Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru

Conditions
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HIV, Adherence, Sexual Behavior, HIV Infections

Intervention / Treatment
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* Other: Cell phone intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell phone intervention<br>Participant receives short text messages | Other: Cell phone intervention<br>* Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages<br>|
| No Intervention: Standard of care<br>Participant receives standard of care support but not short text messages | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported medication adherence |  | 12 months | 
| HIV-1 viral load |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 |  | 12 months | 
| Self-reported HIV transmission risk behaviors |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WWW, Viral Load result, Vulnerable Populations, anti-retroviral therapy, consumer informatics, follow-up, medication adherence, medication compliance, randomization, randomized controlled study, randomized trial, 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, evidence base, randomly assigned, safer sex, treatment adherence, user centered design, web, world wide web