Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial

Patel, Rena C; Oyaro, Patrick; Thomas, Katherine; Wagude, James; Mukui, Irene; Brown, Evelyn; Hassan, Shukri A; Kinywa, Eunice; Oluoch, Frederick; Odhiambo, Francesca; Oyaro, Boaz; Kingwara, Leonard; Karauki, Enericah; Yongo, Nashon; Otieno, Lindah; John‐Stewart, Grace; Abuogi, Lisa

doi:10.1016/s2352-4642(22)00191-2

Cited by 13 publications

(18 citation statements)

References 24 publications

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“…Nationally, suboptimal viral suppression was partially due to the large proportion of children still on NVP or EFV based regimens, known to be associated with high primary resistance [ 39 ], while transition to the newly approved regimen containing LPV/r or Dolutegravir (DTG) started later. However, infants in our cohort were not on NVP based regimen but on LPV/r, and the results of the resistance test imply that the low suppression rate we found cannot be attributed to primary drug resistance to NVP nor to LPV/r [ 40 , 41 ].…”

Section: Discussionmentioning

confidence: 99%

Viral Response among Early Treated HIV Perinatally Infected Infants: Description of a Cohort in Southern Mozambique

et al. 2022

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Early initiation of antiretroviral therapy and adherence to achieve viral load suppression (VLS) are crucial for reducing morbidity and mortality of perinatally HIV-infected infants. In this descriptive cohort study of 39 HIV perinatally infected infants, who started treatment at one month of life in Mozambique, we aimed to describe the viral response over 2 years of follow up. VLS ≤ 400 copies/mL, sustained VLS and viral rebound were described using a Kaplan–Meier estimator. Antiretroviral drug transmitted resistance was assessed for a sub-group of non-VLS infants. In total, 61% of infants reached VLS, and 50% had a rebound. Cumulative probability of VLS was 36%, 51%, and 69% at 6, 12 and 24 months of treatment, respectively. The median duration of VLS was 7.4 months (IQR 12.6) and the cumulative probability of rebound at 6 months was 30%. Two infants had resistance biomarkers to drugs included in their treatment regimen. Our findings point to a low rate of VLS and high rate of viral rebound. More frequent viral response monitoring is advisable to identify infants with rebound and offer timely adherence support. It is urgent to tailor the psychosocial support model of care to this specific age group and offer differentiated service delivery to mother–baby pairs.

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Section: Discussionmentioning

confidence: 99%

Viral Response among Early Treated HIV Perinatally Infected Infants: Description of a Cohort in Southern Mozambique

et al. 2022

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“…These factors would be essential to consider in the scale-up of POC VL testing but are also applicable to centralized VL testing. For example, patients/caregivers in our study reported 200 Kenyan Shillings (approximately $1.85) or less, admittedly only a fraction of the estimated $25 to $30 cost per test, to be a reasonable expense they would be willing to pay out-of-pocket for POC VL testing [ 21 , 22 ]. The fact that patients/caregivers were willing to pay money for the possibility of receiving results sooner signals the value of POC VL testing to them.…”

Section: Discussionmentioning

confidence: 99%

“…Opt4Kids was an open-label trial that examined the impact of POC VL testing in combination with targeted drug resistance (DRM) testing and clinical decision guidance on VS among children living with HIV (CLHIV) on ART [ 22 , 28 ]. The study recruited 704 children aged 1–14 years in five high-volume HIV treatment centers in Kisumu, Kenya, and followed them for the next 12 months.…”

Section: Methodsmentioning

confidence: 99%

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“After viral load testing, I get my results so I get to know which path my life is taking me”: qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies

