Strategic antiretroviral therapy and HIV testing for youth in rural Africa

总结 尽管撒哈拉以南非洲成年艾滋病毒感染者在艾滋病毒治疗方面取得了令人鼓舞的成果， 感染艾滋病毒的青少年和年轻人（10-24岁） 年轻女性受到的影响尤为严重。AYAH的艾滋病毒检测率更低，与护理有关， 保持护理，并显着降低艾滋病毒抑制率。我们的目标是评估一个 一项针对AYAH（SATURN）的策略性ART联合干预的整群随机对照试验（RCT） 在乌干达和肯尼亚农村地区的28个诊所，SATURN是一个创新的生命阶段， 改善女性和男性ART吸收、坚持、保留和病毒抑制的方法 青年适应生命阶段的组合SATURN干预基于以下前提： 参与AYAH的方法受到缺乏动态灵活性和护理适应性的挑战， 认知，社会和生命阶段发展事件的重要轨迹，发生在 青春期和成年早期。我们的干预是基于行为理论， 科学、青年/提供者的投入、进程和成果的可行性以及该区域的试点数据。在 目标1，第一阶段（UG 3），我们将： 以社区为基础的参与性研究（CBPR），以接触未确诊或未参与的AYAH。 护理B）在8名AYAH中启动SATURN干预与标准护理相比的整群RCT 计划在乌干达和肯尼亚的农村地区建立28个诊所。在AIM 2 2期（UH 3）中，我们将：完成RCT 从28家诊所招募AYAH，并比较2.5岁时的保留率和病毒学抑制率。 2a）确定SATURN诊所与对照组的作用机制、障碍和促进因素， SATURN在社区、诊所组织、提供者和患者层面的实施， 方法定性和定量评价。2b）估算相关的增量成本和收益 通过成本效益分析。从UG 3到UH 3的过渡Military：a） 从前8个诊所招募至少400名青年到SATURN RCT; 2）在招募的人中，20%将是新的或 护理外诊断; 3）在干预1年时，通过病毒学抑制实现至少70%的保留率 社区.这项研究建立在各部委之间富有成效的长期合作基础上， 乌干达和肯尼亚的卫生、非洲和美国的研究组织以及PEPFAR执行伙伴 在乌干达和肯尼亚，当地社区参与并开展了大量针对青少年保健协会的形成工作， 以最终传播和可持续性为目标。

SUMMARY Despite encouraging gains in HIV treatment outcomes among adults with HIV in Sub-Saharan Africa, adolescents and young adults(10-24 years of age) living with HIV (AYAH) are being left behind with young women disproportionately affected. AYAH have worse rates of HIV testing, linkage to care, retention in care, and dramatically lower rates of HIV viral suppression. Our goal is to evaluate a strategic ART combination intervention for AYAH (SATURN) in a cluster randomized controlled trial (RCT) of 1,400 AYAH in 28 clinics in rural Uganda and Kenya. SATURN is an innovative life-stage adapted approach to improve ART uptake, adherence, retention and virologic suppression among female and male youth. The life-stage adapted, combination SATURN intervention is based on premise that current approaches to engaging AYAH are challenged by lack of dynamic flexibility and care adaptation to the significant trajectories of cognitive, social, and life-stage developmental events that occur in adolescence and early adulthood. Our intervention is based on behavioral theory, implementation science, youth/provider input, and process and outcome feasibility and pilot data from the region. In AIM 1, Phase-I (UG3), we will: a) Implement youth-led HIV testing and linkage programs using a community-based participatory research (CBPR) to reach AYAH who are undiagnosed or are not engaged in care b) Initiate the clustered RCT of SATURN intervention compared to standard of care among AYAH in 8 of the planned 28 clinics in rural Uganda and Kenya. In AIM 2, Phase-2 (UH3) we will: Complete RCT enrollment of AYAH from 28 clinics and compare the rate of retention and virologic suppression at 2 years in SATURN clinics vs control; and 2a) Identify the mechanisms of action, barriers and facilitators of the SATURN implementation at the community, clinic organization, provider, and patient levels using mixed methods qualitative and quantitative assessments. 2b) Estimate the incremental costs and gains associated with SATURN through cost effectiveness analysis. Transition Milestones to move from UG3 to UH3: a) Enroll at least 400 youth from the first 8 clinics to the SATURN RCT; 2) Of those enrolled, 20% will be new or out-of-care diagnoses; 3) Achieve at least 70% retention with virologic suppression at 1 year in intervention communities. This research builds upon highly productive long-standing collaborations between Ministries of Health in Uganda and Kenya, African and US research organizations, and PEPFAR implementing partners with local community participation and substantial AYAH targeted formative work in Uganda and Kenya and is directed at eventual dissemination and sustainability.