Of the 868 patients who were included in the primary analysis, we assessed baseline data on all 868 and endline data on 857, with the discrepancy reflecting patients who did not complete the study or had substantial missing data on QOL variables. Detailed characteristics of enrolled participants, their clinical and laboratory outcomes, and the costs of the intervention to the provider are reported elsewhere [12] and summarized in Additional file 1: Table S1. The median (IQR) age of the population was 39 years (35–44) and 66% were male. Most participants identified as PWID (87%), of whom 95% self-reported being on medication-assisted therapy (MAT). Just over half the sample (482, 55%) were HIV positive; all were on ART at the time of study enrollment. The 11 patients who were excluded from the final analysis did not differ from those in the analysis in terms of employment status or education level; all those excluded identified as PWID; were younger than 45 years, did not have liver cirrhosis, and were more likely to be co-infected with HIV; and 90% were male (Additional file 1: Table S2).
Responses to all QOL questions at baseline and endline are reported in Additional file 1: Table S3. Below we highlight differences between the two periods in the six domains listed above.
Self-reported health
At study entry, 66% of participants reported their health as either “poor” or “fair”. By study exit, 80% reported their health as “good”, “very good” or “excellent.” Consistent with this result, 73% of participants reported that their health was either “somewhat better” (43%) or “much better (30%) at 24 weeks than at study entry. The proportion of patients who agreed with the statement “my health is excellent” increased from 27% to 68% over the study period, while those agreeing with the statement “I have been feeling bad lately” decreased from 57% to 11%. The mean domain score for health perception increased from 33.7 (95% CI 32.4–35.1) at study entry to 62.3 (60.7–63.9) at 24 weeks (Fig. 1).
Physical activities, role, and social functioning
The proportions of participants who reported being limited in conducting a range of physical activities fell over the study period for all activities (Fig. 2). The largest difference was seen in vigorous activity, where the proportion who reported facing limitations declined from 54% to 32%. The mean domain score for physical functioning increased from 80.5 (95% CI 78.9–82.1) to 89.4 (88.1–90.7). Formal sector employment also rose over the study period, from 33% to 40% of the cohort. The proportion of participants who reported that their health affected “a lot” the quality at which they could perform their main activity decreased from 76% at study entry to 12% at 24 weeks. The mean number of days that participants were unable to perform their main activity due to their health or seeking health care in the past 2 weeks decreased from 1.6 (95% CI 1.5–1.8) days to 0.8 (0.6–1.0) days over the study period. Finally, the mean social functioning score improved from 74.2 (95% CI 72.1–84.8) to 84.8 (83.2–86.5).
Mental health and symptoms
Questions related to anxiety and depression showed a substantial improvement in mental health over the study period (Fig. 2), with the mean score for the mental health domain increasing from 67.0 (95% CI 65.5–68.2) to 70.5 (69.1–66.9).
The proportion of patients who reported having no or very mild inability to focus increased from 54% at study entry to 77% at endline, while those who reported a moderate inability to focus decreased from 23% to 9%. An improvement in reported tiredness and fatigue was also observed, increasing from 21% who reported no or very mild fatigue at study entry to 62% at 24 weeks. Bodily pain improved from 50% reporting no or very mild body pain at initiation to 84% at study endline. The mean domain score for pain improved from 70.1 (95% CI 68.2–72.0) to 89.8 (88.5–91.1) over the study period.
Stratification by HIV status
Participants with HIV and those without did not differ at baseline for any of the domains (Additional file 1: Table S3). Domain scores reported at 24 weeks in the physical functioning domain were lower for PLHIV (87.4, 95% CI 85.5–89.4) than for those not living with HIV (91.9, 90.0–93.5). Improvements in the social domain were larger among those who were not living with HIV (87.7, 95% CI 85.5–89.9) than among those with HIV (82.5, 80.1–84.9). Similarly, health perception improved by a larger margin among those who were not living with HIV (67.9, 95% CI 64.5–70.3) than among those with HIV (57.7, 55.6–59.9). Role functioning was slightly higher among those not living with HIV (87.2 (95% CI 84.7–89.8) vs 85.8 (83.5–88.1)) and domain scores for pain and mental health were marginally higher among PLHIV, but these differences were not statistically significant.
Stratification by SVR
Participants who failed to achieve SVR at 24 weeks but did complete the 24 week-questionnaire (n = 18) data had higher baseline (study entry) domain scores across all domains except for the Mental Health domain (Additional file 1: Table S3) than did those who achieved SVR. The patients who failed treatment, however, reported smaller changes in domain scores over the study period than did those with SVR. Among participants who failed to achieve SVR, health perception improved 65%, in comparison to 86% in the full cohort. Bodily pain improved by 15% among participants who failed to achieve SVR compared to 28% in the full study cohort. Other variables such as education, age, employment status and whether or not participant was considered PWID were also examined but there were no differences in these indicators between people with and without HIV.