Promesa: Urban gardening and peer nutritional counseling to improve HIV care outcomes among people with food insecurity in the Dominican Republic

项目摘要 艾滋病毒和粮食不安全在拉丁美洲和加勒比构成严重和相互关联的问题，包括 在多米尼加共和国(DR)，艾滋病毒被列为前五大死亡原因之一，我们之前的研究 研究发现，近70%的艾滋病毒携带者(PWH)存在中度或严重的粮食不安全。尽管 粮食不安全对不良艾滋病毒治疗结果的有害作用，证据表明可持续 解决粮食不安全和艾滋病毒健康状况不佳的循环的干预措施很少。为了解决这一差距，我们 开发和试点普罗梅萨(通过34卢比的赠款)，一个综合的城市花园和同行营养 咨询干预，并发现它是可行的，可接受的，并在6个月和12个月的初步效果 改善粮食安全和艾滋病毒病毒学抑制。这项为期五年的研究旨在进行一项全面的- 普罗美沙的动力性整群随机对照试验(RCT)评估干预效果 较长时期(18个月)以及干预吸收的调解者、障碍和促进者， 实施和可持续性。具体目标是：(1)确定综合城市的效能 园艺和同伴营养咨询干预对HIV病毒抑制的初步疗效 [无法检测到的艾滋病毒病毒载量(VL)]和坚持抗逆转录病毒疗法和艾滋病毒护理保留护理的次要结果 在DR不同地区的粮食不安全人群中；(2)检查干预效果 中介普罗美沙对ART依从性、护理保留和病毒感染的影响的中间结果 抑制；(3)评估与接受和实施干预措施有关的过程相关因素 (促进者、障碍、保真度和复制成本)，为未来的扩展提供信息。这项试验将包括20家艾滋病毒诊所 随机分为干预组或常规护理对照组(每个诊所25人，共500名研究参与者)。VL和其他 关键结果将在基线以及6个月、12个月和18个月时进行评估。根据我们的干预原因 框架和试点结果，我们假设普罗美沙将改善食品安全和饮食质量，并 减少耻辱和相互竞争的需求，这反过来将改善艾滋病毒的临床结果。主要的因果关系 已确定的路径将为量身定做ProMesa提供信息，以加强在未来传播和实施中的影响。在……里面 此外，我们将收集有关干预实施和 参与者在不同的环境中体验干预，并为扩大规模提供信息。这个 这项研究涉及来自马萨诸塞大学阿默斯特分校、加州大学 加州、旧金山、兰德、圣多明各大学以及多米尼加 农业和公共卫生部、多米尼加全国艾滋病毒/艾滋病理事会和联合国 世界粮食计划署。据我们所知，这将是第一次整合营养咨询的全面试验 与粮食不安全的威尔斯亲王医院开展粮食生产活动，以支持国家和国际目标 以实现病毒抑制和减轻艾滋病毒的疾病和经济负担。

Project Summary HIV and food insecurity pose severe and interrelated problems in Latin America and the Caribbean, including in the Dominican Republic (DR), where HIV ranks as one of the top 5 causes of death and our prior studies have found that nearly 70% of people with HIV (PWH) have moderate or severe food insecurity. Despite the established, detrimental role of food insecurity on poor HIV treatment outcomes, evidence on sustainable interventions that address the cycle of food insecurity and poor HIV health is scarce. To address this gap, we developed and piloted ProMeSA (through an R34 grant), an integrated urban gardens and peer nutritional counseling intervention, and found it feasible, acceptable, and with preliminary efficacy at 6 and 12 months of improving food security and HIV virologic suppression. The purpose of this five-year study is to conduct a fully- powered cluster randomized controlled trial (RCT) of ProMeSA to assess intervention efficacy evaluated over a longer period (18 months) as well as mediators and barriers and facilitators to intervention uptake, implementation, and sustainability. The specific aims are: (1) Determine the efficacy of an integrated urban gardens and peer nutritional counseling intervention on the primary outcome of HIV viral suppression [undetectable HIV viral load (VL)] and secondary outcomes of ART adherence and HIV care retention care among people with food insecurity across diverse regions in the DR; (2) Examine the intervention effects on intermediate outcomes posited to mediate the impact of ProMeSA on ART adherence, care retention, and viral suppression; (3) Evaluate process-related factors associated with intervention uptake and implementation (facilitators, barriers, fidelity, and replication costs) to inform future scale-up. The trial will include 20 HIV clinics randomized to intervention or usual care control (n=25 per clinic; 500 total study participants). VL and other key outcomes will be assessed at baseline, and 6-, 12- and 18-months. Following our intervention causal framework and pilot findings, we hypothesize that ProMeSA will improve food security and diet quality and reduce stigma and competing needs, which in turn will improve HIV clinical outcomes. The predominant causal paths identified will inform tailoring ProMeSA to enhance impact in future dissemination and implementation. In addition, we will collect extensive quantitative and qualitative data on intervention implementation and participant experiences with the intervention across diverse settings and participants to inform scale-up. The study involves a partnership among researchers from the University of Massachusetts Amherst, University of California, San Francisco, RAND, and the Universidad Autonóma de Santo Domingo as well as the Dominican Ministries of Agriculture and Public Health, the Dominican National HIV/AIDS Council, and the United Nations World Food Program. To our knowledge, this will be the first full-scale trial to integrate nutritional counseling with food-generating activities among PWH with food insecurity, in support of national and international goals to achieve viral suppression and reduce the disease- and economic burden of HIV.