Home or Clinic-based Care for Patients With Low CD4 Counts
Home or Clinic-based Care for Patients With Low CD4 Counts
This analysis shows that in a Ugandan trial, HIV-infected people presenting with very low CD4 cell count, who subsequently started on ART, and whose management included home-based care delivered by trained lay workers, had similar survival outcomes as those who received clinic-based care. The adjusted mortality rates for home-based care were actually 20% lower than in facility care but this was probably due to small numbers. When we restricted the analysis to within 6-months of treatment initiation (i.e. when mortality is high and more likely to be HIV-specific), the results were similar.
It is possible that we did not detect an increased mortality among home-based care patients because stratification of participants by CD4 cell count and follow-up period reduced the power of the analysis. However, the confidence intervals were reasonably narrow and the study size was sufficient to rule out major differences. We may also have failed to detect a difference because all the patients were relatively healthy, albeit at low CD4 count. However, we have no reason to think that we systematically excluded sick people. We are likely to have enrolled the vast majority of those eligible for ART who present to health services, since TASO was providing almost all of the ART in the district during the period of the trial (the TASO clinic was based in the grounds of Jinja District Hospital and almost all patients came to TASO for their HIV care).
At the start of the roll-out of ART programme in Uganda and in most African countries, patients presenting with HIV-infection and eligible for treatment were required to undergo 3–4 adherence counselling sessions over a period of about a month or so. During this time, mortality was high; in our case over 30 deaths per 100 person years. Thus, this process is likely to have screened out before randomization some of the very sick patients who might have benefited more from facility care. However, the policy of initiating ART after patients have been informed about adherence remains in place in most countries in Africa, and our results are intended to generalize to this population. We are currently conducting a trial to evaluate immediate initiation of ART followed by adherence counselling (ISRCTN20410413) to target the very sick patients who present late and die before ART is initiated. Late presentation will continue to occur in Africa. Our analysis confirms that the mortality rate in the first 6-months for patients who present with low CD4 cell count is very high, comparable to that seen during the pretreatment period, and that the major route to reducing HIV-associated mortality must be to reach patients and initiate treatment earlier.
Why the outcomes in the home-based care arm, which comprised lay-workers delivering care and support in the community, supported by clinical staff based in the clinic, were approximately equivalent to those in the standard clinic-based arm needs further investigation. The comparison standard care arm was well functioning with qualified doctors and nurses, a reliable drug supply, laboratory back-up and reasonable equipment. Indeed the mortality rate of 6.36 deaths per 100 person-years observed in this study is similar or lower than the rates reported in most other mortality studies in Africa. One explanation might be that the monthly personalized HIV adherence counselling provided by lay-workers in the home during drug delivery resulted in better adherence in the intervention arm and that the effect of this was as powerful as the better clinical monitoring and care that patients may have received at clinic at 3-montly intervals. This confirms that getting patients to adhere to ART should be a very high priority, irrespective of the stage of their illness, and especially where high quality clinical monitoring is not available. Mortality rates of people on ART remain four to five times higher in Africa than in developed countries and retention in HIV care is a major concern. It is not known whether combining clinic management by doctors and nurses with enhanced and personalized adherence support might reduce mortality even further.
The distribution of causes of deaths suggested that deaths attributed to tuberculosis were more common in the home-based care arm than in facility care and deaths attributed to poor nutrition (poor feeding and starvation) were more common in the facility-based arm. However, these findings need to be interpreted with caution as numbers were small and causes of deaths were ascertained by verbal interviews of the relatives of the deceased. However, if these findings are confirmed in other studies, it would suggest that tuberculosis is better detected and managed (and therefore more tuberculosis deaths are averted) in the facility arm than in the home-based arm while lay-workers visiting the homes of patients are better at detecting and averting deaths from poor nutritional intake. There was no difference overall between the two arms in the admissions or outpatients diagnoses.
The findings published in the original article from the Jinja trial were used recently to inform the WHO's guidelines on task shifting from doctors to nurses and trained lay-workers and decentralized care from hospitals to primary care centres and the community. The present analysis shows that this public health approach could be considered for all patients, including those presenting with very low CD4 cell count. We have shown previously, that this approach could be cost-saving for health services from reduced utilisation of clinics and doctor and nurse time and hugely cost saving for patients. Greater cost-effectiveness might be achieved if such models of care are extended to other high burden clinical conditions and to approaches involving integrated care. It is important to remember that the lay-workers in our study had clear referral guidelines and were supervised by clinical staff based in the clinic and modification of the support structures for lay-workers and their nature of responsibilities will need further research. Our study also confirms the importance of adherence support to patients receiving complex lifelong therapy.
As far as we are aware this is the first study to consider the effect of a home-based strategy of ART in patients with low baseline immune function. The achievement of similar survival to clinic-based patients, including during the high-risk period immediately after starting ART, further supports the use of decentralized care in resource-constrained settings.
