Univariate and Multivariate Analysis of Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment Attributed to an Adverse Event (n = 317) Compared With Those Who Completed Treatment (n = 4826)
Characteristic . | Noncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826]) . | ||||||
---|---|---|---|---|---|---|---|
. | Univariate . | Multivariate . | |||||
NCT (%) . | OR . | 95% CI . | P Value . | Adjusted OR . | 95% CI . | P Value . | |
Regimen | |||||||
3HP-DOT (n = 2844) Ref. | 6.4 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
9H-SAT (n = 2299) | 5.9 | 1.1 | .87–1.38 | .43 | 1.73 | 1.01–2.95 | .23 |
Age (y; median, 38) | |||||||
<38 (n = 2534) | 4.5 | 0.56 | .44–.71 | <.001 | 0.61 | .47–.79 | <.001 |
≥38 (n = 2609) Ref. | 7.8 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Sex | |||||||
Female (n = 2282) Ref. | 7.7 | Ref. | Ref. | Ref. | |||
Male (n = 2861) | 5.0 | 0.63 | .50–.79 | <.001 | |||
Race | |||||||
White (n = 2854) Ref. | 6.9 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Black (n = 1315) | 4.1 | 0.58 | .43–.79 | .001 | 0.33 | .23–.47 | <.001 |
Asian (n = 765) | 6.0 | 0.87 | .62–1.21 | .40 | 0.52 | .35–.78 | .001 |
Othera (n = 209) | 10.1 | 1.52 | .94–2.43 | .09 | 0.88 | .51–1.53 | .65 |
Ethnicity | |||||||
Non-Hispanic (n = 3013) Ref. | 7.5 | Ref. | Ref. | Ref. | |||
Hispanic (n = 2130) | 4.2 | 0.54 | .42–.70 | <.001 | |||
HIV status | |||||||
Negative (n = 2518) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Positive (n = 121) | 4.1 | 0.66 | .27–1.64 | .37 | |||
Unknown (n = 2504) | 6.3 | 1.03 | .82–1.30 | .78 | |||
Country of origin | |||||||
Non-US (n = 3133) Ref. | 5.5 | Ref. | Ref. | Ref. | |||
United States (n = 2010) | 7.2 | 1.34 | 1.07–1.68 | .01 | |||
Body mass index | |||||||
Underweight (n = 85) | 4.7 | 0.67 | .24–1.86 | .44 | |||
Normal (n = 1464) Ref. | 6.9 | Ref. | Ref. | Ref. | |||
Overweight (n = 1827) | 6.5 | 0.94 | .71–1.24 | .66 | |||
Obese (n = 1767) | 5.3 | 0.75 | .56–1.0 | .05 | |||
Education | |||||||
≤8th grade (n = 931) | 3.8 | 0.39 | .26–.59 | <.001 | 0.55 | .35–.87 | .01 |
8th grade through some college (n = 3207) | 6.0 | 0.64 | .49–.83 | .001 | 0.90 | .67–1.21 | .49 |
≥College degree (n = 1005) Ref. | 9.1 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Incarcerationb | |||||||
No (n = 4860) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 283) | 7.8 | 1.31 | .83–2.05 | .25 | |||
Unemployed | |||||||
No (n = 4534) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 609) | 6.4 | 1.05 | .74–1.48 | .79 | |||
Homelessc | |||||||
No (n = 4760) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 383) | 6.3 | 1.02 | .66–1.57 | .93 | |||
Alcohol consumptiond | |||||||
No (n = 2406) Ref. | 5.4 | Ref. | Ref. | Ref. | |||
Use (n = 2382) | 6.6 | 1.24 | .97–1.57 | .08 | |||
Abuse (n = 355) | 9.0 | 1.75 | 1.17–2.60 | .01 | |||
Intravenous drug use ever | |||||||
No (n = 4942) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 201) | 10.0 | 1.73 | 1.07–2.78 | .02 | |||
Cirrhosis, by self-report | |||||||
No (n = 4949) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 194) | 10.8 | 1.91 | 1.20–3.05 | .01 | |||
Current smokere | |||||||
No (n = 3642) Ref. | 5.8 | Ref. | Ref. | Ref. | |||
Yes (n = 1501) | 7.1 | 1.26 | .99–1.60 | .07 | |||
Methadone treatment | |||||||
