When this site first went online, we posted the intro to this article, which I wrote last year… I’ve always intended to post the rest of it but never got around to it. Somehow the text got corrupted, but I hope this is closer to what it should be. The rest of the article will be published later this month… after the report on key populations — TS
Adherence clubs, Community ART Groups and other PLHIV- and/or TB delivered services to improve outcomes and support further decentralization of HIV and TB treatment and other chronic care
The best way to tailor a service to meet a community’s need and get the communities buy in, is to involve the community in the design and delivery of the service. And if that service is a matter of life and death to them, they clearly have a vested interest in making the partnership work.
Over the last several years in a few sites in sub-Saharan Africa, communities of people living with HIV (PLHIV), have been constructively engaged by the international humanitarian organisation, Médecins Sans Frontière to help develop innovative models of care for those who are stable on antiretroviral treatment (ART). With training and some supervision, people living with HIV on ART can minimise time spent in the clinic and reduce losses to follow-up (LTFU) by helping each other — bringing delivery of medications, peer-based adherence support and simple clinical monitoring to, or closer to, the home.
MSF has been gathering and analysing the data coming out of these projects, in order to identify how self-management strategies can work better for the long-term care of PLHIV and reduce the burden that managing millions of people who are well on ART places on the health system. In these cohorts, the findings are consistent: patient-centred and driven ART delivery strategies appear to be achieving sustained virological and retention in care outcomes in stable people living with HIV are better than what is being seen with matched patients receiving standard clinic-based care.
And the models appear successful and scale-able. The initial report, published in JAIDS in early 2011, described a new model of care, Community ART Groups (CAGs) in Tete Province, Mozambique. The CAGs are teams of six PLHIV who take turns, every two months, with one attending the clinic (having his lab work done), and bringing back ART for the entire group. After a year of follow-up, out of 1301 evaluable people in the CAGs at the start of the programme, 1269 (97.5%) were still in care, 30 (3%) had died and only 2 (0.2%) were lost to follow-u (LTFU). At AIDS 2012 this past year, Dr Tom Decroo reported on the further scale-up of 1139 CAGS which have enlisted 5229 members. After that the model keeps growing with a median of 16 months of follow-up as of 31 June 2012, the rate of mortality is 2.3/100 person-years, and losses to follow-up LTFU: 0.1/100 person-years. The model has now been extended to include HIV-positive children, with rates of attrition four times lower than the global average for children on ART.
Meanwhile, in Khayelitsha, stable patients have been receiving their treatment and follow-up monitoring in ‘Adherence Clubs’ for almost four years [as of the date this article was written in November 2012], and according to a report at CROI, have had significantly fewer deaths or losses to follow-up (HR= 0.43, 95%CI 0.21-0.91) or virological rebound (HR= 0.33, 95%CI 0.16-0.67). There are now over 400 adherence clubs linked to 35 ART facilities in the Cape Town metropolis maintaining approximately 12 000 PLHIV on ART. As of November 2012, the provincial health department was on the verge of launching the clubs elsewhere in the Western Cape.
Engaging people living with HIV in Prevention, Care, Treatment and Support Services
The Treatment 2.0 strategy has suggested that the community including the community of PLHIV would need to take a greater role in service provision— though it hasn’t been particularly clear in what ways.
“People living with HIV can be involved with psychosocial support tasks, in treatment literacy and importantly in accompanying a referral and tracing other patients who are lost to follow-up,” said Dr Tom Decroo at the HIV and Health Systems pre-meeting held before AIDS 2012 in Washington D.C. “We propose to go one step further and involve them also in medical care tasks such as ARV delivery and to see what is the potential of joining people with HIV communities to bridge the gap between the community and the clinics.”
Although the findings from MSF’s projects do not come from randomised controlled clinical trials, they seem particularly compelling because of the manner in which PLHIV and MSF collaborated to develop a system that PLHIV would benefit from directly. In addition, as Dr Decroo and other colleagues kept repeating — it might be the only way the health system in a country such as South Africa would be able to handle maintaining all 5.5 Million HIV-Positive South African’s on chronic care.
