Table 1:
Enrollment characteristics of the study population by randomization arm
| OLA-guided therapy (n=492) | Standard of Care (n=495) | |
|---|---|---|
| Clinic site | ||
| Nairobi, Ngong Rd | 331 (67%) | 336 (68%) |
| Nairobi, Industrial Area | 42 (9%) | 48 (10%) |
| Maseno | 119 (24%) | 111 (22%) |
| Female | 320 (65%) | 321 (65%) |
| Age (years) | 38 (32–46) | 37 (30–45) |
| 2–24 | 33 (7%) | 53 (11%) |
| 25–34 | 152 (31%) | 162 (33%) |
| 35–49 | 224 (45%) | 215 (43%) |
| ≥50 | 83 (17%) | 65 (13%) |
| Education, adults onlya | ||
| Less than primary | 47 (10%) | 37 (8%) |
| Primary | 180 (37%) | 169 (36%) |
| Secondary | 131 (27%) | 141 (30%) |
| Some College/Technical | 123 (26%) | 123 (26%) |
| Marital status, adults onlya | ||
| Single | 91 (19%) | 73 (15%) |
| Married/Committed relationship | 263 (55%) | 270 (58%) |
| Divorced/Separated/Widowed | 127 (26%) | 127 (27%) |
| Unemployed, adults onlya | 51 (11%) | 41 (9%) |
| Sexual partners in past yearb | ||
| None or never had sex | 173 (37%) | 182 (38%) |
| 1–2 | 284 (60%) | 289 (60%) |
| ≥3 | 12 (3%) | 12 (2%) |
| ART-naïve | 460 (94%) | 463 (94%) |
| CD4 cells per uL | 233 (116–311) | 231 (113–318) |
| Plasma HIV RNA (log10 copies per µL) | 10·8 (9·2–12·1) | 10·7 (9·1–11·8) |
| % Resistance of mutation with highest frequency in individual’s HIV quasispeciesc | ||
| ≥10% | 45 (9%) | 34 (7%) |
| 2–9% | 6 (1%) | 8 (2%) |
| Wild-type | 441 (90%) | 452 (91%) |
| ART regimen post-randomizationd | ||
| Efavirenz | 267 (57%) | 300 (63%) |
| Nevirapine | 160 (34%) | 173 (37%) |
| Lopinavir/ritonavir | 39 (9%) | 0 (0%) |
Data are shown by absolute numbers, “n” (%) or median (IQR).
a
Adults only, OLA-guided therapy (n=481) and SOC (n=470);
b
Does not include 35 responses categorized as “Don’t Know” or “Refused”;
c
Point mutations (K103N, Y181C, G190A, M184V) detected by OLA;
d
ART regimen base, OLA-guided therapy (n=466) and SOC (n=473);
Abbreviations: OLA, oligonucleotide ligation assay