Study design and setting
The study was cross-sectional and consisted in reviewing abstracted retrospective records of SPPTB patients registered at TB clinics in all health facilities in Rwanda using the national electronic TB reporting system (e-TB) from July 2019 to June 2021. This period was chosen because July 2019 is when the TB cases reported by health facilities shifted to reporting individual data in the e-TB.
Study Population
This study was conducted among all SPPTB patients reported in e-TB system from July 2019 to June 2021. Were included in the study patients who have completed at least the intensive phase of first line of TB treatment, and whose follow-up sputum smear results after the second month of TB treatment were recorded. Smear-positive PTB patients without records of follow-up sputum smear examination results after the second month of TB treatment and patients who had died or had interrupted treatment before the end of the intensive phase were excluded from the study.
Sampling
All SPPTB patients reported in the e-TB from July 2019 to June 2021 and who met the inclusion criteria were considered for the study. During the study period, 11,207 TB cases were reported in e-TB. Of this figure, 1824 (16.3%) were extra-pulmonary TB (EPTB) cases, and 1103 (9.8%) were smear-negative pulmonary TB (SNPTB). EPTB and SNPTB cases were excluded from the analysis. Of the total 8279 (73.8%) SPPTB cases, follow-up sputum smear examination after the 2nd month of TB treatment was not done for 844 cases (10.2%) and two cases (0.02%) had Multidrug-Resistant Tuberculosis (MDR-TB), while 222 cases (2%) did not have documented follow-up sputum smear result after the second month of TB treatment, so they were also excluded from our study. The final cases that were included in this study were 7211 (87%) who had recorded a follow-up sputum smear result after the 2nd month of TB treatment (Fig. 1).
Study variables
Dependent variable
Sputum smear conversion at the end of the second month was dichotomized into converted and not converted for patients with a negative follow up sputum smear results and for patients with a positive follow up sputum smear results respectively.
Independent variables
Age was categorized in four groups: <20 years, 20-39 years, 40-59 years, and 60 years and above.
Sex: is male or female.
Residence: was categorized in four provinces - Kigali city, Eastern, Western, Northern and Southern province.
HIV status: was dichotomized into positive or negative.
History of HIV: was categorized in three statuses - newly tested positive, people living with HIV and HIV negative for people who not having HIV.
On ART: was put into three treatment categories - Yes for patients taking ART, No for patients not taking ART and Not applicable for those not having HIV.
On cotrimoxazole: was categorized as - Yes for patients receiving cotrimoxazole, No for patients not taking cotrimoxazole, and Not applicable for not eligible patients to cotrimoxazole
BMI at the initiation of TB treatment was divided into two group: BMI less than 18.5, and BMI equal and greater than18.5
Previous treatment history: was categorized into patients who took TB treatments for the first time were categorized as new, those who had been diagnosed with TB for the second or several times were categorized as relapse, patients who had history of first-line treatment failure were categorized as treatment after failure of first-line treatment, and those who had history of TB infections but did not remember if they had failed their treatments were categorized as other previously treated, and finally those who had been lost while taking their treatment were categorized as treatment after lost to follow up.
Contact of index TB: dichotomized as Yes or No,
Contact of MDR-TB: dichotomized as Yes or No
Diabetes: was categorized in three entities - Yes, No and unknown for those who did not know their diabetic status
TB-nutrition support provided: was dichotomized as Yes or No
Follow up by a community health worker (CHWs): was dichotomized as Yes or No
Data collection and analysis methods
Sociodemographic and clinical characteristics of patients were described with frequencies and proportions. A binary logistic regression was computed between each independent variable and the dependent variable (Sputum smear conversion at the end of the second month). A collinearity test was performed for all independent variables and significant variables from the bivariate analysis with (r=) were considered for the multivariate logistic regression to determine factors statistically associated with sputum smear conversion at the end of the second month. Odds ratio (OR), confidence interval, and p-value were considered statistically significant at 95% confidence level.
Ethical considerations
The study was approved by the University of Rwanda, College of Medicine and Health Sciences, Institutional Review Board (IRB) with Reference number 280/CMHS IRB. In addition, a confidentiality agreement about handling patients’ information was made between the investigator and Rwanda Biomedical Center (RBC). During the data analysis, encryption was performed for patients’ identifiers like names and Tracnet numbers for HIV-positive patients. The full dataset was locked with a password known only by the principal investigator.