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Impact of Peer Health Workers and Mobile Phones on HIV Care

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer Health Workers Intervention
Peer Health Workers and Mobile Phone Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring HIV, AIDS, Community Health Workers, Mobile Phones, Adherence, Antiretroviral Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion in the study is determined by receipt of ARVs in the PEPFAR program.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    A

    B

    C

    Arm Description

    Peer Health Workers Intervention

    Peer Health Workers and Mobile Phone Intervention

    Control

    Outcomes

    Primary Outcome Measures

    Virologic suppression at 6 months
    Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007)
    Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 7, 2008
    Last Updated
    March 28, 2012
    Sponsor
    Johns Hopkins University
    Collaborators
    Doris Duke Charitable Foundation, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00675389
    Brief Title
    Impact of Peer Health Workers and Mobile Phones on HIV Care
    Official Title
    Impact of Peer Health Workers and Mobile Phones on HIV Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Doris Duke Charitable Foundation, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV, AIDS, Community Health Workers, Mobile Phones, Adherence, Antiretroviral Therapy

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Peer Health Workers Intervention
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Peer Health Workers and Mobile Phone Intervention
    Arm Title
    C
    Arm Type
    No Intervention
    Arm Description
    Control
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Health Workers Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Health Workers and Mobile Phone Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Virologic suppression at 6 months
    Time Frame
    6 months
    Title
    Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007)
    Time Frame
    Typically every 24 weeks
    Title
    Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007)
    Time Frame
    Typically weekly to monthly

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion in the study is determined by receipt of ARVs in the PEPFAR program. Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Gray, MBBS
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Larry W Chang, MD, MPH
    Organizational Affiliation
    Johns Hopkins School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20532194
    Citation
    Chang LW, Kagaayi J, Nakigozi G, Ssempijja V, Packer AH, Serwadda D, Quinn TC, Gray RH, Bollinger RC, Reynolds SJ. Effect of peer health workers on AIDS care in Rakai, Uganda: a cluster-randomized trial. PLoS One. 2010 Jun 2;5(6):e10923. doi: 10.1371/journal.pone.0010923.
    Results Reference
    derived

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