As another researcher, Dr Jan Hantelez of the Africa Centre reported at the HIV and Health Systems Meeting in 2012— even with all the nurses at all the PHC and other sites in South Africa – the demand for health care staff and resources as the roll-out of ART continues, and the country tries to meet its other health related goals will outstrip supply.
PLHIV will have little choice but to help provide their own chronic care services.
They have developed adherence clubs and other models where PLHIV are delivering home based care into homes some much other models where PLHIV are either designing, implementing or running treatment services, or they are being involved services, or they are being engaged in the design and implementation of patient engagement in care and/or, MSF and others have been working on are discussed in more detail below, emphasise patient-self-management — which, after integration of ART services into the primary healthcare level, appears to be a next stage of decentralising the ART programme. If such models can be safely scaled up in other settings, they could decrease health facility congestion — freeing up capacity to initiate more PLHIV on ART. By reducing the dependence of PLHIV upon the health facility, they may in fact be the only way to make long term chronic care sustainable.
So, given the human resources for health crisis, even if HIV care and ART is decentralised and integrated into every available health facility in a country, these models may be the only way countries could ever consider universal access to earlier treatment, or adopting a treatment as prevention approach. Anyone advocating for treatment as prevention should take heed of what these MSF-PLHIV collaborations are doing. We’ve seen clinics dispensing ART reach the limit of their capacity before.
Within the first few years of the roll-out, ever increasing numbers of PLHIV in chronic care with ART quickly saturated treatment sites
Before the roll-out of antiretroviral therapy (ART) in sub-Saharan Africa, aid ‘sceptics’ said that the money for the proposed treatment programmes would be wasted, because, they said “PLHIV in Africa would never be able to adhere to the complicated ART regimens”.
Time would prove them wrong, of course. In fact, Africans were better than Westerners at taking their meds in general the early trials said. As far as taking medications on schedule, that is still probably true, but the story doesn’t end there unfortunately. As the ART programmes expanded, programmes would find people living in various situations that presented challenges to adherence.
Many of the first PLHIV to start ART in sub-Saharan Africa also had received more personalised attention than people usually do today —if anything, some were over-prepared for adhering to ART (it is hard to believe now, but some of the early adherence preparation courses in sub-Saharan African settings took place over the course of five weekly visits. Only the most dedicated persons could make it though such a rigorous process. In addition, as ART programmes continued to enrol, more and more people began crowding into the limited number of centralised, primarily hospital based ART sites. Although more ART sites were opened, it didn’t happen nearly fast enough and there were not enough doctors and nurses to keep up with the demand.
As early as 2005, the three much lauded vanguard ART sites at clinics in Khayelitsha that Médecins Sans Frontières (MSF) launched in partnership with the Western Cape Department of Health, and then with the City of Cape Town to run, were showing signs of strain, according to the Khayelitsha activity report that year:
“An appropriate increase in the complement of clinical staff has not kept up within the increasing workload. It appears that staff “burn out” is becoming a problem in certain areas. There have been insufficient nursing personnel and this has hindered the development of the nurse-based approach that was felt to be critical to the successful roll-out of antiretrovirals… it is clear however that the HIV service platform needs to be rapidly expanded in order to keep up with the current and future demand for HIV care…. Without intervention, the three existing clinics will definitely not cope with the current demand for both HIV care and ART, let alone the anticipated demand in coming years.”
Within just two years, the clinics’ enrolment capacity was saturated. In 2007, the clinics were so busy with follow-up visits for the PLHIV already ART, they had less and less time to see and enlist new patients, and waiting lists began to grow. The clinics were always crowded, waiting time grew longer and longer. Since the number of doctors and nurses did not increase, PLHIV starting or on ART received less attention from staff — including less adherence support. The number of patients who were lost to follow up (LTFU) increased and the staff were so busy it was difficult to get around to tracing any ‘no-shows’. Not surprisingly, clinic teams began to burn out and the quality of the services suffered, which in turn lead to more people on treatment being programmatic data.
