Electronic monitors for improving tuberculosis patients’ treatment adherence in China

Approved 26/03/2020, The Xi’an Jiaotong University Health Science Center’s Ethics Committee (No. 28 West Xianning Road, Xi’an, 710049, China; +86 (0)15891725861; fanxj112@xjtu.edu.cn), ref: 2020-119

Treatment adherence calculated from monthly level data for each patient indicating the number of doses taken per month. The researchers will identify treatment adherence ≥80% as high adherence, otherwise it is non-adherence. Treatment adherence is measured every month during the study period.

Measured at baseline, 6, 12, 18, 24, 30, and 36 months:
1. Treatment completion rate, as defined by the WHO standard definitions: a TB patient who finished treatment without having evidence of treatment failure, but who did not have negative sputum smear or culture results in at least one prior instance or in the final month of treatment, either because the tests were not conducted or the results were not available
2. Loss to follow-up rate, as defined by the WHO standard definitions: a TB patient who did not initiate treatment or whose treatment was interrupted for two consecutive months or more
3. Treatment failure, as defined by the WHO standard definitions: a TB patient who received treatment and had positive results from a sputum smear or culture at month five or later
4. Death, as defined by the WHO standard definitions: a TB patient who passed away before starting treatment or while receiving it, for any reason

Based on the RE-AIM framework, the impact of the optimized EM program is also assessed in comparison to standard care for the subsequent secondary outcome measures at baseline, 6, 12, 18, 24, 30, and 36 months:
5. Reach: the quantity and percentage of TB patients who participate in the medication e-monitoring program, as well as their motivations for doing so
6. Effectiveness: the effects of the improved e-monitoring program on TB treatment outcomes, treatment adherence, and financial outcomes
7. Adoption: the number of TB patients enrolled in the optimized e-monitoring program, the number of primary care providers enrolled in the optimized e-monitoring program, and the acceptance level of the optimized e-monitoring program among directors from primary care facilities and CDC
8. Implementation:
8.1. Fidelity: the extent to which the optimized e-monitoring program is implemented as per the original protocol
8.2. Feasibility: the extent to which the optimized e-monitoring program can be implemented in a specific setting
8.3. Outer context: macro-level external factors including social, funding, and leadership
8.4. Inner context: micro-level internal factors including CDC partnership, programmatic staff, feedback, primary care facility, and individual level
9. Maintenance:
9.1. Sustainability of effectiveness: views on maintaining effectiveness from policymakers, directors of CDC and primary care facilities, healthcare providers, and TB patients
9.2. Stakeholders’ satisfaction: satisfaction with the effectiveness and implementation strategy of the optimized e-monitoring program among policymakers, directors of CDC and primary care facilities, health care providers, and TB patients
9.3. Financial sustainability: views on funding and return on investment from policymakers and directors of CDC and primary care facilities
9.4. Institutionalization of interventions: core components that are transferable and require local adaptation for replication in other settings

Data source:
Inner Mongolia Center for Disease Control and Prevention will regularly gather patient data, such as name, age, gender, education, occupation, diagnosis, and treatment results. The results of sputum smears performed at baseline, 6, 12, 18, 24, 30, and 36 months, as well as treatment completion, loss to follow-up, treatment failed, and death will be recorded as routinely tracked treatment outcomes.

In terms of the implementation outcomes, a semi-structured interview will be used to gather the data. Each sampling site will host in-depth interviews. The researchers will consult the managers and staff at each site to determine which employees are best suited for an interview. They will obtain informed consent forms. At each site, interviews will take place over the phone or in person and last for 60 to 90 minutes. The researchers will take notes and record the interviews. Two researchers will independently code the recordings and notes. Additionally, two researchers will conduct the analysis independently at each stage of coding, indexing, and interpreting and come to a consensus in the event of any disagreement. The policy documents, institution reports, and project meeting notes will also be used throughout the study to identify implementation challenges and opportunities, improve the program, and give site staff feedback. The qualitative analysis program NVivo 12.0 will be used to examine all interview data.