Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study.
Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study.
复制标题
DOI：
10.1136/bmjopen-2020-047443
复制
发表时间：
2021-04-24
期刊：
影响因子：
2.9
通讯作者：
Anastos K
中科院分区：
文献类型：
--
作者：
Ross J;Murenzi G;Hill S;Remera E;Ingabire C;Umwiza F;Munyaneza A;Muhoza B;Habimana DS;Mugwaneza P;Zhang C;Yotebieng M;Anastos K
目前的艾滋病毒指南建议采用差别化服务提供模式，减少临床稳定的艾滋病毒感染者前往保健中心的次数。新诊断的艾滋病毒感染者在治疗过程的早期可能需要更多的重症监护，但频繁的预约可能会给患者和卫生系统带来负担。确定用于定义临床稳定性的最佳参数并过渡到较低频率的预约可以减少患者负担和卫生系统成本。本初步研究的目的是探索（1）将开始抗逆转录病毒治疗（ART）后至DSD的时间从12个月缩短至6个月，以及（2）将进入DSD所需的抑制病毒载量从2个减少至1个的可行性和可接受性。本研究是在卢旺达基加利的三家医疗机构进行的一项试点非盲试验。目前的卢旺达指南要求艾滋病毒感染者接受抗逆转录病毒治疗≥12个月，连续两次抑制病毒载量，以便过渡到频率较低的预约。我们将90名参与者随机分为三组：在一次抑制病毒载量后6个月进入DSD（n=30），在两次抑制病毒载量后6个月进入DSD（n=30）或当前标准治疗（n=30）。我们将衡量这种干预的可行性和可接受性;临床结局包括12个月时的病毒抑制（主要结局）和预约出勤率（次要结局）。这项临床试验得到了阿尔伯特·爱因斯坦医学院机构审查委员会和卢旺达国家伦理委员会的批准。调查结果将通过会议和同行审查的出版物以及与利益攸关方举行的会议传播。NCT 04567693。
Current HIV guidelines recommend differentiated service delivery (DSD) models that allow for fewer health centre visits for clinically stable people living with HIV (PLHIV). Newly diagnosed PLHIV may require more intensive care early in their treatment course, yet frequent appointments can be burdensome to patients and health systems. Determining the optimal parameters for defining clinical stability and transitioning to less frequent appointments could decrease patient burden and health system costs. The objectives of this pilot study are to explore the feasibility and acceptability of (1) reducing the time to DSD from 12 to 6 months after antiretroviral therapy (ART) initiation, and (2) reducing the number of suppressed viral loads required to enter DSD from two to one. The present study is a pilot, unblinded trial taking place in three health facilities in Kigali, Rwanda. Current Rwandan guidelines require PLHIV to be on ART for ≥12 months with two consecutive suppressed viral loads in order to transition to less frequent appointments. We will randomise 90 participants to one of three arms: entry into DSD at 6 months after one suppressed viral load (n=30), entry into DSD at 6 months after two suppressed viral loads (n=30) or current standard of care (n=30). We will measure feasibility and acceptability of this intervention; clinical outcomes include viral suppression at 12 months (primary outcome) and appointment attendance (secondary outcome). This clinical trial was approved by the institutional review board of Albert Einstein College of Medicine and by the Rwanda National Ethics Committee. Findings will be disseminated through conferences and peer-reviewed publications, as well as meetings with stakeholders. NCT04567693.
登录
查看更多内容
影响因子：
6
作者：
Wringe, Alison;Cawley, Caoimhe;Nicholas, Sarala
通讯作者：
Nicholas, Sarala
影响因子：
4.5
作者：
van Hout, Ben;Janssen, M. F.;Pickard, A. Simon
通讯作者：
Pickard, A. Simon
影响因子：
6
作者：
Long L;Kuchukhidze S;Pascoe S;Nichols BE;Fox MP;Cele R;Govathson C;Huber AN;Flynn D;Rosen S
通讯作者：
Rosen S
影响因子：
4.4
作者：
Parcesepe A;Tymejczyk O;Remien R;Gadisa T;Kulkarni SG;Hoffman S;Melaku Z;Elul B;Nash D
通讯作者：
Nash D
DOI：
10.1097/qai.0000000000002195
发表时间：
2019-12-01
影响因子：
3.6
作者：
Roberts, D. Allen;Tan, Nicholas;Barnabas, Ruanne V.
通讯作者：
Barnabas, Ruanne V.