Table 4.
Process measures regarding point‐of‐care viral load and drug resistance testing among Opt4Mamas study participants (n=820), February 2019−December 2021
| Intervention group (POC VL; n=411) | Control group (SOC VL; n=409) | |
|---|---|---|
| Participants attending the study visit among those expected a | ||
| 0 months | 411/411 (100%) | 409/409 (100%) |
| 3 months | 283/296 (96%) | 288/301 (96%) |
| 6 months | 53/70 (76%) | 78/85 (92%) |
| Delivery | 345/380 (91%) | 367/376 (98%) |
| Postpartum 3 | 276/373 (74%) | 342/368 (93%) |
| Postpartum 6 | 321/364 (88%) | 333/361 (92%) |
| Subtotal from 0 to postpartum 6 | 1689/1894 (89%) | 1817/1900 (96%) |
| Postpartum 9+ | 34/2148 (2%) | 288/2071 (14%) |
| Total from 0 to postpartum 24 | 1723/4042 (43%) | 2105/3971 (53%) |
| POC VL test conducted b for intended study visit among participants attending the study visit | ||
| 0 months | 409/411 (99.5%) | |
| 3 months | 143/283 (50.5%) | |
| 6 months | 23/53 (43.4%) | |
| Delivery | 309/345 (89.6%) | 16/367 (4.6%) |
| Postpartum 3 | 206/276 (74.6%) | |
| Postpartum 6 | 301/321 (93.8%) | 255/333 (76.6%) |
| Subtotal from 0 to postpartum 6 | 1391/1689 (82.4%) | 271/700 (38.7%) |
| Postpartum 9+ | 28/34 (82.4%) | |
| Total from 0 to postpartum 24 | 1419/1723 (82.4%) | 271/700 (38.7%) |
| SOC VL test conducted b within testing interval among participants regardless of attending the study visit | ||
| 0 months | 156/411 (38%) | 268/409 (65.5%) |
| 3 months | 40/411 (9.7%) | 111/409 (27.1%) |
| 6 months | 10/411 (2.4%) | 60/409 (14.7%) |
| Delivery | ||
| Postpartum 3 | 26/411 (6.3%) | 146/409 (35.7%) |
| Postpartum 6 | 17/411 (4.1%) | 173/409 (42.3%) |
| Subtotal from 0 to postpartum 6 | 249/2055 (12.11%) | 758/2045 (37.1%) |
| Postpartum 9 + months | 16/1233 (1.3%) | 289/1636 (17.7%) |
| Total from 0 to 24 months | 265/3288 (8.1%) | 1047/3681 (28.4%) |
| Either POC for intervention group or SOC for control group VL test returned to participant/caregiver, and within 24 hours of blood draw b | ||
| 0 months | 391/409 (95.6%), 334/409 (81.7%) | Data not available |
| 3 months | 131/143 (91.6%), 106/143 (74.1%) | Data not available |
| 6 months | 19/23 (82.6%), 16/23 (69.6%) | Data not available |
| Delivery | 281/309 (91.0%), 245/309 (79.3%) | Data not available |
| Postpartum 3 | 192/206 (93.2%), 156/206 (75.7%) | Data not available |
| Postpartum 6 | 291/301(96.7%), 93/301 (30.9%) | Data not available |
| Subtotal from 0 to postpartum 6 | 1305/1391 (93.8%), 494/816 (60.5%) | Data not available |
| Postpartum 9 + months | 28/28 (100%), 15/26 (57.7%) | Data not available |
| Total from 0 to 24 months | 1333/1419 (94%), 509/842 (60.5%) | Data not available |
| POC VL test returned to participant, and within 24 hours of blood draw | ||
| 0 months | 391/409 (95.6%), 334/409 (81.7%) | |
| 3 months | 131/143 (91.6%), 106/143 (74.1%) | |
| 6 months | 19/23 (82.6%), 16/23 (69.6%) | |
| Delivery | 281/309 (91.0%), 245/309 (79.3%) | 10/16 (62.5%), 9/16 (56.3%) |
| Postpartum 3 | 192/206 (93.2%), 156/206 (75.7%) | |
| Postpartum 6 | 291/301 (96.7%), 93/301 (30.9%) | 237/255 (93.0%), 189/255 (74.1%) |
| Subtotal from 0 to postpartum 6 | 1305/1391 (93.8%), 494/816 (60.5%) | 247/271 (91.1%), 198/205 (96.6%) |
| Postpartum 9+ | 28/28 (100%), 15/26 (57.7%) | |
