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临床试验/NCT01406626
NCT01406626已完成不适用

Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
356
试验地点
1
主要终点
Retention in Treatment

研究概览

简要总结

This study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.

详细描述

The proposed study has two Primary Specific Aims:

  1. To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
  2. Using a two-group experimental RCT design, to test the adapted peer navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;

The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.

Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.

Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 18 or older
  • Men or TGW diagnosed HIV-positive
  • English or bilingual Spanish speaking
  • Selected for the TCM program (control condition) prior to LINK LA enrollment
  • Residing in LA County upon release
  • Eligible for ART or incarcerated on ART.

排除标准

  • Inability to give informed consent
  • Parole hold or planned transfer to prison
  • Stay in jail <5 days.

研究组 & 干预措施

Peer Navigation Intervention Arm

Experimental

Subjects will receive the following peer navigation services:

  1. 10 Navigator meetings: Navigators will meet with participants in person to teach linkage/retention skills and knowledge

2a) 2 Navigator accompaniment sessions: the peer navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge and things that make it hard or easy for him/her to get regular HIV care

2b) Optional peer navigator accompaniment sessions: If the participant requests, the peer navigator will provide accompaniment to supportive HIV care appointments (one per month max)

  1. 14 peer navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care.

干预措施: Peer Navigator (Behavioral)

Usual Care

No Intervention

Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail

结局指标

主要结局

Retention in Treatment

时间窗: 12 months

This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.

Adherence to Treatment

时间窗: 12 months

How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.

Viral Load

时间窗: 12 months

HIV+ ex jail inmates' viral load

Linkage to HIV Care

时间窗: 12 months

Number of HIV+ ex jail inmates accessing HIV care

次要结局

  • Costs(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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