Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Provincial Government of the Western Cape, Cape Town, South Africa.
PLoS One. 2022 Nov 15;17(11):e0277018. doi: 10.1371/journal.pone.0277018. eCollection 2022.
Differentiated service delivery (DSD) models are recommended for stable people living with HIV on antiretroviral therapy (ART) but there are few rigorous evaluations of patient outcomes.
Adherence clubs (ACs) are a form of DSD run by community health workers at community venues with 2-4 monthly ART refills and annual nurse assessments). Clinic-based care involves 2-monthly ART refills and 4-monthly nurse/doctor assessments. We compared virologic outcomes in stable adults randomised to ACs at four months post-ART initiation to those randomised to primary health care (PHC) ART clinics through 12 months on ART in Cape Town, South Africa (NCT03199027). We hypothesised that adults randomised to ACs would be more likely to be virally suppressed at 12 months post-ART initiation, versus adults randomised to continued PHC care. We enrolled consecutive adults on ART for 3-5 months who met local DSD ['adherence clubs' (AC)] eligibility (clinically stable, VL<400 copies/mL). The primary outcome was VL<400 copies/mL at 12 months on ART.
Between January 2017 and April 2018, 220 adults were randomised (mean age 35 years; 67% female; median ART duration 18 weeks); 85% and 94% of participants randomised to ACs and PHCs attended their first service visit on schedule respectively. By 12 months on ART, 91% and 93% randomised to ACs and PHCs had a VL<400 copies/mL, respectively. In a binomial model adjusted for age, gender, previous ART use and nadir CD4 cell count, there was no evidence of superiority of ACs compared to clinic-based care (RD, -2.42%; 95% CI, -11.23 to 6.38). Findings were consistent when examining the outcome at a threshold of VL <1000 copies/mL.
Stable adults referred to DSDs at 4 months post-ART initiation had comparable virologic outcomes at 12 months on ART versus PHC clinics, with no evidence of superiority. Further research on long-term outcomes is required.
针对接受抗逆转录病毒疗法（ART）的稳定 HIV 感染者，推荐使用差异化服务提供（DSD）模式，但针对患者结局的严格评估很少。
参与式服药俱乐部（AC）是一种 DSD 形式，由社区卫生工作者在社区场所运作，提供每 2-4 个月一次的 ART 续药和每年一次的护士评估。诊所护理则提供每 2 个月一次的 ART 续药和每 4 个月一次的护士/医生评估。我们在南非开普敦比较了随机分配至 AC 的稳定成人在接受 ART 治疗 4 个月后的病毒学结局与随机分配至初级保健（PHC）ART 诊所的成人在接受 ART 治疗 12 个月后的病毒学结局（NCT03199027）。我们假设与继续接受 PHC 护理的成人相比，随机分配至 AC 的成人在接受 ART 治疗 12 个月后的病毒抑制率更高。我们纳入了在当地 DSD（“参与式服药俱乐部”（AC））标准下连续接受 ART 治疗 3-5 个月的连续成年患者（临床稳定，VL<400 拷贝/mL）。主要结局是在接受 ART 治疗 12 个月时 VL<400 拷贝/mL。
2017 年 1 月至 2018 年 4 月，220 名成年人被随机分配（平均年龄 35 岁；67%为女性；ART 治疗中位时长为 18 周）；随机分配至 AC 和 PHC 的参与者分别有 85%和 94%按时参加了他们的首次服务就诊。在接受 ART 治疗 12 个月时，分别有 91%和 93%随机分配至 AC 和 PHC 的参与者 VL<400 拷贝/mL。在调整年龄、性别、既往 ART 使用情况和最低 CD4 细胞计数后，在二项式模型中，AC 与诊所为基础的护理相比，没有证据表明其具有优越性（RD，-2.42%；95%CI，-11.23 至 6.38）。当以 VL<1000 拷贝/mL 为阈值检查结果时，结果也是一致的。
在接受 ART 治疗 4 个月后转诊至 DSD 的稳定成年人在接受 ART 治疗 12 个月时的病毒学结局与 PHC 诊所相当，且没有证据表明 DSD 具有优越性。需要进一步研究长期结局。