No (n = 5035) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 108) | 8.3 | 1.40 | .70–2.79 | .34 | |||
Enrollment sitef | .01 | .02 | |||||
Concomitant medications | |||||||
No (n = 2566) Ref. | 3.6 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Yes (n = 2577) | 8.7 | 2.53 | 1.98–3.25 | <.001 | 1.86 | 1.42–2.44 | <.001 |
LTBI for contact tuberculosis | |||||||
No (n = 1769) Ref. | 7.1 | Ref. | Ref. | Ref. | |||
Yes (n = 3374) | 5.7 | 0.79 | .63–1.0 | .05 | |||
LTBI for tuberculin skin test converter | |||||||
No (n = 3292) Ref. | 5.7 | Ref. | Ref. | Ref. | |||
Yes (n = 1851) | 6.9 | 1.22 | .97–1.54 | .09 | |||
LTBI for fibrosis | |||||||
No (n = 4985) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 158) | 7.0 | 1.14 | .61–2.13 | .67 | |||
LTBI for HIV infection | |||||||
No (n = 5026) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 117) | 4.3 | 0.68 | .27–1.66 | .39 | |||
Having missed an early visitg | |||||||
No (n = 4936) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 207) | 4.8 | 0.77 | .40–1.46 | .42 | |||
Interaction terms | |||||||
Ethnicity × regimen | |||||||
3HP-DOT: Non-Hispanic vs Hispanic | 3.0 | 1.93–4.69 | <.001 | ||||
9H-SAT: Non-Hispanic vs Hispanic | 1.44 | .92–2.26 | .11 | ||||
Cirrhosis, by self-report × regimen | |||||||
3HP-DOT: Cirrhosis: yes vs no | 0.80 | .35–1.83 | .60 | ||||
9H-SAT-: Cirrhosis: yes vs no | 2.93 | 1.52–5.65 | .001 | ||||
Alcohol × sex | |||||||
Male | |||||||
Users vs no alcohol | 1.64 | 1.05–2.57 | .03 | ||||
Abusers vs no alcohol | 2.15 | 1.19–3.89 | .01 | ||||
Female | |||||||
Users vs no alcohol | 0.84 | .59–1.19 | .32 | ||||
Abusers vs no alcohol | 0.70 | .26–1.92 | .49 |
Characteristic . | Noncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826]) . | ||||||
---|---|---|---|---|---|---|---|
. | Univariate . | Multivariate . | |||||
NCT (%) . | OR . | 95% CI . | P Value . | Adjusted OR . | 95% CI . | P Value . | |
Regimen | |||||||
3HP-DOT (n = 2844) Ref. | 6.4 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
9H-SAT (n = 2299) | 5.9 | 1.1 | .87–1.38 | .43 | 1.73 | 1.01–2.95 | .23 |
Age (y; median, 38) | |||||||
<38 (n = 2534) | 4.5 | 0.56 | .44–.71 | <.001 | 0.61 | .47–.79 | <.001 |
≥38 (n = 2609) Ref. | 7.8 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Sex | |||||||
Female (n = 2282) Ref. | 7.7 | Ref. | Ref. | Ref. | |||
Male (n = 2861) | 5.0 | 0.63 | .50–.79 | <.001 | |||
Race | |||||||
White (n = 2854) Ref. | 6.9 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Black (n = 1315) | 4.1 | 0.58 | .43–.79 | .001 | 0.33 | .23–.47 | <.001 |
Asian (n = 765) | 6.0 | 0.87 | .62–1.21 | .40 | 0.52 | .35–.78 | .001 |
Othera (n = 209) | 10.1 | 1.52 | .94–2.43 | .09 | 0.88 | .51–1.53 | .65 |
Ethnicity | |||||||
Non-Hispanic (n = 3013) Ref. | 7.5 | Ref. | Ref. | Ref. | |||
Hispanic (n = 2130) | 4.2 | 0.54 | .42–.70 | <.001 | |||
HIV status | |||||||
Negative (n = 2518) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Positive (n = 121) | 4.1 | 0.66 | .27–1.64 | .37 | |||
Unknown (n = 2504) | 6.3 | 1.03 | .82–1.30 | .78 | |||
Country of origin | |||||||
Non-US (n = 3133) Ref. | 5.5 | Ref. | Ref. | Ref. | |||
United States (n = 2010) | 7.2 | 1.34 | 1.07–1.68 | .01 | |||
Body mass index | |||||||
Underweight (n = 85) | 4.7 | 0.67 | .24–1.86 | .44 | |||
Normal (n = 1464) Ref. | 6.9 | Ref. | Ref. | Ref. | |||
