Table 2.
Comparison of 12‐month study outcomes between arms
| Retention in ART care (primary outcome) a | Viral suppression b | Unscheduled facility visits c | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unadjusted estimates | Adjusted estimates d | Unadjusted estimates | Adjusted estimates d | Unadjusted estimates | Adjusted estimates d | ||||||||||||
| Enrolled, N | Retained, n (%) | RD (95% CI) | p | RD (95% CI) | p | Tested, n/N (%) e | Suppressed n (%) | RR (95% CI) | p | RR (95% CI) | p | No., mean (SD) f | IRR (95% CI) | p | IRR (95% CI) | P | |
| SoC | 212 | 198 (93.4) | Ref | – | Ref | – | 143/198 (72.2) | 142 (99.3) | Ref | – | Ref | – | 0.28 (0.83) | Ref | – | Ref | – |
| 3MC | 128 | 123 (96.1) | 2.9% (‐1.8 to 7.5%) | 0.23 | 4.6% (0.7 to 8.5%) | 0.02 | 72/122 (59.0) | 71 (98.6) | 0.99 (0.97–1.02) | 0.73 | 0.98 (0.92‐1.03) | 0.41 | 0.13 (0.49) | 0.51 (0.13–1.92) | 0.32 | 0.53 (0.16‐1.80) | 0.31 |
| 6MC | 259 | 248 (95.8) | 2.3% (‐1.5 to 6.1%) | 0.24 | 1.7% (‐2.5 to 5.9%) | 0.42 | 103/243 (42.4) | 101 (98.1) | 0.99 (0.96–1.01) | 0.33 | 0.98 (0.95‐1.00) | 0.10 | 0.25 (0.67) | 0.84 (0.24–2.92) | 0.79 | 0.82 (0.25‐2.79) | 0.76 |
| 6MC (vs 3MC) | 259 | 248 (95.8) | ‐0.6% (95% CI: −4.5 3.3%) | 0.77 | 1.1% (‐2.9 to 5.0%) | 0.60 | 103/243 (42.4) | 101 (98.1) | 0.99 (0.96–1.03) | 0.64 | 1.0 (0.94–1.07) | 0.96 | 0.25 (0.67) | 1.55 (0.56–4.22) | 0.40 | 1.65 (0.58‐4.74) | 0.35 |
Risk differences were estimated using binomial population‐averaged generalized estimating equations using an exchangeable correlation structure stratified by trial, specifying for clustering by facility, using robust standard errors, and using a small cluster size variance correction. The measured intracluster correlation coefficient for retention was <0.001.
Risk ratios were estimated using log‐binomial population‐averaged generalized estimating equations using an exchangeable correlation structure stratified by trial, specifying for clustering by facility, using robust standard errors, and using a small cluster size variance correction.
Population‐averaged Poisson regression models were used to estimate incidence rate ratio's stratified by trial, specified for clustering by facility and using robust standard errors.
Adjusted estimates were adjusted for primary healthcare clinic/hospital‐based facility and rural/urban geolocation.
Those tested for viral load /those eligible for viral load testing at 12 months. Those eligible for viral load testing were enrolled participants less those who died, were lost to‐follow up or who had transferred‐out prior to 12 months after enrolment.
Number of unscheduled facility visits between months 0 to 12 of study.
SoC‐participants received three‐monthly dispensing of ART at the facility. 3MC‐participants received three months’ supply of ART in community ART groups (CAGs). 6MC‐participants received 6 months’ supply of ART in CAGs or at community distribution points. ART, antiretroviral therapy; CI, confidence interval; IRR, incidence rate ratio; RD, risk difference; Ref, reference category; RR, risk ratio.