Effectiveness of Multi-Month Dispensing of Anti-Tuberculosis Drugs (MULTI-DAT) Versus Standard of Care on Treatment Success Rate Among People with Drug Susceptible Tuberculosis in Rural Eastern Uganda
October 2007, Uganda Amref
Study Context
Although tuberculosis (TB) is treatable and curable with a standard six-month regimen consisting of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (HRZE), the disease remains a public health problem in developing countries. Frequent travels to health facilities for medication pick-ups impose a heavy burden on the patients, especially those who live further away from the treatment units. Studies have shown that distances ≥5km from home to a TB treatment unit are associated with a lower likelihood of treatment success and a high chance of mortality, and residing ≥2km from a TB treatment unit is associated with relatively unfavorable TB treatment outcomes.
In this study, the researcher hypothesizes that reducing frequent health facility visits will help to overcome physical and economic barriers which deter people with TB from picking up their medication, consequently leading to better adherence to anti-TB medications and optimal treatment outcomes. Therefore, the team conducts a Multi-Month Refill of Anti-TB Drugs (MORAD) study, an open-label, individually randomized controlled trial (RCT), to evaluate the effectiveness of multi-month dispensing of anti-TB drugs (MULTI-DAT) on treatment success rate at 6 months among people with drug-susceptible pulmonary TB (PTB) in rural eastern Uganda.
Evidence from this study will inform the modification of the national TB treatment guidelines and support the national scale-up of MULTI-DAT through the National TB and Leprosy Control Program (NTLP), Ministry of Health (MoH), Uganda.
Study Design
In this study, we propose to evaluate the practicability and effectiveness of MULTI-DAT among people with drug-susceptible pulmonary TB (PTB) aged ≥15 years on the standard 6-month anti-TB treatment regimen in eastern Uganda. The main objectives of the study include 1) to explore stakeholder perceptions regarding the relevance and appropriateness of MULTI-DAT, and 2) to evaluate the effectiveness of MULTI-DAT on cure and treatment success rates at 6 months of treatment compared to the standard of care (SOC).
In the first phase, the team conducts a formative qualitative study on a total of 86 stakeholders through 1) in-depth interviews (IDIs) with people with TB and their treatment supporters in 30 health facilities, and 2) key Informant Interviews (KIIs) with the focal persons at national, sub-national, and district levels. The team adopts the Consolidated Framework for Implementation Research (CFIR) to guide the data collection, coding, analysis, and reporting of findings to ensure systematic assessment of barriers and facilitators to implementing MULTI-DAT (implementation determinants).
The second phase conducts an open-label, individually randomized controlled trial (RCT) to evaluate the effectiveness of MULTI-DAT versus the SOC on rates of cure and treatment success. Using a simple randomization approach, the team enrolls a sample of 250 participants assigned to either the MULTI-DAT or the SOC arm. Under the SOC, the control group is refilled with anti-TB drugs as usual with a total of 8 clinic visits: bi-weekly in the first 2 months of TB treatment (intensive phase) and monthly in the next 4 months of TB treatment (continuation phase). In the intervention group, the timing and number of visits in the intensive and continuation phase are decided based on the findings from the first phase, to minimize the number of visits while enabling sufficient counseling as well as identification and support for non-adherence.
The study measures the primary outcome which is the treatment success rate (TSR) according to the World Health Organization (WHO) standard definitions to evaluate the causal impact of the MULTI-DAT on TB treatment outcomes (treatment failure, death, or loss to follow-up).
Results and Policy Lessons
Results forthcoming.