“We didn’t have the authorisation from government to open more clinics,” Dr. Gilles Van Cutsem said at the time (see HATIP #83). “So we were stuck with three clinics that became monster clinics with now almost 2000 patients on ARVs per clinic with a relatively small number of staff. That’s when the loss to follow-up started to increase even among patients who have been adherent for two to four years in the beginning of the programme. And that’s what most programmes are going to face now with massive scale-up.”
Other programmes would eventually observe similar attrition as ART sites became saturated, with an increasing proportion of patients LTFU. “Sites with higher death and LTFU rates tend to be those that have been offering services for longer periods of time,” Dr Wafaa El-Sadr said at CROI that year.
According to Rosen and Fox’s systematic reviews in 2007 and 2010, in most resource limited settings only about 70-80% were being retained on ART at 24 months though there is a wide range of variation (and different studies may define LTFU differently).
There are less data from mature programmes beyond two years, but attrition is cumulative. There has been a disheartening recent three-year study coming from three mostly agrarian countries: Zimbabwe, Lesotho and Mozambique.  For the three countries together, the cumulative incidence of death and LTFU were 12.5% (11.5%–13.5%) and 25.4% (24.0%–26.9%), respectively. But there were significant differences in the countries: In Zimbabwe 75.1% (72.8%–77.3%) were alive and on ART at 3 years compared with 55.4% (52.8%–58.0%) in Lesotho and only 51.6% (48.0% –55.2%) in Mozambique.
“Our results document the difficulties in retaining patients in care after they initiate ART and must raise concerns about poor long term clinical outcomes in settings with weak health systems and limited access to viral load monitoring and second-line ART regimens,” the authors concluded.
Where did we lose them?
When the increasing numbers of LTFUs first started to attract attention, the first culprit was clearly early deaths on ART. This is partly because, when the ART roll out started, teams began treating the most difficult type of patient… people living with advanced HIV and AIDS. It is important to remember that health-seeking behaviour is often already very low whenever someone’s livelihood is precarious, and food insecurity and poverty may be a constant threat. In light of competing basic needs such as finding where the next meal is coming from and how to feed the family tonight, taking the day off to go to the clinic is simply not what get’s prioritised.
Consequently, health problems — like that nagging cough — would go unaddressed for a very long time. On top of that, until the ART roll out, there was very little that health facilities could offer people living with HIV & AIDS. When the rollout did start, some people presented quite ill. In fact, around 40% of people starting ART at a clinic in Mabarara were classified as ‘late presenters,’ which means they had World Health Organization disease stage 3 or 4 at enrolment — (with recognised AIDS-defining clinical events). Many likely had additional undiagnosed opportunistic infections. Or their CD4 cell counts remained so low that they remained at great risk of developing opportunistic infections, especially TB for quite some time after starting ART because their immune systems had been so weak. A fair number might have developed severe immune reconstitution inflammatory syndrome (IRIS).
Patient tracing activities often did find that early deaths had been occurring in many advanced patients during the first 12 months on treatment. What is worrisome however is that to this day, many patients come in late for treatment — and interventions are needed to keep a closer eye on these patients during the first several months on ART, when the risks are greater. But as clinics became more and more congested, it becomes increasingly difficult for the clinical staff to provide this sort of individualised service.
But mortality has not been the sole cause of LTFU — especially as HIV programmes mature. Moreover, many of the deaths were found to happen long after the patient was LTFU. For instance, Geng et al investigated what had become of random sampling of the people who had initiated ART at a clinic in Mbarara, Uganda but who were now LTFU, defined as having not ‘had any contact for 90 days or longer with the clinic staff after the last given appointment.’ Notably, they found that only 29% were dead. Happily, 51% of the remainder were not only alive, they were still in care — they had transferred to another treatment centres. However, although another 39% were purportedly alive, they couldn’t confirm if they were in care or not. Finally, the remaining 10% were alive but were confirmed to no longer be in care — they had dropped out of the ART programme.
