Evaluation of a unified treatment regimen for all new cases of tuberculosis using guardian-based supervision.

SETTING: Ntcheu District, Malawi, using an oral antituberculosis treatment regimen. OBJECTIVE: To determine whether directly observed treatment (DOT) during the initial phase of treatment supervised either in hospital, at health centres or by guardians in the community, was associated with 1) satisfactory 2-month and 8-month treatment outcomes, and 2) with a reduction of in-patient hospital-bed days. DESIGN: Prospective data collection of all tuberculosis (TB) patients registered between 1 April 1996 and 30 June 1997, with 2-month and 8-month treatment outcomes, sputum smear conversion in smear-positive pulmonary TB patients (PTB) and in-patient hospital-bed days. RESULTS: Among the 600 new patients, 302 had smear-positive PTB, 150 smear-negative PTB and 148 extrapulmonary TB (EPTB). Eight-month treatment completion was 65% for smear-positive PTB patients, which was significantly higher than in patients with smear-negative PTB (45%) and EPTB (54%), due mainly to high 8-month mortality rates. The site of the intensive phase was determined in 596 patients: 178 (30%) received DOT from guardians, 115 (19%) from a health centre and 303 (51%) in hospital. At 2 months, mortality rates were significantly higher in hospitalised patients. Two-month treatment outcomes (including sputum smear conversion rates in smear-positive PTB patients) were similar between patients receiving DOT at health centres or from guardians. Decentralised DOT resulted in a 25% reduction in hospital-bed days in patients alive at 2 months compared with that predicted using the old regimens. CONCLUSION: Decentralising DOT to health centres and to guardians during the intensive phase is associated with satisfactory treatment outcomes.     

Effectiveness of community-based directly observed treatment for tuberculosis in an urban setting in Tanzania: a randomised controlled trial.

SETTING: An urban district in Dar es Salaam city with a high tuberculosis (TB) caseload. OBJECTIVE: To evaluate the effectiveness of community-based direct observation of treatment (DOT) using guardians and former TB patients compared to hospital-based DOT in an urban setting in Tanzania. DESIGN: Unblinded randomised control trial conducted in five sites under operational conditions in Temeke district. No changes to existing treatment delivery were made other than randomisation. The main outcome measure was treatment success. Analysis was by intention to treat. FINDINGS: A total of 587 new tuberculosis patients were enrolled. Among enrolled patients, 260 were assigned to community-based DOT using guardians and former TB patients and 327 to health facility-based DOT. Both DOT options gave similar treatment outcomes. Treatment success rate among patients under community and health facility-based DOT were 85% and 83%, respectively (OR 1.17, 95%CI 0.75-1.83). CONCLUSION: Community-based DOT is as effective as health facility-based DOT and can achieve good treatment outcomes, even in countries with well functioning National Tuberculosis Programmes.     

Community DOT for tuberculosis in a Brazilian favela: comparison with a clinic model.

SETTING: Rio de Janeiro City, Brazil. OBJECTIVE: To compare community-based directly observed treatment (DOT) for tuberculosis (TB), using community health workers (CHWs), with clinic-based DOT. DESIGN: In a longitudinal study in a cohort of TB patients in a region of Rio de Janeiro city, we evaluated treatment modalities and outcomes in 1811 patients diagnosed with TB between 1 January 2003 and 30 December 2004. Patients were offered DOT when they presented to out-patient clinics for an initial diagnosis. DOT was provided in the clinic or in the community, using CHWs, for patients living in a large favela. Outcomes of treatment were assessed using treatment registry databases. RESULTS: Of the 1811 TB patients, 1215 (67%) were treated under DOT; among these, 726 (60%) received clinic-based treatment and 489 (40%) community-based treatment. Patients offered community-based treatment were more likely to accept DOT (99%) than those offered clinic-based treatment (60%, P<0.001). Treatment success rates for new smear-positive and retreatment TB cases were significantly higher among those treated with community-based DOT compared to clinic-based DOT. CONCLUSION: We conclude that using CHWs to deliver DOT in the community may improve TB treatment outcomes in selected areas such as urban slums.     

Can guardians supervise TB treatment as well as health workers? A study on adherence during the intensive phase.

