Investigator(s)
| WHO Technical Officer |
Linh Nhat NGUYEN Global Programme on Tuberculosis & Lung Health (GTB), WHO HQ Linh Nhat NGUYEN 
|
| Principal Investigator |
Medea Gegia Global Programme on Tuberculosis & Lung Health (GTB), WHO HQ Medea Gegia
|
| Co-Investigator(s) |
Francesca Conradie Global Programme on Tuberculosis & Lung Health (GTB), WHO HQ Francesca Conradie
|
Title(s) and abstract
| Scientific title | Survey of National Tuberculosis Programme (NTP) Managers and Civil Society in High Tuberculosis Burden Countries on potential benefits and challenges of the long-acting injectable medicines for TB treatment |
| Public title | Long-acting injectable medicines (LAI) for TB |
| Background | Long-acting injectables (LAIs) represent a groundbreaking technology that has already demonstrated its potential in managing various diseases, including HIV treatment and prevention and contraception. They could revolutionize the treatment of TB disease and infection. The development of LAIs for TB treatment is on the cusp of the active development phase, and having a well-defined target product/regimen profile is essential. This profile will guide the development process, ensuring it aligns with the latest scientific knowledge and meets the needs of end users. The WHO is poised to develop an addendum to the TRPs. National TB Programme (NTP) managers and civil society play critical roles in implementing and succeeding TB control strategies. Understanding their perspectives on key challenges, programmatic needs, and policy implementation can inform global TB strategies and interventions. This survey aims to gather insights from NTP managers and civil society in high-TB-burden countries on the potential benefits and challenges of long-acting injectable medicines for TB treatment. Data from this survey will guide the discussion on the TRP consensus process for LAI and will likely be |
| Objectives | 1. To assess the key challenges faced by implementers and supporters of TB control and elimination efforts. 2. To evaluate the potential benefits and challenges for the use of LAIs in the treatment of TB as perceived by the NTP managers and civil society in high-burden countries. 3. To identify potential programmatic gaps and support needs from global health agencies. |
| Study Methods | Study Design: A cross-sectional survey will target NTP managers, civil society representatives, and healthcare workers from countries with high TB burdens. These individuals will be approached in various ways, including at planned face-to-face meetings. Additionally, responses may be solicited through email contacts. Study Population and Sampling: Participants: National TB Programme managers or their designated representatives from countries with high TB burdens, as defined by WHO; civil society representatives from countries with high TB burdens; and healthcare workers. Sample size: As this is a descriptive study, there is no pre-defined sample size. Data Collection Methods: - A structured questionnaire based on WHO TB policies and programme indicators will be given to participants. - Estimated completion time: 20-30 minutes. - Follow-up reminders will be sent to enhance response rates. Data Analysis: Descriptive statistics will summarise responses. Qualitative responses will be analysed thematically to identify key trends and challenges. |
| Expected outcomes and use of results | Expected outcomes: • overall interest in LAIs for TB treatment if the medications cannot be co-formulated. • trade-off between the duration of coverage and the number of injections required. • trade-off between the duration of coverage and the delivery method. • trade-off between the duration of coverage and the delivery setting. • trade-off between oral lead-in length and treatment duration. Use of results: Data from this survey will guide the discussion on the development of the WHO target regimen profile (TRP) for LAI and will likely be published in the WHO TRP's final report. |
| Keywords | Long-acting injectable medicines, LAI |
Research Details
| Student research | No |
| Start Date | 01-Apr-2025 |
| End Date | 01-Apr-2026 |
| Key Implementing Institution | World Health Organization |
| Multi-country research | Yes |
| South-East Asia, WHO Eastern Mediterranean Region | |
| Nationwide research | No |
| South-East Asia | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Tuberculosis |
| Involves human subjects | Yes |
| Health System and Policy Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Under Review |