aware of the benefit to HIV infection by treating TB and offering supportive care alone, and also additionally offering ART,” she said.

Better TB control

But beyond improving the care and treatment of people with both illnesses, better collaboration between HIV and TB programmes may also be the only way to help overstrained health systems cope with the unparalleled dual burdens of the TB and HIV epidemics.

Just to review recent data from the WHO/STOP TB Partnership: 14 million people are co-infected with TB and HIV, globally; but around 80% of those who are coinfected live in sub-Saharan Africa. In some parts of the continent, up to 80% of the people with active TB are HIV-infected. TB is by far the most common opportunistic infection diagnosed during the first three months on ART — particularly in Africa. 200,000 people with HIV die of TB each year, again, most of them in Africa.

HIV has thrown fuel on the flame of TB.

• People with HIV are at increased risk from both TB reactivation and rapid TB progression
• TB manifestations may be more severe or atypical with more frequent extra-pulmonary TB especially in people with advanced HIV disease
• TB can be more difficult to diagnose, with higher rates of smear negative TB, and chest X-rays can be more difficult to interpret (although in a departure from a few years ago, experts are again recommending their use when affordable and feasible)
• A higher rate of mortality: even though TB is curable, it is the leading cause of death reported for people with HIV in many countries, with a mortality rate around 25% within two years in patients not receiving ART
• There is an increased risk of TB recurrence following treatment in people with HIV

HIV can also impact the care delivered to HIV-negative people with TB. For instance, the dual stigma of HIV-associated TB affects the health seeking behaviour of TB suspects regardless of their HIV status. This has sometimes been used as an excuse not to integrate TB and HIV services within the same facility.

But according to a survey of TB patients in KwaZulu-Natal presented at the South African AIDS Conference, people in the community are already well aware “of the link between TB and HIV/AIDS… On becoming ill with TB, many patients feared they may have HIV/AIDS. This fear led to them delaying accessing health services” (Loveday). This in turn leads to delayed diagnosis, poorer outcomes and increased transmission within the community. Additionally, the increased numbers of people with TB taxes the TB programme’s capacity and can decrease the quality of care for all patients.

The net impact of the dual epidemics on public health systems has been that well-organised programmes that had once been making good progress towards containing TB before the HIV pandemic can no longer do so. Although the annual incidence of TB is stable or falling in most of the world, the total number of cases has been increasing in Southeast Asia and Africa — especially where HIV coinfection is more common.

But it isn’t necessarily because the TB programmes have been poorly managed. At the South African AIDS Conference, Dr de Cock referred to a study from Dr Gavin Churchyard and colleagues that found an increasing incidence of TB in the gold mines in Welkom, Free State, South Africa, despite a model directly observed therapy (DOTS) TB programme. “They showed that even with a tuberculosis control programme that meets all of the WHO recommendations, TB continued to escalate in incidence under the pressure of HIV,” he said. “So clearly TB programmes alone cannot reverse this tide.”

HIV is the main reason why TB programmes have been unable to reach their targets.

“With a TB burden last year of about 300,000 reported cases, we’re definitely not winning this battle against TB,” said Dr Margot Uys of the Department of Health in both KwaZulu Natal, the Northwest Province and the US Centers for Disease Control, at the South African AIDS Conference. “With a success rate of about 54% in our treatment outcomes, it’s far away from the WHO recommendations of 80%. And on top of that we’ve got an HIV prevalence in our TB patients averaging at around 55% but spanning from 30% to 72%, and following last year’s outbreak of XDR-TB we have also got this MDR-TB burden of at least 6,000 MDR-TB cases per year, of which a considerable portion would be XDR-TB.”

 “It will be vital to shift into a higher gear on tuberculosis control. The emergence of XDR-TR is a dramatic wake up call, not only for South Africa but for the whole world,” said Dr Peter Piot, the Director of UNAIDS at the South African AIDS Conference, and then, paraphrasing a comment made by Nelson Mandela himself just a few years earlier: “If we don’t factor and integrate tuberculosis into everything we do, we will get nowhere. We are doomed to fail in our treatment programmes.”

