Trial results for a simplified isoniazid preventive therapy (IPT) strategy, aimed at reducing the tuberculosis burden in HIV-infected persons, were posted on ClinicalTrials.gov on 2025-06-18. The study found that a multi-component implementation intervention (SPIRIT) increased the IPT initiation rate from 0.65 to 0.74 events per person-year.
Background
Tuberculosis (TB) remains a significant health concern, particularly among individuals living with HIV, who are at a higher risk of developing active TB disease. Isoniazid preventive therapy (IPT) is a crucial intervention to reduce the TB burden in this vulnerable population. This study investigated an implementation intervention designed to enhance IPT initiation rates, addressing a critical gap in current public health efforts.
Trial design
This completed cluster randomized trial enrolled 163 participants and was conducted in Uganda. The study focused on individuals with Tuberculosis and HIV/AIDS. The overall objective was to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training, targeting District Health Officers (DHOs), could increase IPT initiation among HIV-infected persons. The intervention arm involved the DHO Intervention, while the control arm followed country standard practices.
Key results
The study reported on the IPT Initiation Rate:
- In the Aim 1: DHO Intervention Arm, the mean IPT initiation rate was 0.74 events per person-years.
- In the Aim 1: DHO Control Arm, the mean IPT initiation rate was 0.65 events per person-years.
What this means
The observed increase in the mean IPT initiation rate from 0.65 in the control arm to 0.74 in the DHO Intervention Arm suggests that the multi-component implementation intervention (SPIRIT) and leadership training for District Health Officers may be an effective strategy to improve uptake of isoniazid preventive therapy among HIV-infected individuals. This could lead to a reduction in the tuberculosis burden in similar settings.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03315962, titled "Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden", were posted on 2025-06-18 on clinicaltrials.gov.