Overweight (n = 1827) | 6.5 | 0.94 | .71–1.24 | .66 | |||
Obese (n = 1767) | 5.3 | 0.75 | .56–1.0 | .05 | |||
Education | |||||||
≤8th grade (n = 931) | 3.8 | 0.39 | .26–.59 | <.001 | 0.55 | .35–.87 | .01 |
8th grade through some college (n = 3207) | 6.0 | 0.64 | .49–.83 | .001 | 0.90 | .67–1.21 | .49 |
≥College degree (n = 1005) Ref. | 9.1 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Incarcerationb | |||||||
No (n = 4860) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 283) | 7.8 | 1.31 | .83–2.05 | .25 | |||
Unemployed | |||||||
No (n = 4534) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 609) | 6.4 | 1.05 | .74–1.48 | .79 | |||
Homelessc | |||||||
No (n = 4760) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 383) | 6.3 | 1.02 | .66–1.57 | .93 | |||
Alcohol consumptiond | |||||||
No (n = 2406) Ref. | 5.4 | Ref. | Ref. | Ref. | |||
Use (n = 2382) | 6.6 | 1.24 | .97–1.57 | .08 | |||
Abuse (n = 355) | 9.0 | 1.75 | 1.17–2.60 | .01 | |||
Intravenous drug use ever | |||||||
No (n = 4942) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 201) | 10.0 | 1.73 | 1.07–2.78 | .02 | |||
Cirrhosis, by self-report | |||||||
No (n = 4949) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 194) | 10.8 | 1.91 | 1.20–3.05 | .01 | |||
Current smokere | |||||||
No (n = 3642) Ref. | 5.8 | Ref. | Ref. | Ref. | |||
Yes (n = 1501) | 7.1 | 1.26 | .99–1.60 | .07 | |||
Methadone treatment | |||||||
No (n = 5035) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 108) | 8.3 | 1.40 | .70–2.79 | .34 | |||
Enrollment sitef | .01 | .02 | |||||
Concomitant medications | |||||||
No (n = 2566) Ref. | 3.6 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Yes (n = 2577) | 8.7 | 2.53 | 1.98–3.25 | <.001 | 1.86 | 1.42–2.44 | <.001 |
LTBI for contact tuberculosis | |||||||
No (n = 1769) Ref. | 7.1 | Ref. | Ref. | Ref. | |||
Yes (n = 3374) | 5.7 | 0.79 | .63–1.0 | .05 | |||
LTBI for tuberculin skin test converter | |||||||
No (n = 3292) Ref. | 5.7 | Ref. | Ref. | Ref. | |||
Yes (n = 1851) | 6.9 | 1.22 | .97–1.54 | .09 | |||
LTBI for fibrosis | |||||||
No (n = 4985) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 158) | 7.0 | 1.14 | .61–2.13 | .67 | |||
LTBI for HIV infection | |||||||
No (n = 5026) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 117) | 4.3 | 0.68 | .27–1.66 | .39 | |||
Having missed an early visitg | |||||||
No (n = 4936) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 207) | 4.8 | 0.77 | .40–1.46 | .42 | |||
Interaction terms | |||||||
Ethnicity × regimen | |||||||
3HP-DOT: Non-Hispanic vs Hispanic | 3.0 | 1.93–4.69 | <.001 | ||||
9H-SAT: Non-Hispanic vs Hispanic | 1.44 | .92–2.26 | .11 | ||||
Cirrhosis, by self-report × regimen | |||||||
3HP-DOT: Cirrhosis: yes vs no | 0.80 | .35–1.83 | .60 | ||||
9H-SAT-: Cirrhosis: yes vs no | 2.93 | 1.52–5.65 | .001 | ||||
Alcohol × sex | |||||||
Male | |||||||
Users vs no alcohol | 1.64 | 1.05–2.57 | .03 | ||||
Abusers vs no alcohol | 2.15 | 1.19–3.89 | .01 | ||||
Female | |||||||
Users vs no alcohol | 0.84 | .59–1.19 | .32 | ||||
Abusers vs no alcohol | 0.70 | .26–1.92 | .49 |
Regimen factor is also part of certain interaction terms. Blank cells indicate not applicable or not tested. Use of a less stringent entry criterion (P ≤ .2) produced the same final model.