SETTING: In sub-Saharan Africa, tuberculosis (TB) has increased over the last two decades due to the human immunodeficiency virus pandemic. In Malawi, 20630 new TB patients were notified to the National Tuberculosis Programme in 1996, a fourfold increase since 1986. Due to this increase in cases and lack of resources (both human and monetary) it is becoming more difficult to ensure directly observed treatment (DOT) in the TB wards. METHODS: In Ntcheu district, Malawi, a new TB regimen was introduced from April 1996 in which patients received supervised treatment by either a health worker or a guardian (i.e., family member). Adherence to the different treatment options was measured by form checks, tablet counts, and tests for detecting isoniazid in the urine. Adherence was measured at 2, 4 and 8 weeks after onset of TB treatment. RESULTS: Overall adherence rate was 95-96%. Inpatients showed the highest adherence rates. Patients on guardian-based DOT (GB-DOT) (n = 35) showed 94% adherence, while patients on health centre based DOT (n = 40) showed more non-adherent behaviour: 11% according to monitoring forms, 14% according to tablet counts and 16% according to urine tests. DISCUSSION: The results suggest that decentralised care is a feasible option for anti-tuberculosis treatment and that guardians can supervise TB treatment just as well as health workers during the intensive phase of TB treatment.     

Directly observed therapy (DOT) is not the entire answer: an operational cohort analysis.

SETTING: New Jersey Medical School National Tuberculosis Center-Lattimore Clinic, a TB Clinic for an inner city population of Newark, New Jersey, USA. OBJECTIVE: Directly observed therapy (DOT) is the recommended standard of TB care. Recent reports suggest that DOT may not be any better than self-administered therapy (SAT). To quantify the impact of different levels of SAT, DOT, and active case management on outcomes of TB treatment at our location, we reviewed the outcomes of six TB patient-cohorts from Newark between 1 January 1994 and 31 December 1996. STUDY DESIGN: A retrospective cohort study of the outcomes of 343 tuberculosis patients treated during the years 1994-1996. The three treatment strategies were 1) self-administered with occasional selective directly observed therapy, 2) universal directly observed therapy alone (universal DOT), and 3) universal DOT with nurse case management (NCM). RESULTS: The first two cohorts who began treatment during the transition may have received more than one treatment strategy. However, universal DOT did not significantly improve the TB treatment completion rates of Cohort 2 over SAT therapy with selective DOT given to Cohort 1. Universal DOT with NCM, Cohorts 3, 4, 5, and 6, significantly increased the TB treatment completion rates by three to six times. A cohort-specific step-wise reduction in duration of treatment from a median of 11.6-7.5 months and an increase in completion rates from 57-81% resulted. The most desirable and optimal (shortest) duration of treatment completion coincided with the application of universal DOT combined with NCM.     

A unified treatment regimen for new cases of tuberculosis in resource-poor countries: a study in a rural district in Malawi.

An oral ambulatory unified treatment regimen was introduced in Ntcheu District, Malawi, between April 1996 and June 1997 for all new patients (600) with tuberculosis (TB). There was no change in the case finding pattern compared with the previous 5 years; 65% of new smear-positive pulmonary tuberculosis (PTB) patients completed treatment, not significantly different compared with the previous 3 years. Treatment completion was significantly lower in patients with smear-negative PTB and extra-pulmonary tuberculosis, due mainly to high mortality rates (40% and 41% respectively). In a rural district with high human immunodeficiency virus sero-prevalence rates in TB patients, case finding and end of treatment outcome of the oral unified regimen were comparable to those of previous regimens.     

Tuberculosis treatment delivery in high burden settings: does patient choice of supervision matter?

SETTING: The Northern Cape Province, Republic of South Africa. OBJECTIVES: To determine the effect of patient choice of treatment delivery option on the treatment outcomes of tuberculosis (TB) patients in a high burden setting under actual programme conditions. DESIGN: Cohort study involving 769 new and retreatment TB patients recruited from 45 randomly selected clinics. Patients were interviewed and subsequent follow-up was done through regular visits to the clinics to check progress through formal health records. RESULTS: There was a statistically significant difference (P < 0.001) between the treatment outcome of new patients (70% successful) and re-treatment patients (54% successful). Direct observation of treatment (DOT) was found to have no effect on the treatment outcome of new patients (P = 0.875), but re-treatment patients were found to fare better with than without DOT (OR 14.2, 95% CI 4.18-53.14, P < 0.001). CONCLUSION: The results obtained for new patients are similar to those of two recent randomised controlled trials on DOT. This study revealed that for new patients, undue emphasis on universal DOT might be unnecessary. It would perhaps be more beneficial to target supervision at those patients who are most likely to benefit from it (i.e., re-treatment patients). This is of particular relevance in high burden, resource-limited settings where universal DOT for all TB patients is generally unfeasible.     

