Back to resultsEvaluation of a Computer-Based System Using Cell Phones for HIV People in Peru (Cell-POS)
Primary Purpose
HIV, Adherence, Sexual Behavior
Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Cell phone intervention
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring 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
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.
Sites / Locations
- Universidad Peruana Cayetano Heredia
- Via Libre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cell phone intervention
Standard of care
Arm Description
Participant receives short text messages
Participant receives standard of care support but not short text messages
Outcomes
Primary Outcome Measures
Self-reported medication adherence
HIV-1 viral load
Secondary Outcome Measures
CD4
Self-reported HIV transmission risk behaviors
Full Information
NCT ID
NCT01118767
First Posted
May 6, 2010
Last Updated
November 12, 2021
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT01118767
Brief Title
Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
Acronym
Cell-POS
Official Title
Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
December 1, 2011 (Actual)
Study Completion Date
December 10, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cell phone intervention
Arm Type
Experimental
Arm Description
Participant receives short text messages
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participant receives standard of care support but not short text messages
Intervention Type
Other
Intervention Name(s)
Cell phone intervention
Intervention Description
Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages
Primary Outcome Measure Information:
Title
Self-reported medication adherence
Time Frame
12 months
Title
HIV-1 viral load
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CD4
Time Frame
12 months
Title
Self-reported HIV transmission risk behaviors
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter H Curioso, MD, MPH
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru
Facility Name
Via Libre
City
Lima
Country
Peru
12. IPD Sharing Statement
Links:
URL
http://projectreporter.nih.gov/project_info_description.cfm?aid=7495168
Description
RePORT Project Information: Evaluation of a Computer-Based System using Cell Phones for HIV people in Peru
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Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
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