Qian

Hassan

Scallon

et al. 2022

BMC Health Serv Res

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Background Viral suppression (VS) is a marker of effective HIV therapy, and viral load (VL) testing is critical for treatment monitoring, especially in high-risk groups such as children and pregnant/postpartum women. Although routine VL testing, via centralized laboratory networks, was implemented in Kenya starting in 2014, optimization and sustainable scale up of VL testing are still needed. Methods We conducted a mixed methods study to evaluate the impact of higher frequency, point-of-care (POC) VL testing in optimizing VS among children and pregnant/postpartum women on antiretroviral treatment (ART) in five HIV treatment facilities in western Kenya in the Opt4Kids and Opt4Mamas studies. We conducted 68 key informant interviews (KIIs) from December 2019 to December 2020 with children and pregnant women living with HIV, child caregivers, providers, laboratory/facility leadership, and county- or national-level policymakers. Our KII guide covered the following domains: (1) barriers and facilitators to ART use and VS, (2) literacy and experiences with VL in routine care and via study, and (3) opinions on how to scale up VL testing for optimal programmatic use. We used inductive coding and thematic analysis to identify dominant themes with convergent and divergent subthemes. Results Three main themes regarding VL testing emerged from our analysis. (1) Key informants uniformly contrasted POC VL testing’s faster results turnaround, higher accessibility, and likely cost-effectiveness against centralized VL testing. (2) Key informants also identified areas of improvement for POC VL testing in Kenya, such as quality control, human resource and infrastructure capacity, supply chain management, and integration of VL testing systems. (3) To enable successful scale-up of VL testing, key informants proposed expanding the POC VL testing scheme, electronic medical records systems, conducting quality checks locally, capacity building and developing strong partnerships between key stakeholders. Conclusion The more accessible, decentralized model of POC VL testing was deemed capable of overcoming critical challenges associated with centralized VL testing and was considered highly desirable for optimizing VS for children and pregnant/postpartum women living with HIV. While POC VL testing has the potential to improve VS rates among these populations, additional research is needed to develop strategies for ensuring the sustainability of POC VL testing programs. Trial registration NCT03820323, 29/01/2019

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“…To date, 2 point-of-care assays have been approved as accurate by the WHO for use in LMICs 13,14 and have been evaluated in our setting. 15,16 Clinical trials of these assays among children, 17 adolescents, 18 and adults [19][20][21] have demonstrated shorter turnaround times, but effects on clinical outcomes have been mixed.…”

Section: Introductionmentioning

confidence: 99%

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

Dorward

Sookrajh

Lessells

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Data are required regarding the feasibility of conducting a randomized trial of point-of-care viral load (VL) testing to guide management of HIV viremia and to provide estimates of effect to guide potential future trial design. Setting: Two public South African clinics during the dolutegravir-based antiretroviral therapy (ART) rollout. Methods: We randomized adults receiving first-line ART, with recent VL ≥1000 copies/mL, in a 1:1 ratio to receive point-of-care Xpert HIV-1 VL versus standard-of-care laboratory VL testing after 12 weeks. Feasibility outcomes included proportions of eligible patients enrolled and completing follow-up and VL process outcomes. Estimates of effect were assessed using the trial primary outcome of VL <50 copies/mL after 24 weeks. Results: From August 2020 to March 2022, we enrolled 80 eligible participants, an estimated 24% of those eligible. 47 of 80 (58.8%) were women, and the median age was 38.5 years (interquartile range [IQR], 33–45). 44 of 80 (55.0%) were receiving dolutegravir, and 36 of 80 (465.0%) were receiving efavirenz. After 12 weeks, point-of-care participants received VL results after median 3.1 hours (IQR 2.6–3.8), versus 7 days (IQR 6–8, P < 0.001) in standard of care. Twelve-week follow-up VL was ≥1000 copies/mL in 13 of 39 (33.3%) point-of-care participants and in 16 of 41 (39.0%) standard-of-care participants; 11 of 13 (84.6%) and 12 of 16 (75.0%) switched to second-line ART. After 24 weeks, 76 of 80 (95.0%) completed follow-up. 27 of 39 (69.2% [95% CI: 53.4 to 81.4]) point-of-care participants achieved VL <50 copies/mL versus 29 of 40 (72.5% [57.0 to 83.9]) standard-of-care participants. Point-of-care participants had median 3 (IQR, 3–4) clinical visits versus 4 (IQR, 4–5) in standard-of-care participants (P < 0.001). Conclusions: It was feasible to conduct a trial of point-of-care VL testing to manage viremia. Point-of-care VL lead to quicker results and fewer clinical visits, but estimates of 24-week VL suppression were similar between arms. Trial Registration: Pan African Clinical Trials Registry: PACTR202001785886049.

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Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial

Cited by 13 publications

References 24 publications

Viral Response among Early Treated HIV Perinatally Infected Infants: Description of a Cohort in Southern Mozambique

Viral Response among Early Treated HIV Perinatally Infected Infants: Description of a Cohort in Southern Mozambique

“After viral load testing, I get my results so I get to know which path my life is taking me”: qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

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