Abbreviations: 3HP-DOT, 3 months of directly observed once-weekly rifapentine (maximum dose, 900 mg) plus isoniazid (maximum dose, 900 mg); 9H-SAT, 9 months of daily self-administered isoniazid (maximum dose, 300 mg); CI, confidence interval; HIV, human immunodeficiency virus; LTBI, latent tuberculosis infection; NCT, noncompletion of treatment; OR, odds ratio; Ref., reference.
a Includes North American Indian and other participants in the United States and Canada.
b History of living in a correctional institution for ≥1 month before enrollment.
c History of homelessness or living in a shelter or single-room occupancy for ≥6 months before enrollment.
d Use: affirmative response to a question asking whether the participant ever drank alcoholic beverages. Abuse: score of ≥2 on the Cut down, Annoyed, Guilty, and Eye-opener questionnaire [9].
e Smoking was ascertained on the basis of the patient's statement of whether smoking was current at time of enrollment.
f Enrollment site was analyzed as the random effect variable of a generalized linear mixed model. Two-tailed P value was calculated on the basis of the z score (estimate/standard error).
g Missing ≥1 of the first 3 directly observed therapy (DOT) sessions for the 3HP regimen or ≥1 of the 3 monthly clinic visits for the 9H regimen, followed by a DOT or a monthly visit, respectively. The variable includes those who did not receive any study dose (n = 148). In the univariate analysis, the need for an interpreter among non-US- or non-Canadian-born participants (n = 3133 [use = 1355; no use = 1778]) resulted in statistical significance (OR, 0.55; 95% CI, .40–.77; P = .001) among participants who did not complete treatment attributed to an adverse event.
Univariate and Multivariate Analysis of Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment Attributed to an Adverse Event (n = 317) Compared With Those Who Completed Treatment (n = 4826)
Characteristic . | Noncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826]) . | ||||||
---|---|---|---|---|---|---|---|
. | Univariate . | Multivariate . | |||||
NCT (%) . | OR . | 95% CI . | P Value . | Adjusted OR . | 95% CI . | P Value . | |
Regimen | |||||||
3HP-DOT (n = 2844) Ref. | 6.4 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
9H-SAT (n = 2299) | 5.9 | 1.1 | .87–1.38 | .43 | 1.73 | 1.01–2.95 | .23 |
Age (y; median, 38) | |||||||
<38 (n = 2534) | 4.5 | 0.56 | .44–.71 | <.001 | 0.61 | .47–.79 | <.001 |
≥38 (n = 2609) Ref. | 7.8 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Sex | |||||||
Female (n = 2282) Ref. | 7.7 | Ref. | Ref. | Ref. | |||
Male (n = 2861) | 5.0 | 0.63 | .50–.79 | <.001 | |||
Race | |||||||
White (n = 2854) Ref. | 6.9 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Black (n = 1315) | 4.1 | 0.58 | .43–.79 | .001 | 0.33 | .23–.47 | <.001 |
Asian (n = 765) | 6.0 | 0.87 | .62–1.21 | .40 | 0.52 | .35–.78 | .001 |
Othera (n = 209) | 10.1 | 1.52 | .94–2.43 | .09 | 0.88 | .51–1.53 | .65 |
Ethnicity | |||||||
Non-Hispanic (n = 3013) Ref. | 7.5 | Ref. | Ref. | Ref. | |||
Hispanic (n = 2130) | 4.2 | 0.54 | .42–.70 | <.001 | |||
HIV status | |||||||
Negative (n = 2518) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Positive (n = 121) | 4.1 | 0.66 | .27–1.64 | .37 | |||
Unknown (n = 2504) | 6.3 | 1.03 | .82–1.30 | .78 | |||
Country of origin | |||||||
