METHODS: Our pilot study was conducted in two Botswana HIV clinics between October 2021 and November 2022. Based on our formative work, we adopted three main strategies; Health worker training on HTN/cardiovascular disease (CVD) management, adaptation of HIV Electronic Health Record (EHR) for HTN/CVD care, and use of treatment partners to support PWH with hypertension for implementation. We employed the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to assess implementation effectiveness and outcomes for BP control at baseline, 6 and 12 months. HIV viral load (VL) suppression was also measured to assess impact of integration on HIV care.
RESULTS: We enrolled 290 participants; 35 (12.1%) were lost to follow-up, leaving 255 (87.9%) at 12-months. Median age was 54 years (IQR 46-62), and 77.2% were females. Our interventions significantly improved BP control to < 140/90 mmHg (or < 130/80 mmHg if diagnosis of diabetes or chronic kidney disease), from 137/290 participants, 47.2% at baseline to 206/290 participants, 71.0%, at 12 months (p < 0.001). Among targeted providers, 94.7% received training, with an associated significant increase in counseling on exercise, diet, and medication (all p < 0.001) but EHR use for BP medication prescribing and cardiovascular risk factor evaluation showed no adoption. In the intention-to-treat analysis, HIV VL suppression at 12 months decreased (85.5% vs 93.8%, p = 0.002) due to loss to follow-up but the per protocol analysis showed no difference in VL suppression between baseline and 12 months (97.3% vs 93.3%, p = 0.060).
CONCLUSIONS: The InterCARE pilot study demonstrated that low-cost practical support measures involving the integration of HIV and hypertension/CVD management could lead to improvements in BP control. These results support the need for a large implementation and effectiveness trial.
BACKGROUND: ClinicalTrials.gov NCT05414526. Registered 18th May 2022.
方法:我们的试点研究于2021年10月至2022年11月在博茨瓦纳的两家HIV诊所进行。根据我们的形成工作,我们采取了三种主要策略;卫生工作者对HTN/心血管疾病(CVD)管理的培训,将HIV电子健康记录(EHR)用于HTN/CVD护理,并使用治疗伙伴支持PWH合并高血压的实施。我们雇佣了Reach,有效性,收养,实施,维护(RE-AIM)框架,以评估基线BP控制的实施有效性和结果,6和12个月。还测量了HIV病毒载量(VL)抑制,以评估整合对HIV护理的影响。
结果:我们招募了290名参与者;35名(12.1%)失去随访,在12个月时留下255人(87.9%)。中位年龄为54岁(IQR46-62),77.2%为女性。我们的干预措施显着改善了血压控制<140/90mmHg(如果诊断为糖尿病或慢性肾脏疾病,则<130/80mmHg),来自137/290名参与者,206/290名参与者的基线为47.2%,71.0%,12个月时(p<0.001)。在目标提供商中,94.7%接受过培训,随着运动咨询的显著增加,饮食,和药物(均p<0.001),但用于BP药物处方和心血管危险因素评估的EHR未显示采用。在意向治疗分析中,12个月时的HIVVL抑制下降(85.5%vs93.8%,p=0.002)由于随访失败,但每个方案分析显示基线和12个月之间的VL抑制没有差异(97.3%vs93.3%,p=0.060)。
结论:InterCARE试点研究表明,涉及整合HIV和高血压/CVD管理的低成本实际支持措施可以改善BP控制。这些结果支持需要进行大规模的实施和有效性试验。
背景:ClinicalTrials.govNCT05414526。2022年5月18日注册。