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Keywords:

  • HIV/AIDS;
  • antiretroviral;
  • Uganda;
  • effectiveness;
  • health services research
  • essai randomisé en grappes;
  • services de santé de l’Ouganda;
  • défis de la recherche;
  • efficacité de l’essai;
  • thérapie antirétrovirale
  • Ensayo aleatorizado en grupos;
  • servicios sanitarios;
  • Uganda;
  • desafíos en investigación;
  • ensayo de efectividad;
  • terapia antirretroviral

Summary

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

Trials integrated into normal health service delivery are designed to evaluate the effectiveness of interventions under real-life conditions. However, integrating research into service delivery creates many operational challenges and raises ethical dilemmas. Here we discuss the operational and ethical issues arising from such trials using the example of a cluster randomized trial evaluating two strategies of ART delivery in Jinja, south-east Uganda.

Intégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en Ouganda

Les études intégrées dans la prestation normale des services de santé sont conçues pour évaluer l’efficacité des interventions en conditions réelles. Cependant, l’intégration de la recherche dans la prestation des services crée de nombreuses difficultés opérationnelles et pose des défis éthiques. Ici, nous discutons des questions éthiques et opérationnelles découlant de ces essais en utilisant l’exemple d’un essai randomisé en grappes pour l’évaluation de deux stratégies de délivrance de l’ART à Jinja, dans le sud-est de l’Ouganda.

Integrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda

Los ensayos integrados en la entrega normal de servicios sanitarios están diseñados para evaluar la efectividad de intervenciones bajo condiciones de la vida real. Sin embargo, el integrar la investigación en la entrega de servicios trae consigo muchos retos a nivel operativo y genera dilemas éticos. Aquí discutimos las cuestiones operativas y éticas que surgen de estos ensayos, utilizando como ejemplo un ensayo, aleatorizado en grupos, de dos estrategias para la entrega de TAR en Jinja, sudeste de Uganda.


Introduction

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

In most clinical trials, study participants usually receive relatively higher quality free care in a systematic standardized way. Subjects are usually managed clinically by specialist staff who may be more experienced and specialized than those working for the routine health service. Both subjects and clinical staff involved in the recruitment and managements of subjects are often given additional incentives (ICH 1996; Mapstone et al. 2007; Rendell et al. 2007). Health service infrastructure is usually enhanced for the purposes of the trial. Although such trials are important for testing proof of concept, the effectiveness of interventions can be considerably lower in real-life settings, especially in Africa where real-life settings differ considerably from trial settings.

Trials integrated into normal health service delivery are designed to evaluate interventions under real-life conditions. Such studies are appealing to policy makers as they can provide immediately applicable results. However, most African health services are severely resource-constrained, and integrating research into service delivery creates many operational challenges for conducting the research to good clinical practice (GCP) (International Conference on Harmonisation 1996; WHO 2006). It also raises ethical dilemmas, in particular to what extent researchers should intervene with assistance or observe and document failing systems or poor clinical management of patients.

Operational challenges of large efficacy trials have been discussed (Cutts et al. 2006). We are conducting a cluster randomized trial comparing two strategies for the delivery of antiretroviral therapy for HIV-infected subjects in Uganda. The trial is integrated into routine health service delivery, with the health service responsible for the care of study patients, and has a long-duration of follow-up of subjects. Here we discuss the operational and ethical issues arising from such trials.

Overview of the trial and study methods

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

The trial is based at the AIDS Support Organisation (TASO) clinic at Jinja. The primary aim of the trial is to determine whether home-based HIV care, which relies less on clinically qualified staff and reduces the need for patients to travel to clinic, leads to approximately equivalent clinical outcomes in patients on ART as a more standard model of care in which patients are managed by clinicians at a clinic or hospital (Amuron et al. 2007). The primary endpoint is virologic failure.

