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

尼日利亚是艾滋病毒感染者人数第二多的国家，也是儿童艾滋病毒感染人数最多的国家。 然而，在全球范围内，它作为公共卫生工作的一个重点而被忽视。在艾滋病规划署方面取得的进展90-90 尼日利亚的90个进球一直很慢，所有进球都<35%。青年和男男性行为者（MSM）是 这是尼日利亚应对艾滋病毒流行的最薄弱环节。针对青年的干预措施（包括难以接触的青年） 男男性行为者）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 这些干预措施与单一干预措施相比具有附加效益。在这项研究中，我们建议 通过非常成功的美国-尼日利亚以艾滋病毒为中心的学术伙伴关系， 与尼日利亚伊巴丹、拉各斯和乔斯的伙伴机构合作。我们将测试两种组合 在艾滋病毒护理的整个过程中，对15至24岁的年轻人进行干预。在UG 3阶段， (Aim（1）制定以下方面的手动干预措施：（a）艾滋病毒检测和联系;（B）艾滋病毒护理结果， 伊巴丹15-24岁的年轻人使用一种组合方法，包括理论上有根据的同龄人， 导航和移动健康组件。一旦开发完成，我们将（目标2）测试每种组合干预措施， 使用前后设计在伊巴丹进行可行性、可接受性和初步疗效的试点试验。两 干预措施包括：2a）社交媒体参与+同行导航，以改善艾滋病毒检测和与 照顾年轻的MSM。如果有增加，这项干预措施的试点测试将被视为成功。 完成艾滋病毒检测的青年男子人数增加30%以上，艾滋病毒发病率增加20%， 与基线相比，48周期间OR=2.0。此外，我们将试点测试：2b）短消息 服务（SMS;通过调整循证干预，TXTXT）+同伴导航干预， 在40名年轻人中改善艾滋病毒护理结果（例如，继续护理、坚持抗逆转录病毒疗法和抑制病毒） PLWH。如果病毒感染比例增加≥ 30%，则认为该初步干预成功 在48周的时间段内，载量< 1000拷贝/mL，反映与基线相比的OR=1.5的效应量。我们 还将评估测量药物依从性的可行性（通过头发中的ART浓度）， 保留护理（通过医疗记录提取）。在UH 3阶段，我们将（目标3）展示可扩展性 在尼日利亚不同的艾滋病毒血清阳性率环境中，两种联合干预措施的效果：3a） 在伊巴丹、拉各斯和乔斯进行随机分级楔形试验（5个步骤，6个地点）;以及3b）测试ART 坚持和保留护理作为调解人和年龄，性别和传播方式作为潜在的 艾滋病护理干预效果的调节者。我们假设，使用相同的主要结果， 如UG 3中所述，在不同环境中和环境内，每种联合干预的效应量将≥ 在UG 3中观察到的效果。我们的目标是开发有效和可扩展的组合干预措施 这些战略将在尼日利亚青年，包括男男性行为者中加速实现艾滋病规划署的90/90/90目标。

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.