Medina-Marino Andrew, Sibanda Nkosiyapha, Putt Mary, Joseph Davey Dvora, Smith Phillip, Thirumurthy Harsha, Bekker Linda-Gail, Buttenheim Alison
Desmond Tutu HIV Centre, University of Cape Town.
University of Pennsylvania.
Res Sq. 2023 Oct 4:rs.3.rs-3349696. doi: 10.21203/rs.3.rs-3349696/v1.
Increasing HIV testing and treatment coverage among people living with HIV (PLHIV) is essential for achieving global AIDS epidemic control. However, compared to women, cis-gender heterosexual men living with HIV are significantly less likely to know their HIV status, initiate anti-retroviral therapy (ART) and achieve viral suppression. This is particularly true in South Africa, where men are also at increased risk of mortality resulting from AIDS-related illnesses. While there is growing knowledge of Treatment as Prevention or the concept Undetectable=Untransmittable (U=U) among PLHIV in Western and high-income countries, the reach and penetration of the U=U message in sub-Saharan Africa remains limited, and few studies have evaluated the impact of accessible and relatable U=U messages on ART initiation and adherence. To address these gaps, rigorous evaluations of interventions that incorporate U=U messages are needed, especially among men in high prevalence settings.
Building on our U=U messages that we previously developed for men using behavioral economics insights and a human-centered design, we will conduct two sequential hybrid type 1 effectiveness-implementation trials to evaluate the impact of U=U messages on men's uptake of community-based HIV testing and ART initiation (Trial 1), and retention in care and achievement of viral suppression (Trial 2). A cluster randomized trial will be implemented for Trial 1, with HIV testing service site-days randomized to U=U or standard-of-care (SoC) messages inviting men to test for HIV. An individual-level randomized control trial will be implemented for Trial 2, with men initiating ART at six government clinics randomized to receive U=U counselling or SoC treatment adherence messaging. We will incorporate a multi-method evaluation to inform future implementation of U=U messaging interventions. The study will be conducted in the Buffalo City Metro Health District of the Eastern Cape Province and in the Cape Town Metro Health District in the Western Cape Province in South Africa.
These trials are the first to rigorously evaluate the impact of U=U messaging on HIV testing uptake, ART initiation and achievement of viral suppression among African men. If effective, these messaging interventions can shape global HIV testing, treatment and adherence counselling guidelines and practices.
提高艾滋病毒感染者（PLHIV）的艾滋病毒检测和治疗覆盖率对于实现全球艾滋病流行控制至关重要。然而，与女性相比，感染艾滋病毒的顺性别异性恋男性知晓自己艾滋病毒感染状况、开始抗逆转录病毒治疗（ART）并实现病毒抑制的可能性要低得多。在南非尤其如此，该国男性因艾滋病相关疾病导致的死亡风险也在增加。虽然在西方和高收入国家，艾滋病毒感染者对治疗即预防或“检测不到即不具传染性”（U=U）概念的了解日益增多，但U=U信息在撒哈拉以南非洲的传播范围和渗透率仍然有限，很少有研究评估通俗易懂且相关的U=U信息对开始接受抗逆转录病毒治疗及治疗依从性的影响。为填补这些空白，需要对纳入U=U信息的干预措施进行严格评估，特别是在高流行率地区的男性中。
基于我们之前利用行为经济学见解和以人为本的设计为男性开发的U=U信息，我们将进行两项连续的1型混合有效性-实施试验，以评估U=U信息对男性接受基于社区的艾滋病毒检测和开始接受抗逆转录病毒治疗（试验1），以及持续接受治疗并实现病毒抑制（试验2）的影响。试验1将实施一项整群随机试验，将艾滋病毒检测服务站点日随机分配为U=U或标准护理（SoC）信息，邀请男性进行艾滋病毒检测。试验2将实施一项个体水平随机对照试验，在六家政府诊所开始接受抗逆转录病毒治疗的男性被随机分配接受U=U咨询或SoC治疗依从性信息。我们将纳入多方法评估，为U=U信息干预措施的未来实施提供参考。该研究将在南非东开普省的布法罗市都会卫生区和西开普省的开普敦都会卫生区进行。
这些试验是首次对U=U信息对非洲男性艾滋病毒检测接受情况、开始接受抗逆转录病毒治疗及实现病毒抑制的影响进行严格评估。如果有效，这些信息干预措施可以塑造全球艾滋病毒检测、治疗和依从性咨询指南及实践。
