Department of Internal Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, CT, United States of America.
Ikerbasque Research Foundation, Bilbao, Spain.
PLoS One. 2024 Nov 7;19(11):e0312165. doi: 10.1371/journal.pone.0312165. eCollection 2024.
Few evidence-based interventions have been widely adopted in common clinical settings, particularly for opioid-dependent people with HIV (PWH) seeking drug treatment. We developed a brief evidence-based intervention, Holistic Health for HIV (3H+), specifically for ease of implementation and integration within drug treatment settings. In this study, we compared 3H+ to the gold standard, Holistic Health Recovery Program (HHRP+) using a non-inferiority trial. Between 2012 and 2017, 106 participants were randomly assigned to either the brief 3H+ intervention or the gold standard HHRP+. HIV treatment (ART adherence, viral suppression) and risk behaviors (sharing injection equipment, condom use) were compared between the two arms at baseline, end-of-intervention (EOI-12 weeks) and at follow-up (24 weeks). Average treatment effect was calculated based on the difference-in-difference (DID) estimator and a non-parametric bootstrap was used to assess non-inferiority. At the 12-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to multiple outcomes: percent sharing syringes and needles (DID:1.4, 95%CI [-18.6,21.5], p<0.01) and attainment of high ART adherence (DID: 9.7, 95%CI: [-13.1, 32.2], p = 0.04). At the 24-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to percent sharing syringes and needles (DID: 8.9, [-10.1, 28.30], p = 0.04) and attainment of viral suppression (DID: 18.9, 95% CI:[-7.1, 42.0], p = 0.01). For other indicators, such as consistent condom use, the hypothesis test for non-inferiority was inconclusive at the 12-week EOI (DID: -20.2, 95%CI [-48.9-10.7], p = 0.51). For HIV treatment as prevention to be effective, PWH need to achieve viral suppression. In the absence of this success, they must reduce HIV risk behaviors. The finding that 3H+ was non-inferior to HHRP+ suggests that brief behavioral interventions can be deployed in real world settings to help more efficiently achieve Ending the HIV Epidemic goals.
在常见的临床环境中，很少有循证干预措施被广泛采用，特别是对于寻求药物治疗的感染艾滋病毒的阿片类药物依赖者（PWH）。我们开发了一种简短的循证干预措施，即艾滋病毒综合健康（3H+），专门用于便于在药物治疗环境中实施和整合。在这项研究中，我们使用非劣效性试验将 3H+与黄金标准的综合健康康复方案（HHRP+）进行了比较。在 2012 年至 2017 年间，106 名参与者被随机分配到简短的 3H+干预组或黄金标准的 HHRP+组。在基线、干预结束时（12 周）和随访（24 周）时，比较了两组之间的艾滋病毒治疗（ART 依从性、病毒抑制）和风险行为（共用注射器具、使用避孕套）。基于差异（DID）估计值计算平均治疗效果，并使用非参数引导法评估非劣效性。在 12 周的干预结束时，发现 3H+在多个结果方面与 HHRP+不劣效：共用注射器和针头的百分比（DID：1.4，95%CI[-18.6，21.5]，p<0.01）和实现高 ART 依从性（DID：9.7，95%CI：[-13.1，32.2]，p=0.04）。在 24 周的干预结束时，发现 3H+在共用注射器和针头的百分比（DID：8.9，[-10.1，28.30]，p=0.04）和实现病毒抑制方面与 HHRP+不劣效：达到病毒抑制（DID：18.9，95%CI：[-7.1，42.0]，p=0.01）。对于其他指标，如坚持使用避孕套，在 12 周的干预结束时，非劣效性假设检验不确定（DID：-20.2，95%CI[-48.9-10.7]，p=0.51）。为了使 HIV 治疗作为预防措施有效，PWH 需要实现病毒抑制。如果没有取得这一成功，他们必须减少艾滋病毒风险行为。发现 3H+与 HHRP+不劣效表明，简短的行为干预措施可以在现实环境中部署，以帮助更有效地实现终结艾滋病流行的目标。