Collaborative TB/HIV activities

“We need to integrate TB/HIV services,” said Dr. J. Muhwa Chakaya of Kenya Medical Research Institute and the National Leprosy and TB Control Programme (NLTP) at the Implementers’ Meeting. “It’s the only way to effectively deliver services.”

To help countries get started, WHO Stop TB Department and Department of HIV/AIDS released basic suggestions for how to better integrate TB and HIV care and treatment in 2004 in the Interim Policy on Collaborative TB/HIV Activities (http://www.who.int/entity/tb/publications/tbhiv_interim_policy/en/index.html).

The policy recommends twelve activities divided into the “policy-making level” activities required to set up, plan and monitor TB/HIV collaboration; the activities carried out by the HIV programme to reduce the burden of TB disease among people living with HIV; and the activities carried out mostly by the TB programmes to reduce the burden of HIV disease among TB patients, by providing prevention services, diagnosing those with HIV and providing or making certain that they receive adequate and appropriate care (see table).

Recommended collaborative TB/HIV activities

These activities are described in more detail in the Interim Policy and in A Guide to Monitoring and Evaluation of Collaborative Activities (http://whqlibdoc.who.int/hq/2004/WHO_HTM_TB_2004.342.pdf). But with the experiences described from the conferences in June, and particularly from the PEPFAR/WHO meeting, it’s possible to expand a bit more on some of these activities.

Establishing mechanisms for collaboration / Creating a conducive policy environment

The following section is meant for anyone involved with or concerned about the delivery of care to people with or at risk of TB and or HIV infection, whether a healthcare worker, nongovernmental organisation (NGOs), civil society, community-based organisation (CBOs) or a person with HIV and/or TB. Mobilisation of the HIV community and other stakeholders at national and local level is necessary to change policy, hold governments and programmes accountable, and make certain that policy is translated into practice both nationally and locally, keeping in mind that the most important level of implementation is at the point of healthcare delivery.

Engaging stakeholders and building advocacy

“One of the problems in TB/HIV is that both sides of the equation are viewed as someone else’s problem,” said Dr de Cock.

Before setting up collaborative bodies for TB/HIV, or fixing ineffective ones, it helps to understand the nature of the programmes that are being dealt with — and how and where they function in each country. TB and HIV/AIDS programmes have traditionally been separate vertical programmes with their own distinct cultures.

 “The TB culture traditionally has been emblematic, epitomising the public health approach with rigid algorithms, very clear sharp outcomes and a standardised simplified approach,” said Dr de Cock. “TB services are oriented in the short term — six months to nine months — have limited diagnostic capacity and have paid little attention to infection control. The TB establishment typically thinks that HIV is an intruder, upsetting the carefully perfected system.”

“In contrast, HIV culture is focused on individuals with an emphasis on human rights, has guidelines that are far from standardised, and of course needs to offer long-term services. It has limited understanding of tuberculosis epidemiology and is dismissive of TB as just another opportunistic illness which is difficult to treat,” he said. One way of fostering better understanding between the two programmes suggested during the PEPFAR/WHO meeting might be to involve TB programme staff in HIV planning cycles and vice-versa.

But another challenge in some countries is that HIV and TB governing bodies operate at different levels in government structures (ministries, etc), which can make collaboration difficult and the convening power of any TB/HIV bodies that may be established weak.

Funding streams are also usually separate for TB and HIV — with TB programmes less well funded, and it may be difficult to use earmarked funding for collaborative TB/HIV activities within the TB programme.

Dealing with such entrenched and often mismatched programmes takes great political commitment, from the grass roots up to high levels, and involvement of all the key stakeholders.

“What are the kind of things we did for these results to be achieved?” said Dr Chakaya. “I think that one of the critical things was political will and leadership.” In the case of his country, he said that the TB programme, the more established of the two “took this to heart and provided the requisite ‘push’ for these activities to happen.”

Likewise, Dr Greet Vandebriel, Deputy County Director Programs for the International Center for AIDS Care and Treatment Programmes (ICAP) in Rwanda, stressed that high-level government commitment to integrating TB and HIV programmes and services, was a crucial ingredient in “the Rwandan ‘recipe’ for success.”