Directly observed treatment of tuberculosis in Hong Kong.

OBJECTIVE: To evaluate the local use of out-patient directly observed treatment (DOT) for tuberculosis (TB) control. SETTING: Seventeen government chest clinics managing around 80% of TB patients in Hong Kong. METHOD: A retrospective cohort. TB patients registered for treatment from 1 July to 31 August 2000 were followed up for 2 years. Baseline socio-demographic and clinical characteristics were correlated with adherence to DOT, mode of treatment and treatment outcomes. RESULTS: Of 988 patients, respectively 142, 140 and 21 switched to non-DOT within 2 months, 2-6 months and after 6 months. More Chinese patients than ethnic minorities switched to non-DOT within the first 2 months (15.2% vs. 0%, P = 0.001). Geographical inconvenience (31.7%) was the primary reason for switching initially, with increasing proportions giving no specific reason after the second month. Patients staying on DOT in the first 2 months had a significantly higher cure rate than those not on DOT, in both univariate (92.7% vs. 83.9%, P = 0.002) and multivariate analysis (OR = 2.5, P = 0.001). Subsequent switching, intermittent or daily regimen did not appear to affect the outcome. CONCLUSION: Significant numbers of patients failed to stay on DOT, and those staying initially had a better outcome.     

DOT in rural China: experience from a case study in Shandong Province, China.

SETTING: Four counties at varying levels of economic development in Shandong Province were sampled. All offered tuberculosis (TB) directly observed treatment (DOT) treatment at the County TB Dispensary (CTBD). OBJECTIVE: To empirically document how DOT and home visits were implemented in rural China and to shed light on whether DOT is one of the key elements through which China achieves its high cure rates for TB. DESIGN: A total of 404 rural smear-positive TB patients registered in the CTBDs were interviewed face-to-face with structured questionnaires. Village doctors and key informants from the CTBDs were also interviewed. RESULTS: The majority of TB patients in rural areas do not receive DOT from village doctors and rarely get support, such as visits as required, from the CTBDs or township health providers in Shandong, China. CONCLUSION: The lack of DOT in Shandong does not have a negative effect on TB treatment outcomes. Given that the DOTS strategy is still the core measure of TB control in China, implementation of other programme elements apart from DOT is necessary to ensure a successful TB treatment programme.     

Administrative monitoring of tuberculosis treatment in Switzerland.

SETTING: Treatment of tuberculosis (TB) is critically dependent on adherence. Directly observed treatment (DOT) has been shown to be effective. OBJECTIVE: To determine operational treatment outcome using administrative treatment monitoring (ATM) to assess the need for more vigorous promotion of DOT. DESIGN: Cohort study in eastern Switzerland, where ATM was started in 2002. Bi-monthly progress forms and a treatment outcome form (after 6 months) were sent to the treating doctors. Forms not returned within 6 weeks were followed up with phone calls. RESULTS: Between 2002 and 2004, 98 (87.5%) of 112 new TB patients completed a 6-month treatment course. Eight elderly patients died of causes other than TB while on treatment, four travelled out of the region and two were lost to follow-up. Treating doctors opted for DOT in only seven cases. CONCLUSION: Given the high success rate of 87.5% in our cohort, more vigorous promotion of DOT is not a priority for TB case management in eastern Switzerland. In our setting, ATM in collaboration with the family doctors offers a valuable alternative to the more time-consuming universal DOT.     

How beds for tuberculosis be provided and utilized?