Discussion
This analysis shows that in a Ugandan trial, HIV-infected people presenting with very low CD4 cell count, who subsequently started on ART, and whose management included home-based care delivered by trained lay workers, had similar survival outcomes as those who received clinic-based care. The adjusted mortality rates for home-based care were actually 20% lower than in facility care but this was probably due to small numbers. When we restricted the analysis to within 6-months of treatment initiation (i.e. when mortality is high and more likely to be HIV-specific), the results were similar.
It is possible that we did not detect an increased mortality among home-based care patients because stratification of participants by CD4 cell count and follow-up period reduced the power of the analysis. However, the confidence intervals were reasonably narrow and the study size was sufficient to rule out major differences. We may also have failed to detect a difference because all the patients were relatively healthy, albeit at low CD4 count. However, we have no reason to think that we systematically excluded sick people. We are likely to have enrolled the vast majority of those eligible for ART who present to health services, since TASO was providing almost all of the ART in the district during the period of the trial (the TASO clinic was based in the grounds of Jinja District Hospital and almost all patients came to TASO for their HIV care).
At the start of the roll-out of ART programme in Uganda and in most African countries, patients presenting with HIV-infection and eligible for treatment were required to undergo 3–4 adherence counselling sessions over a period of about a month or so. During this time, mortality was high; in our case over 30 deaths per 100 person years. Thus, this process is likely to have screened out before randomization some of the very sick patients who might have benefited more from facility care. However, the policy of initiating ART after patients have been informed about adherence remains in place in most countries in Africa, and our results are intended to generalize to this population. We are currently conducting a trial to evaluate immediate initiation of ART followed by adherence counselling (ISRCTN20410413) to target the very sick patients who present late and die before ART is initiated. Late presentation will continue to occur in Africa. Our analysis confirms that the mortality rate in the first 6-months for patients who present with low CD4 cell count is very high, comparable to that seen during the pretreatment period, and that the major route to reducing HIV-associated mortality must be to reach patients and initiate treatment earlier.
Why the outcomes in the home-based care arm, which comprised lay-workers delivering care and support in the community, supported by clinical staff based in the clinic, were approximately equivalent to those in the standard clinic-based arm needs further investigation. The comparison standard care arm was well functioning with qualified doctors and nurses, a reliable drug supply, laboratory back-up and reasonable equipment. Indeed the mortality rate of 6.36 deaths per 100 person-years observed in this study is similar or lower than the rates reported in most other mortality studies in Africa. One explanation might be that the monthly personalized HIV adherence counselling provided by lay-workers in the home during drug delivery resulted in better adherence in the intervention arm and that the effect of this was as powerful as the better clinical monitoring and care that patients may have received at clinic at 3-montly intervals. This confirms that getting patients to adhere to ART should be a very high priority, irrespective of the stage of their illness, and especially where high quality clinical monitoring is not available. Mortality rates of people on ART remain four to five times higher in Africa than in developed countries and retention in HIV care is a major concern. It is not known whether combining clinic management by doctors and nurses with enhanced and personalized adherence support might reduce mortality even further.
The distribution of causes of deaths suggested that deaths attributed to tuberculosis were more common in the home-based care arm than in facility care and deaths attributed to poor nutrition (poor feeding and starvation) were more common in the facility-based arm. However, these findings need to be interpreted with caution as numbers were small and causes of deaths were ascertained by verbal interviews of the relatives of the deceased. However, if these findings are confirmed in other studies, it would suggest that tuberculosis is better detected and managed (and therefore more tuberculosis deaths are averted) in the facility arm than in the home-based arm while lay-workers visiting the homes of patients are better at detecting and averting deaths from poor nutritional intake. There was no difference overall between the two arms in the admissions or outpatients diagnoses.
The findings published in the original article from the Jinja trial were used recently to inform the WHO's guidelines on task shifting from doctors to nurses and trained lay-workers and decentralized care from hospitals to primary care centres and the community. The present analysis shows that this public health approach could be considered for all patients, including those presenting with very low CD4 cell count. We have shown previously, that this approach could be cost-saving for health services from reduced utilisation of clinics and doctor and nurse time and hugely cost saving for patients. Greater cost-effectiveness might be achieved if such models of care are extended to other high burden clinical conditions and to approaches involving integrated care. It is important to remember that the lay-workers in our study had clear referral guidelines and were supervised by clinical staff based in the clinic and modification of the support structures for lay-workers and their nature of responsibilities will need further research. Our study also confirms the importance of adherence support to patients receiving complex lifelong therapy.
As far as we are aware this is the first study to consider the effect of a home-based strategy of ART in patients with low baseline immune function. The achievement of similar survival to clinic-based patients, including during the high-risk period immediately after starting ART, further supports the use of decentralized care in resource-constrained settings.