TASO is a large indigenous non-governmental organization which provides care and counselling for HIV-infected people in the country. The organization follows Ministry of Health guidelines in the clinical management of patients. Clinical staff have similar qualifications and experience as those of government facilities and receive broadly similar remuneration. The trial was integrated into routine service delivery, with TASO being responsible for all patient management. The protocol was approved by the Ugandan National Council of Science and Technology and the Institutional Review Boards of the Uganda Virus Research Institute, the London School of Hygiene and Tropical Medicine, and the US Centers for Disease Control and Prevention.

Study site

Jinja is in south-eastern Uganda. The area is poor and unemployment is high. Patients find it difficult to attend clinics because of the cost of transport and the time it takes to get to clinic. Attracting health care workers to such settings is a major challenge.

The research programme did not provide any financial or other incentives to either health care workers or patients for participating in the research. Although a small amount of money could have made a major difference to individuals, providing such incentives is not part of routine health service procedures. It would have caused inequity among patients and health care workers who were not part of the trial, and would have made the generalization of findings to other settings more difficult.

Patients were assessed for treatment by TASO over three visits to clinic in the course of 4–6 weeks. Treatment was initiated at the clinic. Patients were randomized by geographical clusters of residence to receive either home or facility-based care (Amuron et al. 2007). In the facility-based arm, trial subjects collected drugs from the pharmacy at the TASO clinic monthly and were seen by a nurse who referred them to a doctor or counsellor if necessary. Subjects were also assessed routinely every 3 months by a counsellor and a physician. To those receiving home-based treatment, drugs were delivered at home monthly by TASO field officers. At these visits, patients were monitored using a checklist and adherence support and counselling provided. Subjects were referred to see a physician or counsellor at the TASO clinic when judged necessary by the field officers. Patients were assessed routinely by a counsellor and a physician at 6-monthly intervals at the TASO clinic and asked to return to clinic any time they felt unwell.

TASO field officers are required to have at least a diploma from technical college. In Jinja, 11 of 14 field officers have a university degree and the other three are studying for a degree part-time. The field officers underwent 4 weeks of intensive training and received limited on-going support thereafter by the TASO medical co-ordinator. Counsellors are required to have experience in HIV counselling and in working with people living with HIV and AIDS. They are provided with further training in a 6-week modular course spread over 6 months.

The medical doctors have all completed 5 years of undergraduate study at medical school followed by one year of internship. Most had 1–2 years’ work experience. None was a specialist. The clinical officers have a 3-year medical training followed by 2 years of internship. Clinical staff were supervised by the medical co-ordinator who had approximately 5 years of experience in general medicine. Training of TASO staff was conducted by senior staff based at TASO headquarters and was identical at all TASO centres.

CD4 count and viral load testing was done at baseline, 6-monthly and each time a subject was suspected of treatment failure. The CD4 count testing was done by TASO and was part of the routine clinical management. Samples for viral load were collected for research purposes and tested in batches (i.e. not in real-time). The results were available to TASO physicians and trial subjects on request. Clinical data and data on adherence were collected at these times and each time a subject presented sick. Data on socio-demographics and costs of accessing care were collected at baseline and 12-monthly. The clinical data were collected by TASO physicians and transcribed from clinical notes onto forms by the research team. All other data were collected by the research staff.

Preparatory work was done between July 2004 and February 2005. Recruitment to the trial began in February 2005 and ended in December 2006. All patients treated with ART by TASO were eligible for the trial unless they lived outside the TASO catchment area or on remote islands where TASO were unable to deliver home-based care. In all, 1488 patients were offered participation in the trial by TASO during this period. Eleven were excluded for the trial because they lived on the islands, 24 refused to join the trial and 1453 were recruited after written informed consent. Follow-up is scheduled to continue to 2008. Subjects who were excluded from the trial (because they did not meet the inclusion criteria), who refused to join the trial or who withdrew for whatever reason, were offered ART at TASO Jinja.

The challenge of management of research within routine health service delivery

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

Researchers and health service staff have different goals and usually work for very different organizations. A major challenge is to ensure that they work effectively alongside each other. For health service staff, research often involves a significant additional burden of work on top of a high existing workload and is conducted by individuals outside of the health service. Research can be a burden also for patients, whose primary concern is usually their immediate health need.

