Table 2.
Univariate and multivariate analyses of factors associated with non-completion of study follow-up (n = 841) compared to those who completed study follow-up (n = 6220) in the North American and non-North American regions combined: Cox proportional hazard model (n= 7061)
| Non-completion of follow-up (%) | Multivariate | ||
|---|---|---|---|
| HR (95%CI) | aHR (95%CI) | ||
| Regimen* | |||
| 3HP-DOT (n = 3643) | 10.8 | Reference | Reference |
| 9H-SAT (n = 3418) | 13.1 | 1.2 (1.07–1.41) | 1.2 (1.04–1.37) |
| Age, years (median = 37) | |||
| <37 (n = 3413) | 13.5 | 1.3 (1.15–1.50) | 1.4 (1.21–1.62) |
| ⩾37 (n = 3648) | 10.4 | Reference | Reference |
| Sex | |||
| Female (n = 3194) | 10.4 | Reference | Reference |
| Male (n = 3867) | 13.2 | 1.3 (1.14–1.50) | 1.2 (1.01–1.36) |
| Race | |||
| White (n = 3530) | 13.2 | Reference | Reference |
| Black (n = 1642) | 12.8 | 0.98 (0.83–1.15) | 0.87 (0.72–1.05) |
| Asian (n = 888) | 7.4 | 0.5 (0.42–0.71) | 0.6 (0.45–0.80) |
| Other (n = 1001)† | 9.8 | 0.7 (0.58–0.90) | 0.9 (0.57–1.31) |
| Ethnicity | |||
| Non-Hispanic (n = 3668) | 10.9 | Reference | |
| Hispanic (n = 2650) | 14.1 | 1.3 (1.14–1.51) | |
| Brazil (n = 248) | 10.5 | ||
| Spain (n = 495) | 8.9 | ||
| HIV status | |||
| Negative (n = 3509) | 12.3 | Reference | |
| Positive (n = 206) | 12.1 | 1.0 (0.67–1.49) | |
| Unknown (n = 3346) | 11.5 | 0.9 (0.81–1.06) | |
| Country of origin | |||
| Non-US (n = 4542) | 12.1 | Reference | |
| US (n = 2519) | 11.5 | 1.0 (0.83–1.10) | |
| Educational level | |||
| ⩽8th grade (n = 1444) | 13.0 | 1.4(1.12–1.78) | 1.4 (1.05–1.73) |
| 9th grade, some college (n = 4384) | 12.3 | 1.3 (1.08–1.61) | 1.1 (0.92–1.40) |
| College or higher (n = 1233) | 9.4 | Reference | Reference |
| Incarceration‡ | |||
| No (n = 6665) | 11.5 | Reference | Reference |
| Yes (n = 396) | 18.7 | 1.7 (1.36–2.19) | 1.4 (1.03–1.82) |
| Unemployed | |||
| No (n = 6252) | 11.7 | Reference | Reference |
| Yes (n = 809) | 13.4 | 1.2 (0.95–1.43) | 0.8 (0.60–0.99) |
| Homeless§ | |||
| No (n = 6553) | 11.3 | Reference | Reference |
| Yes (n = 508) | 19.5 | 1.8 (1.49–2.26) | 1.9 (1.42–2.47) |
| Alcohol consumption¶ | |||
| No (n = 3306) | 11.1 | Reference | |
| Use (n = 3229) | 12.3 | 1.1 (0.97–1.29) | |
| Abuse (n = 526) | 14.8 | 1.4(1.10–1.80) | |
| Injection drug use | |||
| No (n = 6780) | 11.7 | Reference | |
| Yes (n = 281) | 16.4 | 1.4(1.07–1.95) | |
| Chronic liver disease (cirrhosis) | |||
| No (n = 6787) | 11.9 | Reference | |
| Yes (n = 274) | 11.3 | 1.0 (0.67–1.37) | |
| Current smoker | |||
| No (n = 4941) | 10.6 | Reference | Reference |
| Yes (n = 2120) | 14.9 | 1.5 (1.27–1.67) | 1.4 (1.16–1.59) |
| Methadone treatment | |||
| No (n = 6920) | 11.9 | Reference | |
| Yes (n = 141) | 11.4 | 1.0 (0.58–1.57) | |
| Potential for pregnancy | |||
| Not possible (n = 4447) | 12.5 | Reference | |
| Female (n = 2506) | 11.1 | 0.9 (0.75–1.0) | |
| Pregnancy (n = 108) | 8.3 | 0.6 (0.33–1.23) | |
| Enrolling site# | |||
| Missing clinic visit** | |||
| No (n = 6633) | 11.5 | Reference | Reference |
| Yes (n = 428) | 18.9 | 1.7 (1.37–2.17) | 1.4 (1.07–1.73) |
3HP-DOT = 3 months of directly observed once-weekly RPT (maximum dose, 900 mg) plus INH (maximum dose, 900 mg); 9H-SAT = 9 months of daily self-administered INH (maximum dose, 300 mg).
Includes North American Indian and other participants in the United States and Canada.
History of living in a correctional institution for ⩾1 month prior to enrollment.
History of homelessness or living in a shelter or single room occupancy for ⩾6 months prior to enrollment.
Use: affirmative response to a question asking whether the participant ever drank alcoholic beverages. Abuse: score of ⩾2 with the CAGE (Cut down, Annoyed, Guilty, Eye-opener) questionnaire.
Enrolling site was analyzed after a random selection of the reference value; overall P < 0.001.
Missed at least one of the first three DOT visits for the 3HP-DOT regimen and at least one of the three monthly clinic visits for the 9H-SAT regimen, followed by a DOT or monthly visit after the missing DOT/visit respectively (includes those who did not receive any study dose).
Note: Body mass index was explored, but due to a lack of statistical significance and lack of a meaningful association with the outcome, it was not included in the table/analyses.
HR = hazard ratio; CI = confidence interval; aHR = adjusted HR; H, INH = isoniazid; P, RPT = rifapentine; DOT = directly observed therapy; SAT = self-administered treatment; HIV = human immunodeficiencyvirus.