| Total from 0 to 24 months | 1333/1419 (94%), 509/842 (60.5%) | 247/271 (91.1%), 198/205 (96.6%) |
| Either POC or SOC VL test returned to provider, and within 24 hours of blood draw c | ||
| 0 months | 391/409 (95.6%), 331/391 (84.7%) | 268/268 (100%) |
| 3 months | 132/143 (92.3%), 107/132 (81.1%) | 111/111 (100%) |
| 6 months | 19/23 (82.6%), 16/19 (84.2%) | 60/60 (100%) |
| Delivery | 281/309 (90.1%), 242/281 (86.1%) | |
| Postpartum 3 | 192/206 (93.2%), 153/192 (79.7%) | 146/146 (100%) |
| Postpartum 6 | 291/301 (96.7%), 93/291 (32.0%) d | 173/173 (100%) |
| Subtotal from 0 to postpartum 6 | 1306/1391 (93.9%), 942/1306 (72.1%) | 758/758 (100%) |
| Postpartum 9 + months | 28/ 28 (100%), 15/28 (53.6%) | 289/289 (100%) |
| Total from 0 to 24 months | 1334/1419 (94%), 957/1334 (71.7%) | 1047/1047 (100%) |
| Number of POC VL test returned to provider, and within 24 hours of blood draw | ||
| 0 months | 391/409 (95.6%), 331/391 (84.7%) | |
| 3 months | 132/143 (92.3%), 107/132 (81.1%) | |
| 6 months | 19/23 (82.6%), 16/19 (84.2%) | |
| Delivery | 281/309 (90.1%), 242/281 (86.1%) | 10/16 (62.5%), 9/10 (90.0%) |
| Postpartum 3 | 192/206 (93.2%), 153/192 (79.7%) | |
| Postpartum 6 | 291/301 (96.7%), 93/291 (32.0%) d | 237/255 (93.0%), 184/237 (77.6%) |
| Subtotal from 0 to postpartum 6 | 1306/1391 (93.9%), 942/1306 (72.1%) | 247/271 (91.1%), 193/247 (78.1%) |
| Postpartum 9 + months | 28/ 28 (100%), 15/28 (53.6%) | |
| Total from 0 to 24 months | 1334/1419 (94%), 957/1334 (71.7%) | 247/271 (91.1%), 193/247 (78.1%) |
| Median (IQR) turnaround time in days for VL requested (from sample collection to result return to provider), by POC VL testing for intervention group and SOC VL testing for control group | 1 (1, 4) | 7 (5, 9) |
| Number of VL tests from enrolment to 6 months postpartum (POC VL for intervention group, SOC VL for control group) | ||
| At least one | 406 (98.8%) | 393 (96.1%) |
| At least two | 358 (87.1%) | 351 (85.8%) |
| Median (IQR) | 4 (2, 5) | 3 (2, 3) |
| Number of VL tests from enrolment to delivery (POC VL for intervention group, SOC VL for control group) | ||
| At least one | 401 (97.6%) | 369 (90.2%) |
| At least two | 305 (74.3%) | 187 (45.7%) |
| Median (IQR) | 2 (2, 3) | 2 (1, 2) |
| Number of VL tests from delivery to 6 months postpartum (POC VL for intervention group, SOC VL for control group) | ||
| At least one | 343 (83.5%) | 355 (86.8%) |
| At least two | 238 (58.0%) | 183 (44.7%) |
| Median (IQR) | 2 (1, 3) | 2 (1, 2) |
Abbreviations: IQR, interquartile range; PI, protease inhibitor; POC, point‐of‐care; SOC, standard‐of‐care; VL, viral load.
a
We define participants attending the study visit as those completing study questionnaires, though not necessarily in‐person, among those expected to attend the study visit (i.e. retention in study).
b
VL tests were considered to have been conducted if a sample was collected for testing and sent for VL testing.
c
Because VL test results are only tracked by results released to the local laboratory in the Kenya Ministry of Health's NASCOP HIV VL database, we are not able to track how many VL tests were requested versus those finally resulted. Thus, the results returned are 100% for SOC.
d
Of note, our study encountered a 3‐month delay in being able to test our study samples via POC VL testing due to the global reagent shortages experienced during the COVID‐19 pandemic.