But how does one create high-level political leadership around collaborative activities where there is little or none? At the PEPFAR/WHO meeting, one roundtable group suggested using the examples and evidence from Kenya and Rwanda or model national pilot projects (there are also model projects in Uganda and South Africa to name a couple) to “sensitise politicians” and other stakeholders to the need for TB/HIV activities. These can be used to demonstrate that collaborative TB/HIV activities are possible in a similar setting, much as the Botswana ART programme was once an example to the rest of Africa that ART scale-up was achievable. “Showing how our activities can help reach international (MDG), donors’ and national targets could be particularly important,” they added.

Grass roots political pressure may also help.

“A crucial partner in all of this is the affected community,” said Dr Reid, “and it should be engaged and involved in designing, advocating for, implementing and especially monitoring the collaborative response.”

Coordinating or harmonising donors, technical agencies and funding sources with the programme was also identified as important at the PEPFAR/WHO meeting. Though donors clearly don’t set policy, their resources can certainly help catalyse it.

“I think what is very critical is that we were provided with finances to be able to do all the things that we needed to do,” according to Dr Chakaya, who said that there had been an exponential growth in funds dedicated to TB/HIV from PEPFAR, the Global Fund, and others. “The funds from PEPFAR and the Global Fund allowed for the first time many other people to become involved in TB/HIV. So multi-stakeholder involvement became possible with this funding which stimulated civil society involvement and private sector involvement and that was extremely important.”

The provincial, state, district levels

A common pitfall is to focus solely on the national programme level —but the best efforts at the national level may go nowhere without engagement of local government, programmes and other stakeholders at the provincial or state, and district levels.

For instance, Dr Annalies van Rie, of the University of North Carolina at Chapel Hill and colleagues were asked by the national government in the Democratic Republic of Congo for technical assistance integrating some HIV services into the TB programme. So they helped develop a national policy for TB/HIV, which included providing provider-initiated HIV testing and counselling of all TB patients, plus cotrimoxazole to those who tested positive (the country has Global Fund funding for the HIV test kits and the cotrimoxazole). Then they rolled the programme out at 14 pilot sites, training the staff, and providing onsite technical assistance.

It worked extremely well, with over 5000 patients tested (around 16% of whom were HIV-positive) even though access to CD4 cell counts and ART (provided by referral to the HIV clinics) was still quite low.

“We showed that it’s really feasible to do it and you can do it with the existing healthcare workers,” said Dr van Rie. “The healthcare workers were motivated, and did not want any premium to be paid to take on this extra work. You do not need massive input of funding, if you have the tests and the cotrimoxazole, but you do need [government] ‘buy-in’ and organisation.”

They had a written agreement with the National TB Control Programme, that on the 1st of January they would take the project over. But this didn’t happen, and the health centres ran out of HIV tests, and many ran out of cotrimoxazole.

“There just wasn’t the political will to take it over. That is what’s missing, which is a great contrast when you see Kenya where it’s also initially set up with international funding, but it’s driven by the national government,” said Dr van Rie. “I think the difference doesn’t lie in the extreme poverty of the Congo, it doesn’t lie in the capacity of the facilities. To me it really lies in taking ownership and wanting to take ownership of it by the local government. We had anticipated this, so we wrote this memorandum of understanding but it was with the national control programme. But what then happened is, the facilities are under the control of the provincial programme and so the provincial programme says, ‘Well, we didn’t sign this!’ and the national programme says, ‘They are not under our responsibility, we do the national programme.’”

Kenya has tried to avoid this problem. “We set up coordinating committees at all levels,” said Dr. Chakaya. “We don’t always know how well the provincial and district committees are working but we have really tried - and we are still trying - to get a lot of more joint planning between TB and HIV.”

Developing operational protocols, training and reporting materials

As Dr Peter Piot emphasised at the opening of the South African AIDS Conference: “Let’s not forget that it is action at the district, at the local level, that will make the ultimate difference for people,” he said. “A national plan is as good as every district plan, and as every district can deliver.”

 “Although most WHO strategies to reduce the burden of HIV in TB patients form part of revised TB-HIV policy in South Africa, uptake has been limited,” said Dr Margot Uys at the South African AIDS Conference. “It seems like there’s integration at the policy making level but not at the programme implementation level.”