The study illustrated that it isn’t wise to make assumptions regarding LTFUs due to early death or poor outcomes, so each site needs to gather information on its own LTFU outcomes. Otherwise, managers could reach erroneous conclusions about what sort of intervention is needed to improve retention in care.
Although the proportion was small in this study, the LTFU who simply quit, and were not planning on coming back to the ART site, cannot really be classified as LTFU anymore since they had been found. These cases ‘disengaged from care” because of their wishes, beliefs or due to some other obstacle to continued access to care. They represent a challenge for the programme, because most will die unless they can be convinced to return to care — and an opportunity, both to get them back in care, and to learn why people are disengaging in care at a particular site.
Structural barriers to retention in care and programmatic responses to improve
According to another paper by Geng et al, a number of structural factors are repeatedly associated with ‘disengagement’ from chronic health services.
Transportation/Distance from ART site: In resource-limited settings, one of the most familiar and critical ones is: ‘it is too far too walk “— the distance and time that it takes to get to the health facility, especially in remote rural settings. This is often true even of the primary care clinic, and the further away, the greater the hardship to get there. It was more likely to be true during the first years of the roll- out, because ART was initially implemented at centralised sites far from much of the infected population.
Financial constraints/Food insecurity: If not poor before contracting HIV, contracting the infection can lead to financial hardship for a variety of reasons, and PLHIV may not be able to afford to taking time off work or away from the farm or business. Going to the health facility may result in out of pocket expenses associated with travel, child care, clinic fees, lab tests and so on. If impoverished, the PLHIV may have to choose between accessing treatment or starving/being able to feed their family. Male gender has been associated with higher rates of LTFU in Africa, partly because they are more likely to have to travel for work.
Stigma & Discrimination: PLHIV who experience (or anticipate experiencing) stigma and discrimination at health facilities may disengage from care — particularly if they are from a marginalised key population.
Failure to disclose to their partner or a family member and lack of support: If someone who has been recently diagnosed has not disclosed to their partner, they may disengage from care out of fear of their HIV status being discovered. Some may start taking antiretrovirals thinking that it can be hidden from intimate partners or family, only to quit taking the medications and drop out of care, when it is more difficult to conceal than expected. Some studies have found that entering into a new relationship can endanger adherence in people who have been taking their medication perfectly for years while they were single — but they had yet to disclose to the person that they were now dating.
Myths about ART, low treatment literacy: Those who have less faith in the service or treatment being provided by the clinic are more likely to disengage from care. In addition to AIDS denialism, which was nurtured by previous administration in South Africa, religious belief and superstitions have lead many to seek non-medical cures.
Disengaging from care is much more common prior going on ART. In fact, a systematic review by Rosen and Fox in 2007, found that only 20–33% of those initially identified as HIV-positive are known to have been retained in pre-ART care to initiate ART.
Retention is generally much better in people who have been started on ART — sometimes markedly so. A study in Malawi, suggested that once the programme could get people onto ART in their setting, retention in care was very good (over 90% at month 12) but for those who in the pre-ART stage in a hospital-based settling in rural Malawi, retention in care was only 4% at month 12.
Despite severe resource constraints, Malawi’s ART programme has reported higher retention in care than most — possibly because from the very beginning, it was conceived as needing to be decentralised to the primary healthcare level and integrated into TB and other services. With very few doctors, the programme focused on training and empowering nurses and clinical officers to prescribe and manage ART.
Decentralisation, integration (when it makes sense) with other health services which are likely to serve as an entry point to care for PLHIV, and task shifting ART management to clinical officers, nurses and lay healthcare workers, have all been reported to improve retention in care in different settings.
MSF’s experience of scaling-up ART in the Lusikisiki district in the Eastern Cape, had demonstrated that retention in care was dramatically better when ART was started at the primary health care level. They noted that, after 12 months, only 2% of people who started ART between January 2004 and July 2005, were lost to follow up compared to 19% at the hospital (see http://www.msf.org.za/docs/lusikisiki_final_report_2006.pdf).
