Intensive Combination Approach to Rollback the Epidemic (iCARE) in Nigerian Adolescents

尼日利亚的艾滋病毒携带者人数(PLWH)位居第二，是儿童艾滋病毒感染者最多的国家 然而，在全球范围内，作为公共卫生努力的重点，它一直被忽视。联合国艾滋病规划署90-90年度进展情况-- 尼日利亚的90个进球进展缓慢，所有进球都只有35%。青年和男男性行为者(MSM)是 尼日利亚应对艾滋病毒疫情的最薄弱环节。针对青年的干预措施(包括难以接触的干预措施 男男性接触者)和改善整个艾滋病毒护理连续体的艾滋病毒护理结果应包括结合 干预措施，因为与单一干预措施相比，这些措施具有附加效益。在这项研究中，我们建议 在美国-尼日利亚以艾滋病毒为中心的学术伙伴关系非常成功的基础上建立基础设施 与尼日利亚伊巴丹、拉各斯和乔斯的伙伴机构合作。我们将测试两个组合 在整个艾滋病毒护理连续体中对15至24岁的年轻人进行干预。在UG3阶段，我们将 (目标1)制定手工干预措施，以：(A)艾滋病毒检测和联系；(B)在 伊巴丹15-24岁的年轻人，采用包括理论上站稳脚跟的同伴在内的组合方法 导航和mHealth组件。一旦开发完成，我们将(目标2)测试每个组合干预措施 在伊巴丹进行试点试验，采用事前设计，评估其可行性、可接受性和初步疗效。两个人 干预措施包括：2)社交媒体参与+同行导航，以改进艾滋病毒检测和联系 年轻男男性接触者的关怀。如果增加了干预措施的试点测试，将被认为是成功的 ≥的青年男子完成艾滋病毒检测的人数增加了30%，艾滋病毒发病率增加了 与基线相比，在48周内OR=2.0。此外，我们将试行测试：2B)一条短信 服务(短信；通过循证干预的改编，TXTXT)+同行导航干预 改善40名年轻人的艾滋病毒护理结果(例如，护理保留、抗逆转录病毒药物治疗和病毒抑制) PLWH。如果≥与病毒的比例增加30%，这种试点干预将被认为是成功的 48周期间的载药量为1000份/毫升，与基线相比，其效果大小为OR=1.5。我们 还将评估衡量药物依从性的可行性(通过头发中的ART浓度)和 保留护理(通过提取病历)。在UH3阶段，我们将(目标3)展示可伸缩性 和尼日利亚不同艾滋病毒血清阳性环境中两种联合干预措施的有效性：3A) 在伊巴丹、拉各斯和乔斯进行随机阶梯楔形试验(5个步骤，6个地点)；以及3)测试ART 坚持和保留护理作为中介，年龄、性别和传播方式作为潜在的传播方式 艾滋病护理干预效果的主持人。我们假设，使用相同的主要结果 与UG3中的措施一样，跨设置和在设置内的每个组合干预的效果大小将为≥ 在UG3中观察到的影响。我们的目标是开发有效和可扩展的联合干预 将在包括男男性接触者在内的尼日利亚青年中加速实现联合国艾滋病规划署90/90/90目标的战略。

Nigeria has the 2nd highest number of people living with HIV (PLWH) and the most pediatric HIV infections globally, however, it has been neglected as a focus of public health efforts. Progress towards UNAIDS 90-90- 90 goals in Nigeria has been slow with all goals < 35%. Youth and men who have sex with men (MSM), are the weakest link in Nigeria's response to the HIV epidemic. Interventions reaching youth (including hard-to-reach MSM) and improving HIV care outcomes across the HIV care continuum should involve combination interventions as these have additive benefits compared to single interventions. In this study, we propose to build on infrastructure developed through a very successful U.S-Nigeria HIV-centered academic partnership in collaboration with partner institutions in Ibadan, Lagos and Jos, Nigeria. We will test two combination interventions among youths aged 15 to 24 years across the HIV care continuum. In the UG3 phase, we will (Aim 1) develop manualized interventions for: (a) HIV testing and linkage; and (b) HIV care outcomes among youth age 15-24 years in Ibadan using a combination approach that includes theoretically-grounded peer navigation and mHealth components. Once developed we will (Aim 2) test each combination intervention in pilot trials in Ibadan for feasibility, acceptability and initial efficacy using a pre-post design. The two interventions include: 2a) social media engagement + peer navigation to improve HIV testing and linkage to care among young MSM. The pilot test for this intervention will be considered successful if there is an increase of ≥ 30% in the number of young men completing HIV tests and an increase in the HIV incidence rate by OR=2.0 over a 48-week period compared to baseline. In addition, we will pilot test: 2b) a short message service (SMS; via adaptation of an evidence-based intervention, TXTXT) + peer navigation intervention to improve HIV care outcomes (e.g. care retention, ART adherence and viral suppression) among 40 young PLWH. This pilot intervention will be considered successful if there is ≥ 30% increase in proportion with viral load < 1000 copies/mL over a 48-week period, reflecting an effect size of OR=1.5 compared to baseline. We will also assess feasibility for measurement of medication adherence (via ART concentration in hair) and retention in care (via medical records abstraction). In the UH3 phase we will (Aim 3) demonstrate the scalability and efficacy of the two combination interventions in different HIV seroprevalence settings in Nigeria by: 3a) conducting a randomized stepped wedge trial (5 steps, 6 sites) in Ibadan, Lagos and Jos; and 3b) testing ART adherence and retention in care as mediators AND age, gender, and mode of transmission as potential moderators of the HIV care intervention effect. We hypothesize that, using the same primary outcome measures as in the UG3, the effect size of each combination intervention across and within settings, will be ≥ the effects observed in the UG3. Our goal is to develop efficacious and scalable combination intervention strategies that will accelerate UNAIDS 90/90/90 goals among Nigerian youths, including MSM.