Non-US (n = 3133) Ref. | 5.5 | Ref. | Ref. | Ref. | |||
United States (n = 2010) | 7.2 | 1.34 | 1.07–1.68 | .01 | |||
Body mass index | |||||||
Underweight (n = 85) | 4.7 | 0.67 | .24–1.86 | .44 | |||
Normal (n = 1464) Ref. | 6.9 | Ref. | Ref. | Ref. | |||
Overweight (n = 1827) | 6.5 | 0.94 | .71–1.24 | .66 | |||
Obese (n = 1767) | 5.3 | 0.75 | .56–1.0 | .05 | |||
Education | |||||||
≤8th grade (n = 931) | 3.8 | 0.39 | .26–.59 | <.001 | 0.55 | .35–.87 | .01 |
8th grade through some college (n = 3207) | 6.0 | 0.64 | .49–.83 | .001 | 0.90 | .67–1.21 | .49 |
≥College degree (n = 1005) Ref. | 9.1 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Incarcerationb | |||||||
No (n = 4860) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 283) | 7.8 | 1.31 | .83–2.05 | .25 | |||
Unemployed | |||||||
No (n = 4534) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 609) | 6.4 | 1.05 | .74–1.48 | .79 | |||
Homelessc | |||||||
No (n = 4760) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 383) | 6.3 | 1.02 | .66–1.57 | .93 | |||
Alcohol consumptiond | |||||||
No (n = 2406) Ref. | 5.4 | Ref. | Ref. | Ref. | |||
Use (n = 2382) | 6.6 | 1.24 | .97–1.57 | .08 | |||
Abuse (n = 355) | 9.0 | 1.75 | 1.17–2.60 | .01 | |||
Intravenous drug use ever | |||||||
No (n = 4942) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 201) | 10.0 | 1.73 | 1.07–2.78 | .02 | |||
Cirrhosis, by self-report | |||||||
No (n = 4949) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 194) | 10.8 | 1.91 | 1.20–3.05 | .01 | |||
Current smokere | |||||||
No (n = 3642) Ref. | 5.8 | Ref. | Ref. | Ref. | |||
Yes (n = 1501) | 7.1 | 1.26 | .99–1.60 | .07 | |||
Methadone treatment | |||||||
No (n = 5035) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 108) | 8.3 | 1.40 | .70–2.79 | .34 | |||
Enrollment sitef | .01 | .02 | |||||
Concomitant medications | |||||||
No (n = 2566) Ref. | 3.6 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Yes (n = 2577) | 8.7 | 2.53 | 1.98–3.25 | <.001 | 1.86 | 1.42–2.44 | <.001 |
LTBI for contact tuberculosis | |||||||
No (n = 1769) Ref. | 7.1 | Ref. | Ref. | Ref. | |||
Yes (n = 3374) | 5.7 | 0.79 | .63–1.0 | .05 | |||
LTBI for tuberculin skin test converter | |||||||
No (n = 3292) Ref. | 5.7 | Ref. | Ref. | Ref. | |||
Yes (n = 1851) | 6.9 | 1.22 | .97–1.54 | .09 | |||
LTBI for fibrosis | |||||||
No (n = 4985) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 158) | 7.0 | 1.14 | .61–2.13 | .67 | |||
LTBI for HIV infection | |||||||
No (n = 5026) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 117) | 4.3 | 0.68 | .27–1.66 | .39 | |||
Having missed an early visitg | |||||||
No (n = 4936) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 207) | 4.8 | 0.77 | .40–1.46 | .42 | |||
Interaction terms | |||||||
Ethnicity × regimen | |||||||
3HP-DOT: Non-Hispanic vs Hispanic | 3.0 | 1.93–4.69 | <.001 | ||||
9H-SAT: Non-Hispanic vs Hispanic | 1.44 | .92–2.26 | .11 | ||||
Cirrhosis, by self-report × regimen | |||||||
3HP-DOT: Cirrhosis: yes vs no | 0.80 | .35–1.83 | .60 | ||||
9H-SAT-: Cirrhosis: yes vs no | 2.93 | 1.52–5.65 | .001 | ||||
Alcohol × sex | |||||||
Male | |||||||
Users vs no alcohol | 1.64 | 1.05–2.57 | .03 | ||||
Abusers vs no alcohol | 2.15 | 1.19–3.89 | .01 | ||||
Female | |||||||
Users vs no alcohol | 0.84 | .59–1.19 | .32 | ||||
Abusers vs no alcohol | 0.70 | .26–1.92 | .49 |
