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Impact of Peer Health Workers and Mobile Phones on HIV Care

Not Applicable
Completed
Conditions
HIV Infections
Interventions
Behavioral: Peer Health Workers Intervention
Behavioral: Peer Health Workers and Mobile Phone Intervention
Registration Number
NCT00675389
Lead Sponsor
Johns Hopkins University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1200
Inclusion Criteria
  • Inclusion in the study is determined by receipt of ARVs in the PEPFAR program.
Exclusion Criteria
  • None

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
APeer Health Workers InterventionPeer Health Workers Intervention
BPeer Health Workers and Mobile Phone InterventionPeer Health Workers and Mobile Phone Intervention
Primary Outcome Measures
NameTimeMethod
Virologic suppression at 6 months6 months
Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007)Typically every 24 weeks
Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007)Typically weekly to monthly
Secondary Outcome Measures
NameTimeMethod
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