Tuberculosis (TB) is a major contributor to the disease burden in developing countries (1-4), including South Africa (5), where it is exacerbated by the epidemic of human immunodeficiency virus (HIV) (6-8). The implementation of DOTS--the internationally recommended strategy for the control of TB (9, 10)--in South Africa since 1996 has improved drug availability, bacteriological diagnosis and programme monitoring. South Africa uses the 6-month (8 months for re-treatment patients) multi-drug regimen that includes rifampicin. Treatment is taken under the direct observation of another person such as a health-care provider or a lay volunteer (11). TB care in the public sector generally covers the poorest areas and is provided free of charge to patients (5). Nevertheless, cure rates in South Africa remain at 65% (5), and are therefore insufficient to control or reverse the epidemic.
Previous studies have suggested that the failure of the TB control programme in South Africa to achieve its treatment outcome targets is multifaceted (12-14) (Fig. 1). Poor quality of care, resulting from rigid clinic routines; poorly motivated staff; and inadequate provider-patient relations, all contribute to poor adherence to treatment (12, 15). Similar problems have been reported elsewhere (16-20). However, there is little rigorous evidence of the effects of interventions that aim to improve the way in which health workers care for TB patients (21, 22).
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To address these problems, a short in-service training programme for primary care clinic staff caring for TB patients was developed. We report here the findings of a cluster randomized controlled trial conducted to evaluate the impact of the programme on the outcomes of TB treatment (23).
The objective of the present study was to assess whether the addition to the DOTS strategy of an experiential, participatory training intervention for clinic staff would improve treatment outcomes, when compared to those achieved with DOTS alone, in TB patients attending clinics with low rates for the successful treatment of TB (< 70%) in South Africa.
Our study hypothesis was that training would have a positive impact on patient adherence and treatment outcomes through better provider-client relations and improvements in the organization of TB care. The approach was pragmatic: we tested an intervention that could be realistically implemented in public sector facilities in South Africa and in countries with similar health-care delivery systems, and that examined key outcomes of TB control programmes (24-26).
The study was undertaken in nurse-managed municipal primary health clinics that provided care to TB patients in Cape Town, South Africa. These clinics manage more than 90% of ambulatory TB treatment in the city. Many of the clinics are based in low-income, periurban townships. All had good access to diagnostic and referral facilities and drug supplies.
Ethics and consent
Study approval was granted by the Medical Research Council of South Africa and health department managers in Cape Town. The facilitators met the staff of each clinic allocated to the intervention group to discuss the programme and to seek their consent for participation. One clinic allocated to the intervention group refused the intervention, but was analysed on an intention-to-treat basis.
Primary care clinics had to meet the following entry criteria for participation in the trial.
* The overall successful treatment completion rate for all adult patients with smear-positive pulmonary TB was less than 70% in the year preceding the trial (1997). This ensured that only clinics with poor treatment outcomes were entered into the trial. Fifty-nine of the 90 municipal clinics were eligible under this criterion, accounting for 82% of the annual total load of adult, smear-positive pulmonary TB patients in Cape Town. …