Our solution was to form a genuine partnership between the research team, TASO and the trial subjects. TASO asked the primary research question and the research team provided the tools to answer it. Secondary questions were asked in partnership. All cadre of TASO staff and patient groups were consulted both in defining the research questions and in the implementation of the research programme. Regular meetings were held, with many chaired by the Director of TASO. Protocols and data collection instruments were developed in consultation between research staff, TASO health service staff and patient representatives. Repeated explanations were provided on the value of research and how research findings could be used by both staff and patients.

Providing information to all cadre of research and TASO health service staff and to patients was key to the partnership. TASO informed patients about the research trial through meetings, mostly at the clinic, and through their drama group, which held regular sessions in the community. The drama group comprised volunteer clients. The research team worked with TASO and leaders of the patient support groups to allay fears and misconceptions about the research. Since the trial began, research staff have provided routine regular feedback on trial progress and findings of process data to staff at least monthly, to patient representative groups every 3–6 months, and to patients annually. Feedback has also been provided to the wider community in the district and the Ministry of Health and other groups who influence policy, such as the UK Department for International Development in Uganda and the Uganda AIDS Commission.

The challenges of incorporating research on health service staff workloads

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

Most health services in Africa are under considerable strain and do not have capacity to take on additional responsibility. TASO’s programmatic staff at its headquarters and clinicians, senior counselling, field and nursing staff on the ground in Jinja provided input in the preparation of the trial. TASO staff received training in research methods from the research team and sensitized the community and patients about the trial. This was a considerable undertaking and TASO did this without any additional resources or financial support from the research team over a period of 6–8 months.

TASO began its ART programme on October 2004 and recruitment of patients into the trial started on 5 February after ethical clearance. The trial added strain to TASO health services and it became clear that standards of clinical and laboratory investigations might fall as a result of incorporating the research. Thus, in March 2005, the research programme offered to pay TASO to hire four staff: a laboratory technician, a records clerk, a physician and a counsellor. The laboratory technician, records clerk and counsellor were hired quickly and began work in April 2005. However, despite extensive advertising, a physician could not be identified until October 2006. In November 2006, when 1350 patients had been recruited into the trial, and the workload had increased considerably, the research programme provided TASO with funds for two more field officers. All six staff were employed by TASO under their usual terms and conditions. Overall, the posts have ensured that TASO continues to provide its normal health service and fulfils the requirements of the trial.

The challenges of recruitment into a trial, data collection and field work in a health service setting

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

We evaluated health worker workloads before the trial began and assessed the feasibility of adding the extra demands of data collection and other trial procedures. It was evident that data collection by TASO had to be minimal to ensure quality because of their high patient load. Thus, physicians were asked to collect data only on HIV staging and clinical diagnoses, and nursing staff to collect body weight and height.

To assist the TASO programme, the research team devised an algorithm for identifying patients for recruitment into the trial or due for follow-up appointments. Clinical files were made ready with pre-printed sticky labels with identity numbers on each day. Blood sampling was done by a research laboratory technician, supported by a TASO laboratory technician working in the same room. Trial subjects were bled once and blood separated for CD4 testing and storage.

All other data (including data on socio-demographics, knowledge, attitudes and behaviour and adherence) were collected by research staff. A major challenge is that data when collected in a health service setting can be unreliable as patients may think it affects their right to care. Thus, TASO staff sensitized the community and patients in various talks and drama group plays stressing the independence of the research team and the need to get accurate and honest answers. During the consent process, the research team went over the issues again. All interviews took place in our research building, which was separate from the TASO clinic. We interviewed patients soon after arrival and before they saw TASO staff (i.e. before any counselling had taken place). Sensitive questions (e.g. the consumption of alcohol which TASO counsellors had advised patients against) were preceded by a short pre-amble of the challenges of adhering consistently to advice and of our need to obtain accurate reliable data. Importantly, we ensured that patients participating in the research did not miss their position in the queue to see TASO clinical or counselling staff.

