Clinical trial NCT01118767: Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
Official title: Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Adherence
Sexual Behavior
HIV Infections
Keywords: Adherence
Appointment
Cell Phone
Cellular Phone
Clinic
Computers
Controlled Clinical Trials, Randomized
HIV/AIDS
Health Informatics
Health behavior
Information Technology
Internet
Intervention
Medication
Patient Satisfaction
Patient Self-Report
Patients
Peru
Phone
Public Health
Public Health Informatics
Randomized
Randomized Controlled Clinical Trials
Randomized Controlled Trials
Research
Secondary Prevention
Self-Report
Sex Behavior
Sexual Behavior
Sexually Transmitted Diseases
Sexually Transmitted Infection
Survey Instrument
Surveys
Telephone
Telephone, Cellular
Text
Unprotected Sex
Viral Load result
Vulnerable Populations
WWW
anti-retroviral therapy
consumer informatics
evidence base
follow-up
medication adherence
medication compliance
randomization
randomized controlled study
randomized trial
randomly assigned
safer sex
treatment adherence
user centered design
web
world wide web
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2010-05-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru.

Detailed description: Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet been addressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors.

Eligibility criteria: Inclusion Criteria:

* HIV-positive healthy male or female aged greater than or equal to 18
* Currently on ART
* Patients with a mobile phone for their personal use (not shared)
* Patients who know how to retrieve read text messages on their mobile phone
* Signed and dated written informed consent prior to admission to the study

Exclusion Criteria:

* Patients whose clinical condition might have interfered with the study (e.g., deafness, serious mental illness, mental retardation)
* Patients unable to give their informed consent.

Primary outcomes:
measure: Self-reported medication adherence
timeFrame: 12 months
measure: HIV-1 viral load
timeFrame: 12 months
Secondary outcomes:
measure: CD4
timeFrame: 12 months
measure: Self-reported HIV transmission risk behaviors
timeFrame: 12 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
city: Lima
country: Peru
facility: Via Libre
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Walter H Curioso, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: