FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti

翻译后摘要：性活跃的艾滋病毒感染的少女是一个非常脆弱和服务不足 人口如果及时接受抗逆转录病毒疗法（ART）治疗并继续接受护理， 正常的预期寿命此外，抗逆转录病毒疗法将减少艾滋病毒在以下人群中的垂直传播和性传播： 性活跃，怀孕率高，有多个血清反应阴性的伴侣。在海地和其他 在资源贫乏的国家，感染艾滋病毒的青少年失去护理的可能性是成年人的三倍， 只有大约50%的艾滋病毒感染青少年在一年内仍在接受护理。 我们开发了FANMI（我的家人），这是一种创新模式，旨在改善青春期女孩的艾滋病毒护理。HIV- 16-19岁的受感染女孩每月以5-8人为一组接受艾滋病毒护理。所有艾滋病毒护理都是在一个 社区中心，而不是诊所。每月一次的就诊整合了临床护理、同伴群体 咨询和社会活动在一个单一的会议由同一提供者，以简化护理和加强 同行和供应商之间的关系。我们初步研究的初步数据显示， 继续上学的情况有所改善，91%的女孩在一年内继续接受照料。 主要目的：在海地Au Prince的GHESKIO中心进行随机对照试验。我们 将160名16-19岁的HIV感染女孩（每组80名）随机分配至FANMI， 主要研究终点为12个月时存活并接受护理。我们将有>80%的能力检测到 12个月时的保留率从标准组的60%提高到FANMI的85%。 次要目的：比较FANMI与标准治疗的以下结局： a. 12个月时血浆HIV-1 RNA < 1000拷贝/微升。我们预测，30%的参与者在标准 与FAMNI组的60%相比，FAMNI组在12个月时将具有抑制的病毒载量， 保留，增加访问出席率，并改善ART依从性。 B.性风险行为：自我报告的性活动、安全套使用、性传播感染的发生率， 怀孕率超过12个月。 C.可接受性：我们将进行深入访谈，以评估FANMI和与保留相关的因素。 D. FANMI与标准治疗的卫生保健利用和成本。 FANMI有可能大大改善艾滋病毒感染青少年的治疗结果， 艾滋病毒/艾滋病护理级联，并成为海地和其他资源贫乏国家青少年艾滋病毒护理的典范。

Abstract: Sexually active HIV-infected adolescent girls are an extremely vulnerable and underserved population. If treated promptly with antiretroviral therapy (ART) and retained in care, individuals have a near normal life expectancy. Further, ART will decrease vertical and sexual HIV transmission in a population who are sexually active, have high rates of pregnancy and multiple seronegative partners. However, in Haiti and other resource poor countries, HIV-infected adolescents are three times more likely to be lost from care than adults, with only approximately 50% of HIV-infected teens remaining in care at one year. We have developed FANMI (My Family), an innovative model to improve HIV care for adolescent girls. HIV- infected girls age 16-19 years attend monthly HIV care in cohorts of 5-8 peers. All HIV care takes place in a community center rather than in a medical clinic. Each monthly visit integrates clinical care, peer group counseling, and social activities in a single session by the same provider to simplify care and strengthen the relationships between peers and providers. Preliminary data from our pilot study suggest dramatic improvements in retention with 91% of girls remaining in care at one year. Primary Aim: To conduct a randomized controlled trial at the GHESKIO Center in Port au Prince, Haiti. We will randomize 160 HIV-infected girls age 16-19 years (80 per arm) to FANMI versus standard of care with the primary study endpoint being alive and in care at 12 months. We will have >80% power to detect an improvement in retention at 12 months from 60% in the standard group to 85% in FANMI. Secondary Aims: To compare FANMI versus standard care on the following outcomes: a. Plasma HIV-1 RNA < 1000 copies/µl at 12 months. We predict that 30% of participants in the standard arm will have a suppressed viral load at 12 months compared to 60% in the FAMNI arm due to improved retention, increased visit attendance, and improved ART adherence. b. Sexual risk behavior: self-reported sexual activity, condom use, incidence of sexually-transmitted infections, and pregnancy rate over 12 months. c. Acceptability: We will conduct in-depth interviews to evaluate FANMI and factors associated with retention. d. Health care utilization and costs of FANMI versus standard care. FANMI has the potential to dramatically improve HIV-infected adolescent treatment outcomes across the HIV care cascade and serve as a model of adolescent HIV care in Haiti and other resource-poor countries.