Ekwunife Obinna Ikechukwu, Anetoh Maureen Ugonwa, Kalu Stephen Okorafor, Ele Prince Udegbunam, Egbewale Bolaji Emmanuel, Eleje George Uchenna
Department of Clinical Pharmacy and Pharmacy Management, Nnamdi Azikiwe University, Awka, Nigeria.
Virology Laboratory, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.
Contemp Clin Trials Commun. 2022 Sep 15;30:100997. doi: 10.1016/j.conctc.2022.100997. eCollection 2022 Dec.
Adolescents living with HIV (ALHIV) have had worse outcomes compared to adults. They face enormous difficulty in accessing HIV care services. We hypothesize that conditional economic incentives (CEI) and motivational interviewing could increase retention in care, medication adherence and ultimately viral load suppression. Therefore, we evaluated the one-year impact of conditional economic incentives and motivational interviewing on the health outcomes of ALHIV in Anambra State, Nigeria.
Using a cluster-randomised design, we examined the one-year (from December 1, 2018, to November 30, 2019), individual-level impact of an Incentive Scheme comprising conditional economic incentives and motivational interviewing on achieving undetectable viral load (primary outcome), CD4 count, adherence to antiretroviral therapy and retention in care (secondary outcomes) by ALHIV in Anambra State, Nigeria. Twelve HIV treatment hospitals were stratified according to the type of clinic (secondary or tertiary) and randomly assigned to the intervention arm or control arm to receive the Incentive Scheme or routine care, respectively. ALHIV aged 10-19 years, initiated into HIV care for a minimum of 6 months, and who adhered poorly to medications (<100% adherence rate) were eligible for the study. Participants in the intervention arm received motivational interviewing at the study baseline and every visit. They also received US$5.6 when HIV viral load (VL) was <20 copies/mL at month 3, US$2.8 if the VL remained suppressed at months 6 and 9, and US$5.6 if the VL remained <20 copies/mL at month 12.
Of the 246 trial participants, 119 were in the intervention while 127 were in the control arm. There was no difference in the baseline characteristics of the participants between the intervention and control arm except for the number of participants with undetectable viral load and the number of participants with ≥95% adherence. Although participants in the intervention arm had a 10.1% increase while those in the control arm had a 1.6% decrease in proportion with undetectable viral load (≤20 copies/ml) after 12 months, the change in the primary outcome was not statistically significant. Similarly, the differences in the secondary outcomes were not statistically significant.
The Incentive Scheme did not improve the virologic outcome of ALHIV after 12 months. Differences in the secondary outcomes after 12 months were also not significantly different from the baseline.
We registered the trial retrospectively with The Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/(PACTR201806003040425) on 2/2/2018.
与成年人相比，感染艾滋病毒的青少年（ALHIV）的治疗效果更差。他们在获得艾滋病毒护理服务方面面临巨大困难。我们假设，有条件经济激励措施（CEI）和动机性访谈可以提高护理留存率、药物依从性，并最终实现病毒载量抑制。因此，我们评估了有条件经济激励措施和动机性访谈对尼日利亚阿南布拉州ALHIV健康结局的一年影响。
采用整群随机设计，我们研究了一项激励计划（包括有条件经济激励措施和动机性访谈）对尼日利亚阿南布拉州ALHIV实现不可检测病毒载量（主要结局）、CD4细胞计数、抗逆转录病毒疗法依从性和护理留存率（次要结局）的一年（从2018年12月1日至2019年11月30日）个体水平影响。12家艾滋病毒治疗医院根据诊所类型（二级或三级）进行分层，并随机分配到干预组或对照组，分别接受激励计划或常规护理。年龄在10 - 19岁、开始接受艾滋病毒护理至少6个月且药物依从性差（依从率<100%）的ALHIV符合研究条件。干预组的参与者在研究基线和每次就诊时接受动机性访谈。当第3个月艾滋病毒病毒载量（VL）<20拷贝/毫升时，他们还会获得5.6美元；如果第6个月和第9个月病毒载量仍被抑制，则获得2.8美元；如果第12个月病毒载量仍<20拷贝/毫升，则获得5.6美元。
在246名试验参与者中，119名在干预组，127名在对照组。除了病毒载量不可检测的参与者数量和依从性≥95%的参与者数量外，干预组和对照组参与者的基线特征没有差异。尽管干预组参与者在12个月后病毒载量不可检测（≤20拷贝/毫升）的比例增加了10.1%，而对照组参与者的这一比例下降了1.6%，但主要结局的变化在统计学上并不显著。同样，次要结局方面的差异在统计学上也不显著。
激励计划在12个月后并未改善ALHIV的病毒学结局。12个月后次要结局的差异与基线相比也没有显著差异。
我们于2018年2月2日在泛非临床试验注册中心（https://pactr.samrc.ac.za/(PACTR201806003040425)）对该试验进行了回顾性注册。
