Izudi Jonathan, Castelnuovo Barbara, King Rachel, Cattamanchi Adithya
Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.
University of California Global Health Institute (UCGHI), University of California, San Francisco, San Francisco, CA, United States of America.
PLOS Glob Public Health. 2023 Aug 7;3(8):e0002240. doi: 10.1371/journal.pgph.0002240. eCollection 2023.
Intensive adherence counseling (IAC) is recommended for people living with HIV (PLHIV) with viral load (VL) ≥1,000 copies/ml after ≥6 months of anti-retroviral therapy (ART). We evaluated the effect of IAC on VL suppression and all-cause mortality among PLHIV on first-line ART with VL ≥1,000 copies/ml after ≥6 months of ART in Kampala, Uganda using regression discontinuity design, a quasi-experimental method for effect estimation when interventions depend on a cut-off. PLHIV just above VL ≥1,000 copies/ml cut-off who received ≥3 IAC sessions formed the intervention group while those just below the cut-off who received routine psychosocial support constituted the control group. Primary outcome was repeat VL suppression defined as VL <1,000 copies/ml approximately 9-12 months following initial VL assessment. Secondary outcome was all-cause mortality. We used logistic regression for causal-effect analysis, reported as odds ratio (OR) with a 95% confidence interval (CI). We performed sensitivity analyses to assess the robustness of findings to varying bandwidths at the cut-off. We found 3,735 PLHIV were started on ART between Nov 2020 and Nov 2021 of whom 3,199 were included in the analysis (3,085 control, 114 intervention). Within an optimal bandwidth, there were 236 participants (222 control, 14 intervention) with similar demographic and clinical characteristics. Repeat VL suppression was lower in the intervention than in the control group (85.7% versus 98.6%, p = 0.021) while all-cause mortality was similar (0% versus 0.5%, p = 1.000). In multivariable analysis, the odds of repeat VL suppression were 91% lower in the intervention than control group (OR = 0.09; 95% CI, 0.01-0.66). Findings are robust to varying bandwidths around the cut-off. We concluded IAC is ineffective in suppressing VL among PLHIV on first-line ART in Kampala, Uganda. Findings suggest a need to investigate the IAC implementation fidelity for successful translation in practice and the reasons for VL persistence beyond the suppression threshold.
对于接受抗逆转录病毒治疗（ART）≥6个月后病毒载量（VL）≥1000拷贝/毫升的艾滋病毒感染者（PLHIV），建议进行强化依从性咨询（IAC）。我们在乌干达坎帕拉，对接受一线ART且ART≥6个月后VL≥1000拷贝/毫升的PLHIV中，IAC对VL抑制和全因死亡率的影响进行了评估，采用回归间断设计，这是一种当干预取决于一个临界值时用于效应估计的准实验方法。VL刚高于≥1000拷贝/毫升临界值且接受≥3次IAC咨询的PLHIV构成干预组，而VL刚低于临界值且接受常规心理社会支持的PLHIV构成对照组。主要结局是重复VL抑制，定义为在首次VL评估后约9 - 12个月时VL <1000拷贝/毫升。次要结局是全因死亡率。我们使用逻辑回归进行因果效应分析，结果以比值比（OR）及95%置信区间（CI）表示。我们进行了敏感性分析，以评估在临界值处不同带宽下研究结果的稳健性。我们发现，在2020年11月至2021年11月期间，有3735名PLHIV开始接受ART治疗，其中3199名被纳入分析（3085名对照组，114名干预组）。在最佳带宽范围内，有236名参与者（222名对照组，14名干预组）具有相似的人口统计学和临床特征。干预组的重复VL抑制率低于对照组（85.7%对98.6%，p = 0.021），而全因死亡率相似（0%对0.5%，p = 1.000）。在多变量分析中，干预组重复VL抑制的几率比对照组低91%（OR = 0.09；95% CI，0.01 - 0.66）。研究结果在临界值附近不同带宽下具有稳健性。我们得出结论，在乌干达坎帕拉，IAC对接受一线ART的PLHIV抑制VL无效。研究结果表明，有必要调查IAC在实际应用中的实施保真度，以及VL持续高于抑制阈值的原因。