In 1951 when TB Control Law was legislated, and the government of Japan started intensive TB programme mainly consisting of mass health examination, BCG vaccination and distribution of appropriate treatment for TB cases, there were about 100,000 beds for TB, similar to the number of then TB deaths, and many TB patients died before admission to sanatoria. Urgent measures were taken to increase beds for TB with a target of 250,000, 2.5 times of then TB death. The target was achieved in 1957. Thereafter, the number of beds for TB as well as the occupancy rate had decreased with the decline of TB, and then policy on beds for TB could be summarized as follows: (1) top priority was given to increase the number of beds for TB, (2) general hospitals were improved with the progress of medical science and economic development, while no improvement was done on TB beds with the assumption that the need for TB beds will soon disappear, (3) minimum unit of TB beds was a TB ward with generally 40 to 50 beds, (4) an idea to provide TB bed in a general hospital came out only since 1992 as a small model project, (5) it was intended to segregate infectious TB patients from the community, however, no consideration was made about super-infection among patients themselves and the infection to health care workers, (6) admission of TB cases to a general bed and admission of non-TB cases to a TB ward was not legally permitted, (7) cost for TB treatment was set on a low level. Recent data indicate that the occupancy rate of TB beds was 43.5%, and the average stay in TB beds is still slightly over 100 days, and observing by prefectures, marked differences were seen. Taking into account changes in the pattern on TB patients such as aging and the increase of cases with serious complications and most health care workers in TB wards are not yet infected with TB, it is needed to divide TB beds into two types, one for new cases and the other for chronic cases. Beds for new cases should be provided in principle as a single room in a general hospital with good ventilation system, and DOT should be started in a hospital. Stay in this type of bed should not exceed 2 months, and higher medical fee should be provided. Beds for chronic cases could be provided in a TB ward. MDRTB cases are admitted in bed for chronic cases, however, preferably in a single room, and if active intervention such as chest surgery is tried in a few sophisticated hospital, medical fee for acute bed should be applied. Now, we have to change our mind from old concept of beds in TB ward to a TB bed in a single room with good ventilation.     

Twice-weekly, directly observed treatment for HIV-infected and uninfected tuberculosis patients: cohort study in rural South Africa.

OBJECTIVE: To determine the effectiveness of twice-weekly directly observed therapy (DOT) for tuberculosis (TB) in HIV-infected and uninfected patients, irrespective of their previous treatment history. Also to determine the predictive value of 2-3 month smears on treatment outcome. METHODS: Four hundred and sixteen new and 113 previously treated adults with culture positive pulmonary TB (58% HIV infected, 9% combined drug resistance) in Hlabisa, South Africa. Daily isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) given in hospital (median 17 days), followed by HRZE twice a week to 2 months and HR twice a week to 6 months in the community. RESULTS: Outcomes at 6 months among the 416 new patients were: transferred out 2%; interrupted treatment 17%; completed treatment 3%; failure 2%; and cured 71%. Outcomes were similar among HIV-infected and uninfected patients except for death (6 versus 2%; P = 0.03). Cure was frequent among adherent HIV-infected (97%; 95% CI 94-99%) and uninfected (96%; 95% CI 92-99%) new patients. Outcomes were similar among previously treated and new patients, except for death (11 versus 4%; P = 0.01), and cure among adherent previously treated patients 97% (95% CI 92-99%) was high. Smear results at 2 months did not predict the final outcome. CONCLUSION: A twice-weekly rifampicin-containing drug regimen given under DOT cures most adherent patients irrespective of HIV status and previous treatment history. The 2 month smear may be safely omitted. Relapse rates need to be determined, and an improved system of keeping treatment interrupters on therapy is needed. Simplified TB treatment may aid implementation of the DOTS strategy in settings with high TB caseloads secondary to the HIV epidemic.     

Effectiveness of DOT for tuberculosis treatment outcomes: a prospective cohort study in Bangkok, Thailand.

SETTING: All health care centres under the Department of Health, Bangkok Metropolitan Administration. OBJECTIVES: To investigate patterns of drug administration for tuberculosis (TB) patients and to determine whether these patterns affect treatment success rates. DESIGN: In a prospective cohort study conducted during May 2004 to November 2005, newly diagnosed TB patients aged >/=15 years were enrolled after giving informed consent. The cohort was followed until treatment outcome. Structured questionnaires were used to interview patients three times: at the first visit, at the end of the intensive phase and at treatment completion. Data were also collected from treatment cards. RESULTS: Five patterns of drug administration were used in the health centres: centre-based directly observed treatment (DOT), family-based DOT, self-administered treatment (SAT), centre-based DOT + SAT and centre- + family-based DOT. The pattern of drug administration had a significant impact on treatment success (P < 0.001). Using unconditional binary multiple logistic regression controlling for confounding factors, centre- + family-based DOT had the highest success rates compared with centre-based DOT (OR 20.9, 95%CI 5.0-88.3). CONCLUSION: The pattern of drug administration impacted on treatment success. Centre- + family-based DOT, family-based DOT and centre-based DOT + SAT achieved higher rates of treatment success than the World Health Organization target. Centre-based DOT had the lowest success.     

Results of directly observed treatment for tuberculosis in Ensenada, Mexico: not all DOTS programs are created equally.

