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| Sponsors and Collaborators: |
Johns Hopkins University Doris Duke Charitable Foundation MRC/UVRI Uganda Research Unit on Aids National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00675389 |
Purpose
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:
| Condition | Intervention |
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HIV Infections |
Behavioral: Peer Health Workers Intervention Behavioral: Peer Health Workers and Mobile Phone Intervention |
| MedlinePlus related topics: | AIDS |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Factorial Assignment, Efficacy Study |
| Official Title: | Impact of Peer Health Workers and Mobile Phones on HIV Care |
| Enrollment: | 1200 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Experimental
Peer Health Workers Intervention
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Behavioral: Peer Health Workers Intervention
Peer health workers are themselves PLWHA on ART who have demonstrated good ART adherence for at least 6 months. The peers are responsible for ~15-20 patients and are expected to visit the patients in their homes once every two weeks. At these visits, peers record a review of symptoms, client self-report of adherence, and a pill count. At the clinic, peers assist with patient organization and share their experiences, particularly with patients about to start ART. Peer health workers undergo an initial, intensive two day residential training course and are provided with a bike and basic supplies, and a modest amount of remuneration to encourage compliance with their responsibilities and promote a high program retention rate.
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B: Experimental
Peer Health Workers and Mobile Phone Intervention
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Behavioral: Peer Health Workers and Mobile Phone Intervention
In addition to the peer health worker intervention, this arm adds a mobile phone intervention consisting of the following: during home visits, peers with mobile phones, using data collected on their home visit forms, send real-time text messages containing this clinical and adherence data back to the central clinic to be reviewed by clinical staff within a 24 hour period. Peers may also call, toll-free, back to a central clinic Warmline with any questions or concerns.
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C: No Intervention
Control
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Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Johns Hopkins University |
| Doris Duke Charitable Foundation |
| MRC/UVRI Uganda Research Unit on Aids |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Principal Investigator: | Ronald Gray, MBBS | Johns Hopkins Bloomberg School of Public Health |
More Information
| Responsible Party: | Bloomberg School of Public Health ( Ronald Gray ) |
| Study ID Numbers: | IRB00000748 |
| First Received: | May 7, 2008 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00675389 |
| Health Authority: | United States: Institutional Review Board; Uganda: Uganda National Council for Science and Technology |
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