Randomized Control Trial and Cohort Study of HIV Testing and Linkage to Care, Maryland and Rhode Island, 2011

This study is part of the Seek, Test, Treat and Retain (STTR) Collaboration Project that involved over twenty studies in the fields of HIV and drug abuse. All studies were independently developed, but were chosen for the collaboration because they focused on one or more steps of the HIV treatment cascade: Seek, Test, Treat and Retain. As part of STTR Collaboration Project, the studies were grouped into Criminal Justice-related studies and Vulnerable Population-related studies. The data collected by these studies included twelve common domains (e.g., Demographic characteristics, Mental Health) in each of which a shared questionnaire or instrument was taken up by the studies and adapted to fit the study.
This study has two components.
Study #1:
The main objectives of Study 1 were to determine the willingness to the community corrections community to undergo testing, and to test rapid HIV testing on-site in community corrections to referral to an off-site HIV testing location. Participants were probationers or parolees in both Providence, Rhode Island and Baltimore City, Maryland (participants split 50/50 between sites). The outcomes were undergoing HIV testing and receiving the test results.
Study #2:
Randomized controlled trial of linkage to HIV care among probationers or parolees known to have HIV who were randomized to referral to treatment as usual (TAU) or Project Bridge which provided intensive case management, medical and social support. (Note: participants could "cross over" into Project Bridge at 6 months if they failed to engage with care in the TAU group.) The outcomes included retention in care, use of ART, and viral load. Assessments were done at baseline for both studies, and every 3 months thereafter until 18 months for study 2. If incarcerated, assessments were done in prison/jail.

本研究隶属于探寻、检测、治疗与留存（Seek, Test, Treat and Retain，简称STTR）合作项目，该项目涵盖人类免疫缺陷病毒（Human Immunodeficiency Virus，简称HIV）与药物滥用领域的20余项独立研究。所有研究均独立开展，因聚焦HIV治疗流程链的一个或多个环节（探寻、检测、治疗与留存）而入选该合作项目。作为STTR合作项目的组成部分，所有研究被划分为刑事司法相关研究与脆弱人群相关研究两类。各研究收集的数据包含12个通用研究领域（如人口统计学特征（Demographic characteristics）、心理健康状况（Mental Health）），每个领域均采用统一的问卷或评估工具，并针对各研究场景进行适配调整。

本研究包含两个子研究。

子研究1：
本研究1的核心目标为探究社区矫正对象接受HIV检测的意愿，并评估在社区矫正场所内开展快速HIV检测以转诊至校外HIV检测点的可行性。研究对象为罗德岛州普罗维登斯市与马里兰州巴尔的摩市的缓刑人员及假释人员，两地参与者占比各为50%。研究结局指标为接受HIV检测及获取检测结果。

子研究2：
针对确诊HIV感染的缓刑及假释人员开展诊疗衔接服务的随机对照试验。将参与者随机分配至常规诊疗（treatment as usual，简称TAU）组与桥接计划（Project Bridge）组，后者提供强化个案管理、医疗与社会支持。（注：若常规诊疗组参与者未参与诊疗服务，可在6个月时交叉入组桥接计划组）。研究结局指标包括诊疗随访留存率、抗反转录病毒治疗（Antiretroviral Therapy，简称ART）使用情况及病毒载量。两项研究均在基线阶段开展评估，子研究2在此之后每3个月进行一次评估，直至18个月随访期结束；若参与者处于监禁状态，则在监狱/看守所内完成评估。