SETTING: Tuberculosis (TB) program in Ensenada, Mexico. OBJECTIVE: To evaluate the impact of the DOTS strategy on adherence and cure rates in everyday practice. DESIGN: Retrospective analysis of 629 patients diagnosed with TB. MEASUREMENTS AND RESULTS: A total of 70% of the patients under directly observed treatment (DOT) were cured vs. 72.8% of those under self-administered treatment (SAT, P = 0.57). There was no difference on the length of therapy according to treatment regimen (4.82 +/- 2.41 for DOT vs. 4.93 +/- 2.16 for SAT, P = 0.61); 16.8% of patients under DOT abandoned treatment vs. 14.1% in the SAT group (P = 0.40). Logistic regression analysis confirmed the previous findings, with length of treatment under 6 months being the strongest predictive variable for treatment failure (OR 18.8, P < 0.00). The type of regimen (DOT vs. SAT) was not predictive of treatment failure (OR for failure for SAT regimen 0.65, P = 0.14). CONCLUSIONS: Cure and completion of treatment rates in our population under study did not differ significantly when comparing DOT vs. SAT. Those in charge of the DOTS programs in a given country need to assess which are the most important ingredients for success in their particular program.     

Evaluation of efficacy of community-based vs. institutional-based direct observed short-course treatment for the control of tuberculosis in Kilombero district,Tanzania

Tuberculosis (TB) has reappeared as a serious public health problem. Non-compliance to antituber-culous drug treatment is cited as one of the major obstacles to the containment of the epidemic. Compliance may be optimized by Directly Observed Treatment (DOT) and short-course treatment regimens. Since 1986, Tanzanian TB patients have received daily DOT at health facilities for the first 2 months of the treatment course. However, adherence and cure rates have been falling as the number of TB cases continues to increase and the burden on already stretched health facilities threatens to become unmanageable. We used an open cluster randomized controlled trial to compare community-based DOT (CBDOT) using a short-course drug regimen with institutional-based DOT (IBDOT). A total of 522 (301 IBDOT and 221 CBDOT) patients with sputum-positive TB were recruited. Overall, there was no significant difference in conversion and cure rates between the two strategies [M-H pooled odds ratio (OR) 0.62; 95% confidence interval (CI) 0.23, 1.71 and OR = 1.58; 95% CI 0.32, 7.88, respectively] suggesting that CBDOT may be a viable alternative to IBDOT. CBDOT may be particularly useful in parts of the country where people live far from health facilities.     

A spoonful of sugar...: improving adherence to tuberculosis treatment using financial incentives.

OBJECTIVE: To determine whether incentives increase adherence to directly observed therapy (DOT) for tuberculosis (TB) treatment. METHODS: The TB program gave a five-dollar grocery coupon for each DOT appointment kept to 55 patients who had missed at least 25% of DOT doses over a 4-week period. Treatment completion rates were compared with an historic control group of 52 patients who began treatment a year earlier, who would have been eligible for incentives but did not receive them. RESULTS: Incentive program patients were more likely than control patients to complete therapy within 32 weeks (OR 5.73, 95%CI 2.25-14.84) and 52 weeks (OR 7.29, 95%CI 2.45-22.73). CONCLUSION: Patient incentives can increase adherence to DOT in TB programs.     

DOT and timely treatment completion among Asian-born immigrant tuberculosis patients.

SETTING: A large urban tuberculosis (TB) control program. OBJECTIVES: To identify factors associated with directly observed therapy (DOT) participation and to quantify how early use of DOT affected treatment duration. DESIGN: A retrospective study of 731 Asian-born patients with drug-susceptible Mycobacterium tuberculosis isolates who were verified in New York City between 1993 and 1997 and completed treatment. RESULTS: Overall, 297 (41%) of 731 patients in the study participated in DOT for some or all of their TB treatment. DOT participation was significantly associated with TB disease in a pulmonary site (adjusted odds ratio [aOR] 2.85, 95% CI 1.86-4.35), more recent year of diagnosis (aOR 1.70, 95% CI 1.50-1.94) and male sex (aOR 1.86, 95% CI 1.30-2.66). Patients who received > or = 70% of their TB treatment at a health department chest clinic were also significantly more likely to participate in DOT (aOR 3.83, 95% CI 2.55-5.74). Among 297 DOT patients, those who completed treatment by 9 months received a greater amount of treatment by DOT during the first 4 months of treatment than those who took longer to complete treatment. CONCLUSION: Earlier DOT participation can lead to overall shorter treatment duration. Health care providers should encourage TB patients to participate in DOT as early as possible in their TB treatment.     

Outcome of patients with tuberculosis who transfer between reporting units in Malawi.