Characteristic . | Noncompletion of Treatment Attributed to an Adverse Event (NCT-AE) (n = 5143 [317 + 4826]) . | ||||||
---|---|---|---|---|---|---|---|
. | Univariate . | Multivariate . | |||||
NCT (%) . | OR . | 95% CI . | P Value . | Adjusted OR . | 95% CI . | P Value . | |
Regimen | |||||||
3HP-DOT (n = 2844) Ref. | 6.4 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
9H-SAT (n = 2299) | 5.9 | 1.1 | .87–1.38 | .43 | 1.73 | 1.01–2.95 | .23 |
Age (y; median, 38) | |||||||
<38 (n = 2534) | 4.5 | 0.56 | .44–.71 | <.001 | 0.61 | .47–.79 | <.001 |
≥38 (n = 2609) Ref. | 7.8 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Sex | |||||||
Female (n = 2282) Ref. | 7.7 | Ref. | Ref. | Ref. | |||
Male (n = 2861) | 5.0 | 0.63 | .50–.79 | <.001 | |||
Race | |||||||
White (n = 2854) Ref. | 6.9 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Black (n = 1315) | 4.1 | 0.58 | .43–.79 | .001 | 0.33 | .23–.47 | <.001 |
Asian (n = 765) | 6.0 | 0.87 | .62–1.21 | .40 | 0.52 | .35–.78 | .001 |
Othera (n = 209) | 10.1 | 1.52 | .94–2.43 | .09 | 0.88 | .51–1.53 | .65 |
Ethnicity | |||||||
Non-Hispanic (n = 3013) Ref. | 7.5 | Ref. | Ref. | Ref. | |||
Hispanic (n = 2130) | 4.2 | 0.54 | .42–.70 | <.001 | |||
HIV status | |||||||
Negative (n = 2518) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Positive (n = 121) | 4.1 | 0.66 | .27–1.64 | .37 | |||
Unknown (n = 2504) | 6.3 | 1.03 | .82–1.30 | .78 | |||
Country of origin | |||||||
Non-US (n = 3133) Ref. | 5.5 | Ref. | Ref. | Ref. | |||
United States (n = 2010) | 7.2 | 1.34 | 1.07–1.68 | .01 | |||
Body mass index | |||||||
Underweight (n = 85) | 4.7 | 0.67 | .24–1.86 | .44 | |||
Normal (n = 1464) Ref. | 6.9 | Ref. | Ref. | Ref. | |||
Overweight (n = 1827) | 6.5 | 0.94 | .71–1.24 | .66 | |||
Obese (n = 1767) | 5.3 | 0.75 | .56–1.0 | .05 | |||
Education | |||||||
≤8th grade (n = 931) | 3.8 | 0.39 | .26–.59 | <.001 | 0.55 | .35–.87 | .01 |
8th grade through some college (n = 3207) | 6.0 | 0.64 | .49–.83 | .001 | 0.90 | .67–1.21 | .49 |
≥College degree (n = 1005) Ref. | 9.1 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Incarcerationb | |||||||
No (n = 4860) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 283) | 7.8 | 1.31 | .83–2.05 | .25 | |||
Unemployed | |||||||
No (n = 4534) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 609) | 6.4 | 1.05 | .74–1.48 | .79 | |||
Homelessc | |||||||
No (n = 4760) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 383) | 6.3 | 1.02 | .66–1.57 | .93 | |||
Alcohol consumptiond | |||||||
No (n = 2406) Ref. | 5.4 | Ref. | Ref. | Ref. | |||
Use (n = 2382) | 6.6 | 1.24 | .97–1.57 | .08 | |||
Abuse (n = 355) | 9.0 | 1.75 | 1.17–2.60 | .01 | |||
Intravenous drug use ever | |||||||
No (n = 4942) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 201) | 10.0 | 1.73 | 1.07–2.78 | .02 | |||
Cirrhosis, by self-report | |||||||
No (n = 4949) Ref. | 6.0 | Ref. | Ref. | Ref. | |||
Yes (n = 194) | 10.8 | 1.91 | 1.20–3.05 | .01 | |||
Current smokere | |||||||
No (n = 3642) Ref. | 5.8 | Ref. | Ref. | Ref. | |||
Yes (n = 1501) | 7.1 | 1.26 | .99–1.60 | .07 | |||
Methadone treatment | |||||||
No (n = 5035) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 108) | 8.3 | 1.40 | .70–2.79 | .34 | |||
Enrollment sitef | .01 | .02 | |||||
Concomitant medications | |||||||
No (n = 2566) Ref. | 3.6 | Ref. | Ref. | Ref. | Ref. | Ref. | Ref. |