So Dr Uys and colleagues from the Medical Research Council and the Foundation for Professional Development developed an operational framework for a model TB and HIV services integration site implemented in Richmond Hospital, in the midlands of KwaZulu-Natal, which has had some success in identifying and enrolling people with TB and HIV into HIV care (at least those who voluntarily choose to get an HIV test).

This programme — TB HIV AIDS Treatment and Integrated Therapy (that’s it) — is now being expanded to three or four other districts in different geographical regions in the country focusing on sites where there is little infrastructure.

There are also several other model TB/HIV integration sites within South Africa, but a perusal of the handful of poster presentations at the South Africa AIDS Conference suggested that some districts are largely being left to their own devices about how to implement collaborative activities — with mixed results (Dhlamini, Stephens, Scott, Verkujt, Ndlhovu).

 But must each district in the country go through the process of developing its own operational protocols independently? It does make one wonder whether there isn’t a lot of reinvention of the wheel going on — and whether there isn’t a way to scale up more efficiently, rapidly and equitably. And how reporting and monitoring and evaluation from these districts will be synchronised is anyone’s guess.

In contrast, the national leadership in Rwanda and Kenya drove the process. As soon as the countries had convened their coordinating bodies and had adopted the WHO TB/HIV collaborative activities into their national policies, they wasted no time in revising their TB and HIV technical manuals and guidelines, developing operational protocols and training manuals that mainstreamed TB/HIV, and disseminating them to all the treatment sites. In Rwanda, informational, education and communication (IEC) materials were also developed and distributed. The whole process took around a year.

Both countries developed and implemented systems for monitoring and evaluation (M&E) of TB/HIV services — and started recording and reporting their TB/HIV indicators immediately (both by the third quarter of 2005). M&E is crucial for a host of reasons as it allows programmes to measure performance (see whether they are reaching their goal and to identify problems if they are not). Furthermore, it serves as the foundation and measure for any subsequent efforts in quality improvement.

Registers were adapted so that TB components were included in HIV registers (such as whether the patient has been screened for TB) and HIV components in TB registers (HIV test, cotrimoxazole, CD4 counts), and data recording and reporting was harmonised between TB and HIV programmes. Using internationally recommended registers and tools could facilitate this, and WHO is close to completing the standardisation of its recording and reporting forms for care and treatment to include TB/HIV integration indicators.

Both Rwanda and Kenya also performed intensive and continuous staff training and technical support. In Rwanda, “The TB/HIV model centres served as practical training sites,” said Dr Vandebriel. “Between April - June, 2007, 21 nurses and nine MDs from the TB and ART services were trained.” Training consisted of a two-day visit to complement theoretical TB and HIV care and treatment trainings.

In Kenya, training and technical support was possible despite human resource constraints, including a hiring moratorium, according to Dr. Chakaya: “We had to use some crazy mechanisms to get people in and we were lucky that we were among the countries that were selected as the first tier for the Intensive Support and Action Countries (ISAC). And of course we had PEPFAR, which allowed us to get 36 additional coordinators to stimulate action at high TB/HIV burden districts. So we were able to train people in all our districts; and we provided technical support for the development of guidelines or checklists.”

And taking a page from the books of TB control, Kenya set national targets for implementation of the TB/HIV activities.

“We provided targets, and this was the key thing. Every service delivery point was provided targets for TB, HIV and all other elements of TB control. This was extremely important,” said Dr Chakaya. Kenya aimed at testing 80% of TB patients for HIV, and providing cotrimoxazole and ART, and screening 20% people living with HIV for TB. Nationally, they are reaching the target for cotrimoxazole already — so perhaps they should start aiming for 100%.

Virtually everything Kenya and Rwanda did found its way onto a list of critical enablers to successful scale-up of TB/HIV services, presented Dr Haileyesus Getahun of WHO’s Stop TB Department at the PEPFAR/WHO meeting, but target setting was at the very top of his list, followed by setting the national policy, and producing and disseminating operational guides and training manuals.

It was a message that some participants at the PEPFAR/WHO meeting seemed eager to take home.

“The second lesson [we’ve learned] is the value of both guidelines for TB/HIV integration and supporting those with operation protocols at the implementation side of guidelines, recognising that there are multiple models of TB/HIV integration,” said the representative from South Africa.