Ways of ensuring high quality data

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

In most service delivery settings, the care and accuracy invested in procedures such as data collection fall well below those required in a clinical trial, and ensuring GCP standards is difficult. The research programme aimed for 100% compliance to standard operating procedures for recruitment, collection, storage, transport and testing of blood samples, collection of outcome data (deaths, admissions, serious adverse events, treatment failure) and follow-up of study subjects who failed to attend routine clinical appointments.

The research team wrote down procedures and instructions to assist with data collection and field work. Colour charts were drawn up showing the data collection requirements for different patient attendances. However, we soon realized that there was no culture of referring to written documents or charts and reverted to enhanced training and supervision. Role plays and drama sessions were used extensively to do this. In a small number of patient interviews, a supervisor was present after permission from the client. The times taken by interviewers over the consent procedure were monitored and a small proportion of patients were re-interviewed to ask them how well they had been informed about the trial and their rights. The information gathered was fed back to the interviewer and discussed at trial meetings.

The research team checked the data collected by TASO clinicians on the same morning as the clinic and spoke to clinicians immediately if any data were missing or suspected to be incorrect. Usually this was done while the trial subject was still in the building. The research team did spot checks on the laboratory and for example checked the time taken to process blood samples. The protocol stated that plasma should be separated and stored within 2 h of a subject being bled. All data were double-entered and verified within 48 h of collection. These were used to monitor compliance to the standard operating procedures.

The research team attended most meetings held by the TASO clinicians, counsellors, nursing staff, management and field staff. Information on compliance with standard operating procedures and data quality was fed back to the various teams as well as to individuals. Feedback was provided both verbally and in written reports. The research team spent time on the ground with both TASO clinic and field staff to better understand their problems. Additional training in trial procedures was provided to staff who had difficulty in understanding. A supportive but competitive spirit was encouraged to enhance quality of data.

By December 2007, data were 100% complete on CD4 count, plasma viral load, age, various clinical variables and outcomes. Blood had been separated and stored at a median 19 min (range 10, 120) after collection. We had had 15 833 follow-up patient visits at the clinic (both routine and referrals). Adherence and other data had been collected in each presentation except in 278 instances when subjects were judged too sick to be interviewed.

The challenges of management of staff

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

Over the course of the recruitment, the research team comprised 16 full-time staff on the ground. TASO staff comprised four physicians, seven nurses, two pharmacy technicians, three laboratory staff, 20 counsellors, 14 field staff, 15 administrative staff and nine others full-time and seven part-time. We had clear written understanding of the roles of the organizations and the different groups and responsibilities were discussed regularly at investigators meetings. Both TASO and MRC had transparent policies on recruitment, training and career development and support in management, administration and training from their head offices in Kampala and Entebbe respectively.

Major challenges were in increases in workload, which were difficult to estimate in advance because of the limited understanding of ART programmes and difficulty of attracting physicians to service delivery. A major and unexpected challenge was staff sickness due to road accidents, both while working and during private travel. Several senior staff from both organizations had serious road accidents. This was less of a challenge for the research team who were able to second staff from our head office with little or no notice but it was a problem for TASO, whose systems were less flexible and whose resources were more limited.

The remuneration packages of research staff were higher than those of service delivery staff. However, no resentment appeared evident, possibly because of the close partnership which had evolved. Providing TASO staff with incentives could have affected the spirit of the partnership and introduced inequity between TASO staff in Jinja and the other TASO centres.

Ethical challenges of monitoring and observing vs. intervention

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

ART programmes have been challenging undertakings in most settings in Africa, largely because of the weak health infrastructure. At the start of this programme, TASO faced several programmatic difficulties. For example, there was a shortage of stavudine and for a period, patients on stavudine were prescribed 1–2 weeks’ supplies instead of the usual 1-month supply, thus increasing considerably the workload for the clinic. Several TASO clinical posts were unfilled. TASO could not respond fast enough to a workload which increased rapidly (in part because of the trial). Also, TASO clinicians were relatively junior and less experienced than the research clinical team.

Deciding when to intervene to assist the programme or individual patient management presented major dilemmas to the research team. This was probably the single most frequently discussed issue among investigators. On the one hand, none of the investigators wanted responsibility to be taken away from the TASO health service or to create a setting from which results would be difficult to generalize or to provide a service that could not be sustained. The research team also did not want to refuse requests for assistance, especially those relating to the clinical management of patients.