“ART-scale up must be accompanied by decentralisation of treatment to the most peripheral level…. Appropriate systems need to be created to accommodate the ever-increasing patient load. This includes capacitating all levels of healthcare workers (in the South African settings, especially nurses) to deliver and monitor ART and ensuring additional adherence support by non-medical staff,” Dr Van Cutsem recommend that ART-scale up be accompanied “by decentralisation of treatment to the most peripheral level and to a greater number of service points in order to avoid the creation of “monster” treatment sites where adequate follow-up cannot be maintained.”
In order to improve follow-up, Dr Van Cutsem and colleagues also recommends that: “appropriate systems need to be created to accommodate the ever-increasing patient load. This includes capacitating all levels of health care workers (in the South African settings especially nurses) to deliver and monitor ART and ensuring additional adherence support by non-medical staff.”
A decision was made to decentralise ART services to many more peripheral sites. Task shifting approaches were explored, including training people from within the community, expert PLHIV in particular, to provide adherence support and follow-up in order to improve services, and reduce the burden on health workers and health centres — and to improve retention in care for those on ART.
Nevertheless, retention in care in many programmes remains inadequate, particularly in remote rural settings.
For instance, it has been noted that Mozambique is one of the only countries with such a high burden of HIV that has not allowed nurses to prescribe, and yet, the data from Lesotho, which is lauded for its nurse-driven ART programme did not seem to have significantly different results. But the terrain may simply present too great a challenge going to the clinic.
Decentralisation is not a ‘perfect’ panacea
Furthermore, although decentralisation and nurse-based care are essential to expand access to ART, it may not be enough to simply move services closer to where the patient lives. Even if patients are effectively linked to a local clinic only to find an unfriendly nurse, or if the facility is so under resourced that patients do not receive care that is equivalent to what they received at the ART site at the tertiary hospital, they may not attend the PHC.
The likelihood that a patient who has been down referred to the PHC may not receive all the services that he or she have come to expect — such as community-based peer educators, timely lab results, and a sense of privacy — should not be glossed over for purposes of political expediency when discussing decentralisation. At the IAS meeting in 2011, there were some less than positive reports about the uptake of decentralised services in some settings, such as Tanzania, and a down referral site in South Africa. In Tanzania, the patients simply returned to the up-referral site, while in South Africa, PLHIV actually had a toyi- toying march, protesting being sent to the down-referral site which they believed would not provide as high a quality of service. And, frankly, they may have been right —at least at first, since the tertiary facility was well-established and HIV care at the PHC just starting out. The best longterm solutions may not always be the best solution for the individual.
One potential shortcoming at a PHC is that they may not be able to provide a patient with supportive services that may have been in place at the older better funded dedicated ART sites. In addition, its staff — if they have been sensitised to PLHIV or key populations at all — are unlikely to have an appreciation for concepts such as the patient empowerment, or an understanding of HIV stigma and discrimination — not to mention Greater Involvement of People Living With HIV or linkages to PLHIV networks. Those sorts of relationships with the local PLHIV need to be fostered, of course but it is not clear to what extent this emphasised in a practical way at clinics where nurses already feel overwhelmed.
Reasons for disengaging in care may change over the course of living with HIV infection
So while people might be glad a treatment facility is closer to them, they might just wind up defaulting because of lack of social support and information for adherence. Conversely, they may default simply because they are sick of being treated like a patient.
In Uganda, a recent study reported that a key reason for people to be lost to follow-up who had been taking ART and were stable on treatment for one to four years, – besides from death or transferring to another clinic – is the desire for their lives to return to normal… to demedicalise their lives.
They just wanted to get away from the clinic— which would perhaps be the best for their health anyway (with less risk of exposure to TB and other infections).
“We need to go much further. The ambition today is to provide ART to many more people, and much earlier in their infection, over a long-term period,” wrote Ford and Mills in Plos Med last year. “Realizing this ambition will depend on defining models of ART delivery that are minimally intrusive to patient’s lives. We […] want to support continuous adherence to an effective treatment regimen such that HIV care is largely a self-managed chronic disease.”
Part II looks more closely at the community-based models that could better meet the needs of people (who don’t want to be forever seen as patients).
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