Yes (n = 2577) | 8.7 | 2.53 | 1.98–3.25 | <.001 | 1.86 | 1.42–2.44 | <.001 |
LTBI for contact tuberculosis | |||||||
No (n = 1769) Ref. | 7.1 | Ref. | Ref. | Ref. | |||
Yes (n = 3374) | 5.7 | 0.79 | .63–1.0 | .05 | |||
LTBI for tuberculin skin test converter | |||||||
No (n = 3292) Ref. | 5.7 | Ref. | Ref. | Ref. | |||
Yes (n = 1851) | 6.9 | 1.22 | .97–1.54 | .09 | |||
LTBI for fibrosis | |||||||
No (n = 4985) Ref. | 6.1 | Ref. | Ref. | Ref. | |||
Yes (n = 158) | 7.0 | 1.14 | .61–2.13 | .67 | |||
LTBI for HIV infection | |||||||
No (n = 5026) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 117) | 4.3 | 0.68 | .27–1.66 | .39 | |||
Having missed an early visitg | |||||||
No (n = 4936) Ref. | 6.2 | Ref. | Ref. | Ref. | |||
Yes (n = 207) | 4.8 | 0.77 | .40–1.46 | .42 | |||
Interaction terms | |||||||
Ethnicity × regimen | |||||||
3HP-DOT: Non-Hispanic vs Hispanic | 3.0 | 1.93–4.69 | <.001 | ||||
9H-SAT: Non-Hispanic vs Hispanic | 1.44 | .92–2.26 | .11 | ||||
Cirrhosis, by self-report × regimen | |||||||
3HP-DOT: Cirrhosis: yes vs no | 0.80 | .35–1.83 | .60 | ||||
9H-SAT-: Cirrhosis: yes vs no | 2.93 | 1.52–5.65 | .001 | ||||
Alcohol × sex | |||||||
Male | |||||||
Users vs no alcohol | 1.64 | 1.05–2.57 | .03 | ||||
Abusers vs no alcohol | 2.15 | 1.19–3.89 | .01 | ||||
Female | |||||||
Users vs no alcohol | 0.84 | .59–1.19 | .32 | ||||
Abusers vs no alcohol | 0.70 | .26–1.92 | .49 |
Regimen factor is also part of certain interaction terms. Blank cells indicate not applicable or not tested. Use of a less stringent entry criterion (P ≤ .2) produced the same final model.
Abbreviations: 3HP-DOT, 3 months of directly observed once-weekly rifapentine (maximum dose, 900 mg) plus isoniazid (maximum dose, 900 mg); 9H-SAT, 9 months of daily self-administered isoniazid (maximum dose, 300 mg); CI, confidence interval; HIV, human immunodeficiency virus; LTBI, latent tuberculosis infection; NCT, noncompletion of treatment; OR, odds ratio; Ref., reference.
a Includes North American Indian and other participants in the United States and Canada.
b History of living in a correctional institution for ≥1 month before enrollment.
c History of homelessness or living in a shelter or single-room occupancy for ≥6 months before enrollment.
d Use: affirmative response to a question asking whether the participant ever drank alcoholic beverages. Abuse: score of ≥2 on the Cut down, Annoyed, Guilty, and Eye-opener questionnaire [9].
e Smoking was ascertained on the basis of the patient's statement of whether smoking was current at time of enrollment.
f Enrollment site was analyzed as the random effect variable of a generalized linear mixed model. Two-tailed P value was calculated on the basis of the z score (estimate/standard error).
g Missing ≥1 of the first 3 directly observed therapy (DOT) sessions for the 3HP regimen or ≥1 of the 3 monthly clinic visits for the 9H regimen, followed by a DOT or a monthly visit, respectively. The variable includes those who did not receive any study dose (n = 148). In the univariate analysis, the need for an interpreter among non-US- or non-Canadian-born participants (n = 3133 [use = 1355; no use = 1778]) resulted in statistical significance (OR, 0.55; 95% CI, .40–.77; P = .001) among participants who did not complete treatment attributed to an adverse event.
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