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
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
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
NCT ID
NCT00675389
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)
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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Impact of Peer Health Workers and Mobile Phones on HIV Care
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