Table 5.
Association of Subject Characteristics at Study Entry with Adverse Outcomes (Hospitalization or Death): Results of Bivariate and Multivariable Linear Regression
| Subject characteristics (n = 324) | Bivariate OR for poor outcome (hospitalization or death), 95% CI | p | Multivariable OR for poor outcome (hospitalization or death), 95% CI | p |
|---|---|---|---|---|
| Demographics | ||||
| Study site | ||||
| Coalane | 0.81 (0.27, 2.49) | 0.719 | 0.15 (0.02, 0.99) | 0.049 |
| Inhassunge | 2.00 (0.84, 4.76) | 0.117 | 1.78 (0.52, 6.15) | 0.361 |
| Namacurra | Reference | Reference | ||
| Gender, pregnancy status | ||||
| Male | 1.32 (0.56, 3.10) | 0.520 | — | |
| Female, not pregnant | Reference | — | ||
| Pregnant | 0.16 (0.02, 1.25) | 0.081 | — | |
| Age (years) | 1.00 (0.96, 1.04) | 0.990 | ||
| Illiterate | 1.05 (0.48, 2.31) | 0.893 | ||
| Did not accept home visits | 0.53 (0.12, 2.41) | 0.412 | ||
| HIV/AIDS status | ||||
| Most recent CD4 count (cells/μl), categories with adjustment for 3 categories of ART at enrollment | ||||
| <350, no ART at enrollment | 8.77 (1.70, 45.36) | 0.010 | 8.94 (1.18, 67.49) | 0.034 |
| <350, start ART at enrollment | 5.38 (0.38, 75.38) | 0.212 | 3.29 (0.06, 181.82) | 0.561 |
| <350, already on ART at enrollment | 6.45 (1.09, 38.13) | 0.040 | 13.66 (1.31, 141.46) | 0.028 |
| > = 350 | Reference | Reference | ||
| No CD4 available | 6.92 (1.29, 37.17) | 0.024 | 12.39 (1.37, 111.82) | 0.025 |
| On co-trimoxazole prophylaxis at enrollment | 0.48 (0.21, 1.08) | 0.076 | 0.13 (0.03, 0.57) | 0.007 |
| On zidovudine (ART or prevention of mother-to-child transmission) at enrollment | 0.55 (0.23, 1.32) | 0.181 | ||
| Clinical characteristics at visit 1 | ||||
| Temperature (axillary, °C) (2 missing) | 2.91 (1.84, 4.62) | <0.001 | 2.21 (1.26, 3.87) | 0.005 |
| Body mass index (kg/m2) (7 missing) | 0.75 (0.64, 0.88) | <0.001 | 0.76 (0.61, 0.95) | 0.014 |
| Hemoglobin (g/dl) at baseline | 0.73 (0.53, 0.996) | 0.047 | — | |
| Key diagnoses and comorbidities at first or any study visit | ||||
| Lowest Hb recorded during study (Hb nadir) | 0.62 (0.47, 0.83) | 0.001 | 0.43 (0.25, 0.73) | 0.002 |
| Smear-positive pulmonary TB, first or any visita | Undefined | — | ||
| Smear-negative pulmonary TB, visit 1 | 6.81 (2.48, 18.69) | <0.001 | — | |
| TB suspect at visit 1 | 6.81 (2.48, 18.69) | <0.001 | — | |
| Active TB, not diagnosed until after enrollment visit (enrollment visit only) | 4.03 (1.22, 13.29) | 0.022 | — | — |
| Bacteremia (detected on blood culture drawn at this visit), visit 1 | 8.25 (2.07, 32.81) | 0.003 | 5.89 (0.85, 40.58) | 0.072 |
| Malaria (rapid test positive), visit 1 | 0.51 (0.15, 1.81) | 0.300 | ||
| Oral candida, any visit | 4.03 (1.22, 13.29) | 0.022 | — | |
| Esophageal candida (any visit)b | Undefined. | — | ||
| Any bleeding, any study visit | 5.96 (0.81, 44.09) | 0.080 | 110.21 (4.31, 2819.10) | 0.002 |
| Suspected Stage III Anemia, visit 1 or any visita | Undefined. | |||
| Suspected ADR CTX, any visit | 0.93 (0.20, 4.40) | 0.932 | ||
| Suspected ADR ZDV, any visit Hb | 2.74 (0.78, 9.53) | 0.114 | ||
| Management at any study visit | ||||
| Start ART, visit 1 | 0.69 (0.08, 5.76) | 0.735 | ||
| Start ZDV (ART or PMTCT), any visit | 0.31 (0.04, 2.40) | 0.262 | ||
| Stop ZDV, any study visit | 2.74 (0.78, 9.53) | 0.114 | ||
| Start CTX, any study visit | 0.89 (0.34, 2.34) | 0.816 | ||
| Stop CTX, any study visit | 0.93 (0.20, 4.40) | 0.932 | ||
| Start antimalarial, visit 1 | 0.71 (0.23, 2.19) | 0.555 | ||
| Start TB treatment, any study visit | 1.27 (0.26, 6.19) | 0.768 | ||
| Start antibiotics, any study visit | 1.97 (0.90, 4.31) | 0.089 | — | |
| Start antifungals, any study visit | 1.84 (0.71, 4.75) | 0.209 | ||
| Start iron supplements, first or any study visitc | Undefined. | |||
| Start anthelminthics, any study visit | 0.45 (0.13, 1.53) | 0.202 | ||
| No new interventions other than iron, anthelmintics, and/or antimalarial, all visits | 0.32 (0.17, 0.88) | 0.027 | — | |
a
Undefined: no adverse outcomes in this category.
b
Undefined: all subjects in this category had adverse outcomes.
c
Undefined: all subjects with known outcomes and non-missing data were started on iron at study visit 1.
ADR, adverse drug reaction; ART, combination antiretroviral therapy; CD4, CD4+ T-lymphocyte count, cells/μL; CI, confidence interval; CTX, co-trimoxazole prophylaxis; Hb, hemoglobin, g/dL; LTFU, lost to follow-up; OR, odds ratio; PMTCT, prevention of mother-to-child transmission of HIV; TB, tuberculosis; ZDV, zidovudine.