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），艾滋病毒是五大死亡原因之一，我们之前的研究 近70%的艾滋病毒感染者（PWH）有中度或严重的粮食不安全。尽管 粮食不安全对艾滋病毒治疗效果不佳的既定有害作用， 解决粮食不安全和艾滋病毒健康状况不佳循环的干预措施很少。为了弥补这一差距，我们 开发和试点ProMeSA（通过R34赠款），一个综合的城市花园和同伴营养 咨询干预，并认为这是可行的，可接受的，并在6个月和12个月的初步疗效， 改善粮食安全和抑制艾滋病毒。这项为期五年的研究的目的是进行全面的- ProMeSA的有把握度的群集随机对照试验（RCT），以评估在 更长的时间（18个月）以及干预措施吸收的调解人、障碍者和促进者， 执行和可持续性。具体目标是：（1）确定城市综合体的效能 花园和同伴营养咨询干预对HIV病毒抑制的主要结局 [不可检测的HIV病毒载量（VL）]和ART依从性和HIV护理保留护理的次要结局 （2）研究干预措施对发展中国家不同地区粮食不安全人口的影响; 中间结果被假定为介导ProMeSA对ART依从性、护理保留和病毒感染的影响。 抑制;（3）评估与干预措施的吸收和实施相关的过程相关因素 （促进因素、障碍、忠诚度和复制成本），为未来的规模扩大提供信息。该试验将包括20个艾滋病诊所 随机分为干预组或常规护理对照组（每个诊所n=25;共500名研究参与者）。VL和其他 将在基线、6个月、12个月和18个月时评估关键结局。在我们的干预后， 框架和试点结果，我们假设ProMeSA将改善食品安全和饮食质量， 减少耻辱感和相互竞争的需求，这反过来又会改善艾滋病毒临床结果。主要原因 所确定的途径将为定制ProMeSA提供信息，以加强未来传播和实施的影响。在 此外，我们将收集有关干预措施实施情况的大量定量和定性数据， 参与者在不同环境和参与者中的干预经验，为扩大规模提供信息。的 这项研究涉及到来自马萨诸塞州阿默斯特大学， 加州、旧金山弗朗西斯科、兰德公司和圣多明各自治大学以及多米尼加 农业部、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，这将是第一个全面的试验， 在粮食不安全的PWH中开展粮食生产活动，以支持国家和国际目标 以实现病毒抑制和减少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.