| Methods |
237 individuals "randomized"; blinding: providers unclear, participants unclear, assessors unclear. 54 (23%) lost to follow‐up; intention to treat analysis. |
| Participants |
HIV positive, PPD negative individuals living in Haiti. Inclusion criteria: Age >18 years; HIV symptom free (CDC category A); PPD < 5mm induration; informed consent; negative sputum examination results by smear and culture; negative chest x‐ray; no history of TB. Exclusion Criteria: Positive sputum examination results by smear and culture; a history of TB; pregnant. |
| Interventions |
1) Control (placebo) plus pyridoxine (vitamin B6): 50 mg daily for 1 year.
2) INH 300 mg plus pyridoxine 50 mg daily for 1 year. |
| Outcomes |
1) Active TB: ATS definition‐ 2 of the following required a) clinical symptoms suggesting TB, b) AFB on Ziehl Nielsen stain or MTb cultured from sputum or biopsy sample, c) chest X‐ray independently evaluated as highly suggestive of TB. If no microbiological confirmation, response to anti‐TB meds required. 2) AIDS: CDC classification of HIV infection. 3) Death. ‐‐ Mean duration of follow‐up 2.5 years. |
| Notes |
All patients were treated for opportunistic infections but none were on ART. 91% had +ve reactions to candida + mumps. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
Unclear risk |
Unclear for providers, participants and assessors |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
23% lost to follow‐up |
