Primary and secondary outcomes by study arm
| HIVST | SOC | Risk difference (95% CI) | Adjusted risk difference (95% CI) | Risk ratio (95% CI) | Adjusted risk ratio (95% CI) | ||||
| n/N (%) | GM | n/N (%) | GM | P value | P value | P value | P value | k | |
| Primary outcome | |||||||||
| HIV testing in the last 12 months | 1768/2582 (68.5%) | 68.1% | 1422/2908 (48.9%) | 48.1% | 19.2% (10.1% to 28.3%) <0.001 | 16.1% (6.5% to 25.7%) 0.002 | 1.42 (1.2 to 1.66) <0.001 | 1.33 (1.13 to 1.58) 0.002 | 0.17 |
| Stratified by age group* | |||||||||
| 16–19 years | 252/366 (68.9%) | 69.5% | 185/439 (42.1%) | 39.2% | 27.5% (13.4% to 41.5%) <0.001 | 26.1% (12.9% to 39.2%) <0.001 | 1.77 (1.31 to 2.41) <0.001 | 1.78 (1.33 to 2.38) <0.001 | |
| ≥20 years | 1516/2216 (68.4%) | 68.0% | 1237/2469 (50.1%) | 49.5% | 17.6% (8.1% to 27.0%) <0.001 | 14.7% (4.8% to 24.6%) 0.006 | 1.37 (1.16 to 1.63) <0.001 | 1.3 (1.09 to 1.55) 0.006 | |
| Stratified by sex† | |||||||||
| Male | 699/1075 (65.0%) | 64.1% | 529/1264 (41.9%) | 41.2% | 22.3% (10.1% to 34.5%) 0.001 | 20.6% (7.1% to 34.0%) 0.01 | 1.55 (1.25 to 1.94) <0.001 | 1.51 (1.18 to 1.93) 0.002 | |
| Female | 1069/1507 (70.9%) | 70.9% | 893/1644 (54.3%) | 53.1% | 16.9% (8.4% to 25.4%) <0.001 | 12.8% (4.0% to 21.6%) 0.007 | 1.33 (1.14 to 1.56) <0.001 | 1.24 (1.06 to 1.45) 0.01 | |
| Stratified by household wealth index‡ | |||||||||
| Lowest | 463/723 (64.0%) | 60.6% | 427/902 (47.3%) | 46.0% | 14.5% (3.1% to 25.9%) 0.02 | 13.0% (1.1% to 24.8%) 0.03 | 1.32 (1.06 to 1.64) 0.02 | 1.28 (1.02 to 1.61) 0.04 | |
| Middle | 590/829 (71.2%) | 70.8% | 454/868 (52.3%) | 51.6% | 18.2% (8.7% to 27.6%) <0.001 | 13.8% (3.7% to 23.8%) 0.01 | 1.37 (1.17 to 1.61) <0.001 | 1.27 (1.07 to 1.5) 0.008 | |
| Highest | 660/961 (68.7%) | 70.2% | 477/1013 (47.1%) | 46.4% | 22.8% (11.5% to 34.2%) <0.001 | 20.2% (8.3% to 32.1%) 0.002 | 1.51 (1.24 to 1.86) <0.001 | 1.45 (1.17 to 1.79) 0.002 | |
| Secondary outcomes | |||||||||
| Lifetime HIV testing | 2243/2582 (86.9%) | 87.1% | 2283/2908 (78.5%) | 78.6% | 8.6% (4.7% to 12.5%) <0.001 | 6.3% (2.3% to 10.3%) 0.004 | 1.11 (1.06 to 1.16) <0.001 | 1.08 (1.03 to 1.13) 0.004 | 0.04 |
| ART initiation per 100 000 population across intervention period§ | 527/44 390 (1187.2) | 1159.1 | 468/51 488 (909.0) | 810.6 | 366.9 (−90.1 to 823.8) 0.11 | 309.1 (−95.5 to 713.7) 0.13 | 1.43 (0.91 to 2.24) 0.11 | 1.34 (0.92 to 1.96) 0.12 | 0.46 |
HIV testing outcomes adjusted for cluster-level baseline outcomes (testing in the last 12 months) and individual-level covariates (age, sex, marital status). Subgroup analysis by age group adjusts for the same covariates except for age group. Subgroup analysis by sex adjusts for the same covariates except for sex. ART initiation outcome adjusted for cumulative incidence of ART initiations in 12-month preintervention period.
Post hoc analysis with one SOC cluster dropped due to exposure to separate community-based HIVST implementation. For HIV testing in the last 12 months, HIVST: 1768/2582 (68.5%), SOC: 1230/2665 (46.2%); adjusted RD: 19.0% (11.5%–26.5%), p<0.001. For lifetime HIV testing, HIVST: 2243/2582 (86.9%), SOC: 2074/2665 (77.8%); adjusted RD: 6.9% (3.0%–10.8%), p<0.001.
*P value for interaction, p=0.18.
†P value for interaction, p=0.07.
‡P value for interaction (middle vs lowest), p=0.74. P value for interaction (highest vs lowest), p=0.18.
§Denominator for ART initiations is the estimated population of adults ≥16 years in the evaluation area, which was estimated using village and health facility registers.
ART, antiretroviral therapy; GM, geometric mean (of cluster-level proportions); HIVST, HIV self-testing; k, coefficient of variation in health facility-defined clusters; RD, risk difference; SOC, standard of care.