Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial.
<h4>Background</h4>In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rat...
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Public Library of Science (PLoS)
2023-01-01
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| author | Vinie Kouamou Rhoderick Machekano Tichaona Mapangisana Caroline Maposhere Reggie Mutetwa Justen Manasa Tinei Shamu Kathy McCarty Shungu Munyati Junior Mutsvangwa Mampedi Bogoshi Dennis Israelski David Katzenstein |
| author_facet | Vinie Kouamou Rhoderick Machekano Tichaona Mapangisana Caroline Maposhere Reggie Mutetwa Justen Manasa Tinei Shamu Kathy McCarty Shungu Munyati Junior Mutsvangwa Mampedi Bogoshi Dennis Israelski David Katzenstein |
| author_sort | Vinie Kouamou |
| collection | DOAJ |
| description | <h4>Background</h4>In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.<h4>Methods</h4>The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.<h4>Results</h4>Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.<h4>Conclusion</h4>In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH. |
| format | Article |
| id | doaj-art-e19469a1fc8848c5a5b09bdca143439e |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2023-01-01 |
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| spelling | doaj-art-e19469a1fc8848c5a5b09bdca143439e2025-08-20T03:51:24ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01182e028127910.1371/journal.pone.0281279Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial.Vinie KouamouRhoderick MachekanoTichaona MapangisanaCaroline MaposhereReggie MutetwaJusten ManasaTinei ShamuKathy McCartyShungu MunyatiJunior MutsvangwaMampedi BogoshiDennis IsraelskiDavid Katzenstein<h4>Background</h4>In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.<h4>Methods</h4>The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.<h4>Results</h4>Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.<h4>Conclusion</h4>In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0281279&type=printable |
| spellingShingle | Vinie Kouamou Rhoderick Machekano Tichaona Mapangisana Caroline Maposhere Reggie Mutetwa Justen Manasa Tinei Shamu Kathy McCarty Shungu Munyati Junior Mutsvangwa Mampedi Bogoshi Dennis Israelski David Katzenstein Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. PLoS ONE |
| title | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. |
| title_full | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. |
| title_fullStr | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. |
| title_full_unstemmed | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. |
| title_short | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. |
| title_sort | clinic based samba ii vs centralized laboratory viral load assays among hiv 1 infected children adolescents and young adults in rural zimbabwe a randomized controlled trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0281279&type=printable |
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