Clinical trial NCT00675389: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
AIDS
Community Health Workers
Mobile Phones
Adherence
Antiretroviral Therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
name: MRC/UVRI and LSHTM Uganda Research Unit
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-05-09
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Virologic suppression at 6 months
timeFrame: 6 months
measure: Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007)
timeFrame: Typically every 24 weeks
measure: Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007)
timeFrame: Typically weekly to monthly
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Ronald Gray, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Larry W Chang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.