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临床试验/NCT01366690
NCT01366690已完成不适用

The PeerCARE Study (Peer Community-based Assistant in REtention): Effect of Peer Health Workers on People Living With HIV Not on Antiretroviral Therapy-A Randomized Trial

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Engagement in Care

研究概览

简要总结

The provision of HIV care and prevention services in resource-limited settings (RLS) entails substantial challenges due to a human resource crisis.[1] One strategy to address this human resource crisis is task shifting-the redistribution of tasks from higher trained providers to health workers with less training. Peer supporters, a group of community health workers who are people living with HIV (PLHIV), are an underutilized cadre to whom tasks can be shifted. Peers have been used extensively and effectively in HIV/AIDS programs in RLS, typically as peer educators who provide HIV prevention and education services.[2] Peers may be a potential source for not only providing care, but also impacting patient behaviors through peer counseling, education, and psychosocial support.

With the scale up of HIV counseling and testing in RLS, increasing numbers of PLHIV know their serostatus and could potentially be engaged in care and prevention services. While antiretroviral therapy (ART) is a critical component of care which has been a source of much attention, PLHIV who are not yet on ART can also benefit from being engaged in care and utilizing other evidence-based health interventions besides ART. Also, many HIV/AIDS care programs have difficulty both retaining PLHIV in care prior to ART and initiating ART in a timely fashion. Additionally, many PLHIV not yet on ART still engage in risky sexual behaviors and do not fully utilize a proven basic preventive care package (BCP) set of interventions (cotrimoxazole prophylaxis, bed nets, and safe water systems). Peers may be able to impact PLHIV not yet on ART by improving linkages to care, facilitating timely initiation of preventive interventions and ART, and decreasing risky sexual behaviors. However, well-designed and evaluated operations research is needed to assess peer support effects on these care and behavioral outcomes.

The objective of this study is to assess the impact of a peer support home visit intervention on patient engagement in care, utilization of a basic care package (BCP) of preventive care interventions, and risky sexual behaviors among people living with HIV (PLHIV) not on antiretroviral therapy (ART) through an individually randomized, operations research, community-based trial. We will compare outcomes between PLHIV who receive the peer-led intervention to those who do not. The primary outcomes will be engagement in care, BCP adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive the peer intervention will have improved engagement in care compared to PLHIV not receiving the intervention; (2) PLHIV who receive the peer intervention are more likely to adhere to a BCP of interventions to prevent illness compared to PLHIV not receiving the intervention; (3) PLHIV who receive the peer intervention will have less risky sexual behaviors compared to PLHIV not receiving the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Newly found to be HIV-infected through Rakai Health Sciences Program (RHSP) testing
  • Agreed to receive HIV results
  • Able to give consent for this study
  • Age 18 years or greater

排除标准

  • 未提供

结局指标

主要结局

Engagement in Care

时间窗: 1 Year

Basic Care Package Adherence

时间窗: 1 Year

Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)

Condom Use

时间窗: 1 Year

Consistent, inconsistent, or never condom use.

次要结局

  • ART Use(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Larry William Chang

Assistant Professor of Medicine

Johns Hopkins University

研究点 (1)

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