Impact of Peer Health Workers and Mobile Phones on HIV Care

This study has been completed.

Sponsor:

Collaborators:

Doris Duke Charitable Foundation

MRC/UVRI Uganda Research Unit on Aids

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Larry William Chang, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00675389

First received: May 7, 2008

Last updated: March 28, 2012

Last verified: March 2012

History of Changes

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:

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.

Condition	Intervention
HIV Infections	Behavioral: Peer Health Workers Intervention Behavioral: Peer Health Workers and Mobile Phone Intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Impact of Peer Health Workers and Mobile Phones on HIV Care

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Virologic suppression at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) [ Time Frame: Typically weekly to monthly ] [ Designated as safety issue: No ]


Enrollment:	1200
Study Start Date:	March 2006
Study Completion Date:	January 2012
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Peer Health Workers Intervention	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.
Experimental: B Peer Health Workers and Mobile Phone Intervention	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.
No Intervention: C Control

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675389

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)

Investigators


Principal Investigator:	Ronald Gray, MBBS	Johns Hopkins Bloomberg School of Public Health
Principal Investigator:	Larry W Chang, MD, MPH	Johns Hopkins School of Medicine

More Information

No publications provided


Responsible Party:	Larry William Chang, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00675389 History of Changes
Other Study ID Numbers:	IRB00000748
Study First Received:	May 7, 2008
Last Updated:	March 28, 2012
Health Authority:	United States: Institutional Review Board Uganda: Uganda National Council for Science and Technology

Keywords provided by Johns Hopkins University:


HIV AIDS Community Health Workers	Mobile Phones Adherence Antiretroviral Therapy

ClinicalTrials.gov processed this record on February 27, 2015

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