| Highly active antiretroviral treatment (HAART) is becoming increasingly available in sub- Saharan Africa. Implementation has started at the (referral) hospital level. Scaling-up HAART to more peripheral levels of the health care system, in general that of the district, is necessary to deal with the large burden of cases. This requires strategies of patient management that are adapted to the situation at these levels, with their limitations in human resources, training levels, and laboratory and other diagnostic facilities. Such strategies should include feasible approaches to e.g. assessment of eligibility for HAART, monitoring of treatment outcome, recognition and treatment of side-effects, and treatment adherence (e.g. through community involvement). The strategies should be based on evidence from clinical studies, and on evidence from operational studies that assess their safety and effectiveness at the district level. This implementation research should be multidisciplinary, addressing issues that range from simplified laboratory techniques to patient motivation to adhere to treatment. It should also address the challenges posed by demographic developments, in particular rapid urbanization. As with TB, HIV case loads 3 NACCAP are highest in major urban areas, overburdening health services, while case holding and treatment adherence are difficult. Urban TB and TB-HIV management is a neglected area and few data from outside referral hospital settings are available. Currently the capacity for high-quality implementation research in sub-Saharan Africa is limited. This project aims to build such capacity by developing study sites, but also by financial and scientific support of PhD programs (which will increase senior staffing levels), MSc/MPH thesis work (which will stimulate curriculum development and create a reservoir of qualified young scientists) and continued education of senior staff. This aims to increase critical scientific mass and enhance international competitiveness in Uganda (where basic capacity, also for training, exists), and to develop operational research and related training in Rwanda. The latter will be done in close collaboration with the Ugandan institute. It will focus on developing management strategies of HIV and TB, including HAART, for large-scale implementation at the district level, in urban and rural settings. The project will make use of clinical experience and study results from other projects in the INTERACT programme, and have strong involvement of the public health sector (health care delivery, disease control programmes). A major role will be for learning-by-doing, i.e. several operational studies will be done as part of this project. There are important reasons for close interaction between clinical management and the public health context in this project. First, public health services play a pivotal role in health care delivery at the district level. Their input is vital for any disease management model to be implementable at large scale. Second, there are unavoidable tensions between individual patients interests and those of the community at large, e.g. in choice of treatment regimens with regard to development of drug resistance. It is thus necessary that national disease control strategies are taken into account from the outset. There are also several reasons for the interaction, in this project, between HIV and TB. Up to 50% of patients diagnosed with TB in sub-Saharan Africa may be HIV infected and eligible for HAART. This makes TB an efficient point of entry for HIV treatment. Combined TB and HIV treatment provides challenges with regard to drug interactions and side-effects (e.g. immune reconstitution syndrome, IRS) for which the best clinical management has not been established, but also opportunities for combining services (e.g. treatment supervision). And importantly, the DOTS strategy for TB control provides a use ful template for implementing HAART delivery, since it addresses issues that are critical to HAART as well, such as standardized diagnosis using simple laboratory techniques, standardized treatment regimens, assurance of treatment adherence by observed drug intake and simple standardized monitoring of treatment outcomes. Our approach is therefore to start studying operational aspects of TB management under routine conditions, focusing on treatment adherence, case holding and acceptance of HIV testing. The lessons learned from these studies will then be used for developing and evaluating management strategies of HIV-infected patients (with or without TB). This will focus on clinical and simplified laboratory assessment of eligibility, treatment response, and side-effects; assuring patient adherence by community involvement; assuring case holding by systems for defaulter tracing and referral; and diagnosis of smear-negative TB among HIV-infected patients. We find it essential that the operational research agenda matches the needs identified by control programmes and local staff during implementation. Therefore, detailed study plans for the 2nd phase will be developed at the end of the 2nd project year. |
