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Published on: July 28, 2023
Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial
S Moyo1, S Verver, A Hawkridge
1South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine & School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa. sizulu.moyo@uct.ac.za
Insights
Home visits combined with record surveillance significantly increased tuberculosis case detection in BCG-vaccinated children compared to record surveillance alone. The disease profile remained similar between strategies.
Area of Science:
- Pediatrics
- Infectious Diseases
- Public Health
Background:
- Tuberculosis (TB) remains a significant global health challenge, particularly in high-burden rural settings.
- Early and effective case-finding strategies are crucial for controlling TB transmission, especially in vulnerable populations like infants.
- Bacille Calmette-Guérin (BCG) vaccination is a standard preventive measure, but its impact on TB case detection strategies requires evaluation.
Purpose of the Study:
- To compare the effectiveness of two distinct TB case-finding strategies in BCG-vaccinated children up to two years of age.
- To evaluate differences in TB case yield and disease characteristics between active home-based screening and passive surveillance methods.
- To assess the utility of combining home visits with record surveillance for improved TB detection.
Main Methods:
- A randomized controlled trial was conducted in a high TB burden rural area of South Africa.
- BCG-vaccinated infants were enrolled shortly after birth and assigned to either: (1) 3-monthly home visits for TB screening plus record surveillance, or (2) record surveillance only.
- Standardized investigations were used to evaluate suspected TB cases in both groups over a two-year period.
Main Results:
- A total of 4786 infants were enrolled, with 2392 in Group 1 and 2394 in Group 2.
- The TB case-finding rate was significantly higher in Group 1 (2.2/100 person-years) compared to Group 2 (0.8/100 person-years), yielding a rate ratio of 2.6 (95% CI 1.8-4.0).
- No significant differences were observed in the proportion of bacteriological confirmation, TB symptoms, or signs between the two groups.
Conclusions:
- Combining home visits with record surveillance demonstrates superior effectiveness in detecting more TB cases in young children compared to record surveillance alone.
- The clinical and microbiological profile of detected TB cases did not significantly differ between the active screening and passive surveillance groups.
- These findings support the implementation of integrated active and passive case-finding strategies for enhanced TB detection in high-risk pediatric populations.
Setting:
A high tuberculosis (TB) burden rural area in South Africa.
Objective:
To compare TB case yield and disease profile among bacille Calmette-Guérin (BCG) vaccinated children using two case-finding strategies from birth until 2 years of age.
Design:
BCG-vaccinated infants were enrolled within 2 weeks of birth and randomised to 3-monthly home visits for questionnaire-based TB screening plus record surveillance of TB registers, hospital admission and X-ray lists at health facilities for TB suspects and cases (Group 1), or record surveillance (as above) only (Group 2). Both groups received a close-out visit after 2 years. Participants were evaluated for suspected TB disease using standardised investigations.
Results:
A total of 4786 infants were enrolled: 2392 were randomised to Group 1 and 2394 to Group 2. The case-finding rate was significantly greater in Group 1 (2.2/100 py) than in Group 2 (0.8/100 py), with a case-finding rate ratio of 2.6 (95%CI 1.8-4.0, P < 0.001). Although the proportion of cases with bacteriological confirmation was lower in Group 1, this difference did not reach statistical significance. There was also no significant difference in the proportions with TB symptoms and signs.
Conclusion:
Home visits combined with record surveillance detected significantly more cases than record surveillance with a single study-end visit. The TB case profile did not differ significantly between the two groups.
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