The research team assisted in clinical decisions when asked to do so by TASO clinicians. Usually this was in complex or life-threatening cases. In the 12 months since February 2005, the research team assisted with 15 consultations. Between February 2006 and December 2007, assistance was provided in nine consultations. The research team also participated in six clinical meetings to discuss complex cases, mostly as observers, but intervened in complex clinical decisions when asked. The research programme purchased buffer supplies of drugs for use by TASO when they had shortages. From February 2005 to January 2007, these were used on 12 occasions. Thereafter, TASO did not have any shortages because of the greater availability of drugs and possibly the organizations increased experience in procurement. Observations of the quality of the service delivery were collated by the research team and fed back to TASO senior staff at the investigators’ meetings.

Conclusions

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References

We have integrated a large trial into routine service delivery to compare a home-based with a facility-based model of ART delivery. The findings will be informative about home-based ART delivery, may serve as proof of concept for reducing reliance on clinicians based in hospitals and could have implications for home-based support services beyond ART alone (for example combining ART with cardiovascular disease prevention services). However, this was a challenging undertaking both for the health service staff and for the researchers. We considered a non-randomized study, for example to allow subjects to choose their mode of care or to evaluate the two strategies in separate settings. However, both approaches are subject to considerable bias and we chose a randomized study because of the need for strong reliable evidence, which is especially important in Africa where resources are scarce and strategy needs to be evidence-based.

Although we integrated the trial into routine health service delivery, and kept the input of researchers in clinical management minimal so as to observe the two strategies in settings as close to real-life settings as possible, it is likely that the presence of the research had some beneficial effect on TASO Jinja. We provided regular feedback on adherence to protocols, on inconsistencies in data, and assisted in the tracking and follow-up of patients. We also provided assistance in procuring drugs when drug supply was short and in managing some complex clinical cases. Many of the lessons learnt at TASO Jinja were quickly fed back to the organization and used to improve service delivery at the other TASO centres.

This is a large complex trial. There have been very few trials conducted in Africa in the past which have been integrated into service delivery in this way or which have examined different strategies of providing ART. Getting information across to potential trial participants, especially on the need for randomization and for systematic follow-up and collection of data, has been a major challenge. This was met effectively through a partnership between researchers, health service staff and patients. Only 24 subjects refused to enter the programme and relatively few have withdrawn (and withdrawals have almost all been due to migration or because the subjects have found a service provider nearer home). This would not have been possible without a genuine partnership between stakeholders, which is essential in such complex research environments.

In summary, it is vitally important that research studies integrated into routine health services are done in a partnership between researchers and health service staff. Data collection by health service staff and other demands on their time should be kept minimal and monitored to ensure that service delivery does not suffer from the increased workload arising from the research; where appropriate support for hiring additional health service staff should be provided. Quality control to monitor data collection and compliance to standard operating procedures is essential with standards set very high for key activities. A partnership with patients is also vital but the research team should be perceived by patients as independent of the health service. The ethical issues arising from the research need to be monitored by researchers and health service staff.

References

  1. Top of page
  2. SummaryIntégration de la recherche dans la prestation de routine des services dans un programme de traitement antirétroviral: leçons tirés d’un essai randomisé en grappes comparant les stratégies de prise en charge du VIH à Jinja, en OugandaIntegrando la investigación en la entrega rutinaria de servicios en un programa de tratamiento antiretroviral: lecciones aprendidas de un ensayo aleatorizado en grupos comparando estrategias de cuidados para VIH en Jinja, Uganda
  3. Introduction
  4. Overview of the trial and study methods
  5. The challenge of management of research within routine health service delivery
  6. The challenges of incorporating research on health service staff workloads
  7. The challenges of recruitment into a trial, data collection and field work in a health service setting
  8. Ways of ensuring high quality data
  9. The challenges of management of staff
  10. Ethical challenges of monitoring and observing vs. intervention
  11. Conclusions
  12. Acknowledgements
  13. References
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