Table 1.
Baseline characteristics of the study sample
| Total (n=77) |
Directly observed therapy (DOT) study arm (n=39) |
Treatment as usual (TAU) study arm (n=38) |
p value* |
||
|---|---|---|---|---|---|
| Sociodemographic characteristics | |||||
| Age, mean (sd) | 47 (7) | 45 (7) | 49 (7) | 0.05 | |
| Sex, n (%) | |||||
| Male | 41 (53) | 19 (49) | 22 (58) | 0.42 | |
| Race, n (%) | |||||
| White | 10 (13) | 5 (13) | 5 (13) | 0.70 | |
| Black | 31 (40) | 14 (36) | 17 (45) | ||
| Other | 36 (47) | 20 (51) | 16 (42) | ||
| Ethnicity, n (%) | |||||
| Hispanic | 35 (45) | 20 (51) | 15 (39) | 0.30 | |
| Non-Hispanic | 42 (55) | 19 (49) | 23 (61) | ||
| Education, n (%) | |||||
| Less than high school | 38 (49) | 19 (49) | 19 (50) | 0.89 | |
| High school (partial or completed) | 20 (26) | 11 (28) | 9 (24) | ||
| College (partial or completed) | 19 (25) | 9 (23) | 10 (26) | 0.74 | |
| Marital status, n (%) | |||||
| Married or living with partner | 34 (44) | 17 (44) | 17 (45) | 0.14 | |
| Widowed, separated or divorced | 22 (29) | 8 (20) | 14 (37) | ||
| Single | 21 (27) | 14 (36) | 7 (18) | ||
| Employment status, n (%) | |||||
| Employed | 2 (3) | 1 (3) | 1 (3) | 1.00 | |
| Unemployed or unable to work, n (%) | 75 (97) | 38 (97) | 37 (97) | ||
| Insurance, n (%) † | |||||
| Medicaid | 69 (90) | 33 (85) | 36 (95) | 0.26 | |
| Medicare | 16 (21) | 10 (26) | 6 (16) | 0.40 | |
| Private insurance | 6 (8) | 3 (8) | 3 (8) | 1.00 | |
|
Antiretroviral regimen and HIV clinical characteristics |
|||||
| Self-reported seven-day antiretroviral adherence ‡ |
|||||
| 100%, n (%) | 55 (72) | 25 (66) | 30 (79) | 0.20 | |
| <100%, n (%) | 21 (27) | 13 (34) | 8 (21) | ||
| Median duration of HIV infection, years (IQR) |
13 (9-17) | 12 (8-15) | 15 (10-18) | 0.09 | |
| Duration of antiretroviral therapy, n (%) § | |||||
| <1 year | 18 (24) | 8 (21) | 10 (28) | 0.83 | |
| 1 – 5 years | 34 (44) | 18 (49) | 16 (44) | ||
| >5 years | 21 (27) | 11 (30) | 10 (28) | ||
| Number of pills in antiretroviral regimen, n (%) ¶ |
|||||
| One | 8 (10) | 4 (10) | 4 (10) | 0.12 | |
| Two | 39 (51) | 25 (64) | 14 (37) | ||
| Three | 24 (31) | 8 (21) | 16 (42) | ||
| Four | 5 (7) | 2 (5) | 3 (8) | ||
| Five | 1 (1) | 0 | 1 (3) | ||
| Frequency of antiretroviral dosing, n (%) | |||||
| Once per day | 21 (27) | 9 (23) | 12 (32) | 0.40 | |
| Two or more times per day | 56 (73) | 30 (77) | 26 (68) | ||
| Viral load (copies/ml), n (%) | |||||
| <75 | 36 (47) | 20 (51) | 16 (42) | 0.11 | |
| 75 – 400 | 5 (6) | 4 (10) | 1 (3) | ||
| 401 - 10,000 | 21 (27) | 8 (21) | 13 (34) | ||
| 10,001 - 100,000 | 12 (16) | 4 (10) | 8 (21) | ||
| > 100,000 | 3 (4) | 3 (8) | 0 | ||
| HIV viral load < 75 copies/ml, n (%) | 41 (53) | 19 (49) | 22 (58) | 0.42 | |
| Mean viral load, log10 copies/ml | 2.81 | 2.74 | 2.89 | 0.43 | |
| Median CD4+ T cell count, cells/mm3, (IQR) (n=74) |
345 (151-494) | 367 (189 - 509) | 277 (110 - 453) | 0.34 | |
| CD4+ T cell count ≥ 350, n (%) | 37 (50) | 21 (55) | 16 (44) | 0.35 | |
| Substance use characteristics | |||||
| Median duration methadone maintenance, years (IQR) (n=48) |
10 (5-16) | 9 (4-15) | 10 (6-16) | 0.93 | |
| Median methadone dose, mg (IQR) (n=74) |
125 (90-180) | 135 (90-170) | 120 (90-185) | 0.85 | |
| Reported use of illicit drug in 30 days prior to baseline, n (%) |
|||||
| Heroin | 20 (26) | 9 (24) | 11 (29) | 0.60 | |
| Cocaine | 22 (29) | 9 (24) | 13 (34) | 0.31 | |
| Crack | 27 (35) | 14 (37) | 13 (34) | 0.81 | |
| Marijuana | 11 (14) | 7 (19) | 4 (11) | 0.30 | |
| Amphetamine | 3 (4) | 1 (3) | 2 (5) | 1.00 | |
| Hazardous alcohol use (AUDIT ≥8) | 15 (20) | 6 (16) | 9 (24) | 0.36 | |
| Positive baseline urine toxicology report, n (%) |
|||||
| Opioid (non-methadone) | 24 (31) | 11 (30) | 13 (35) | 0.62 | |
| Cocaine (including crack) | 42 (55) | 19 (51) | 23 (62) | 0.35 | |
| Benzodiazepine | 7 (9) | 3 (8) | 4 (11) | 0.71 | |
| Marijuana | 13 (17) | 6 (16) | 7 (19) | 0.72 | |
| Amphetamine | 0 (0) | 0 | 0 | 1.00 |
*
p value for difference between DOT and TAU groups
†
Categories not mutually exclusive
‡
Data missing for 1 participant
§
Data missing for 4 participants
¶
Participants reporting <3 pills were prescribed combination antiretroviral medications co-formulated in one pill