Table 3.
Regression Model for Composite Maternal–Fetus/Infant Outcome Score (Higher Score Is Worse) for the TB APPRISE Study
| Univariable Results | Multivariable results | |||||
|---|---|---|---|---|---|---|
| Predictors and Groupa | Slopeb Estimate | 95% CI | P | Slopec Estimate | 95% CI | P |
| Study arm/ARV regimen at baseline interaction | .07 | .049 | ||||
| EFV-containing regimen at baseline: immediate INH – deferred INH | 1.2 | (−3.5, 5.9) | .62 | 1.5 | (−3.2, 6.2) | .53 |
| NVP-containing regimen at baseline: immediate INH – deferred INH | 13.1 | (1.2, 25.1) | 0.04 | 14.3 | (2.4, 26.2) | 0.02 |
| HBsAG positive vs negative | 7.3 | (4.3, 18.9) | .22 | … | … | … |
| Hepatitis C positive vs negative serology | 10.6 | (−11.5, 35.6) | .35 | … | … | … |
| CD4 count (cells/mm3) (per 10 cells higher) | −.04 | (−.1, .05) | .33 | … | … | … |
| HIV RNA < LLQ vs ≥LLQ | −6.2 | (−10.7, −1.8) | .006 | −6.7 | (−11.2, −2.1) | .004 |
| Maternal age (years) (per year of age) | −.2 | (−.6, .2) | .35 | … | … | … |
| Midupper arm circumference (ref: obese >31) (in cm): | .04 | .02 | ||||
| Malnourished: <23 | 13.3 | (2.3, 24.2) | .02 | 15.1 | (3.7, 26.6) | .01 |
| Normal: 23–31 | −.5 | (−5.3, 4.4) | .85 | −.3 | (−5.2, 4.5) | .88 |
| Initiated cotrimoxazole before or at study entry vs never | 3.7 | (−.7, 8.0) | .10 | 4.8 | (.4, 9.2) | .03 |
| Current vs never/previous smoking | 9.5 | (−6.5, 25.5) | .25 | … | … | … |
| Food insecure vs not food insecure | 1.2 | (−5.2, 7.7) | .71 | … | … | … |
| Twin pregnancy vs singleton | 21.2 | (1.4, 41.0) | .04 | 20.5 | (−.2, 41.2) | .052 |
All models included gestational age strata (parameter estimates and P values not shown as gestational age was a stratification factor in the randomization). P values for overall tests and for covariates with >2 levels relative to the reference category are from F tests. Reference categories are omitted. Abbreviations: APPRISE, Ante vs. Postpartum Prevention with INH in HIV Seropositive mothers and their Exposed infants; ARV, antiretroviral; CI, confidence interval; EFV, efavirenz; HBsAG, hepatitis B surface antigen; HIV, human immunodeficiency virus; INH, isoniazid; LLQ, lower limit of quantification; NVP, nevirapine; ref, reference; TB, tuberculosis; TB APPRISE,TB Ante vs. Postpartum Prevention with INH in HIV Seropositive mothers and their Exposed infants.
aFor the study arm/ARV regimen at baseline interaction, the difference between immediate and deferred INH are provided by receipt of an EFV- or NVP-containing regimen at baseline.
bUnadjusted regression coefficient (if categorical, this is the difference in mean score from the reference group).
cAdjusted regression coefficient was adjusted for parameter estimates shown. For study arm–ARV regimen interaction, slope estimates are for pairwise comparisons of immediate vs deferred INH within ARV groups.