Skalland Timothy M, de Dieu Tapsoba Jean, Zangeneh Sahar Z, Floyd Sian, Ayles Helen, Bock Peter, Fidler Sarah, Eshleman Susan H, Hayes Richard J, Donnell Deborah
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, 1100 Fairview Ave N, Mail Stop M2-C200, 206-667-118698109, Seattle, WA, USA.
Center for Official Statistics, RTI International, Research Triangle Park, USA.
AIDS Res Ther. 2025 Mar 7;22(1):30. doi: 10.1186/s12981-025-00720-0.
HPTN 071 (PopART) implemented a comprehensive HIV prevention package which aimed to reduce HIV incidence within 21 communities of Zambia and South Africa: Arm A, PopART intervention of universal HIV testing and treatment; Arm B, PopART intervention of universal HIV testing with ART provided according to local guidelines; and Arm C, standard of care. Analyses so far have not accounted for the sampling design of the enrolled cohort. We performed a sample-weighted re-analysis of the primary outcome of the PopART trial to derive a population-based estimate of the intervention effect.
Enrollment used a two-stage sampling design: household and adult participant within each household. We constructed post-stratification weights to match the age and sex distribution of the target population in these communities. Weighted Poisson regression was used to estimate community-level HIV incidence. The PopART intervention effect was estimated using log-transformed community-level incidence estimates in an ANCOVA model.
The analysis based on community-level incidence shows a 25% reduction in incidence for Arm B communities compared to standard of care (RR: 0.75, 95% CI: 0.56-1.02, p = 0.06) while Arm A communities show no difference in HIV incidence compared to standard of care (RR: 1.08, 95% CI: 0.81-1.46, p = 0.56).
Our re-analysis shows 25% reduction in HIV incidence comparing Arm B to Arm C communities. No effect was observed comparing Arm A communities to Arm C communities. These results align with the primary results of the PopART trial.
gov number, NCT01900977, HPTN 071 [PopArt].
HPTN 071(PopART)实施了一项全面的艾滋病预防方案,旨在降低赞比亚和南非21个社区的艾滋病发病率:A组,采用普及艾滋病检测和治疗的PopART干预措施;B组,采用普及艾滋病检测并根据当地指南提供抗逆转录病毒治疗的PopART干预措施;C组,采用标准治疗。到目前为止的分析尚未考虑入组队列的抽样设计。我们对PopART试验的主要结局进行了样本加权重新分析,以得出基于人群的干预效果估计值。
入组采用两阶段抽样设计:家庭以及每个家庭中的成年参与者。我们构建了后分层权重,以匹配这些社区中目标人群的年龄和性别分布。使用加权泊松回归来估计社区层面的艾滋病发病率。在协方差分析模型中,使用对数转换后的社区层面发病率估计值来估计PopART干预效果。
基于社区层面发病率的分析显示,与标准治疗相比,B组社区的发病率降低了25%(风险比:0.75,95%置信区间:0.56 - 1.02,p = 0.06),而与标准治疗相比,A组社区的艾滋病发病率没有差异(风险比:1.08,95%置信区间:0.81 - 1.46,p = 0.56)。
我们的重新分析显示,将B组社区与C组社区相比,艾滋病发病率降低了25%。将A组社区与C组社区相比,未观察到效果。这些结果与PopART试验的主要结果一致。
美国国立医学图书馆临床试验注册中心编号,NCT01900977,HPTN 071 [PopArt]