Department of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.
PLoS One. 2024 Nov 19;19(11):e0308923. doi: 10.1371/journal.pone.0308923. eCollection 2024.
In people living with HIV, adherence to antiretroviral therapy (ART) is essential for achieving and sustaining viral suppression and reducing mortality. In young people living with HIV, ART adherence and retention remain a challenge with unsatisfactory viral suppression rates despite facility-based intensive adherence counseling that is the standard of care. Few studies have evaluated mHealth adherence interventions among young people living with HIV in resource-limited settings.
This was a randomized parallel trial. Young people aged between15-24 living with HIV, initiating ART, or on ART for not more than 6 months at three ART clinics were recruited and randomized to a ratio of 1:1 to either standard of care or the intervention "Call for Life-Interactive Voice Response" with standard of care, between 12th August 2020 and 1st June 2022. The intervention is mobile technology-based software, that has interactive voice response functionalities, with a web-based interface, that allows interaction through the use of voice and tones via a dial pad. The primary outcome was viral suppression defined as HIV RNA below 1,000 copies per mL at 12 months with retention in care and viral suppression at month 6 as a secondary outcome. Descriptive statistics were used for participant characteristics. Primary outcomes and factors associated with viral load failure were assessed using the log-binomial model. All calculations were done using statistical software release 16.0.
A total of 206 participants were recruited and randomized; the mean age was 22.5(SD±1.9) years and 81% (167/206) were female. The intervention had 78.6% (81/103), females, while the standard of care had 83.5% (86/103). Viral suppression at 12 months in the intervention arm was 73.6% (67/91) versus 51.9% (40/77) in the standard of care arm, p=0.01. Retention in care was 88.4% (91/103) in the intervention vs. 74.7% (77/103) in the standard of care arm p=0.01.
This is the first study in Uganda to demonstrate that mHealth has the potential to improve medication adherence and retention in care among youth living with HIV in Uganda.
NCT04718974 Registry: clinical Trials.gov.
在感染艾滋病毒的人群中，坚持接受抗逆转录病毒治疗（ART）对于实现并维持病毒抑制以及降低死亡率至关重要。尽管提供了以机构为基础的强化依从性咨询作为标准护理，但在感染艾滋病毒的年轻人中，ART 依从性和保留仍然是一个挑战，导致病毒抑制率并不理想。在资源有限的环境中，很少有研究评估过移动医疗依从性干预措施在感染艾滋病毒的年轻人中的应用。
这是一项随机平行试验。招募了年龄在 15-24 岁之间、新开始接受 ART 治疗或在三个 ART 诊所接受 ART 治疗不超过 6 个月的感染艾滋病毒的年轻人，并将他们按照 1:1 的比例随机分配至标准护理组或干预组“生命呼叫-交互式语音应答”，同时接受标准护理，招募和随机分配时间为 2020 年 8 月 12 日至 2022 年 6 月 1 日。该干预措施是一种基于移动技术的软件，具有交互式语音应答功能，并有一个基于网络的界面，允许通过拨号盘使用语音和音调进行交互。主要结局是 12 个月时 HIV RNA 低于 1000 拷贝/毫升的病毒抑制，次要结局是 6 个月时保留在护理中以及病毒抑制。采用描述性统计方法对参与者特征进行分析。采用对数二项式模型评估主要结局和与病毒载量失败相关的因素。所有计算均使用统计软件版本 16.0 进行。
共招募了 206 名参与者并进行了随机分组；平均年龄为 22.5（SD±1.9）岁，81%（167/206）为女性。干预组有 78.6%（81/103）为女性，而标准护理组有 83.5%（86/103）为女性。干预组在 12 个月时的病毒抑制率为 73.6%（67/91），而标准护理组为 51.9%（40/77），p=0.01。干预组的护理保留率为 88.4%（91/103），而标准护理组为 74.7%（77/103），p=0.01。
这是乌干达首例研究，证明移动医疗有可能改善乌干达感染艾滋病毒的年轻人的药物依从性和护理保留率。
NCT04718974 注册：clinicaltrials.gov。
