Albert Einstein College of Medicine, 3300 Kossuth Avenue, Bronx, NY, 10467, USA.
Division of HIV, STIs and Viral Hepatitis, Rwanda Biomedical Center, Kigali, Rwanda.
BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z.
BACKGROUND: Differentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH. METHODS: We conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression. RESULTS: Among 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41). CONCLUSIONS: The majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD. TRIAL REGISTRATION: Clinicaltrials.gov NCT04567693; first registered on September 28, 2020.
背景：针对艾滋病毒感染者（PLHIV）的差异化服务提供（DSD）项目将资格限定为已接受抗逆转录病毒治疗（ART）的患者，但对于新诊断的 PLHIV 接受 ART 治疗多长时间才能被视为已确立尚不确定。我们旨在确定新诊断的 PLHIV 在接受 ART 治疗后六个月即进入 DSD 的可行性、可接受性和初步影响。
方法：我们在卢旺达的三个卫生机构开展了一项试点随机对照试验。参与者被随机分配到以下三组：（1）在接受 ART 治疗后六个月，如果病毒载量得到一次抑制（DSD-1VL），则进入 DSD；（2）在接受 ART 治疗后六个月，如果病毒载量连续两次得到抑制（DSD-2VL），则进入 DSD；（3）常规治疗（TAU）。我们通过评估被分配到干预组的参与者中进入 DSD 的比例来评估可行性，通过患者调查和评估临床工作人员是否违反研究分配来评估可接受性，并通过比较各研究组在 12 个月时的病毒抑制情况来评估初步效果。
结果：在 90 名参与者中，31 名被随机分配到 DSD-1VL 组，31 名被随机分配到 DSD-2VL 组，28 名被随机分配到 TAU 组。在被随机分配到 DSD-1VL 或 DSD-2VL 的 62 名参与者中，有 37 名（60%）在 6 个月时进入 DSD，而有 21 名（34%）没有进入 DSD，因为他们的病毒载量未得到抑制。患者对临床（平均评分为 5 分制的 3.8 分）和非临床（平均评分为 4.1 分）护理元素的接受度均较高，且在不同研究组之间无显著差异。在 DSD-1VL、DSD-2VL 和 TAU 组中，12 个月时的病毒抑制率分别为 81%、81%和 68%（p=0.41）。
结论：大多数被随机分配到干预组的参与者进入了 DSD，并且与 TAU 相比，他们的病毒抑制率相似。结果表明，新诊断的 PLHIV 在接受 ART 治疗后六个月即可早期进入 DSD，这支持了世卫组织目前关于 DSD 的指南。
试验注册：Clinicaltrials.gov NCT04567693；首次注册于 2020 年 9 月 28 日。
J Int AIDS Soc. 2021-10
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