A randomised controlled trial of lay health workers as direct observers for treatment of tuberculosis.
METHODS
Study conducted in a suburb of Cape Town, South Africa.


OBJECTIVE
Comparison of successful tuberculosis treatment outcome rates between self supervision, supervision by lay health worker (LHW), and supervision by clinic nurse.


METHODS
Open, randomised, controlled trial with intention-to-treat analysis.


RESULTS
All groups (n = 156) achieved similar outcomes (LHW vs. clinic nurse: risk difference 17.2%, 95% confidence interval [CI] -0.1-34.5; LHW vs. self supervision 15%, 95%CI -3.7-33.6). New patients benefit from LHW supervision (LHW vs clinic nurse: risk difference 24.2%, 95%CI 6-42.5, LHW vs. self supervision 39.1%, 95%CI 17.8-60.3) as do female patients (LHW vs. clinic nurse 48.3%, 95%CI 22.8-73.8, LHW vs. self supervision 32.6%, 95%CI 6.4-58.7).


CONCLUSIONS
LHW supervision approaches statistically significant superiority, but fails to reach it most likely due to the study's limitation, the small sample size. It is possible that subgroups (new and female patients) do well under LHW supervision. LHW supervision could be offered as one of several supervision options within TB control programmes.
Zwarenstein
M
M
Health Systems Division, Medical Research Council, Tygerberg, South Africa. merrick.zwarenstein@mrc.ac.za
Schoeman
J H
JH
Vundule
C
C
Lombard
C J
CJ
Tatley
M
M
D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003150:Community Health Workers; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011718:Pyrazinamide / Q000008:administration & dosage / Q000627:therapeutic use*; D012293:Rifampin / Q000008:administration & dosage / Q000627:therapeutic use*; D013019:South Africa; D014376:Tuberculosis / Q000188:drug therapy* / Q000517:prevention & control
D000995:Antitubercular Agents; D004338:Drug Combinations; C087181:isoniazid, pyrazinamide, rifampin drug combination; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin