Heffron Renee, Muwonge Timothy R, Thomas Katherine K, Nambi Florence, Nakabugo Lylianne, Kibuuka Joseph, Thomas Dorothy, Feutz Erika, Meisner Allison, Ware Norma C, Wyatt Monique A, Simoni Jane M, Katz Ingrid T, Kadama Herbert, Baeten Jared M, Mujugira Andrew
University of Washington, 325 Ninth Avenue, Box 359927 Seattle, Washington, USA.
University of Alabama Birmingham, Birmingham, Alabama, USA.
EClinicalMedicine. 2022 Aug 11;52:101611. doi: 10.1016/j.eclinm.2022.101611. eCollection 2022 Oct.
Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program.
Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128.
From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses.
Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV.
National Institute of Mental Health (R01MH110296).
全球范围内扩大艾滋病毒暴露前预防（PrEP）服务，包括为艾滋病毒阴性者提供服务，这些服务是与艾滋病毒感染者（血清学不同的伴侣）合作开展的。需要有关艾滋病毒相关结果的数据，包括PrEP的接受情况和依从性以及抗逆转录病毒治疗（ART），以描述将PrEP纳入现有艾滋病毒项目的影响。
采用阶梯式楔形整群随机试验设计，我们通过将PrEP纳入现有的艾滋病毒感染者ART项目，在乌干达为血清学不同伴侣中的艾滋病毒阴性成员提供PrEP服务。该项目为ART提供者提供PrEP培训、持续的技术援助以及PrEP药物的临时供应链机制。通过对在ART诊所依次登记的艾滋病毒血清学不同伴侣的医疗记录进行数据提取，收集了关于PrEP起始、PrEP再填充、ART起始以及6个月时（在42 - 270天测量）艾滋病毒病毒血症的主要数据。在控制时间和群组的情况下，使用修正的泊松回归模型比较了PrEP项目启动前后的病毒抑制情况（<1000拷贝/毫升）。该试验已在ClinicalTrials.gov注册，注册号为NCT03586128。
从2018年6月1日至2020年12月15日，乌干达坎帕拉和瓦基索的12个ART诊所共纳入了1381对艾滋病毒血清学不同的伴侣，其中PrEP服务启动前纳入730对，启动后纳入651对。在基线期，99.4%的艾滋病毒感染伴侣启动了ART，6个月时85.0%的人病毒得到抑制。在PrEP启动后纳入的艾滋病毒阴性伴侣中，81.0%（527/651）在登记后90天内启动了PrEP；在这527人中，6个月后11.2%的人寻求再填充。在我们有统计学效力的意向性分析中，艾滋病毒感染伴侣中分别有82.1%和76.7%的人病毒得到抑制，这在统计学上没有显著差异（RR = 0.94，95%CI：0.82 - 1.07），并且在敏感性分析中保持稳定。
将PrEP纳入ART诊所覆盖了很大比例的血清学不同关系中的人群，并且并没有提高艾滋病毒感染伴侣中本已很高的艾滋病毒病毒抑制率。
国家心理健康研究所（R01MH110296）。
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