Table 4.
Univariate and multivariate analysis of factors associated with non-completion of study follow-up (n = 771) compared to those who completed study follow-up (n = 5547) in the North American region: Cox proportional hazard model (n = 6318)
| Non-completion of follow-up % | Univariate* HR (95%CI) | Multivariate aHR (95%CI) | |
|---|---|---|---|
| Regimen† | |||
| 3HP-DOT (n = 3254) | 11.2 | Reference | Reference |
| 9H-SAT (n = 3064) | 13.3 | 1.2 (1.05–1.39) | 1.2 (1.05–1.39) |
| Age, years (median = 37) | |||
| <37 (n = 3048) | 13.9 | 1.3 (1.14–1.52) | 1.4 (1.20–1.61) |
| ⩾37 (n = 3270) | 10.6 | Reference | Reference |
| Sex | |||
| Female (n = 2838) | 10.7 | Reference | |
| Male (n = 3480) | 13.5 | 1.3 (1.12–1.49) | |
| Race | |||
| White (n = 3530) | 13.2 | Reference | Reference |
| African American (n = 1642) | 12.8 | 1.0 (0.83–1.16) | 0.9 (0.78–1.14) |
| Asian (n = 888) | 7.4 | 0.5 (0.42–0.71) | 0.5 (0.39–0.70) |
| Other (n = 258)‡ | 10.9 | 0.8 (0.55–1.19) | 0.8 (0.55–1.26) |
| Ethnicity | |||
| Non-Hispanic (n = 3668) | 10.9 | Reference | |
| Hispanic (n = 2650) | 14.1 | 1.3 (1.13–1.50) | |
| HIV status | |||
| Negative (n = 3142) | 12.6 | Reference | |
| Positive (n = 148) | 12.2 | 1.0 (0.61–1.57) | |
| Unknown (n = 3028) | 11.8 | 0.9 (0.81–1.08) | |
| Country of origin | |||
| Non-US (n = 3799) | 12.7 | Reference | Reference |
| US (n = 2519) | 11.5 | 0.9 (0.79–1.05) | 0.6 (0.50–0.73) |
| Educational level | |||
| ⩽8th grade (n = 1145) | 14.4 | 1.6 (1.27–2.05) | |
| 9th grade, some college (n = 3997) | 12.5 | 1.4(1.12–1.70) | |
| College or higher (n = 1176) | 9.2 | Reference | |
| Incarceration§ | |||
| No (n = 5925) | 11.8 | Reference | Reference |
| Yes (n = 393) | 18.8 | 1.7 (1.34–2.16) | 1.4 (1.08–1.91) |
| Unemployed | |||
| No (n = 5534) | 12.0 | Reference | |
| Yes (n = 784) | 13.5 | 1.1 (0.93–1.41) | |
| Homeless¶ | |||
| No (n = 5815) | 11.6 | Reference | Reference |
| Yes (n = 503) | 19.5 | 1.8 (1.44–2.21) | 2.0 (1.50–2.58) |
| Alcohol consumption# | |||
| No (n = 2909) | 11.2 | Reference | |
| Use (n = 2925) | 12.6 | 1.1 (0.98–1.32) | |
| Abuse (n = 484) | 15.7 | 1.5 (1.15–1.90) | |
| Injection drug use | |||
| No (n = 6052) | 12.0 | Reference | |
| Yes (n = 266) | 16.2 | 1.4(1.02–1.89) | |
| Chronic liver disease (cirrhosis) | |||
| No (n = 6068) | 12.2 | Reference | |
| Yes (n = 250) | 12.0 | 1.0 (0.69–1.44) | |
| Current smoker | |||
| No (n = 4394) | 10.9 | Reference | Reference |
| Yes (n = 1924) | 15.3 | 1.5 (1.27–1.70) | 1.5 (1.28–1.77) |
| Methadone treatment | |||
| No (n = 6182 | 12.2 | Reference | |
| Yes (n = 136) | 11.8 | 1.0 (0.59–1.59) | |
| Potential for pregnancy | |||
| Not possible (n = 3970) | 12.7 | Reference | |
| Female (n = 2243) | 11.5 | 0.9 (0.77–1.03) | |
| Pregnancy (n = 105) | 8.6 | 0.6 (0.33–1.25) | |
| Enrolling site** | |||
| Missing an early clinic visit††‡‡ | |||
| No (n = 5906) | 11.8 | Reference | |
| Yes (n = 412) | 18.0 | 1.6 (1.24–2.0) | |
In univariate analysis, among 2498 non-US/Canada-born participants, 34 used the services of an interpreter, while 2464 did not; respectively 11.9% and 14.7% of those who did not complete study follow-up did not need and did need an interpreter; this difference was non-significant (HR 1.3, 95%CI 0.53–3.10, P = 0.58).
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 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.
Missing 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).
The relation between missing an early clinic visit and history of incarceration or homelessness was non-significant. 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 immunodeficiency virus.