Impact of Peer Health Workers and Mobile Phones on HIV Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 主要终点
- Virologic suppression at 6 months
研究概览
简要总结
The provision of antiretroviral therapy (ART) in rural, resource-limited settings entails substantial challenges due to limitations in the health service infrastructure and in human resources for HIV/AIDS care. In addition, long geographical distances between providers, care facilities, and patients can represent a significant barrier to appropriate and timely care. The use of peer health workers as frontline adherence supporters and clinical monitors in order to improve care in underserviced settings has been implemented by a number of programs, but the effect of peer support on HIV care outcomes has not been extensively evaluated. Mobile phones have also been proposed as a potential method of improving access to health care in resource-limited environments by expediting communication and data transfer, but rigorous studies on their effectiveness in Africa have not yet been conducted.
The Rakai Health Science Project (RHSP) was founded in 1987 to study the HIV epidemic in the rural setting of Rakai District in southwest Uganda. Since June 2004, the US President's Plan for AIDS Relief (PEPFAR) has enabled the RHSP to provide ART through a community-based distribution system which includes clinical monitoring via a decentralized, mobile clinic approach. By late 2006, the program has screened 4,397 HIV-infected individuals and initiated ART in 849 patients. One of the challenges of providing ART in this setting has been the distance between many patients' homes and the clinic and medical staff trained in HIV care. This distance and the lack of communication channels make frequent clinic contacts difficult and has raised concerns about adherence and management of drug toxicity. This study will investigate whether peer health workers can help support this AIDS care program and improve patient outcomes.
This study is a three armed, community-randomized operations research trial to assess the effectiveness of peer health workers, with and without mobile phones, in improving the delivery of HIV care in the resource-limited Rakai setting. The three arms will be: a) communities with peer health workers, b) communities with peer health workers and mobile phones, and c) control communities without peer health workers.
Study hypotheses include:
- Peer health workers, by supporting adherence and by managing simple clinical issues, will reduce virologic treatment failure and improve ARV adherence compared to patients in communities without peer educators.
- Mobile phone technology used by peer health workers, by more rapidly addressing adherence and clinical problems, will reduce treatment failure and improve adherence compared to patients in communities with peer health workers without mobile phones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion in the study is determined by receipt of ARVs in the PEPFAR program.
排除标准
- 未提供
结局指标
主要结局
Virologic suppression at 6 months
时间窗: 6 months
Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007)
时间窗: Typically every 24 weeks
Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007)
时间窗: Typically weekly to monthly
次要结局
未报告次要终点
研究者
Larry William Chang
Assistant Professor of Medicine
Johns Hopkins University