SETTING: All 43 non-private hospitals in Malawi which in 1999 registered and treated patients with tuberculosis (TB). OBJECTIVE: To determine the proportion of TB patients who transferred from one reporting unit to another and their treatment outcome, and to compare outcome results between the main TB register and the transfer-in register. DESIGN: Retrospective data collection, using the main TB register and transfer-in register, on all patients registered in Malawi in 1999. RESULTS: There were 24,908 patients, of whom 3249 (13%) in total were transfers. Significantly more patients transferred from mission hospitals (23%) compared with central (8%) or district (5%) hospitals (P < 0.001). The date of transfer was recorded for 1406 patients, of whom 1170 (83%) transferred in the first 10 weeks. Respectively 45% and 58% of transfer patients had unknown outcomes in the main TB register and transfer-in register; these rates were significantly lower in smear-positive pulmonary TB (PTB) patients. A total of 1357 patients were entered into transfer-in registers; 694 patients had matched names and/or registration numbers in both registers. Of the matched patients, 373 (54%) had similar treatment outcomes. CONCLUSION: It is common for patients to transfer between treatment units, but the quality of the data for patients who transfer is poor, and needs to be improved.     

DOT for patients with limited access to health care facilities in a hill district of eastern Nepal.

SETTING: The hill district in Nepal, where access to health care facilities is difficult. OBJECTIVE: To compare results before and after a decentralised directly observed treatment (DOT) intervention. DESIGN: Prospective study of patients registered in Dhankuta district, Nepal, 1996-1999. Patients received their intensive phase treatment under health worker supervision via one of three DOT options: 1) ambulatory from the peripheral government health facilities; 2) ambulatory from an international non-governmental organisation (INGO) TB clinic in district centre; or 3) resident in INGO TB hostel in district centre. Historical data from 1995-1996, with unsupervised short-course chemotherapy, were used for comparison. RESULTS: Of 307 new cases, respectively 126 (41%), 86 (28%) and 95 (31%) took their intensive phase treatment via options 1, 2 and 3. Smear conversion (at 2 months) and cure rates in new smear-positive pulmonary tuberculosis cases were respectively 81.6% (vs. 58.8% historical, P = 0.001) and 84.9% (vs. 76.7% historical, P = 0.03). Overall costs to the INGO provider fell by 7%, mainly as a result of staffing reductions in the INGO services made possible by rationalisation with government services during the intervention. CONCLUSION: By offering varied DOT delivery routes, including an in-patient option, satisfactory results are possible with DOT even in areas where access to health care facilities is difficult. Provision of in-patient care via an INGO TB hostel allowed a significant proportion of new cases (31%) to receive their intensive phase treatment who otherwise may have had difficulty accessing treatment, due either to the distance to the nearest health facility or to disease severity. Substitution of government hospital beds or local hotel beds for the INGO hostel beds may allow the model to be reproduced elsewhere in similar geographical conditions in Nepal, but further studies should be performed in a non-INGO supported district beforehand.     

Human immunodeficiency virus and the outcome of treatment for new and recurrent pulmonary tuberculosis in African patients

The purpose of this study was to evaluate the impact of human immunodeficiency virus (HIV) infection on treatment for tuberculosis (TB). The study population comprised 28,522 black Southern African gold miners. Patients with sputum culture-positive new or recurrent pulmonary TB diagnosed in 1995 were prospectively enrolled in the cohort. Directly observed therapy (DOT) was practiced and outcomes were assessed at 6 mo after treatment was begun. There were 376 cases of TB (incidence 1,318 per 100,000), of which 190 (50%) were HIV positive and 82 (22%) had recurrent TB. There was no association between HIV status and history of previous TB or drug resistance. Neither the treatment interruption rate (2%) nor the rate at which patients transferred out of the treatment program (1.6%) were associated with HIV status. Excluding deaths, cure rates were similar for HIV-positive and HIV-negative patients (89% versus 88%), but significantly lower in those with recurrent than in those with new TB (77% versus 92%). Mortality was 0.5% in HIV-negative patients versus 13.7% in HIV-positive patients, and in the latter group was associated with CD4(+) lymphocyte depletion. Autopsy examination showed that in HIV-positive patients, early mortality was due to TB whereas late deaths were most commonly due to cryptococcal pneumonia. The study showed that a well-run TB control program can result in acceptable cure rates even in a population with a very high incidence of TB and HIV infection. Particular vigilance is needed for concurrent infections, which may contribute significantly to mortality during treatment of TB in HIV-positive patients.